<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03300050</url>
  </required_header>
  <id_info>
    <org_study_id>CVIA 057 (1082166-1)</org_study_id>
    <nct_id>NCT03300050</nct_id>
  </id_info>
  <brief_title>Safety and Immunogenicity of a Live-attenuated Universal Flu Vaccine Followed by an Inactivated Universal Flu Vaccine</brief_title>
  <official_title>A Phase 1, Randomized, Controlled, Observer-blind Study to Assess the Reactogenicity, Safety, and Immunogenicity of a Live Attenuated Universal Influenza Vaccine (cH8/1N1 LAIV) Administered as a Single Priming Dose Followed Three Months Later by a Single Booster Dose of an Inactivated Universal Influenza Vaccine (cH5/1N1 IIV) (Adjuvanted With AS03A or Unadjuvanted) in 18 Through 39 Year-old Healthy Subjects, Contrasted With a Two Dose Schedule of an Inactivated Universal Influenza Vaccine (cH8/1N1 IIV + AS03A Followed Three Months Later by cH5/1N1 IIV + AS03A)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PATH</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Emmes Company, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>PATH</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The clinical study will evaluate safety and the immune response of a prime- boost regimen&#xD;
      with a live attenuated influenza vaccine (LAIV) prime and an inactivated split influenza&#xD;
      vaccine (IIV) boost with or without adjuvant.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, multi-center, randomized, controlled, observer-blind, Phase 1 trial in&#xD;
      healthy male and female adults 18 through 39 years of age to evaluate safety and the immune&#xD;
      response of a prime boost regimen with LAIV prime and IIV boost with or without adjuvant.&#xD;
      Participants will be randomized 4:3:1:3:2 to one of five groups to receive a first dose of&#xD;
      study cH8/1N1 LAIV (or placebo) or study cH8/1N1 IIV + AS03A adjuvant (or placebo) followed&#xD;
      three months later by study cH5/1N1 IIV +/- AS03A adjuvant (or placebo).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 10, 2017</start_date>
  <completion_date type="Actual">August 9, 2019</completion_date>
  <primary_completion_date type="Actual">April 24, 2018</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Eligible enrolled subjects will be randomized to any of the treatment arms (LAIV-IIV, Groups 1, 2, and 3; or IIV-IIV, Groups 4 and 5) under one allocation sequence, stratified by site, to allow comparability between study groups, such as LAIV-IIV vs IIV-IIV regimens (Groups 1 vs 4). Groups 1-3 will be inpatient and receive either LAIV or placebo as nasal drops at Dose 1. Groups 4-5 ill be outpatient and receive either IIV or placebo as an injection at Dose 1.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>An unblinded pharmacist will prepare Dose 1 and Dose 2. Participants and study staff will remain blinded to their exact treatment group but will be unblinded to their overall group allocation (inpatient or outpatient).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Solicited Local Reactions Within 7 Days Following Each Vaccination</measure>
    <time_frame>7 days after each vaccination (Days 1-8 and Days 85-92)</time_frame>
    <description>Solicited adverse events were assessed by study staff for 60 minutes after each vaccination and and then by study participants daily for 7 days on a a diary card.&#xD;
Solicited local reactions included:&#xD;
Post LAIV dose: nasal congestion, rhinorrhea;&#xD;
Post IIV dose: pain, redness, swelling.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Solicited General Reactions Within 7 Days Following Each Vaccination</measure>
    <time_frame>7 days after each vaccination (Days 1-8 and Days 85-92)</time_frame>
    <description>Solicited adverse events were assessed by study staff for 60 minutes after each vaccination and and then by study participants daily for 7 days on a a diary card.&#xD;
Solicited general reactions included:&#xD;
abdominal pain&#xD;
arthralgia&#xD;
cough&#xD;
diarrhea&#xD;
fatigue&#xD;
fever&#xD;
headache&#xD;
myalgia&#xD;
nausea&#xD;
shivering&#xD;
sore throat&#xD;
vomiting&#xD;
wheezing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Unsolicited Adverse Events Within 28 Days Following Any Vaccination</measure>
    <time_frame>28 days after each vaccination (Days 1 to 28 and Days 85 to 113)</time_frame>
    <description>Unsolicited adverse events (AEs) are any AEs reported spontaneously by the participant, observed by the study personnel during study visits or those identified during review of medical records or source documents, such as diary cards. Participants were asked to record any unsolicited symptoms or other illness description in their diary card during the 28 days after each vaccination.&#xD;
All AEs, including clinical laboratory test results, were assessed by a study clinician and the study subject (as applicable) to quantify severity using a protocol-defined grading system as mild (mild symptoms, easily tolerated, not interfering with daily activities), moderate (causing some interference with daily activity), or severe (severe symptoms that prevent normal every day activities).&#xD;
The investigator assessed the relationship between study vaccines and the occurrence of each AE using clinical judgment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Grade 2 or Higher Hematological and Biochemical Laboratory Abnormalities From Day 8 to Day 113</measure>
    <time_frame>Days 8, 29, 85, 92, and 113</time_frame>
    <description>Hematological and biochemical parameters assessed included hemoglobin, platelets, red blood cells, white blood cells (WBC), absolute neutrophil count (ANC), lymphocytes, monocytes, eosinophils, basophils, alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, blood urea nitrogen (BUN) and BUN-to-creatinine ratio.&#xD;
Grading of laboratory parameters was based on the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (severe), or Grade 4 (Potentially life-threatening).&#xD;
Grade 2 or higher:&#xD;
BUN: &gt; 26 mg/dL&#xD;
Creatinine: &gt; 1.7 mg/dL&#xD;
ALT, AST: &gt; 2.5 × upper limit of normal (ULN)&#xD;
Hemoglobin: &lt; 11.0 g/dL (females) or &lt; 12.5 g/dL (males) or change from baseline &gt; 1.5 g/dL&#xD;
WBC: &gt; 15,000 cell/mm³ or &lt; 2,500 cell/mm³&#xD;
Lymphocytes: &lt; 750 cell/mm³&#xD;
ANC: &lt; 1,500 cell/mm³&#xD;
Eosinophils: &gt; 1,500 cell/mm³&#xD;
Platelets: &lt; 125,000 cell/mm³</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With a Medically Attended Event (MAE), Laboratory-Confirmed Influenza-like Illness (LC-ILI), Potential Immune-mediated Disease (pIMD), or Serious Adverse Event (SAE) up to Day 113</measure>
    <time_frame>Through Day 113 (28 days post-dose 2)</time_frame>
    <description>An MAE is an event for which the participant received medical attention such as hospitalization, an emergency room visit, or a visit to or from medical personnel.&#xD;
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.&#xD;
LC-ILI is defined as at least 1 systemic symptom (fever or myalgia) AND at least 1 respiratory symptom (cough or sore throat), confirmed by polymerase chain reaction (PCR) assay.&#xD;
An SAE is an AE that met any of the following:&#xD;
Death&#xD;
Life threatening&#xD;
Required inpatient hospitalization or prolongation of existing hospitalization&#xD;
Results in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions&#xD;
Results in congenital anomaly/birth defect&#xD;
An important medical event that may jeopardize the well-being of the subject or require medical or surgical intervention to prevent an above outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Any Grade 2 or Higher Hematological and Biochemical Laboratory Abnormalities From Month 9 to Month 15</measure>
    <time_frame>Month 9 (6 months post-dose 2) and Month 15 (12 months post-dose 2)</time_frame>
    <description>Hematological and biochemical parameters assessed included hemoglobin, platelets, red blood cells, white blood cells (WBC), absolute neutrophil count (ANC), lymphocytes, monocytes, eosinophils, basophils, alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, blood urea nitrogen (BUN) and BUN-to-creatinine ratio.&#xD;
Grading of laboratory parameters was based on the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (severe), or Grade 4 (Potentially life-threatening).&#xD;
Grade 2 or higher:&#xD;
BUN: &gt; 26 mg/dL&#xD;
Creatinine: &gt; 1.7 mg/dL&#xD;
ALT, AST: &gt; 2.5 × upper limit of normal (ULN)&#xD;
Hemoglobin: &lt; 11.0 g/dL (females) or &lt; 12.5 g/dL (males) or change from baseline &gt; 1.5 g/dL&#xD;
WBC: &gt; 15,000 cell/mm³ or &lt; 2,500 cell/mm³&#xD;
Lymphocytes: &lt; 750 cell/mm³&#xD;
ANC: &lt; 1,500 cell/mm³&#xD;
Eosinophils: &gt; 1,500 cell/mm³&#xD;
Platelets: &lt; 125,000 cell/mm³</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With a Medically Attended Event (MAE), Laboratory-Confirmed Influenza-like Illness (LC-ILI), Potential Immune-mediated Disease (pIMD), or Serious Adverse Event (SAE) up to End of Study</measure>
    <time_frame>From first dose to end of study, 588 days (21 months; 18 months post-dose 2)</time_frame>
    <description>An MAE is an event for which the participant received medical attention such as hospitalization, an emergency room visit, or a visit to or from medical personnel.&#xD;
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.&#xD;
LC-ILI is defined as at least 1 systemic symptom (fever or myalgia) AND at least 1 respiratory symptom (cough or sore throat), confirmed by PCR assay.&#xD;
An SAE is an AE that met any of the following:&#xD;
Death&#xD;
Life threatening&#xD;
Required inpatient hospitalization or prolongation of existing hospitalization&#xD;
Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions&#xD;
Resulted in congenital anomaly/birth defect&#xD;
An important medical event that may jeopardize the well-being of the subject or require medical or surgical intervention to prevent an above outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants in Groups 1, 2, and 3 With Detectable Influenza A Virus in Nasal and Oropharyngeal Swabs on Days 1 to 5</measure>
    <time_frame>Days 1 to 5</time_frame>
    <description>To detect viral shedding participants who received LAIV vaccine or intranasal sterile saline as the prime dose had nasal and oropharyngeal swabs collected on Days 1 to 5. Influenza type A virus ribonucleic acid (RNA) was detected using reverse transcription polymerase chain reaction (RT-PCR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants in Groups 1, 2, and 3 With Viable Vaccine Virus in Cell Culture Through 5 Days Post-vaccination</measure>
    <time_frame>Days 1 to 5</time_frame>
    <description>To study virus infectivity, nasal and oropharyngeal swab specimens that tested influenza A positive by RT-PCR were further tested for viability of virus in Madin Darby canine kidney (MDCK) cell culture and stained with monoclonal antibody specific to the cH8/1N1 LAIV virus to confirm detected virus is of vaccine origin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Serum Anti-H1 Hemagglutinin Stalk Immunoglobulin G Antibody Seropositivity</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), Month 9 (6 months post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Anti-H1 hemagglutinin (HA) stalk immunoglobulin G (IgG) was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgG antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .&#xD;
Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned. Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 65.3 EU/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titer of Serum Anti-H1 Hemagglutinin Stalk IgG Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), Month 9 (6 months post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgG antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .&#xD;
Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned. The lower limit of quantitation (LLOQ) for the assay was 65.3 EU/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a ≥ 4-fold Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk IgG Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), Month 9 (6 months post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgG antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk IgG Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), Month 9 (6 months post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgG antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Geometric Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk IgG Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), Month 9 (6 months post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgG antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).&#xD;
Mean geometric increase represents the fold-rise in antibody titer from baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Serum Anti-H1 Hemagglutinin Stalk Immunoglobulin A Antibody Seropositivity</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Anti-H1 hemagglutinin stalk immunoglobulin A (IgA) was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgA antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .&#xD;
Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 1:100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titer of Serum Anti-H1 Hemagglutinin Stalk IgA Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Anti-H1 hemagglutinin stalk immunoglobulin A (IgA) was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgA antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a ≥ 4-fold Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk IgA Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Anti-H1 hemagglutinin stalk immunoglobulin A (IgA) was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgA antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk IgA Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Anti-H1 hemagglutinin stalk immunoglobulin A (IgA) was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgA antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Geometric Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk IgA Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Anti-H1 hemagglutinin stalk immunoglobulin A (IgA) was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgA antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .&#xD;
Mean geometric increase represents the fold-rise in antibody titer from baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Serum Anti-H1 Hemagglutinin Stalk Neutralizing Antibody Seropositivity</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Anti H1 hemagglutinin stalk neutralizing antibodies were quantified using a microneutralization (MN) assay using a virus that expresses a chimeric hemagglutinin that contains an exotic HA head domain (strain A/mallard/Sweden/81/2002 [H6N1]) and the H1 stalk domain (strain A/California/04/2009 [H1N1pandemic]) and an exotic neuraminidase, N5, for which humans are generally naïve (strain: A/mallard/Sweden/86/2003 [H12N5]).&#xD;
Seropositivity rate was defined as the percentage of participants with an antibody titer of ≥ 1:10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titer of Serum Anti-H1 Hemagglutinin Stalk Neutralizing Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Anti H1 hemagglutinin stalk neutralizing antibodies were quantified using a microneutralization (MN) assay using a virus that expresses a chimeric hemagglutinin that contains an exotic HA head domain (strain A/mallard/Sweden/81/2002 ([H6N1]) and the H1 stalk domain (strain A/California/04/2009 ([H1N1pandemic]) and an exotic neuraminidase, N5, for which humans are generally naïve (strain: A/mallard/Sweden/86/2003 [H12N5]). The LLOQ for the assay was 1:10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a ≥ 4-fold Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk Neutralizing Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Anti H1 hemagglutinin stalk neutralizing antibodies were quantified using a microneutralization (MN) assay using a virus that expresses a chimeric hemagglutinin that contains an exotic HA head domain (strain A/mallard/Sweden/81/2002 ([H6N1]) and the H1 stalk domain (strain A/California/04/2009 ([H1N1pandemic]) and an exotic neuraminidase, N5, for which humans are generally naïve (strain: A/mallard/Sweden/86/2003 [H12N5]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk Neutralizing Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Anti H1 hemagglutinin stalk neutralizing antibodies were quantified using a microneutralization (MN) assay using a virus that expresses a chimeric hemagglutinin that contains an exotic HA head domain (strain A/mallard/Sweden/81/2002 ([H6N1]) and the H1 stalk domain (strain A/California/04/2009 ([H1N1pandemic]) and an exotic neuraminidase, N5, for which humans are generally naïve (strain: A/mallard/Sweden/86/2003 [H12N5]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Geometric Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk Neutralizing Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Anti H1 hemagglutinin stalk neutralizing antibodies were quantified using a microneutralization (MN) assay using a virus that expresses a chimeric hemagglutinin that contains an exotic HA head domain (strain A/mallard/Sweden/81/2002 [H6N1]) and the H1 stalk domain (strain A/California/04/2009 [H1N1pandemic]) and an exotic neuraminidase, N5, for which humans are generally naïve (strain: A/mallard/Sweden/86/2003 [H12N5]).&#xD;
Mean geometric increase represents the fold-rise in antibody titer from baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Antibody-dependent Cell-mediated Cytotoxicity (ADCC) to the H1 Hemagglutinin Stalk</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Antibody-dependent cell-mediated cytotoxicity (ADCC) is an immune response leading to lysis of antibody-coated target cells by immune effector cells and is triggered by the interaction between the Fc portion of an antibody and Fc-gamma receptors expressed on immune effector cells.&#xD;
This bioluminescent assay measured antibodies to a chimeric hemagglutinin (H6 head domain and H1 stalk domain) virus that mediate ADCC activity via the Fc-receptor. ADCC activity was measured in relative luciferase units (RLU) for serial dilutions of serum samples using a plate reader.&#xD;
ADCC activity was expressed by the area under the curve (AUC) of luminescence (RLU) per serial dilution (X-fold serial dilutions).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fold-Increase From Baseline in Serum ADCC to the H1 Hemagglutinin Stalk</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Antibody-dependent cell-mediated cytotoxicity (ADCC) is an immune response leading to lysis of antibody-coated target cells by immune effector cells and is triggered by the interaction between the Fc portion of an antibody and Fc-gamma receptors expressed on immune effector cells.&#xD;
This bioluminescent assay measured antibodies to a chimeric hemagglutinin (H6 head domain and H1 stalk domain) virus that mediate ADCC activity via the Fc-receptor. ADCC activity was measured by the area under the curve (AUC) of luminescence per serial dilution.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a ≥ 4-fold Increase From Baseline in Serum ADCC to the H1 Hemagglutinin Stalk</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Antibody-dependent cell-mediated cytotoxicity (ADCC) is an immune response leading to lysis of antibody-coated target cells by immune effector cells and is triggered by the interaction between the Fc portion of an antibody and Fc-gamma receptors expressed on immune effector cells.&#xD;
This bioluminescent assay measured antibodies to a chimeric hemagglutinin (H6 head domain and H1 stalk domain) virus that mediate ADCC activity via the Fc-receptor. ADCC activity was measured by the area under the curve (AUC) of luminescence per serial dilution.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum ADCC to the H1 Hemagglutinin Stalk</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Antibody-dependent cell-mediated cytotoxicity (ADCC) is an immune response leading to lysis of antibody-coated target cells by immune effector cells and is triggered by the interaction between the Fc portion of an antibody and Fc-gamma receptors expressed on immune effector cells.&#xD;
This bioluminescent assay measured antibodies to a chimeric hemagglutinin (H6 head domain and H1 stalk domain) virus that mediate ADCC activity via the Fc-receptor. ADCC activity was measured by the area under the curve (AUC) of luminescence per serial dilution.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Anti-H1 Hemagglutinin Stalk Salivary IgG Antibody Seropositivity</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgG antibodies in saliva against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).&#xD;
Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 1:10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titer of Anti-H1 Hemagglutinin Stalk Salivary IgG Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgG antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]). The LLOQ for the assay was 1:10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a ≥ 4-fold Increase From Baseline in Anti-H1 Hemagglutinin Stalk Salivary IgG</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgG antibodies in saliva against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Anti-H1 Hemagglutinin Stalk Salivary IgG</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgG antibodies in saliva against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Geometric Increase of Anti-H1 Hemagglutinin Stalk Salivary IgG Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgG antibodies in saliva against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).&#xD;
Mean geometric increase represents the fold-rise in antibody titer from baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Anti-H1 Hemagglutinin Stalk Secretory IgA Antibody Seropositivity in Saliva</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Anti-H1 hemagglutinin stalk secretory immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured secretory IgA antibodies antibodies (actively secreted in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).&#xD;
Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 1:4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titer of Anti-H1 Hemagglutinin Stalk Secretory IgA Antibodies in Saliva</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Anti-H1 hemagglutinin stalk secretory immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured secretory IgA antibodies antibodies (actively secreted in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]). The LLOQ for the assay was 1:4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a ≥ 4-fold Increase From Baseline in Anti-H1 Hemagglutinin Stalk Secretory IgA Antibodies in Saliva</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Anti-H1 hemagglutinin stalk secretory immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured secretory IgA antibodies (actively secreted in the mucosa) against the H1 stalk domain in saliva by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Anti-H1 Hemagglutinin Stalk Secretory IgA Antibodies in Saliva</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Anti-H1 hemagglutinin stalk secretory immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured secretory IgA antibodies (actively secreted in the mucosa) against the H1 stalk domain in saliva by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Geometric Increase From Baseline in Anti-H1 Hemagglutinin Stalk Secretory IgA in Saliva</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Anti-H1 hemagglutinin stalk secretory immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured secretory IgA antibodies antibodies (actively secreted in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).&#xD;
Mean geometric increase represents the fold-rise in antibody titer from Baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Anti-H1 Hemagglutinin Stalk Total IgA Antibody Seropositivity in Saliva</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Anti-H1 hemagglutinin stalk total immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured total IgA antibodies antibodies (secreted through active and passive transfer processes in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).&#xD;
Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 1:10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titer of Anti-H1 Hemagglutinin Stalk Total IgA Antibodies in Saliva</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Anti-H1 hemagglutinin stalk total immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured total IgA antibodies antibodies (secreted through active and passive transfer processes in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]). The LLOQ for the assay was 1:10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a ≥ 4-fold Increase From Baseline in Anti-H1 Hemagglutinin Stalk Total IgA Antibodies in Saliva</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Anti-H1 hemagglutinin stalk total immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured total IgA antibodies antibodies (secreted through active and passive transfer processes in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Anti-H1 Hemagglutinin Stalk Total IgA Antibodies in Saliva</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Anti-H1 hemagglutinin stalk total immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured total IgA antibodies antibodies (secreted through active and passive transfer processes in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Geometric Increase From Baseline in Anti-H1 Hemagglutinin Stalk Total IgA Antibodies in Saliva</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>Anti-H1 hemagglutinin stalk total immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured total IgA antibodies (secreted through active and passive transfer processes in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).&#xD;
Mean geometric increase represents the fold-rise in antibody titer from baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Serum Anti-H2 Full-length Hemagglutinin IgG Antibody Seropositivity</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H2, of which the stalk domain shares about 78% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H2 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on A/mallard/Netherlands/5/1999 (H2N9) HA.&#xD;
Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned. Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 22.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titer of Serum Anti-H2 Full-length Hemagglutinin IgG Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H2, of which the stalk domain shares about 78% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H2 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on A/mallard/Netherlands/5/1999 (H2N9) HA. Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a ≥ 4-fold Increase From Baseline in Serum Anti-H2 Full-length Hemagglutinin IgG Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H2, of which the stalk domain shares about 78% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H2 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on A/mallard/Netherlands/5/1999 (H2N9) HA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum Anti-H2 Full-length Hemagglutinin IgG Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H2, of which the stalk domain shares about 78% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H2 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on A/mallard/Netherlands/5/1999 (H2N9) HA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Geometric Increase of Serum Anti-H2 Full-length Hemagglutinin IgG Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H2, of which the stalk domain shares about 78% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H2 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on A/mallard/Netherlands/5/1999 (H2N9) HA.&#xD;
Mean geometric increase represents the fold-rise in antibody titer from Baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Serum Anti-H9 Full-length Hemagglutinin IgG Antibody Seropositivity</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H9, the stalk domain of which shares about 59% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H9 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/chicken/Hong Kong/G9/1997 (H9N2) HA. Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned.&#xD;
Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 31.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titer of Serum Anti-H9 Full-length Hemagglutinin IgG Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H9, the stalk domain of which shares about 59% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H9 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/chicken/Hong Kong/G9/1997 (H9N2) HA. Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned. The LLOQ for the assay was 31 EU/mL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a ≥ 4-fold Increase From Baseline in Serum Anti-H9 Full-length Hemagglutinin IgG Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H9, the stalk domain of which shares about 59% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H9 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/chicken/Hong Kong/G9/1997 (H9N2) HA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum Anti-H9 Full-length Hemagglutinin IgG Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H9, the stalk domain of which shares about 59% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H9 full-length(ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/chicken/Hong Kong/G9/1997 (H9N2) HA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Geometric Increase of Serum Anti-H9 Full-length Hemagglutinin IgG Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H9, the stalk domain of which shares about 59% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H9 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/chicken/Hong Kong/G9/1997 (H9N2) HA.&#xD;
Mean geometric increase represents the fold-rise in antibody titer from Baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Serum Anti-H18 Full-length Hemagglutinin IgG Antibody Seropositivity</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin distantly related to the currently circulating influenza A/H1 viruses, subtype H18, the stalk domain of which shares about 65% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H18 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/flat-faced bat/Peru/033/10 (H18N11) HA. Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned.&#xD;
Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 42.3.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titer of Serum Anti-H18 Full-length Hemagglutinin IgG Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin distantly related to the currently circulating influenza A/H1 viruses, H18, the stalk domain of which shares about 65% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H18 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/flat-faced bat/Peru/033/10 (H18N11) HA. Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a ≥ 4-fold Increase From Baseline in Serum Anti-H18 Full-length Hemagglutinin IgG Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin distantly related to the currently circulating influenza A/H1 viruses, subtype H18, the stalk domain of which shares about 65% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H18 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/flat-faced bat/Peru/033/10 (H18N11) HA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum Anti-H18 Full-length Hemagglutinin IgG Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin distantly related to the currently circulating influenza A/H1 viruses, subtype H18, the stalk domain of which shares about 65% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H18 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/flat-faced bat/Peru/033/10 (H18N11) HA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Geometric Increase of Serum Anti-H18 Full-length Hemagglutinin IgG Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin distantly related to the currently circulating influenza A/H1 viruses, subtype H18, the stalk domain of which shares about 65% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H18 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/flat-faced bat/Peru/033/10 (H18N11) HA.&#xD;
Mean geometric increase represents the fold-rise in antibody titer from Baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Serum Anti-Human H1N1 Virus Neutralizing Antibody Seropositivity</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>This assay was performed to measure the neutralizing potential of antibodies against the currently circulating human H1N1 isolate which is similar to the stalk used in study vaccines.&#xD;
Anti-human H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Singapore/GP1908/2015 (IVR-180).&#xD;
Seropositivity rate was defined as the percentage of participants with an antibody titer of ≥ 1:10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titer of Serum Anti-Human H1N1 Virus Neutralizing Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>This assay was performed to measure the neutralizing potential of antibodies against the currently circulating human H1N1 isolate which is similar to the stalk used in study vaccines.&#xD;
Anti-human H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Singapore/GP1908/2015 (IVR-180). The LLOQ for the assay was 1:10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a ≥ 4-fold Increase in Serum Anti-Human H1N1 Virus Neutralizing Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>This assay was performed to measure the neutralizing potential of antibodies against the currently circulating human H1N1 isolate which is similar to the stalk used in study vaccines.&#xD;
Anti-human H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Singapore/GP1908/2015 (IVR-180).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum Anti-Human H1N1 Virus Neutralizing Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>This assay was performed to measure the neutralizing potential of antibodies against the currently circulating human H1N1 isolate which is similar to the stalk used in study vaccines.&#xD;
Anti-human H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Singapore/GP1908/2015 (IVR-180).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Geometric Increase of Serum Anti-Human H1N1 Virus Neutralizing Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>This assay was performed to measure the neutralizing potential of antibodies against the currently circulating human H1N1 isolate which is similar to the stalk used in study vaccines.&#xD;
Anti-human H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Singapore/GP1908/2015 (IVR-180).&#xD;
Mean geometric increase represents the fold-rise in antibody titer from Baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Serum Anti-Avian-Swine H1N1 Virus Neutralizing Antibody Seropositivity</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>This assay was performed to measure the neutralizing potential of cross-reactive antibodies to a Group 1 influenza against an H1N1 virus isolate that currently circulates in animals and is antigenically different from current human isolates.&#xD;
Anti-avian-swine H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Swine/Jiangsu/40/2011 (asH1N1).&#xD;
Seropositivity rate was defined as the percentage of participants with an antibody titer of ≥ 1:10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titer of Serum Anti-Avian-Swine H1N1 Virus Neutralizing Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>This assay was performed to measure the neutralizing potential of cross-reactive antibodies to a Group 1 influenza against an H1N1 virus isolate that currently circulates in animals and is antigenically different from current human isolates.&#xD;
Anti-avian-swine H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Swine/Jiangsu/40/2011 (asH1N1). The LLOQ for the assay was 1:10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a ≥ 4-fold Increase in Serum Anti-Avian-Swine H1N1 Virus Neutralizing Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>This assay was performed to measure the neutralizing potential of cross-reactive antibodies to a Group 1 influenza against an H1N1 virus isolate that currently circulates in animals and is antigenically different from current human isolates.&#xD;
Anti-avian-swine H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Swine/Jiangsu/40/2011 (asH1N1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a ≥ 10-fold Increase in Serum Anti-Avian-Swine H1N1 Virus Neutralizing Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>This assay was performed to measure the neutralizing potential of cross-reactive antibodies to a Group 1 influenza against an H1N1 virus isolate that currently circulates in animals and is antigenically different from current human isolates.&#xD;
Anti-avian-swine H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Swine/Jiangsu/40/2011 (asH1N1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Geometric Increase From Baseline in Serum Anti-Avian-Swine H1N1 Virus Neutralizing Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>This assay was performed to measure the neutralizing potential of cross-reactive antibodies to a Group 1 influenza against an H1N1 virus isolate that currently circulates in animals and is antigenically different from current human isolates.&#xD;
Anti-avian-swine H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Swine/Jiangsu/40/2011 (asH1N1).&#xD;
Mean geometric increase represents the fold-rise in antibody titer from Baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Serum Anti-H5N8 Virus Neutralizing Antibody Seropositivity</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>This assay was performed to measure the induction of antibodies reactive against the head domain of a group 1 influenza virus with a heterosubtypic hemagglutinin from a recent avian influenza virus. Anti-H5N8 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using a reverse genetics (RG) reassortant virus based on Puerto Rico (PR)/8 for 6 genes with 2 surface proteins: HA and neuraminidase (NA) from A/Gyrfalcon/Washington/41088-6/2014 (H5N8).&#xD;
Seropositivity rate was defined as the percentage of participants with an antibody titer of ≥ 1:10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titer of Serum Anti-H5N8 Virus Neutralizing Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>This assay was performed to measure the induction of antibodies reactive against the head domain of a group 1 influenza virus with a heterosubtypic hemagglutinin from a recent avian influenza virus. Anti-H5N8 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using a reverse genetics (RG) reassortant virus based on PR8 for 6 genes with 2 surface proteins: HA and NA from A/Gyrfalcon/Washington/41088-6/2014 (H5N8). The LLOQ for the assay was 1:10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a ≥ 4-fold Increase in Serum Anti-H5N8 Virus Neutralizing Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>This assay was performed to measure the induction of antibodies reactive against the head domain of a group 1 influenza virus with a heterosubtypic hemagglutinin from a recent avian influenza virus. Anti-H5N8 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using a reverse genetics (RG) reassortant virus based on PR8 for 6 genes with 2 surface proteins: HA and NA from A/Gyrfalcon/Washington/41088-6/2014 (H5N8).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a ≥ 10-fold Increase in Serum Anti-H5N8 Virus Neutralizing Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>This assay was performed to measure the induction of antibodies reactive against the head domain of a group 1 influenza virus with a heterosubtypic hemagglutinin from a recent avian influenza virus. Anti-H5N8 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using a reverse genetics (RG) reassortant virus based on PR8 for 6 genes with 2 surface proteins: HA and NA from A/Gyrfalcon/Washington/41088-6/2014 (H5N8).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Geometric Increase From Baseline in Serum Anti-H5N8 Virus Neutralizing Antibodies</measure>
    <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
    <description>This assay was performed to measure the induction of antibodies reactive against the head domain of a group 1 influenza virus with a heterosubtypic hemagglutinin from a recent avian influenza virus. Anti-H5N8 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using a reverse genetics (RG) reassortant virus based on PR8 for 6 genes with 2 surface proteins: HA and NA from A/Gyrfalcon/Washington/41088-6/2014 (H5N8).&#xD;
Mean geometric increase represents the fold-rise in antibody titer from Baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">65</enrollment>
  <condition>Influenza</condition>
  <condition>Vaccine</condition>
  <arm_group>
    <arm_group_label>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + adjuvant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received 0.5 mL of normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4: cH8/1N1 IIV + adjuvant and cH5/1N1 IIV + adjuvant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 5: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>cH8/1N1 LAIV</intervention_name>
    <description>Live-attenuated influenza virus vaccine (LAIV) expressing chimeric hemagglutinin (HA) with the H8 head and H1 stalk and neuraminidase (NA) subtype 1 (N1) (cH8/1N1):&#xD;
HA head, A/mallard/Sweden/24/2002 (H8N4); HA stalk, A/California/04/2009 (H1N1); NA, A/California/04/2009 (H1N1) containing the backbone of the cold-adapted/temperature sensitive of the Russian LAIV A/Leningrad/134/17/1957 (Len17 IDCDCRG46D).&#xD;
Administered intranasally as drops at a dose of 10⁷·⁵ (plus or minus ⁰·⁵) 50% egg infectious dose (EID50), formulated in a total volume of 0.5 mL sterile saline (0.25 mL per nostril).</description>
    <arm_group_label>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + adjuvant</arm_group_label>
    <arm_group_label>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>AS03-adjuvanted cH5/1N1 IIV</intervention_name>
    <description>Chimeric H5 head with H1 stalk plus N1 (cH5/1N1) split virion inactivated influenza virus vaccine (IIV) plus AS03 adjuvant: HA head, A/Vietnam/1203/2004 (H5N1); HA stalk, A/California/04/2009 (H1N1); NA, A/California/04/2009 (H1N1).&#xD;
Administered intramuscularly at a dose of 15 μg of hemagglutinin in a volume of 0.5 mL of phosphate buffered saline (PBS).</description>
    <arm_group_label>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + adjuvant</arm_group_label>
    <arm_group_label>Group 4: cH8/1N1 IIV + adjuvant and cH5/1N1 IIV + adjuvant</arm_group_label>
    <other_name>cH5/1N1 IIV + AS03 adjuvant</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>cH5/1N1 IIV</intervention_name>
    <description>Chimeric H5 head with H1 stalk plus N1 (cH5/1N1) split virion inactivated influenza virus vaccine (IIV):&#xD;
HA head, A/Vietnam/1203/2004 (H5N1); HA stalk, A/California/04/2009 (H1N1); NA, A/California/04/2009 (H1N1).&#xD;
Administered intramuscularly at a dose of 15 μg of hemagglutinin in a volume of 0.5 mL of phosphate buffered saline (PBS).</description>
    <arm_group_label>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>AS03-adjuvanted cH8/1N1 IIV</intervention_name>
    <description>Chimeric H8 head with H1 stalk plus N1 (cH8/1N1) inactivated influenza vaccine plus AS03 adjuvant: HA head, A/mallard/Sweden/24/2002 (H8N4); HA stalk, A/California/04/2009 (H1N1); NA, A/California/04/2009 (H1N1).&#xD;
Administered intramuscularly at a dose of 15 μg of hemagglutinin in a volume of 0.5 mL of phosphate buffered saline (PBS).</description>
    <arm_group_label>Group 4: cH8/1N1 IIV + adjuvant and cH5/1N1 IIV + adjuvant</arm_group_label>
    <other_name>cH8/1N1 IIV + AS03 adjuvant</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>Administered intranasally as 0.25 mL nasal drops per nostril</description>
    <arm_group_label>Group 3: Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Phosphate buffered saline (PBS)</intervention_name>
    <description>Administered intramuscularly as 0.5 mL injection</description>
    <arm_group_label>Group 3: Placebo</arm_group_label>
    <arm_group_label>Group 5: Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to understand planned study procedures and demonstrate comprehension of the&#xD;
             protocol procedures and knowledge of study by passing a written examination prior to&#xD;
             vaccination.&#xD;
&#xD;
          -  In the opinion of the investigator, can and will comply with the requirements of the&#xD;
             protocol (e.g., completion of the diary cards, return for follow-up visits).&#xD;
&#xD;
          -  Written informed consent obtained from the subject prior to performance of any study&#xD;
             specific procedure.&#xD;
&#xD;
          -  Male or non-pregnant female between, and including, 18 and 39 years of age at the time&#xD;
             of the first vaccination.&#xD;
&#xD;
          -  Healthy subjects without acute or chronic, clinically significant pulmonary,&#xD;
             cardiovascular, hepatic or renal functional abnormality*.&#xD;
&#xD;
          -  Female subjects of non-childbearing potential may be enrolled in the study.&#xD;
&#xD;
          -  Female subjects of childbearing potential must have a negative pregnancy test within&#xD;
             24 hours of vaccination.&#xD;
&#xD;
          -  Female subjects of childbearing potential must have practiced adequate contraception&#xD;
             for 30 days prior to first vaccination and agree to continue adequate contraception&#xD;
             until 2 months after completion of the vaccination series (Month 5).&#xD;
&#xD;
          -  Male subjects must be surgically sterile (e.g., vasectomy) or agree to practice&#xD;
             adequate contraception from the first vaccination until 2 months after completion of&#xD;
             the vaccination series (Month 5). Please refer to the glossary of terms for the&#xD;
             definition of adequate contraception.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of any investigational or non-registered product (drug or vaccine) other than the&#xD;
             study vaccines.&#xD;
&#xD;
          -  Any medical condition that in the judgment of the investigator would make&#xD;
             intramuscular injection unsafe.&#xD;
&#xD;
          -  Medically diagnosed deviated nasal septum or nasal obstruction.&#xD;
&#xD;
          -  Chronic administration (defined as more than 14 days in total) of immunosuppressants&#xD;
             or other immune-modifying drugs within 6 months before the first dose.&#xD;
&#xD;
          -  Administration of long-acting immune-modifying drugs (e.g., infliximab, rituximab)&#xD;
             within 6 months before the first dose (Visit 03), or planned administration any time&#xD;
             during the study period.&#xD;
&#xD;
          -  Planned administration/administration of a vaccine not foreseen by the study protocol&#xD;
             in the period starting 30 days before the first dose (Visit 03) up to Month 15 (Visit&#xD;
             15)&#xD;
&#xD;
          -  Persons who should be annually vaccinated against influenza who live with or care for&#xD;
             persons at high risk for influenza-related complications.&#xD;
&#xD;
          -  History of influenza vaccination within 6 months prior to study enrollment or&#xD;
             unwillingness to forego seasonal influenza vaccination during the entire study period.&#xD;
&#xD;
          -  History of vaccination with an investigational pandemic influenza vaccine other than&#xD;
             an 2009 H1N1 Pandemic (H1N1pdm09) vaccine.&#xD;
&#xD;
          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on&#xD;
             medical history and physical examination.&#xD;
&#xD;
          -  Infection with human immunodeficiency virus regardless of clinical stage of&#xD;
             immunodeficiency.&#xD;
&#xD;
          -  History of current infection with hepatitis B virus or hepatitis C virus regardless of&#xD;
             clinical presentation.&#xD;
&#xD;
          -  History of or current autoimmune disease.&#xD;
&#xD;
          -  Subjects diagnosed with excessive daytime sleepiness or narcolepsy; or history of&#xD;
             narcolepsy in a subject's parent or sibling.&#xD;
&#xD;
          -  History of Guillain-Barré syndrome.&#xD;
&#xD;
          -  History of any reaction or hypersensitivity likely to be exacerbated by any component&#xD;
             of the vaccines (including egg proteins); a history of anaphylactic-type reaction to&#xD;
             consumption of eggs; or a history of severe adverse reaction to a previous influenza&#xD;
             vaccine.&#xD;
&#xD;
          -  Hypersensitivity to latex.&#xD;
&#xD;
          -  Administration of immunoglobulins and/or any blood products during the period starting&#xD;
             3 months before the first dose of study vaccines or planned administration during the&#xD;
             study period.&#xD;
&#xD;
          -  Pregnant or lactating female.&#xD;
&#xD;
          -  Female planning to become pregnant or male planning to father a child or either&#xD;
             planning to discontinue contraceptive precautions.&#xD;
&#xD;
          -  Current smoker.&#xD;
&#xD;
          -  During screening, have a positive test for opiates without a prescription.&#xD;
&#xD;
          -  History of chronic alcohol consumption and/or drug abuse as deemed by the investigator&#xD;
             to render the potential subject unable/unlikely to provide accurate safety reports.&#xD;
&#xD;
          -  Have a history of convulsions or encephalomyelitis within 90 days prior to study&#xD;
             vaccination.&#xD;
&#xD;
          -  Have any diagnosis, current or past, of schizophrenia, bipolar disease, or other&#xD;
             psychiatric diagnosis that may interfere with subject compliance or safety&#xD;
             evaluations.&#xD;
&#xD;
          -  Have been hospitalized for psychiatric illness, history of suicide attempt, or&#xD;
             confinement for danger to self or others within 10 years prior to study vaccination.&#xD;
&#xD;
          -  Blood donation or planned blood donation within 30 days prior to the study vaccination&#xD;
             through 30 days after the last blood drawn for this study.&#xD;
&#xD;
          -  Have signs or symptoms that could confound or confuse assessment of study vaccine&#xD;
             reactogenicity.&#xD;
&#xD;
          -  Any hematological or biochemical parameter that is out of range of normal, and is&#xD;
             considered clinically significant by the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Bernstein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Medical Center, Cincinnati</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jeffrey Guptill, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <results_first_submitted>November 17, 2020</results_first_submitted>
  <results_first_submitted_qc>February 1, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">February 21, 2021</results_first_posted>
  <last_update_submitted>February 1, 2021</last_update_submitted>
  <last_update_submitted_qc>February 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>live attenuated influenza vaccine</keyword>
  <keyword>inactivated influenza vaccine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 9, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT03300050/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT03300050/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited from the community and enrolled at Cincinnati Children's Hospital Medical Center (Cincinnati, OH, USA) and the Duke Early Phase Clinical Research Unit (Durham, NC, USA) between October 10, 2017, and November 27, 2017.</recruitment_details>
      <pre_assignment_details>Participants were randomly assigned in a 4:3:1:3:2 ratio to one of five treatment groups. Randomization was blocked (block size 13) and stratified by site. Participants received two sequential study vaccinations, an initial priming dose on Day 1 followed by a booster dose on Day 85.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
          <description>Participants received 0.5 mL chimeric H8/1N1 live-attenuated influenza virus vaccine (cH8/1N1 LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03 (Adjuvant System 03)-adjuvanted chimeric H5/1N1 inactivated influenza virus vaccine (cH5/1N1 IIV) administered as an intramuscular injection on Day 85.</description>
        </group>
        <group group_id="P2">
          <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
          <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
        </group>
        <group group_id="P3">
          <title>Group 3: Placebo</title>
          <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
        </group>
        <group group_id="P4">
          <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
          <description>Participants received 0.5 mL AS03-adjuvanted chimeric H8/1N1 inactivated influenza vaccine (cH8/1N1 IIV) administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
        </group>
        <group group_id="P5">
          <title>Group 5: Placebo</title>
          <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="15"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="16"/>
                <participants group_id="P5" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Treatment</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="15"/>
                <participants group_id="P5" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received All Scheduled Treatments</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="15"/>
                <participants group_id="P5" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="17"/>
                <participants group_id="P2" count="13"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="15"/>
                <participants group_id="P5" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Not Eligible at Randomization</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All enrolled participants</population>
      <group_list>
        <group group_id="B1">
          <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
          <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
        </group>
        <group group_id="B2">
          <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
          <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
        </group>
        <group group_id="B3">
          <title>Group 3: Placebo</title>
          <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
        </group>
        <group group_id="B4">
          <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
          <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
        </group>
        <group group_id="B5">
          <title>Group 5: Placebo</title>
          <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
        </group>
        <group group_id="B6">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="5"/>
            <count group_id="B4" value="16"/>
            <count group_id="B5" value="10"/>
            <count group_id="B6" value="66"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.9" spread="5.3"/>
                    <measurement group_id="B2" value="27.5" spread="5.9"/>
                    <measurement group_id="B3" value="25.0" spread="3.7"/>
                    <measurement group_id="B4" value="30.3" spread="5.5"/>
                    <measurement group_id="B5" value="29.3" spread="4.6"/>
                    <measurement group_id="B6" value="28.9" spread="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="10"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="5"/>
                    <measurement group_id="B6" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="63"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="14"/>
                    <measurement group_id="B5" value="7"/>
                    <measurement group_id="B6" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="3"/>
                    <measurement group_id="B6" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Solicited Local Reactions Within 7 Days Following Each Vaccination</title>
        <description>Solicited adverse events were assessed by study staff for 60 minutes after each vaccination and and then by study participants daily for 7 days on a a diary card.&#xD;
Solicited local reactions included:&#xD;
Post LAIV dose: nasal congestion, rhinorrhea;&#xD;
Post IIV dose: pain, redness, swelling.</description>
        <time_frame>7 days after each vaccination (Days 1-8 and Days 85-92)</time_frame>
        <population>Participants who received the priming dose and booster dose</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Solicited Local Reactions Within 7 Days Following Each Vaccination</title>
          <description>Solicited adverse events were assessed by study staff for 60 minutes after each vaccination and and then by study participants daily for 7 days on a a diary card.&#xD;
Solicited local reactions included:&#xD;
Post LAIV dose: nasal congestion, rhinorrhea;&#xD;
Post IIV dose: pain, redness, swelling.</description>
          <population>Participants who received the priming dose and booster dose</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post Prime Dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Any Local Reacton</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="11"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Nasal Congestion</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="NA">Reaction not applicable for intramuscular injection</measurement>
                    <measurement group_id="O5" value="NA">Reaction not applicable for intramuscular injection</measurement>
                  </measurement_list>
                </category>
                <category>
                  <title>Rhinorrhea</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="NA">Reaction not applicable for intramuscular injection</measurement>
                    <measurement group_id="O5" value="NA">Reaction not applicable for intramuscular injection</measurement>
                  </measurement_list>
                </category>
                <category>
                  <title>Pain</title>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Reaction not applicable for intranasal administration</measurement>
                    <measurement group_id="O2" value="NA">Reaction not applicable for intranasal administration</measurement>
                    <measurement group_id="O3" value="NA">Reaction not applicable for intranasal administration</measurement>
                    <measurement group_id="O4" value="11"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Redness</title>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Reaction not applicable for intranasal administration</measurement>
                    <measurement group_id="O2" value="NA">Reaction not applicable for intranasal administration</measurement>
                    <measurement group_id="O3" value="NA">Reaction not applicable for intranasal administration</measurement>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Swelling</title>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Reaction not applicable for intranasal administration</measurement>
                    <measurement group_id="O2" value="NA">Reaction not applicable for intranasal administration</measurement>
                    <measurement group_id="O3" value="NA">Reaction not applicable for intranasal administration</measurement>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Booster Dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Any Local Reacton</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="8"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Nasal Congestion</title>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Reaction not applicable for intramuscular injection</measurement>
                    <measurement group_id="O2" value="NA">Reaction not applicable for intramuscular injection</measurement>
                    <measurement group_id="O3" value="NA">Reaction not applicable for intramuscular injection</measurement>
                    <measurement group_id="O4" value="NA">Reaction not applicable for intramuscular injection</measurement>
                    <measurement group_id="O5" value="NA">Reaction not applicable for intramuscular injection</measurement>
                  </measurement_list>
                </category>
                <category>
                  <title>Rhinorrhea</title>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Reaction not applicable for intramuscular injection</measurement>
                    <measurement group_id="O2" value="NA">Reaction not applicable for intramuscular injection</measurement>
                    <measurement group_id="O3" value="NA">Reaction not applicable for intramuscular injection</measurement>
                    <measurement group_id="O4" value="NA">Reaction not applicable for intramuscular injection</measurement>
                    <measurement group_id="O5" value="NA">Reaction not applicable for intramuscular injection</measurement>
                  </measurement_list>
                </category>
                <category>
                  <title>Pain</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="8"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Redness</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Swelling</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Solicited General Reactions Within 7 Days Following Each Vaccination</title>
        <description>Solicited adverse events were assessed by study staff for 60 minutes after each vaccination and and then by study participants daily for 7 days on a a diary card.&#xD;
Solicited general reactions included:&#xD;
abdominal pain&#xD;
arthralgia&#xD;
cough&#xD;
diarrhea&#xD;
fatigue&#xD;
fever&#xD;
headache&#xD;
myalgia&#xD;
nausea&#xD;
shivering&#xD;
sore throat&#xD;
vomiting&#xD;
wheezing</description>
        <time_frame>7 days after each vaccination (Days 1-8 and Days 85-92)</time_frame>
        <population>Participants who received the priming dose and booster dose</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Solicited General Reactions Within 7 Days Following Each Vaccination</title>
          <description>Solicited adverse events were assessed by study staff for 60 minutes after each vaccination and and then by study participants daily for 7 days on a a diary card.&#xD;
Solicited general reactions included:&#xD;
abdominal pain&#xD;
arthralgia&#xD;
cough&#xD;
diarrhea&#xD;
fatigue&#xD;
fever&#xD;
headache&#xD;
myalgia&#xD;
nausea&#xD;
shivering&#xD;
sore throat&#xD;
vomiting&#xD;
wheezing</description>
          <population>Participants who received the priming dose and booster dose</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post Prime Dose: Any General Reaction</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Prime Dose: Fever</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Prime Dose: Shivering</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Prime Dose: Fatigue</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Prime Dose: Headache</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Prime Dose: Myalgia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Prime Dose: Arthralgia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Prime Dose: Nausea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Prime Dose: Vomiting</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Prime Dose: Abdominal Pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Prime Dose: Diarrhea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Prime Dose: Sore Throat</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Prime Dose: Cough</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Prime Dose: Wheezing</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Booster Dose: Any General Reaction</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Booster Dose : Fever</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Booster Dose: Shivering</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Booster Dose: Fatigue</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Booster Dose : Headache</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Booster Dose: Myalgia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Booster Dose: Arthralgia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Booster Dose: Nausea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Booster Dose: Vomiting</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Booster Dose: Abdominal Pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Booster Dose: Diarrhea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Booster Dose: Sore Throat</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Booster Dose: Cough</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Booster Dose: Wheezing</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Unsolicited Adverse Events Within 28 Days Following Any Vaccination</title>
        <description>Unsolicited adverse events (AEs) are any AEs reported spontaneously by the participant, observed by the study personnel during study visits or those identified during review of medical records or source documents, such as diary cards. Participants were asked to record any unsolicited symptoms or other illness description in their diary card during the 28 days after each vaccination.&#xD;
All AEs, including clinical laboratory test results, were assessed by a study clinician and the study subject (as applicable) to quantify severity using a protocol-defined grading system as mild (mild symptoms, easily tolerated, not interfering with daily activities), moderate (causing some interference with daily activity), or severe (severe symptoms that prevent normal every day activities).&#xD;
The investigator assessed the relationship between study vaccines and the occurrence of each AE using clinical judgment.</description>
        <time_frame>28 days after each vaccination (Days 1 to 28 and Days 85 to 113)</time_frame>
        <population>Participants who received at least one study vaccination</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Unsolicited Adverse Events Within 28 Days Following Any Vaccination</title>
          <description>Unsolicited adverse events (AEs) are any AEs reported spontaneously by the participant, observed by the study personnel during study visits or those identified during review of medical records or source documents, such as diary cards. Participants were asked to record any unsolicited symptoms or other illness description in their diary card during the 28 days after each vaccination.&#xD;
All AEs, including clinical laboratory test results, were assessed by a study clinician and the study subject (as applicable) to quantify severity using a protocol-defined grading system as mild (mild symptoms, easily tolerated, not interfering with daily activities), moderate (causing some interference with daily activity), or severe (severe symptoms that prevent normal every day activities).&#xD;
The investigator assessed the relationship between study vaccines and the occurrence of each AE using clinical judgment.</description>
          <population>Participants who received at least one study vaccination</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs related to study vaccine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild AEs related to study vaccine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate AEs related to study vaccine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe adverse events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe AEs related to study vaccine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Grade 2 or Higher Hematological and Biochemical Laboratory Abnormalities From Day 8 to Day 113</title>
        <description>Hematological and biochemical parameters assessed included hemoglobin, platelets, red blood cells, white blood cells (WBC), absolute neutrophil count (ANC), lymphocytes, monocytes, eosinophils, basophils, alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, blood urea nitrogen (BUN) and BUN-to-creatinine ratio.&#xD;
Grading of laboratory parameters was based on the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (severe), or Grade 4 (Potentially life-threatening).&#xD;
Grade 2 or higher:&#xD;
BUN: &gt; 26 mg/dL&#xD;
Creatinine: &gt; 1.7 mg/dL&#xD;
ALT, AST: &gt; 2.5 × upper limit of normal (ULN)&#xD;
Hemoglobin: &lt; 11.0 g/dL (females) or &lt; 12.5 g/dL (males) or change from baseline &gt; 1.5 g/dL&#xD;
WBC: &gt; 15,000 cell/mm³ or &lt; 2,500 cell/mm³&#xD;
Lymphocytes: &lt; 750 cell/mm³&#xD;
ANC: &lt; 1,500 cell/mm³&#xD;
Eosinophils: &gt; 1,500 cell/mm³&#xD;
Platelets: &lt; 125,000 cell/mm³</description>
        <time_frame>Days 8, 29, 85, 92, and 113</time_frame>
        <population>Participants who received at least one study vaccination</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Grade 2 or Higher Hematological and Biochemical Laboratory Abnormalities From Day 8 to Day 113</title>
          <description>Hematological and biochemical parameters assessed included hemoglobin, platelets, red blood cells, white blood cells (WBC), absolute neutrophil count (ANC), lymphocytes, monocytes, eosinophils, basophils, alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, blood urea nitrogen (BUN) and BUN-to-creatinine ratio.&#xD;
Grading of laboratory parameters was based on the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (severe), or Grade 4 (Potentially life-threatening).&#xD;
Grade 2 or higher:&#xD;
BUN: &gt; 26 mg/dL&#xD;
Creatinine: &gt; 1.7 mg/dL&#xD;
ALT, AST: &gt; 2.5 × upper limit of normal (ULN)&#xD;
Hemoglobin: &lt; 11.0 g/dL (females) or &lt; 12.5 g/dL (males) or change from baseline &gt; 1.5 g/dL&#xD;
WBC: &gt; 15,000 cell/mm³ or &lt; 2,500 cell/mm³&#xD;
Lymphocytes: &lt; 750 cell/mm³&#xD;
ANC: &lt; 1,500 cell/mm³&#xD;
Eosinophils: &gt; 1,500 cell/mm³&#xD;
Platelets: &lt; 125,000 cell/mm³</description>
          <population>Participants who received at least one study vaccination</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hemoglobin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White blood cell count</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Absolute neutrophil count</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basophils</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Red blood cells</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood urea nitrogen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BUN to creatinine ratio</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alanine aminotransferase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asparate aminotransferase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With a Medically Attended Event (MAE), Laboratory-Confirmed Influenza-like Illness (LC-ILI), Potential Immune-mediated Disease (pIMD), or Serious Adverse Event (SAE) up to Day 113</title>
        <description>An MAE is an event for which the participant received medical attention such as hospitalization, an emergency room visit, or a visit to or from medical personnel.&#xD;
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.&#xD;
LC-ILI is defined as at least 1 systemic symptom (fever or myalgia) AND at least 1 respiratory symptom (cough or sore throat), confirmed by polymerase chain reaction (PCR) assay.&#xD;
An SAE is an AE that met any of the following:&#xD;
Death&#xD;
Life threatening&#xD;
Required inpatient hospitalization or prolongation of existing hospitalization&#xD;
Results in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions&#xD;
Results in congenital anomaly/birth defect&#xD;
An important medical event that may jeopardize the well-being of the subject or require medical or surgical intervention to prevent an above outcome.</description>
        <time_frame>Through Day 113 (28 days post-dose 2)</time_frame>
        <population>Participants who received at least one study vaccination</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Medically Attended Event (MAE), Laboratory-Confirmed Influenza-like Illness (LC-ILI), Potential Immune-mediated Disease (pIMD), or Serious Adverse Event (SAE) up to Day 113</title>
          <description>An MAE is an event for which the participant received medical attention such as hospitalization, an emergency room visit, or a visit to or from medical personnel.&#xD;
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.&#xD;
LC-ILI is defined as at least 1 systemic symptom (fever or myalgia) AND at least 1 respiratory symptom (cough or sore throat), confirmed by polymerase chain reaction (PCR) assay.&#xD;
An SAE is an AE that met any of the following:&#xD;
Death&#xD;
Life threatening&#xD;
Required inpatient hospitalization or prolongation of existing hospitalization&#xD;
Results in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions&#xD;
Results in congenital anomaly/birth defect&#xD;
An important medical event that may jeopardize the well-being of the subject or require medical or surgical intervention to prevent an above outcome.</description>
          <population>Participants who received at least one study vaccination</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LC-ILIs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>pIMDs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Any Grade 2 or Higher Hematological and Biochemical Laboratory Abnormalities From Month 9 to Month 15</title>
        <description>Hematological and biochemical parameters assessed included hemoglobin, platelets, red blood cells, white blood cells (WBC), absolute neutrophil count (ANC), lymphocytes, monocytes, eosinophils, basophils, alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, blood urea nitrogen (BUN) and BUN-to-creatinine ratio.&#xD;
Grading of laboratory parameters was based on the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (severe), or Grade 4 (Potentially life-threatening).&#xD;
Grade 2 or higher:&#xD;
BUN: &gt; 26 mg/dL&#xD;
Creatinine: &gt; 1.7 mg/dL&#xD;
ALT, AST: &gt; 2.5 × upper limit of normal (ULN)&#xD;
Hemoglobin: &lt; 11.0 g/dL (females) or &lt; 12.5 g/dL (males) or change from baseline &gt; 1.5 g/dL&#xD;
WBC: &gt; 15,000 cell/mm³ or &lt; 2,500 cell/mm³&#xD;
Lymphocytes: &lt; 750 cell/mm³&#xD;
ANC: &lt; 1,500 cell/mm³&#xD;
Eosinophils: &gt; 1,500 cell/mm³&#xD;
Platelets: &lt; 125,000 cell/mm³</description>
        <time_frame>Month 9 (6 months post-dose 2) and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants who received at least one study vaccination</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Any Grade 2 or Higher Hematological and Biochemical Laboratory Abnormalities From Month 9 to Month 15</title>
          <description>Hematological and biochemical parameters assessed included hemoglobin, platelets, red blood cells, white blood cells (WBC), absolute neutrophil count (ANC), lymphocytes, monocytes, eosinophils, basophils, alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, blood urea nitrogen (BUN) and BUN-to-creatinine ratio.&#xD;
Grading of laboratory parameters was based on the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (severe), or Grade 4 (Potentially life-threatening).&#xD;
Grade 2 or higher:&#xD;
BUN: &gt; 26 mg/dL&#xD;
Creatinine: &gt; 1.7 mg/dL&#xD;
ALT, AST: &gt; 2.5 × upper limit of normal (ULN)&#xD;
Hemoglobin: &lt; 11.0 g/dL (females) or &lt; 12.5 g/dL (males) or change from baseline &gt; 1.5 g/dL&#xD;
WBC: &gt; 15,000 cell/mm³ or &lt; 2,500 cell/mm³&#xD;
Lymphocytes: &lt; 750 cell/mm³&#xD;
ANC: &lt; 1,500 cell/mm³&#xD;
Eosinophils: &gt; 1,500 cell/mm³&#xD;
Platelets: &lt; 125,000 cell/mm³</description>
          <population>Participants who received at least one study vaccination</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hemoglobin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin change from baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White blood cell count</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Absolute neutrophil count</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basophils</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Red blood cells</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood urea nitrogen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BUN to creatinine ratio</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alanine aminotransferase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asparate aminotransferase</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With a Medically Attended Event (MAE), Laboratory-Confirmed Influenza-like Illness (LC-ILI), Potential Immune-mediated Disease (pIMD), or Serious Adverse Event (SAE) up to End of Study</title>
        <description>An MAE is an event for which the participant received medical attention such as hospitalization, an emergency room visit, or a visit to or from medical personnel.&#xD;
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.&#xD;
LC-ILI is defined as at least 1 systemic symptom (fever or myalgia) AND at least 1 respiratory symptom (cough or sore throat), confirmed by PCR assay.&#xD;
An SAE is an AE that met any of the following:&#xD;
Death&#xD;
Life threatening&#xD;
Required inpatient hospitalization or prolongation of existing hospitalization&#xD;
Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions&#xD;
Resulted in congenital anomaly/birth defect&#xD;
An important medical event that may jeopardize the well-being of the subject or require medical or surgical intervention to prevent an above outcome.</description>
        <time_frame>From first dose to end of study, 588 days (21 months; 18 months post-dose 2)</time_frame>
        <population>Participants who received at least one study vaccination</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Medically Attended Event (MAE), Laboratory-Confirmed Influenza-like Illness (LC-ILI), Potential Immune-mediated Disease (pIMD), or Serious Adverse Event (SAE) up to End of Study</title>
          <description>An MAE is an event for which the participant received medical attention such as hospitalization, an emergency room visit, or a visit to or from medical personnel.&#xD;
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.&#xD;
LC-ILI is defined as at least 1 systemic symptom (fever or myalgia) AND at least 1 respiratory symptom (cough or sore throat), confirmed by PCR assay.&#xD;
An SAE is an AE that met any of the following:&#xD;
Death&#xD;
Life threatening&#xD;
Required inpatient hospitalization or prolongation of existing hospitalization&#xD;
Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions&#xD;
Resulted in congenital anomaly/birth defect&#xD;
An important medical event that may jeopardize the well-being of the subject or require medical or surgical intervention to prevent an above outcome.</description>
          <population>Participants who received at least one study vaccination</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>MAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LC-ILIs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>pIMDs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants in Groups 1, 2, and 3 With Detectable Influenza A Virus in Nasal and Oropharyngeal Swabs on Days 1 to 5</title>
        <description>To detect viral shedding participants who received LAIV vaccine or intranasal sterile saline as the prime dose had nasal and oropharyngeal swabs collected on Days 1 to 5. Influenza type A virus ribonucleic acid (RNA) was detected using reverse transcription polymerase chain reaction (RT-PCR).</description>
        <time_frame>Days 1 to 5</time_frame>
        <population>Participants who received LAIV (Groups 1, 2, and 3) with evaluable samples</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants in Groups 1, 2, and 3 With Detectable Influenza A Virus in Nasal and Oropharyngeal Swabs on Days 1 to 5</title>
          <description>To detect viral shedding participants who received LAIV vaccine or intranasal sterile saline as the prime dose had nasal and oropharyngeal swabs collected on Days 1 to 5. Influenza type A virus ribonucleic acid (RNA) was detected using reverse transcription polymerase chain reaction (RT-PCR).</description>
          <population>Participants who received LAIV (Groups 1, 2, and 3) with evaluable samples</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants in Groups 1, 2, and 3 With Viable Vaccine Virus in Cell Culture Through 5 Days Post-vaccination</title>
        <description>To study virus infectivity, nasal and oropharyngeal swab specimens that tested influenza A positive by RT-PCR were further tested for viability of virus in Madin Darby canine kidney (MDCK) cell culture and stained with monoclonal antibody specific to the cH8/1N1 LAIV virus to confirm detected virus is of vaccine origin.</description>
        <time_frame>Days 1 to 5</time_frame>
        <population>Participants who received LAIV (Groups 1, 2, and 3) and tested positive for influenza A virus by RT-PCR at any time during the 5 days post LAIV dose and with evaluable samples</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants in Groups 1, 2, and 3 With Viable Vaccine Virus in Cell Culture Through 5 Days Post-vaccination</title>
          <description>To study virus infectivity, nasal and oropharyngeal swab specimens that tested influenza A positive by RT-PCR were further tested for viability of virus in Madin Darby canine kidney (MDCK) cell culture and stained with monoclonal antibody specific to the cH8/1N1 LAIV virus to confirm detected virus is of vaccine origin.</description>
          <population>Participants who received LAIV (Groups 1, 2, and 3) and tested positive for influenza A virus by RT-PCR at any time during the 5 days post LAIV dose and with evaluable samples</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Overall</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="1"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="3"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Serum Anti-H1 Hemagglutinin Stalk Immunoglobulin G Antibody Seropositivity</title>
        <description>Anti-H1 hemagglutinin (HA) stalk immunoglobulin G (IgG) was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgG antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .&#xD;
Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned. Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 65.3 EU/mL.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), Month 9 (6 months post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Serum Anti-H1 Hemagglutinin Stalk Immunoglobulin G Antibody Seropositivity</title>
          <description>Anti-H1 hemagglutinin (HA) stalk immunoglobulin G (IgG) was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgG antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .&#xD;
Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned. Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 65.3 EU/mL.</description>
          <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (pre-vaccination)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 9 (6 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titer of Serum Anti-H1 Hemagglutinin Stalk IgG Antibodies</title>
        <description>Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgG antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .&#xD;
Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned. The lower limit of quantitation (LLOQ) for the assay was 65.3 EU/mL.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), Month 9 (6 months post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titer of Serum Anti-H1 Hemagglutinin Stalk IgG Antibodies</title>
          <description>Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgG antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .&#xD;
Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned. The lower limit of quantitation (LLOQ) for the assay was 65.3 EU/mL.</description>
          <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (pre-vaccination)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11503" lower_limit="7698" upper_limit="17187"/>
                    <measurement group_id="O2" value="10213" lower_limit="6559" upper_limit="15903"/>
                    <measurement group_id="O3" value="12966" lower_limit="2459" upper_limit="68377"/>
                    <measurement group_id="O4" value="12028" lower_limit="6658" upper_limit="21729"/>
                    <measurement group_id="O5" value="8615" lower_limit="5517" upper_limit="13453"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11337" lower_limit="7790" upper_limit="16499"/>
                    <measurement group_id="O2" value="10347" lower_limit="6810" upper_limit="15721"/>
                    <measurement group_id="O3" value="11832" lower_limit="2593" upper_limit="53992"/>
                    <measurement group_id="O4" value="84207" lower_limit="63756" upper_limit="111219"/>
                    <measurement group_id="O5" value="7975" lower_limit="5317" upper_limit="11961"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62238" lower_limit="44507" upper_limit="87034"/>
                    <measurement group_id="O2" value="22073" lower_limit="14577" upper_limit="33423"/>
                    <measurement group_id="O3" value="10628" lower_limit="NA" upper_limit="5749922">&lt; LLOQ (65.3 EU/mL)</measurement>
                    <measurement group_id="O4" value="62992" lower_limit="46931" upper_limit="84549"/>
                    <measurement group_id="O5" value="9226" lower_limit="5791" upper_limit="14696"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 9 (6 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19955" lower_limit="13334" upper_limit="29863"/>
                    <measurement group_id="O2" value="10846" lower_limit="7108" upper_limit="16549"/>
                    <measurement group_id="O3" value="8364" lower_limit="NA" upper_limit="12544501">&lt; LLOQ (65.3 EU/mL)</measurement>
                    <measurement group_id="O4" value="31228" lower_limit="21153" upper_limit="46101"/>
                    <measurement group_id="O5" value="7043" lower_limit="4019" upper_limit="12345"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16046" lower_limit="10632" upper_limit="24218"/>
                    <measurement group_id="O2" value="13470" lower_limit="8300" upper_limit="21860"/>
                    <measurement group_id="O3" value="16195"/>
                    <measurement group_id="O4" value="27323" lower_limit="17736" upper_limit="42092"/>
                    <measurement group_id="O5" value="6825" lower_limit="4132" upper_limit="11272"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Adjusted Geometric Mean Titer (GMT) Ratio 28 Days Post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>GMT Ratio</param_type>
            <param_value>2.73</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.73</ci_lower_limit>
            <ci_upper_limit>4.29</ci_upper_limit>
            <estimate_desc>GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Adjusted GMT Ratio 28 Days Post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.9411</p_value>
            <method>ANCOVA</method>
            <param_type>GMT Ratio</param_type>
            <param_value>1.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.68</ci_lower_limit>
            <ci_upper_limit>1.66</ci_upper_limit>
            <estimate_desc>GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Adjusted GMT Ratio 28 Days Post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>ANCOVA</method>
            <param_type>GMT Ratio</param_type>
            <param_value>0.39</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.24</ci_lower_limit>
            <ci_upper_limit>0.62</ci_upper_limit>
            <estimate_desc>GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a ≥ 4-fold Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk IgG Antibodies</title>
        <description>Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgG antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), Month 9 (6 months post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a ≥ 4-fold Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk IgG Antibodies</title>
          <description>Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgG antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .</description>
          <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="17.6"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="70.8"/>
                    <measurement group_id="O4" value="80.0" lower_limit="51.9" upper_limit="95.7"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0" lower_limit="47.6" upper_limit="92.7"/>
                    <measurement group_id="O2" value="15.4" lower_limit="1.9" upper_limit="45.4"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="57.1" lower_limit="28.9" upper_limit="82.3"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 9 (6 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" lower_limit="0.2" upper_limit="31.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="21.4" lower_limit="4.7" upper_limit="50.8"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="33.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1" lower_limit="0.2" upper_limit="33.9"/>
                    <measurement group_id="O2" value="15.4" lower_limit="1.9" upper_limit="45.4"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="23.1" lower_limit="5.0" upper_limit="53.8"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0025</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference</param_type>
            <param_value>59.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>23.59</ci_lower_limit>
            <ci_upper_limit>81.02</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.4421</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference</param_type>
            <param_value>17.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.24</ci_lower_limit>
            <ci_upper_limit>49.00</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0461</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference</param_type>
            <param_value>-41.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-68.75</ci_lower_limit>
            <ci_upper_limit>-4.80</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk IgG Antibodies</title>
        <description>Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgG antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), Month 9 (6 months post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk IgG Antibodies</title>
          <description>Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgG antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .</description>
          <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="17.6"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="70.8"/>
                    <measurement group_id="O4" value="33.3" lower_limit="11.8" upper_limit="61.6"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0" lower_limit="7.3" upper_limit="52.4"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="14.3" lower_limit="1.8" upper_limit="42.8"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 9 (6 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="21.8"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="33.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Geometric Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk IgG Antibodies</title>
        <description>Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgG antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).&#xD;
Mean geometric increase represents the fold-rise in antibody titer from baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), Month 9 (6 months post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Geometric Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk IgG Antibodies</title>
          <description>Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgG antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).&#xD;
Mean geometric increase represents the fold-rise in antibody titer from baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
          <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>fold-rise</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0.9" upper_limit="1.0"/>
                    <measurement group_id="O2" value="1.0" lower_limit="0.9" upper_limit="1.1"/>
                    <measurement group_id="O3" value="0.9" lower_limit="0.8" upper_limit="1.1"/>
                    <measurement group_id="O4" value="7.0" lower_limit="4.3" upper_limit="11.4"/>
                    <measurement group_id="O5" value="0.9" lower_limit="0.9" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8" lower_limit="3.8" upper_limit="8.8"/>
                    <measurement group_id="O2" value="2.2" lower_limit="1.6" upper_limit="3.2"/>
                    <measurement group_id="O3" value="1.0" lower_limit="0.3" upper_limit="3.7"/>
                    <measurement group_id="O4" value="4.9" lower_limit="3.2" upper_limit="7.5"/>
                    <measurement group_id="O5" value="1.1" lower_limit="0.8" upper_limit="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 9 (6 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" lower_limit="1.4" upper_limit="2.3"/>
                    <measurement group_id="O2" value="1.1" lower_limit="0.9" upper_limit="1.4"/>
                    <measurement group_id="O3" value="0.8" lower_limit="0.6" upper_limit="1.1"/>
                    <measurement group_id="O4" value="2.4" lower_limit="1.7" upper_limit="3.5"/>
                    <measurement group_id="O5" value="0.8" lower_limit="0.6" upper_limit="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" lower_limit="1.1" upper_limit="1.9"/>
                    <measurement group_id="O2" value="1.4" lower_limit="0.9" upper_limit="2.0"/>
                    <measurement group_id="O3" value="0.8"/>
                    <measurement group_id="O4" value="2.1" lower_limit="1.5" upper_limit="3.0"/>
                    <measurement group_id="O5" value="0.8" lower_limit="0.6" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Serum Anti-H1 Hemagglutinin Stalk Immunoglobulin A Antibody Seropositivity</title>
        <description>Anti-H1 hemagglutinin stalk immunoglobulin A (IgA) was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgA antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .&#xD;
Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 1:100.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Serum Anti-H1 Hemagglutinin Stalk Immunoglobulin A Antibody Seropositivity</title>
          <description>Anti-H1 hemagglutinin stalk immunoglobulin A (IgA) was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgA antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .&#xD;
Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 1:100.</description>
          <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (pre-vaccination)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titer of Serum Anti-H1 Hemagglutinin Stalk IgA Antibodies</title>
        <description>Anti-H1 hemagglutinin stalk immunoglobulin A (IgA) was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgA antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titer of Serum Anti-H1 Hemagglutinin Stalk IgA Antibodies</title>
          <description>Anti-H1 hemagglutinin stalk immunoglobulin A (IgA) was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgA antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .</description>
          <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>titer</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (pre-vaccination)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5815" lower_limit="3281" upper_limit="10306"/>
                    <measurement group_id="O2" value="3536" lower_limit="1831" upper_limit="6826"/>
                    <measurement group_id="O3" value="6935" lower_limit="2425" upper_limit="19834"/>
                    <measurement group_id="O4" value="3408" lower_limit="1765" upper_limit="6580"/>
                    <measurement group_id="O5" value="2887" lower_limit="1754" upper_limit="4753"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6070" lower_limit="3585" upper_limit="10277"/>
                    <measurement group_id="O2" value="4781" lower_limit="2230" upper_limit="10249"/>
                    <measurement group_id="O3" value="7824" lower_limit="1280" upper_limit="47812"/>
                    <measurement group_id="O4" value="15919" lower_limit="8635" upper_limit="29347"/>
                    <measurement group_id="O5" value="3163" lower_limit="1698" upper_limit="5893"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23595" lower_limit="15414" upper_limit="36116"/>
                    <measurement group_id="O2" value="11095" lower_limit="5304" upper_limit="23210"/>
                    <measurement group_id="O3" value="7571" lower_limit="371" upper_limit="154530"/>
                    <measurement group_id="O4" value="18079" lower_limit="10319" upper_limit="31677"/>
                    <measurement group_id="O5" value="2818" lower_limit="1797" upper_limit="4417"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10267" lower_limit="5724" upper_limit="18417"/>
                    <measurement group_id="O2" value="8460" lower_limit="3625" upper_limit="19745"/>
                    <measurement group_id="O3" value="5740"/>
                    <measurement group_id="O4" value="11856" lower_limit="5992" upper_limit="23458"/>
                    <measurement group_id="O5" value="2765" lower_limit="1546" upper_limit="4945"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk IgA (Serum) Humoral Response: Adjusted GMT Ratio 28 Days Post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1665</p_value>
            <method>ANCOVA</method>
            <param_type>GMT Ratio</param_type>
            <param_value>1.71</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.84</ci_lower_limit>
            <ci_upper_limit>3.48</ci_upper_limit>
            <estimate_desc>GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk IgA (Serum) Humoral Response: Adjusted GMT Ratio 28 Days Post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.9377</p_value>
            <method>ANCOVA</method>
            <param_type>GMT Ratio</param_type>
            <param_value>1.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.55</ci_lower_limit>
            <ci_upper_limit>2.20</ci_upper_limit>
            <estimate_desc>GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Adjusted GMT Ratio 28 Days Post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.3088</p_value>
            <method>ANCOVA</method>
            <param_type>GMT Ratio</param_type>
            <param_value>0.64</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.31</ci_lower_limit>
            <ci_upper_limit>1.33</ci_upper_limit>
            <estimate_desc>GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a ≥ 4-fold Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk IgA Antibodies</title>
        <description>Anti-H1 hemagglutinin stalk immunoglobulin A (IgA) was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgA antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a ≥ 4-fold Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk IgA Antibodies</title>
          <description>Anti-H1 hemagglutinin stalk immunoglobulin A (IgA) was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgA antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .</description>
          <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="17.6"/>
                    <measurement group_id="O2" value="7.1" lower_limit="0.2" upper_limit="33.9"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="70.8"/>
                    <measurement group_id="O4" value="53.3" lower_limit="26.6" upper_limit="78.7"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.5" lower_limit="35.4" upper_limit="84.8"/>
                    <measurement group_id="O2" value="46.2" lower_limit="19.2" upper_limit="74.9"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="64.3" lower_limit="35.1" upper_limit="87.2"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.3" lower_limit="1.8" upper_limit="42.8"/>
                    <measurement group_id="O2" value="23.1" lower_limit="5.0" upper_limit="53.8"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="46.2" lower_limit="19.2" upper_limit="74.9"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.4667</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference</param_type>
            <param_value>16.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-19.85</ci_lower_limit>
            <ci_upper_limit>48.88</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&gt;0.9999</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference</param_type>
            <param_value>-1.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-34.76</ci_lower_limit>
            <ci_upper_limit>32.17</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk IgG (Serum) Humoral Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.4495</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference</param_type>
            <param_value>-18.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-51.15</ci_lower_limit>
            <ci_upper_limit>19.37</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk IgA Antibodies</title>
        <description>Anti-H1 hemagglutinin stalk immunoglobulin A (IgA) was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgA antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk IgA Antibodies</title>
          <description>Anti-H1 hemagglutinin stalk immunoglobulin A (IgA) was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgA antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .</description>
          <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="17.6"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="70.8"/>
                    <measurement group_id="O4" value="26.7" lower_limit="7.8" upper_limit="55.1"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.8" lower_limit="4.0" upper_limit="45.6"/>
                    <measurement group_id="O2" value="15.4" lower_limit="1.9" upper_limit="45.4"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="28.6" lower_limit="8.4" upper_limit="58.1"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="7.7" lower_limit="0.2" upper_limit="36.0"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Geometric Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk IgA Antibodies</title>
        <description>Anti-H1 hemagglutinin stalk immunoglobulin A (IgA) was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgA antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .&#xD;
Mean geometric increase represents the fold-rise in antibody titer from baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Geometric Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk IgA Antibodies</title>
          <description>Anti-H1 hemagglutinin stalk immunoglobulin A (IgA) was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgA antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .&#xD;
Mean geometric increase represents the fold-rise in antibody titer from baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
          <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>fold-rise</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0.9" upper_limit="1.2"/>
                    <measurement group_id="O2" value="1.4" lower_limit="1.0" upper_limit="1.8"/>
                    <measurement group_id="O3" value="1.1" lower_limit="0.5" upper_limit="2.7"/>
                    <measurement group_id="O4" value="4.7" lower_limit="2.6" upper_limit="8.5"/>
                    <measurement group_id="O5" value="1.1" lower_limit="0.9" upper_limit="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" lower_limit="2.9" upper_limit="7.9"/>
                    <measurement group_id="O2" value="3.4" lower_limit="2.0" upper_limit="5.6"/>
                    <measurement group_id="O3" value="0.9" lower_limit="0.0" upper_limit="18.9"/>
                    <measurement group_id="O4" value="5.0" lower_limit="2.8" upper_limit="9.1"/>
                    <measurement group_id="O5" value="1.0" lower_limit="0.8" upper_limit="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" lower_limit="1.2" upper_limit="2.7"/>
                    <measurement group_id="O2" value="2.6" lower_limit="1.7" upper_limit="3.8"/>
                    <measurement group_id="O3" value="0.6"/>
                    <measurement group_id="O4" value="3.1" lower_limit="1.6" upper_limit="5.9"/>
                    <measurement group_id="O5" value="1.0" lower_limit="0.7" upper_limit="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Serum Anti-H1 Hemagglutinin Stalk Neutralizing Antibody Seropositivity</title>
        <description>Anti H1 hemagglutinin stalk neutralizing antibodies were quantified using a microneutralization (MN) assay using a virus that expresses a chimeric hemagglutinin that contains an exotic HA head domain (strain A/mallard/Sweden/81/2002 [H6N1]) and the H1 stalk domain (strain A/California/04/2009 [H1N1pandemic]) and an exotic neuraminidase, N5, for which humans are generally naïve (strain: A/mallard/Sweden/86/2003 [H12N5]).&#xD;
Seropositivity rate was defined as the percentage of participants with an antibody titer of ≥ 1:10.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Serum Anti-H1 Hemagglutinin Stalk Neutralizing Antibody Seropositivity</title>
          <description>Anti H1 hemagglutinin stalk neutralizing antibodies were quantified using a microneutralization (MN) assay using a virus that expresses a chimeric hemagglutinin that contains an exotic HA head domain (strain A/mallard/Sweden/81/2002 [H6N1]) and the H1 stalk domain (strain A/California/04/2009 [H1N1pandemic]) and an exotic neuraminidase, N5, for which humans are generally naïve (strain: A/mallard/Sweden/86/2003 [H12N5]).&#xD;
Seropositivity rate was defined as the percentage of participants with an antibody titer of ≥ 1:10.</description>
          <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (pre-vaccination)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titer of Serum Anti-H1 Hemagglutinin Stalk Neutralizing Antibodies</title>
        <description>Anti H1 hemagglutinin stalk neutralizing antibodies were quantified using a microneutralization (MN) assay using a virus that expresses a chimeric hemagglutinin that contains an exotic HA head domain (strain A/mallard/Sweden/81/2002 ([H6N1]) and the H1 stalk domain (strain A/California/04/2009 ([H1N1pandemic]) and an exotic neuraminidase, N5, for which humans are generally naïve (strain: A/mallard/Sweden/86/2003 [H12N5]). The LLOQ for the assay was 1:10.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titer of Serum Anti-H1 Hemagglutinin Stalk Neutralizing Antibodies</title>
          <description>Anti H1 hemagglutinin stalk neutralizing antibodies were quantified using a microneutralization (MN) assay using a virus that expresses a chimeric hemagglutinin that contains an exotic HA head domain (strain A/mallard/Sweden/81/2002 ([H6N1]) and the H1 stalk domain (strain A/California/04/2009 ([H1N1pandemic]) and an exotic neuraminidase, N5, for which humans are generally naïve (strain: A/mallard/Sweden/86/2003 [H12N5]). The LLOQ for the assay was 1:10.</description>
          <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>titer</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (pre-vaccination)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48" lower_limit="34" upper_limit="67"/>
                    <measurement group_id="O2" value="49" lower_limit="29" upper_limit="83"/>
                    <measurement group_id="O3" value="63" lower_limit="NA" upper_limit="881">&lt; LLOQ (1:10)</measurement>
                    <measurement group_id="O4" value="58" lower_limit="36" upper_limit="93"/>
                    <measurement group_id="O5" value="43" lower_limit="25" upper_limit="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48" lower_limit="32" upper_limit="72"/>
                    <measurement group_id="O2" value="38" lower_limit="23" upper_limit="62"/>
                    <measurement group_id="O3" value="50" lower_limit="NA" upper_limit="368">&lt; LLOQ (1:10)</measurement>
                    <measurement group_id="O4" value="111" lower_limit="74" upper_limit="166"/>
                    <measurement group_id="O5" value="40" lower_limit="24" upper_limit="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="153" lower_limit="103" upper_limit="277"/>
                    <measurement group_id="O2" value="94" lower_limit="56" upper_limit="157"/>
                    <measurement group_id="O3" value="40" lower_limit="NA" upper_limit="267306">&lt; LLOQ (1:10)</measurement>
                    <measurement group_id="O4" value="138" lower_limit="96" upper_limit="197"/>
                    <measurement group_id="O5" value="37" lower_limit="24" upper_limit="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62" lower_limit="41" upper_limit="96"/>
                    <measurement group_id="O2" value="58" lower_limit="35" upper_limit="96"/>
                    <measurement group_id="O3" value="80"/>
                    <measurement group_id="O4" value="99" lower_limit="62" upper_limit="158"/>
                    <measurement group_id="O5" value="40" lower_limit="25" upper_limit="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Adjusted GMT Ratio 28 Days Post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0928</p_value>
            <method>ANCOVA</method>
            <param_type>GMT Ratio</param_type>
            <param_value>1.61</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.94</ci_lower_limit>
            <ci_upper_limit>2.77</ci_upper_limit>
            <estimate_desc>GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Adjusted GMT Ratio 28 Days Post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.4198</p_value>
            <method>ANCOVA</method>
            <param_type>GMT Ratio</param_type>
            <param_value>1.32</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.77</ci_lower_limit>
            <ci_upper_limit>2.26</ci_upper_limit>
            <estimate_desc>GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Adjusted GMT Ratio 28 Days Post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.6754</p_value>
            <method>ANCOVA</method>
            <param_type>GMT Ratio</param_type>
            <param_value>0.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.47</ci_lower_limit>
            <ci_upper_limit>1.45</ci_upper_limit>
            <estimate_desc>GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a ≥ 4-fold Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk Neutralizing Antibodies</title>
        <description>Anti H1 hemagglutinin stalk neutralizing antibodies were quantified using a microneutralization (MN) assay using a virus that expresses a chimeric hemagglutinin that contains an exotic HA head domain (strain A/mallard/Sweden/81/2002 ([H6N1]) and the H1 stalk domain (strain A/California/04/2009 ([H1N1pandemic]) and an exotic neuraminidase, N5, for which humans are generally naïve (strain: A/mallard/Sweden/86/2003 [H12N5]).</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a ≥ 4-fold Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk Neutralizing Antibodies</title>
          <description>Anti H1 hemagglutinin stalk neutralizing antibodies were quantified using a microneutralization (MN) assay using a virus that expresses a chimeric hemagglutinin that contains an exotic HA head domain (strain A/mallard/Sweden/81/2002 ([H6N1]) and the H1 stalk domain (strain A/California/04/2009 ([H1N1pandemic]) and an exotic neuraminidase, N5, for which humans are generally naïve (strain: A/mallard/Sweden/86/2003 [H12N5]).</description>
          <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3" lower_limit="0.1" upper_limit="26.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="70.8"/>
                    <measurement group_id="O4" value="20.0" lower_limit="4.3" upper_limit="48.1"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0" lower_limit="24.7" upper_limit="75.3"/>
                    <measurement group_id="O2" value="30.8" lower_limit="9.1" upper_limit="61.4"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="35.7" lower_limit="12.8" upper_limit="64.9"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1" lower_limit="0.2" upper_limit="33.9"/>
                    <measurement group_id="O2" value="15.4" lower_limit="1.9" upper_limit="45.4"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="15.4" lower_limit="1.9" upper_limit="45.4"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Seroresponse (&gt;4-Fold) Rate 28 Days Post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.4515</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference</param_type>
            <param_value>19.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-17.19</ci_lower_limit>
            <ci_upper_limit>50.49</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Seroresponse (&gt;4-Fold) Rate 28 Days Post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.4837</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference</param_type>
            <param_value>14.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-21.22</ci_lower_limit>
            <ci_upper_limit>46.19</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk MN (Serum) Assay: Seroresponse (&gt;4-Fold) Rate 28 Days Post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&gt;0.9999</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference</param_type>
            <param_value>-4.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-38.80</ci_lower_limit>
            <ci_upper_limit>30.46</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk Neutralizing Antibodies</title>
        <description>Anti H1 hemagglutinin stalk neutralizing antibodies were quantified using a microneutralization (MN) assay using a virus that expresses a chimeric hemagglutinin that contains an exotic HA head domain (strain A/mallard/Sweden/81/2002 ([H6N1]) and the H1 stalk domain (strain A/California/04/2009 ([H1N1pandemic]) and an exotic neuraminidase, N5, for which humans are generally naïve (strain: A/mallard/Sweden/86/2003 [H12N5]).</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk Neutralizing Antibodies</title>
          <description>Anti H1 hemagglutinin stalk neutralizing antibodies were quantified using a microneutralization (MN) assay using a virus that expresses a chimeric hemagglutinin that contains an exotic HA head domain (strain A/mallard/Sweden/81/2002 ([H6N1]) and the H1 stalk domain (strain A/California/04/2009 ([H1N1pandemic]) and an exotic neuraminidase, N5, for which humans are generally naïve (strain: A/mallard/Sweden/86/2003 [H12N5]).</description>
          <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="17.6"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="70.8"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="21.8"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3" lower_limit="0.2" upper_limit="30.2"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Geometric Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk Neutralizing Antibodies</title>
        <description>Anti H1 hemagglutinin stalk neutralizing antibodies were quantified using a microneutralization (MN) assay using a virus that expresses a chimeric hemagglutinin that contains an exotic HA head domain (strain A/mallard/Sweden/81/2002 [H6N1]) and the H1 stalk domain (strain A/California/04/2009 [H1N1pandemic]) and an exotic neuraminidase, N5, for which humans are generally naïve (strain: A/mallard/Sweden/86/2003 [H12N5]).&#xD;
Mean geometric increase represents the fold-rise in antibody titer from baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Geometric Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk Neutralizing Antibodies</title>
          <description>Anti H1 hemagglutinin stalk neutralizing antibodies were quantified using a microneutralization (MN) assay using a virus that expresses a chimeric hemagglutinin that contains an exotic HA head domain (strain A/mallard/Sweden/81/2002 [H6N1]) and the H1 stalk domain (strain A/California/04/2009 [H1N1pandemic]) and an exotic neuraminidase, N5, for which humans are generally naïve (strain: A/mallard/Sweden/86/2003 [H12N5]).&#xD;
Mean geometric increase represents the fold-rise in antibody titer from baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
          <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>fold-rise</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0.8" upper_limit="1.3"/>
                    <measurement group_id="O2" value="0.8" lower_limit="0.6" upper_limit="1.0"/>
                    <measurement group_id="O3" value="0.8" lower_limit="0.3" upper_limit="2.1"/>
                    <measurement group_id="O4" value="1.9" lower_limit="1.5" upper_limit="2.5"/>
                    <measurement group_id="O5" value="0.9" lower_limit="0.6" upper_limit="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" lower_limit="2.2" upper_limit="5.2"/>
                    <measurement group_id="O2" value="2.1" lower_limit="1.4" upper_limit="3.1"/>
                    <measurement group_id="O3" value="0.7" lower_limit="0.0" upper_limit="57.8"/>
                    <measurement group_id="O4" value="2.2" lower_limit="1.6" upper_limit="3.0"/>
                    <measurement group_id="O5" value="0.9" lower_limit="0.7" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" lower_limit="0.9" upper_limit="1.6"/>
                    <measurement group_id="O2" value="1.3" lower_limit="0.9" upper_limit="1.9"/>
                    <measurement group_id="O3" value="0.5"/>
                    <measurement group_id="O4" value="1.5" lower_limit="1.1" upper_limit="2.2"/>
                    <measurement group_id="O5" value="0.9" lower_limit="0.6" upper_limit="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Antibody-dependent Cell-mediated Cytotoxicity (ADCC) to the H1 Hemagglutinin Stalk</title>
        <description>Antibody-dependent cell-mediated cytotoxicity (ADCC) is an immune response leading to lysis of antibody-coated target cells by immune effector cells and is triggered by the interaction between the Fc portion of an antibody and Fc-gamma receptors expressed on immune effector cells.&#xD;
This bioluminescent assay measured antibodies to a chimeric hemagglutinin (H6 head domain and H1 stalk domain) virus that mediate ADCC activity via the Fc-receptor. ADCC activity was measured in relative luciferase units (RLU) for serial dilutions of serum samples using a plate reader.&#xD;
ADCC activity was expressed by the area under the curve (AUC) of luminescence (RLU) per serial dilution (X-fold serial dilutions).</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Antibody-dependent Cell-mediated Cytotoxicity (ADCC) to the H1 Hemagglutinin Stalk</title>
          <description>Antibody-dependent cell-mediated cytotoxicity (ADCC) is an immune response leading to lysis of antibody-coated target cells by immune effector cells and is triggered by the interaction between the Fc portion of an antibody and Fc-gamma receptors expressed on immune effector cells.&#xD;
This bioluminescent assay measured antibodies to a chimeric hemagglutinin (H6 head domain and H1 stalk domain) virus that mediate ADCC activity via the Fc-receptor. ADCC activity was measured in relative luciferase units (RLU) for serial dilutions of serum samples using a plate reader.&#xD;
ADCC activity was expressed by the area under the curve (AUC) of luminescence (RLU) per serial dilution (X-fold serial dilutions).</description>
          <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>RLU * dilution factor</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (pre-vaccination)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="321389" lower_limit="91992" upper_limit="581362"/>
                    <measurement group_id="O2" value="200649" lower_limit="30810" upper_limit="542237"/>
                    <measurement group_id="O3" value="486775" lower_limit="173346" upper_limit="566708"/>
                    <measurement group_id="O4" value="331849" lower_limit="227546" upper_limit="558058"/>
                    <measurement group_id="O5" value="109178" lower_limit="38622" upper_limit="239985"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="322530" lower_limit="70776" upper_limit="432268"/>
                    <measurement group_id="O2" value="183017" lower_limit="88548" upper_limit="457200"/>
                    <measurement group_id="O3" value="693225" lower_limit="104524" upper_limit="807975"/>
                    <measurement group_id="O4" value="869805" lower_limit="606000" upper_limit="1327125"/>
                    <measurement group_id="O5" value="103919" lower_limit="32655" upper_limit="241028"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1334738" lower_limit="875063" upper_limit="1801500"/>
                    <measurement group_id="O2" value="366815" lower_limit="188478" upper_limit="795829"/>
                    <measurement group_id="O3" value="474913" lower_limit="175000" upper_limit="774825"/>
                    <measurement group_id="O4" value="863811" lower_limit="524405" upper_limit="1521176"/>
                    <measurement group_id="O5" value="65371" lower_limit="28729" upper_limit="307257"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="334076" lower_limit="132771" upper_limit="767038"/>
                    <measurement group_id="O2" value="353639" lower_limit="74637" upper_limit="840500"/>
                    <measurement group_id="O3" value="708455" lower_limit="708455" upper_limit="708455"/>
                    <measurement group_id="O4" value="508248" lower_limit="368035" upper_limit="979896"/>
                    <measurement group_id="O5" value="130882" lower_limit="47973" upper_limit="310940"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison of Serum cH6/1 - ADCC Activity: AUC at 28 Days Post-Boost</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0031</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Difference</param_type>
            <param_value>2.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.56</ci_lower_limit>
            <ci_upper_limit>7.49</ci_upper_limit>
            <estimate_desc>Based on log10 AUC, using the Hodges-Lehmann location parameter difference back-transformed to the original scale.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of Serum cH6/1 - ADCC Activity: AUC at 28 Days Post-Boost</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.2048</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Difference</param_type>
            <param_value>1.25</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.73</ci_lower_limit>
            <ci_upper_limit>2.23</ci_upper_limit>
            <estimate_desc>Based on log10 AUC, using the Hodges-Lehmann location parameter difference back-transformed to the original scale.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of Serum cH6/1 - ADCC Activity: AUC at 28 Days Post-Boost</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0392</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Difference</param_type>
            <param_value>0.43</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.18</ci_lower_limit>
            <ci_upper_limit>1.00</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fold-Increase From Baseline in Serum ADCC to the H1 Hemagglutinin Stalk</title>
        <description>Antibody-dependent cell-mediated cytotoxicity (ADCC) is an immune response leading to lysis of antibody-coated target cells by immune effector cells and is triggered by the interaction between the Fc portion of an antibody and Fc-gamma receptors expressed on immune effector cells.&#xD;
This bioluminescent assay measured antibodies to a chimeric hemagglutinin (H6 head domain and H1 stalk domain) virus that mediate ADCC activity via the Fc-receptor. ADCC activity was measured by the area under the curve (AUC) of luminescence per serial dilution.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at Baseline and each time point. The-per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Fold-Increase From Baseline in Serum ADCC to the H1 Hemagglutinin Stalk</title>
          <description>Antibody-dependent cell-mediated cytotoxicity (ADCC) is an immune response leading to lysis of antibody-coated target cells by immune effector cells and is triggered by the interaction between the Fc portion of an antibody and Fc-gamma receptors expressed on immune effector cells.&#xD;
This bioluminescent assay measured antibodies to a chimeric hemagglutinin (H6 head domain and H1 stalk domain) virus that mediate ADCC activity via the Fc-receptor. ADCC activity was measured by the area under the curve (AUC) of luminescence per serial dilution.</description>
          <population>Participants in the per-protocol population with available data at Baseline and each time point. The-per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>fold-increase</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" lower_limit="0.77" upper_limit="1.00"/>
                    <measurement group_id="O2" value="1.1" lower_limit="0.90" upper_limit="1.35"/>
                    <measurement group_id="O3" value="1.2" lower_limit="0.60" upper_limit="1.66"/>
                    <measurement group_id="O4" value="2.4" lower_limit="1.29" upper_limit="4.59"/>
                    <measurement group_id="O5" value="1.0" lower_limit="0.58" upper_limit="1.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" lower_limit="2.22" upper_limit="14.36"/>
                    <measurement group_id="O2" value="3.8" lower_limit="1.33" upper_limit="18202.00"/>
                    <measurement group_id="O3" value="1.2" lower_limit="1.01" upper_limit="1.37"/>
                    <measurement group_id="O4" value="2.3" lower_limit="1.49" upper_limit="4.78"/>
                    <measurement group_id="O5" value="1.0" lower_limit="0.51" upper_limit="1.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" lower_limit="0.67" upper_limit="5.20"/>
                    <measurement group_id="O2" value="1.8" lower_limit="0.79" upper_limit="4.27"/>
                    <measurement group_id="O3" value="1.25" lower_limit="1.25" upper_limit="1.25"/>
                    <measurement group_id="O4" value="1.9" lower_limit="0.82" upper_limit="2.12"/>
                    <measurement group_id="O5" value="0.9" lower_limit="0.76" upper_limit="1.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison of Serum cH6/1 - ADCC Activity: Fold Increase in AUC at 28 Days Post-Boost</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.8243</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Difference</param_type>
            <param_value>1.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.14</ci_lower_limit>
            <ci_upper_limit>4.95</ci_upper_limit>
            <estimate_desc>Based on the Hodges-Lehmann location parameter difference on the log scale then back-transformed to the original scale.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of Serum cH6/1 - ADCC Activity: Fold Increase in AUC at 28 Days Post-Boost</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.2530</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Difference</param_type>
            <param_value>1.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.67</ci_lower_limit>
            <ci_upper_limit>6.06</ci_upper_limit>
            <estimate_desc>Based on the Hodges-Lehmann location parameter difference on the log scale then back-transformed to the original scale.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of Serum cH6/1 - ADCC Activity: Fold Increase in AUC at 28 Days Post-Boost</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.5654</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
            <param_type>Difference</param_type>
            <param_value>1.83</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.47</ci_lower_limit>
            <ci_upper_limit>39.92</ci_upper_limit>
            <estimate_desc>Based on the Hodges-Lehmann location parameter difference on the log scale then back-transformed to the original scale.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a ≥ 4-fold Increase From Baseline in Serum ADCC to the H1 Hemagglutinin Stalk</title>
        <description>Antibody-dependent cell-mediated cytotoxicity (ADCC) is an immune response leading to lysis of antibody-coated target cells by immune effector cells and is triggered by the interaction between the Fc portion of an antibody and Fc-gamma receptors expressed on immune effector cells.&#xD;
This bioluminescent assay measured antibodies to a chimeric hemagglutinin (H6 head domain and H1 stalk domain) virus that mediate ADCC activity via the Fc-receptor. ADCC activity was measured by the area under the curve (AUC) of luminescence per serial dilution.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at Baseline and each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a ≥ 4-fold Increase From Baseline in Serum ADCC to the H1 Hemagglutinin Stalk</title>
          <description>Antibody-dependent cell-mediated cytotoxicity (ADCC) is an immune response leading to lysis of antibody-coated target cells by immune effector cells and is triggered by the interaction between the Fc portion of an antibody and Fc-gamma receptors expressed on immune effector cells.&#xD;
This bioluminescent assay measured antibodies to a chimeric hemagglutinin (H6 head domain and H1 stalk domain) virus that mediate ADCC activity via the Fc-receptor. ADCC activity was measured by the area under the curve (AUC) of luminescence per serial dilution.</description>
          <population>Participants in the per-protocol population with available data at Baseline and each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="17.6"/>
                    <measurement group_id="O2" value="8.3" lower_limit="0.2" upper_limit="38.5"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="70.8"/>
                    <measurement group_id="O4" value="26.7" lower_limit="7.8" upper_limit="55.1"/>
                    <measurement group_id="O5" value="10.0" lower_limit="0.3" upper_limit="44.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0" lower_limit="24.7" upper_limit="75.3"/>
                    <measurement group_id="O2" value="45.5" lower_limit="16.7" upper_limit="76.6"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="42.9" lower_limit="17.7" upper_limit="71.1"/>
                    <measurement group_id="O5" value="10.0" lower_limit="0.3" upper_limit="44.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.6" lower_limit="8.4" upper_limit="58.1"/>
                    <measurement group_id="O2" value="27.3" lower_limit="6.0" upper_limit="61.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="15.4" lower_limit="1.9" upper_limit="45.4"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum ADCC to the H1 Hemagglutinin Stalk</title>
        <description>Antibody-dependent cell-mediated cytotoxicity (ADCC) is an immune response leading to lysis of antibody-coated target cells by immune effector cells and is triggered by the interaction between the Fc portion of an antibody and Fc-gamma receptors expressed on immune effector cells.&#xD;
This bioluminescent assay measured antibodies to a chimeric hemagglutinin (H6 head domain and H1 stalk domain) virus that mediate ADCC activity via the Fc-receptor. ADCC activity was measured by the area under the curve (AUC) of luminescence per serial dilution.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at Baseline and each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum ADCC to the H1 Hemagglutinin Stalk</title>
          <description>Antibody-dependent cell-mediated cytotoxicity (ADCC) is an immune response leading to lysis of antibody-coated target cells by immune effector cells and is triggered by the interaction between the Fc portion of an antibody and Fc-gamma receptors expressed on immune effector cells.&#xD;
This bioluminescent assay measured antibodies to a chimeric hemagglutinin (H6 head domain and H1 stalk domain) virus that mediate ADCC activity via the Fc-receptor. ADCC activity was measured by the area under the curve (AUC) of luminescence per serial dilution.</description>
          <population>Participants in the per-protocol population with available data at Baseline and each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="17.6"/>
                    <measurement group_id="O2" value="8.3" lower_limit="0.2" upper_limit="38.5"/>
                    <measurement group_id="O3" value="0." lower_limit="0.0" upper_limit="70.8"/>
                    <measurement group_id="O4" value="13.3" lower_limit="1.7" upper_limit="40.5"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.3" lower_limit="11.0" upper_limit="58.7"/>
                    <measurement group_id="O2" value="45.5" lower_limit="16.7" upper_limit="76.6"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="14.3" lower_limit="1.8" upper_limit="42.8"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.3" lower_limit="1.8" upper_limit="42.8"/>
                    <measurement group_id="O2" value="18.2" lower_limit="2.3" upper_limit="51.8"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="7.7" lower_limit="0.2" upper_limit="36.0"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Anti-H1 Hemagglutinin Stalk Salivary IgG Antibody Seropositivity</title>
        <description>Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgG antibodies in saliva against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).&#xD;
Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 1:10.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Anti-H1 Hemagglutinin Stalk Salivary IgG Antibody Seropositivity</title>
          <description>Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgG antibodies in saliva against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).&#xD;
Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 1:10.</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (pre-vaccination)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.4"/>
                    <measurement group_id="O2" value="84.6"/>
                    <measurement group_id="O3" value="66.7"/>
                    <measurement group_id="O4" value="86.7"/>
                    <measurement group_id="O5" value="88.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.4"/>
                    <measurement group_id="O2" value="84.6"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="87.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="88.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="91.7"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="88.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titer of Anti-H1 Hemagglutinin Stalk Salivary IgG Antibodies</title>
        <description>Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgG antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]). The LLOQ for the assay was 1:10.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titer of Anti-H1 Hemagglutinin Stalk Salivary IgG Antibodies</title>
          <description>Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgG antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]). The LLOQ for the assay was 1:10.</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>titer</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (pre-vaccination)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40" lower_limit="24" upper_limit="65"/>
                    <measurement group_id="O2" value="43" lower_limit="18" upper_limit="103"/>
                    <measurement group_id="O3" value="21" lower_limit="NA" upper_limit="520">&lt; LLOQ (1:10)</measurement>
                    <measurement group_id="O4" value="55" lower_limit="24" upper_limit="123"/>
                    <measurement group_id="O5" value="45" lower_limit="17" upper_limit="121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31" lower_limit="21" upper_limit="48"/>
                    <measurement group_id="O2" value="40" lower_limit="18" upper_limit="91"/>
                    <measurement group_id="O3" value="42" lower_limit="14" upper_limit="130"/>
                    <measurement group_id="O4" value="155" lower_limit="67" upper_limit="356"/>
                    <measurement group_id="O5" value="36" lower_limit="11" upper_limit="114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="161" lower_limit="102" upper_limit="254"/>
                    <measurement group_id="O2" value="131" lower_limit="49" upper_limit="346"/>
                    <measurement group_id="O3" value="15" lower_limit="NA" upper_limit="1153">&lt; LLOQ (1:10)</measurement>
                    <measurement group_id="O4" value="233" lower_limit="117" upper_limit="462"/>
                    <measurement group_id="O5" value="61" lower_limit="16" upper_limit="224"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67" lower_limit="32" upper_limit="142"/>
                    <measurement group_id="O2" value="51" lower_limit="22" upper_limit="114"/>
                    <measurement group_id="O3" value="35"/>
                    <measurement group_id="O4" value="168" lower_limit="76" upper_limit="372"/>
                    <measurement group_id="O5" value="43" lower_limit="16" upper_limit="119"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.8830</p_value>
            <method>ANCOVA</method>
            <param_type>GMT Ratio</param_type>
            <param_value>1.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.45</ci_lower_limit>
            <ci_upper_limit>3.27</ci_upper_limit>
            <estimate_desc>GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.9238</p_value>
            <method>ANCOVA</method>
            <param_type>GMT Ratio</param_type>
            <param_value>0.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.33</ci_lower_limit>
            <ci_upper_limit>2.26</ci_upper_limit>
            <estimate_desc>GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.6926</p_value>
            <method>ANCOVA</method>
            <param_type>GMT Ratio</param_type>
            <param_value>0.71</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.26</ci_lower_limit>
            <ci_upper_limit>1.97</ci_upper_limit>
            <estimate_desc>GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a ≥ 4-fold Increase From Baseline in Anti-H1 Hemagglutinin Stalk Salivary IgG</title>
        <description>Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgG antibodies in saliva against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a ≥ 4-fold Increase From Baseline in Anti-H1 Hemagglutinin Stalk Salivary IgG</title>
          <description>Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgG antibodies in saliva against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="19.5"/>
                    <measurement group_id="O2" value="7.7" lower_limit="0.2" upper_limit="36.0"/>
                    <measurement group_id="O3" value="33.3" lower_limit="0.8" upper_limit="90.6"/>
                    <measurement group_id="O4" value="40.0" lower_limit="16.3" upper_limit="67.7"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="36.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.3" lower_limit="26.6" upper_limit="78.7"/>
                    <measurement group_id="O2" value="41.7" lower_limit="15.2" upper_limit="72.3"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="57.1" lower_limit="28.9" upper_limit="82.3"/>
                    <measurement group_id="O5" value="12.5" lower_limit="0.3" upper_limit="52.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.1" lower_limit="5.0" upper_limit="53.8"/>
                    <measurement group_id="O2" value="9.1" lower_limit="0.2" upper_limit="41.3"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="33.3" lower_limit="9.9" upper_limit="65.1"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="36.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.7036</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference</param_type>
            <param_value>11.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-25.72</ci_lower_limit>
            <ci_upper_limit>45.82</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&gt;0.9999</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference</param_type>
            <param_value>-3.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-37.90</ci_lower_limit>
            <ci_upper_limit>31.31</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk IgG (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.6951</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference</param_type>
            <param_value>-15.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-49.56</ci_lower_limit>
            <ci_upper_limit>22.79</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Anti-H1 Hemagglutinin Stalk Salivary IgG</title>
        <description>Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgG antibodies in saliva against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Anti-H1 Hemagglutinin Stalk Salivary IgG</title>
          <description>Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgG antibodies in saliva against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="19.5"/>
                    <measurement group_id="O2" value="7.7" lower_limit="0.2" upper_limit="36.0"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="70.8"/>
                    <measurement group_id="O4" value="13.3" lower_limit="1.7" upper_limit="40.5"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="36.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.0" lower_limit="4.3" upper_limit="48.1"/>
                    <measurement group_id="O2" value="16.7" lower_limit="2.1" upper_limit="48.4"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="21.4" lower_limit="4.7" upper_limit="50.8"/>
                    <measurement group_id="O5" value="12.5" lower_limit="0.3" upper_limit="52.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7" lower_limit="0.2" upper_limit="36.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="28.5"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="25.0" lower_limit="5.5" upper_limit="57.2"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="36.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Geometric Increase of Anti-H1 Hemagglutinin Stalk Salivary IgG Antibodies</title>
        <description>Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgG antibodies in saliva against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).&#xD;
Mean geometric increase represents the fold-rise in antibody titer from baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Geometric Increase of Anti-H1 Hemagglutinin Stalk Salivary IgG Antibodies</title>
          <description>Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured IgG antibodies in saliva against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).&#xD;
Mean geometric increase represents the fold-rise in antibody titer from baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>fold-rise</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="13"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" lower_limit="0.5" upper_limit="1.1"/>
                    <measurement group_id="O2" value="0.9" lower_limit="0.5" upper_limit="1.7"/>
                    <measurement group_id="O3" value="2.0" lower_limit="0.1" upper_limit="51.6"/>
                    <measurement group_id="O4" value="2.8" lower_limit="1.2" upper_limit="6.7"/>
                    <measurement group_id="O5" value="0.8" lower_limit="0.4" upper_limit="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="2.2" upper_limit="7.3"/>
                    <measurement group_id="O2" value="3.4" lower_limit="1.6" upper_limit="6.9"/>
                    <measurement group_id="O3" value="1.2" lower_limit="0.0" upper_limit="1145.6"/>
                    <measurement group_id="O4" value="3.6" lower_limit="1.5" upper_limit="8.4"/>
                    <measurement group_id="O5" value="1.6" lower_limit="0.5" upper_limit="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="4.0"/>
                    <measurement group_id="O2" value="1.5" lower_limit="0.9" upper_limit="2.6"/>
                    <measurement group_id="O3" value="1.2"/>
                    <measurement group_id="O4" value="2.8" lower_limit="0.9" upper_limit="9.1"/>
                    <measurement group_id="O5" value="0.8" lower_limit="0.4" upper_limit="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Anti-H1 Hemagglutinin Stalk Secretory IgA Antibody Seropositivity in Saliva</title>
        <description>Anti-H1 hemagglutinin stalk secretory immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured secretory IgA antibodies antibodies (actively secreted in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).&#xD;
Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 1:4.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Anti-H1 Hemagglutinin Stalk Secretory IgA Antibody Seropositivity in Saliva</title>
          <description>Anti-H1 hemagglutinin stalk secretory immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured secretory IgA antibodies antibodies (actively secreted in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).&#xD;
Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 1:4.</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (pre-vaccination)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="9"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titer of Anti-H1 Hemagglutinin Stalk Secretory IgA Antibodies in Saliva</title>
        <description>Anti-H1 hemagglutinin stalk secretory immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured secretory IgA antibodies antibodies (actively secreted in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]). The LLOQ for the assay was 1:4.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titer of Anti-H1 Hemagglutinin Stalk Secretory IgA Antibodies in Saliva</title>
          <description>Anti-H1 hemagglutinin stalk secretory immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured secretory IgA antibodies antibodies (actively secreted in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]). The LLOQ for the assay was 1:4.</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>titer</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (pre-vaccination)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86" lower_limit="52" upper_limit="143"/>
                    <measurement group_id="O2" value="102" lower_limit="55" upper_limit="190"/>
                    <measurement group_id="O3" value="58" lower_limit="10" upper_limit="323"/>
                    <measurement group_id="O4" value="221" lower_limit="148" upper_limit="330"/>
                    <measurement group_id="O5" value="155" lower_limit="75" upper_limit="332"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80" lower_limit="48" upper_limit="133"/>
                    <measurement group_id="O2" value="118" lower_limit="72" upper_limit="193"/>
                    <measurement group_id="O3" value="77" lower_limit="NA" upper_limit="604449">&lt; LLOQ (1:4)</measurement>
                    <measurement group_id="O4" value="191" lower_limit="95" upper_limit="381"/>
                    <measurement group_id="O5" value="119" lower_limit="46" upper_limit="308"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93" lower_limit="52" upper_limit="166"/>
                    <measurement group_id="O2" value="136" lower_limit="86" upper_limit="213"/>
                    <measurement group_id="O3" value="47" lower_limit="NA" upper_limit="11552">&lt; LLOQ (1:4)</measurement>
                    <measurement group_id="O4" value="201" lower_limit="116" upper_limit="347"/>
                    <measurement group_id="O5" value="115" lower_limit="41" upper_limit="324"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97" lower_limit="42" upper_limit="224"/>
                    <measurement group_id="O2" value="109" lower_limit="56" upper_limit="213"/>
                    <measurement group_id="O3" value="87"/>
                    <measurement group_id="O4" value="190" lower_limit="115" upper_limit="314"/>
                    <measurement group_id="O5" value="105" lower_limit="37" upper_limit="294"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.3203</p_value>
            <method>ANCOVA</method>
            <param_type>GMT Ratio</param_type>
            <param_value>0.65</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.32</ci_lower_limit>
            <ci_upper_limit>1.33</ci_upper_limit>
            <estimate_desc>GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.5009</p_value>
            <method>ANCOVA</method>
            <param_type>GMT Ratio</param_type>
            <param_value>0.72</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.35</ci_lower_limit>
            <ci_upper_limit>1.47</ci_upper_limit>
            <estimate_desc>GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.9542</p_value>
            <method>ANCOVA</method>
            <param_type>GMT Ratio</param_type>
            <param_value>1.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.51</ci_lower_limit>
            <ci_upper_limit>2.37</ci_upper_limit>
            <estimate_desc>GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a ≥ 4-fold Increase From Baseline in Anti-H1 Hemagglutinin Stalk Secretory IgA Antibodies in Saliva</title>
        <description>Anti-H1 hemagglutinin stalk secretory immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured secretory IgA antibodies (actively secreted in the mucosa) against the H1 stalk domain in saliva by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a ≥ 4-fold Increase From Baseline in Anti-H1 Hemagglutinin Stalk Secretory IgA Antibodies in Saliva</title>
          <description>Anti-H1 hemagglutinin stalk secretory immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured secretory IgA antibodies (actively secreted in the mucosa) against the H1 stalk domain in saliva by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="14"/>
                <count group_id="O5" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="17.6"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="36.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" lower_limit="0.2" upper_limit="31.9"/>
                    <measurement group_id="O2" value="8.3" lower_limit="0.2" upper_limit="38.5"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="41.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.6" lower_limit="8.4" upper_limit="58.1"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="26.5"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="26.5"/>
                    <measurement group_id="O5" value="12.5" lower_limit="0.3" upper_limit="52.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&gt;0.9999</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference</param_type>
            <param_value>-1.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-30.62</ci_lower_limit>
            <ci_upper_limit>23.79</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&gt;0.9999</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference</param_type>
            <param_value>6.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-16.24</ci_lower_limit>
            <ci_upper_limit>30.34</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk Secretory IgA (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.4615</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference</param_type>
            <param_value>8.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-19.94</ci_lower_limit>
            <ci_upper_limit>36.04</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Anti-H1 Hemagglutinin Stalk Secretory IgA Antibodies in Saliva</title>
        <description>Anti-H1 hemagglutinin stalk secretory immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured secretory IgA antibodies (actively secreted in the mucosa) against the H1 stalk domain in saliva by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Anti-H1 Hemagglutinin Stalk Secretory IgA Antibodies in Saliva</title>
          <description>Anti-H1 hemagglutinin stalk secretory immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured secretory IgA antibodies (actively secreted in the mucosa) against the H1 stalk domain in saliva by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="14"/>
                <count group_id="O5" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="17.6"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="36.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" lower_limit="0.2" upper_limit="31.9"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="26.5"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="41.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.3" lower_limit="1.8" upper_limit="42.8"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="26.5"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="26.5"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="36.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Geometric Increase From Baseline in Anti-H1 Hemagglutinin Stalk Secretory IgA in Saliva</title>
        <description>Anti-H1 hemagglutinin stalk secretory immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured secretory IgA antibodies antibodies (actively secreted in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).&#xD;
Mean geometric increase represents the fold-rise in antibody titer from Baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Geometric Increase From Baseline in Anti-H1 Hemagglutinin Stalk Secretory IgA in Saliva</title>
          <description>Anti-H1 hemagglutinin stalk secretory immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured secretory IgA antibodies antibodies (actively secreted in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).&#xD;
Mean geometric increase represents the fold-rise in antibody titer from Baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>fold-rise</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="14"/>
                <count group_id="O5" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" lower_limit="0.6" upper_limit="1.4"/>
                    <measurement group_id="O2" value="1.1" lower_limit="0.7" upper_limit="1.7"/>
                    <measurement group_id="O3" value="1.3" lower_limit="1.1" upper_limit="1.6"/>
                    <measurement group_id="O4" value="0.8" lower_limit="0.4" upper_limit="1.4"/>
                    <measurement group_id="O5" value="0.7" lower_limit="0.3" upper_limit="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" lower_limit="0.5" upper_limit="1.6"/>
                    <measurement group_id="O2" value="1.4" lower_limit="0.9" upper_limit="2.3"/>
                    <measurement group_id="O3" value="1.1" lower_limit="0.3" upper_limit="5.0"/>
                    <measurement group_id="O4" value="0.9" lower_limit="0.6" upper_limit="1.3"/>
                    <measurement group_id="O5" value="0.6" lower_limit="0.3" upper_limit="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="12"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="0.5" upper_limit="2.7"/>
                    <measurement group_id="O2" value="1.1" lower_limit="0.6" upper_limit="2.3"/>
                    <measurement group_id="O3" value="1.6"/>
                    <measurement group_id="O4" value="0.9" lower_limit="0.7" upper_limit="1.3"/>
                    <measurement group_id="O5" value="0.7" lower_limit="0.2" upper_limit="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Anti-H1 Hemagglutinin Stalk Total IgA Antibody Seropositivity in Saliva</title>
        <description>Anti-H1 hemagglutinin stalk total immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured total IgA antibodies antibodies (secreted through active and passive transfer processes in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).&#xD;
Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 1:10.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Anti-H1 Hemagglutinin Stalk Total IgA Antibody Seropositivity in Saliva</title>
          <description>Anti-H1 hemagglutinin stalk total immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured total IgA antibodies antibodies (secreted through active and passive transfer processes in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).&#xD;
Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 1:10.</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (pre-vaccination)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titer of Anti-H1 Hemagglutinin Stalk Total IgA Antibodies in Saliva</title>
        <description>Anti-H1 hemagglutinin stalk total immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured total IgA antibodies antibodies (secreted through active and passive transfer processes in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]). The LLOQ for the assay was 1:10.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titer of Anti-H1 Hemagglutinin Stalk Total IgA Antibodies in Saliva</title>
          <description>Anti-H1 hemagglutinin stalk total immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured total IgA antibodies antibodies (secreted through active and passive transfer processes in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]). The LLOQ for the assay was 1:10.</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>titer</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="12"/>
                <count group_id="O5" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (pre-vaccination)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="364" lower_limit="175" upper_limit="758"/>
                    <measurement group_id="O2" value="487" lower_limit="259" upper_limit="916"/>
                    <measurement group_id="O3" value="317" lower_limit="NA" upper_limit="NA">&lt; LLOQ (1:10), 2.181^12</measurement>
                    <measurement group_id="O4" value="792" lower_limit="420" upper_limit="1494"/>
                    <measurement group_id="O5" value="541" lower_limit="252" upper_limit="1162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="369" lower_limit="198" upper_limit="687"/>
                    <measurement group_id="O2" value="685" lower_limit="408" upper_limit="1148"/>
                    <measurement group_id="O3" value="280" lower_limit="NA" upper_limit="NA">&lt; LLOQ (1:10), 3.7115^9</measurement>
                    <measurement group_id="O4" value="849" lower_limit="477" upper_limit="1509"/>
                    <measurement group_id="O5" value="321" lower_limit="81" upper_limit="1265"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="12"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="625" lower_limit="265" upper_limit="1477"/>
                    <measurement group_id="O2" value="543" lower_limit="269" upper_limit="1094"/>
                    <measurement group_id="O3" value="39"/>
                    <measurement group_id="O4" value="1149" lower_limit="662" upper_limit="1995"/>
                    <measurement group_id="O5" value="672" lower_limit="204" upper_limit="2210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="353" lower_limit="152" upper_limit="823"/>
                    <measurement group_id="O2" value="527" lower_limit="330" upper_limit="843"/>
                    <measurement group_id="O3" value="239"/>
                    <measurement group_id="O4" value="966" lower_limit="507" upper_limit="1838"/>
                    <measurement group_id="O5" value="401" lower_limit="116" upper_limit="1390"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.9164</p_value>
            <method>ANCOVA</method>
            <param_type>GMT Ratio</param_type>
            <param_value>1.20</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.38</ci_lower_limit>
            <ci_upper_limit>3.80</ci_upper_limit>
            <estimate_desc>GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.8642</p_value>
            <method>ANCOVA</method>
            <param_type>GMT Ratio</param_type>
            <param_value>0.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.21</ci_lower_limit>
            <ci_upper_limit>2.79</ci_upper_limit>
            <estimate_desc>GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Adjusted GMT Ratio 28 Days Post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.6545</p_value>
            <method>ANCOVA</method>
            <param_type>GMT Ratio</param_type>
            <param_value>0.63</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.18</ci_lower_limit>
            <ci_upper_limit>2.27</ci_upper_limit>
            <estimate_desc>GMT ratio computed after fitting an analysis of covariance (ANCOVA) model on the log10 transformed titers, including vaccine group as fixed effect and the pre-vaccination titer as covariate.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a ≥ 4-fold Increase From Baseline in Anti-H1 Hemagglutinin Stalk Total IgA Antibodies in Saliva</title>
        <description>Anti-H1 hemagglutinin stalk total immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured total IgA antibodies antibodies (secreted through active and passive transfer processes in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a ≥ 4-fold Increase From Baseline in Anti-H1 Hemagglutinin Stalk Total IgA Antibodies in Saliva</title>
          <description>Anti-H1 hemagglutinin stalk total immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured total IgA antibodies antibodies (secreted through active and passive transfer processes in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5" lower_limit="1.6" upper_limit="38.3"/>
                    <measurement group_id="O2" value="7.1" lower_limit="0.2" upper_limit="33.9"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="11.1" lower_limit="0.3" upper_limit="48.2"/>
                    <measurement group_id="O5" value="14.3" lower_limit="0.4" upper_limit="57.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.8" lower_limit="9.1" upper_limit="61.4"/>
                    <measurement group_id="O2" value="23.1" lower_limit="5.0" upper_limit="53.8"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="45.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.0" lower_limit="6.7" upper_limit="65.2"/>
                    <measurement group_id="O2" value="23.1" lower_limit="5.0" upper_limit="53.8"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                    <measurement group_id="O5" value="16.7" lower_limit="0.4" upper_limit="64.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Seroresponse (&gt;4-Fold) Rate 28 Days Post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&gt;0.9999</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference</param_type>
            <param_value>7.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-27.10</ci_lower_limit>
            <ci_upper_limit>40.96</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.1045</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference</param_type>
            <param_value>30.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.76</ci_lower_limit>
            <ci_upper_limit>58.19</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>Comparison of Anti-H1 HA-stalk Total IgA (Saliva), Mucosal Response: Seroresponse (≥4-fold) Rate 28 Days Post-Boost Dose</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.2292</p_value>
            <method>Fisher Exact</method>
            <param_type>Difference</param_type>
            <param_value>23.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.62</ci_lower_limit>
            <ci_upper_limit>50.86</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Anti-H1 Hemagglutinin Stalk Total IgA Antibodies in Saliva</title>
        <description>Anti-H1 hemagglutinin stalk total immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured total IgA antibodies antibodies (secreted through active and passive transfer processes in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Anti-H1 Hemagglutinin Stalk Total IgA Antibodies in Saliva</title>
          <description>Anti-H1 hemagglutinin stalk total immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured total IgA antibodies antibodies (secreted through active and passive transfer processes in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3" lower_limit="0.2" upper_limit="30.2"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="33.6"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="41.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7" lower_limit="0.2" upper_limit="36.0"/>
                    <measurement group_id="O2" value="7.7" lower_limit="0.2" upper_limit="36.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="45.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" lower_limit="0.3" upper_limit="44.5"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="45.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Geometric Increase From Baseline in Anti-H1 Hemagglutinin Stalk Total IgA Antibodies in Saliva</title>
        <description>Anti-H1 hemagglutinin stalk total immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured total IgA antibodies (secreted through active and passive transfer processes in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).&#xD;
Mean geometric increase represents the fold-rise in antibody titer from baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Geometric Increase From Baseline in Anti-H1 Hemagglutinin Stalk Total IgA Antibodies in Saliva</title>
          <description>Anti-H1 hemagglutinin stalk total immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).&#xD;
The ELISA measured total IgA antibodies (secreted through active and passive transfer processes in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).&#xD;
Mean geometric increase represents the fold-rise in antibody titer from baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>fold-rise</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="2"/>
                <count group_id="O4" value="11"/>
                <count group_id="O5" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="0.6" upper_limit="2.2"/>
                    <measurement group_id="O2" value="1.4" lower_limit="0.8" upper_limit="2.5"/>
                    <measurement group_id="O3" value="0.9" lower_limit="0.0" upper_limit="458.5"/>
                    <measurement group_id="O4" value="0.7" lower_limit="0.4" upper_limit="1.4"/>
                    <measurement group_id="O5" value="0.6" lower_limit="0.2" upper_limit="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" lower_limit="0.6" upper_limit="4.6"/>
                    <measurement group_id="O2" value="1.2" lower_limit="0.5" upper_limit="3.2"/>
                    <measurement group_id="O3" value="0.7"/>
                    <measurement group_id="O4" value="1.1" lower_limit="0.7" upper_limit="1.8"/>
                    <measurement group_id="O5" value="0.9" lower_limit="0.3" upper_limit="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="11"/>
                    <count group_id="O5" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" lower_limit="0.3" upper_limit="5.0"/>
                    <measurement group_id="O2" value="1.2" lower_limit="0.6" upper_limit="2.3"/>
                    <measurement group_id="O4" value="0.9" lower_limit="0.5" upper_limit="1.6"/>
                    <measurement group_id="O5" value="0.8" lower_limit="0.2" upper_limit="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Serum Anti-H2 Full-length Hemagglutinin IgG Antibody Seropositivity</title>
        <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H2, of which the stalk domain shares about 78% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H2 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on A/mallard/Netherlands/5/1999 (H2N9) HA.&#xD;
Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned. Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 22.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Serum Anti-H2 Full-length Hemagglutinin IgG Antibody Seropositivity</title>
          <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H2, of which the stalk domain shares about 78% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H2 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on A/mallard/Netherlands/5/1999 (H2N9) HA.&#xD;
Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned. Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 22.</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (pre-vaccination)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titer of Serum Anti-H2 Full-length Hemagglutinin IgG Antibodies</title>
        <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H2, of which the stalk domain shares about 78% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H2 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on A/mallard/Netherlands/5/1999 (H2N9) HA. Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titer of Serum Anti-H2 Full-length Hemagglutinin IgG Antibodies</title>
          <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H2, of which the stalk domain shares about 78% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H2 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on A/mallard/Netherlands/5/1999 (H2N9) HA. Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned.</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (pre-vaccination)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6973" lower_limit="4596" upper_limit="10578"/>
                    <measurement group_id="O2" value="6027" lower_limit="3882" upper_limit="9357"/>
                    <measurement group_id="O3" value="7354" lower_limit="4095" upper_limit="13206"/>
                    <measurement group_id="O4" value="7554" lower_limit="4005" upper_limit="14249"/>
                    <measurement group_id="O5" value="5597" lower_limit="3569" upper_limit="8776"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7079" lower_limit="4720" upper_limit="10616"/>
                    <measurement group_id="O2" value="6324" lower_limit="4106" upper_limit="9740"/>
                    <measurement group_id="O3" value="6757" lower_limit="4149" upper_limit="11002"/>
                    <measurement group_id="O4" value="67191" lower_limit="50322" upper_limit="89715"/>
                    <measurement group_id="O5" value="4971" lower_limit="3179" upper_limit="7774"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39171" lower_limit="26079" upper_limit="58833"/>
                    <measurement group_id="O2" value="13584" lower_limit="8684" upper_limit="21250"/>
                    <measurement group_id="O3" value="8348" lower_limit="1232" upper_limit="56577"/>
                    <measurement group_id="O4" value="41005" lower_limit="28395" upper_limit="59213"/>
                    <measurement group_id="O5" value="5493" lower_limit="3326" upper_limit="9072"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13289" lower_limit="8311" upper_limit="21250"/>
                    <measurement group_id="O2" value="10682" lower_limit="6480" upper_limit="17609"/>
                    <measurement group_id="O3" value="12289"/>
                    <measurement group_id="O4" value="26453" lower_limit="15699" upper_limit="44576"/>
                    <measurement group_id="O5" value="6283" lower_limit="3643" upper_limit="10836"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a ≥ 4-fold Increase From Baseline in Serum Anti-H2 Full-length Hemagglutinin IgG Antibodies</title>
        <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H2, of which the stalk domain shares about 78% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H2 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on A/mallard/Netherlands/5/1999 (H2N9) HA.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a ≥ 4-fold Increase From Baseline in Serum Anti-H2 Full-length Hemagglutinin IgG Antibodies</title>
          <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H2, of which the stalk domain shares about 78% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H2 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on A/mallard/Netherlands/5/1999 (H2N9) HA.</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="17.6"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="70.8"/>
                    <measurement group_id="O4" value="80.0" lower_limit="51.9" upper_limit="95.7"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.8" lower_limit="41.3" upper_limit="89.0"/>
                    <measurement group_id="O2" value="7.7" lower_limit="0.2" upper_limit="36.0"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="71.4" lower_limit="41.9" upper_limit="91.6"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O2" value="7.7" lower_limit="0.2" upper_limit="36.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="46.2" lower_limit="19.2" upper_limit="74.9"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum Anti-H2 Full-length Hemagglutinin IgG Antibodies</title>
        <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H2, of which the stalk domain shares about 78% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H2 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on A/mallard/Netherlands/5/1999 (H2N9) HA.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum Anti-H2 Full-length Hemagglutinin IgG Antibodies</title>
          <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H2, of which the stalk domain shares about 78% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H2 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on A/mallard/Netherlands/5/1999 (H2N9) HA.</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="17.6"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="70.8"/>
                    <measurement group_id="O4" value="53.3" lower_limit="26.6" upper_limit="78.7"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0" lower_limit="7.3" upper_limit="52.4"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="14.3" lower_limit="1.8" upper_limit="42.8"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O2" value="7.7" lower_limit="0.2" upper_limit="36.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Geometric Increase of Serum Anti-H2 Full-length Hemagglutinin IgG Antibodies</title>
        <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H2, of which the stalk domain shares about 78% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H2 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on A/mallard/Netherlands/5/1999 (H2N9) HA.&#xD;
Mean geometric increase represents the fold-rise in antibody titer from Baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Geometric Increase of Serum Anti-H2 Full-length Hemagglutinin IgG Antibodies</title>
          <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H2, of which the stalk domain shares about 78% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H2 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on A/mallard/Netherlands/5/1999 (H2N9) HA.&#xD;
Mean geometric increase represents the fold-rise in antibody titer from Baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>fold-rise</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                    <measurement group_id="O3" value="0.9" lower_limit="0.8" upper_limit="1.1"/>
                    <measurement group_id="O4" value="8.9" lower_limit="5.2" upper_limit="15.1"/>
                    <measurement group_id="O5" value="0.9" lower_limit="0.8" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8" lower_limit="4.0" upper_limit="8.5"/>
                    <measurement group_id="O2" value="2.2" lower_limit="1.7" upper_limit="2.9"/>
                    <measurement group_id="O3" value="1.1" lower_limit="0.6" upper_limit="1.9"/>
                    <measurement group_id="O4" value="5.1" lower_limit="3.2" upper_limit="8.1"/>
                    <measurement group_id="O5" value="1.0" lower_limit="0.8" upper_limit="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.7" upper_limit="2.3"/>
                    <measurement group_id="O2" value="1.8" lower_limit="1.2" upper_limit="2.6"/>
                    <measurement group_id="O3" value="1.3"/>
                    <measurement group_id="O4" value="3.3" lower_limit="2.2" upper_limit="5.0"/>
                    <measurement group_id="O5" value="1.1" lower_limit="0.9" upper_limit="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Serum Anti-H9 Full-length Hemagglutinin IgG Antibody Seropositivity</title>
        <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H9, the stalk domain of which shares about 59% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H9 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/chicken/Hong Kong/G9/1997 (H9N2) HA. Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned.&#xD;
Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 31.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Serum Anti-H9 Full-length Hemagglutinin IgG Antibody Seropositivity</title>
          <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H9, the stalk domain of which shares about 59% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H9 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/chicken/Hong Kong/G9/1997 (H9N2) HA. Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned.&#xD;
Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 31.</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (pre-vaccination)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titer of Serum Anti-H9 Full-length Hemagglutinin IgG Antibodies</title>
        <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H9, the stalk domain of which shares about 59% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H9 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/chicken/Hong Kong/G9/1997 (H9N2) HA. Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned. The LLOQ for the assay was 31 EU/mL.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titer of Serum Anti-H9 Full-length Hemagglutinin IgG Antibodies</title>
          <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H9, the stalk domain of which shares about 59% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H9 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/chicken/Hong Kong/G9/1997 (H9N2) HA. Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned. The LLOQ for the assay was 31 EU/mL.</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (pre-vaccination)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10613" lower_limit="7193" upper_limit="15660"/>
                    <measurement group_id="O2" value="8703" lower_limit="5569" upper_limit="13603"/>
                    <measurement group_id="O3" value="13257" lower_limit="2295" upper_limit="76571"/>
                    <measurement group_id="O4" value="10436" lower_limit="5654" upper_limit="19261"/>
                    <measurement group_id="O5" value="7981" lower_limit="5204" upper_limit="12240"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10610" lower_limit="7246" upper_limit="15536"/>
                    <measurement group_id="O2" value="8683" lower_limit="5540" upper_limit="13611"/>
                    <measurement group_id="O3" value="11641" lower_limit="2239" upper_limit="60530"/>
                    <measurement group_id="O4" value="37478" lower_limit="24971" upper_limit="56248"/>
                    <measurement group_id="O5" value="7477" lower_limit="5076" upper_limit="11013"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40587" lower_limit="26113" upper_limit="63083"/>
                    <measurement group_id="O2" value="16410" lower_limit="10647" upper_limit="25291"/>
                    <measurement group_id="O3" value="11081" lower_limit="NA" upper_limit="18410906">&lt; LLOQ (31 EU/mL)</measurement>
                    <measurement group_id="O4" value="41113" lower_limit="26860" upper_limit="62931"/>
                    <measurement group_id="O5" value="8244" lower_limit="5491" upper_limit="12377"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16809" lower_limit="10261" upper_limit="27536"/>
                    <measurement group_id="O2" value="12271" lower_limit="7422" upper_limit="20287"/>
                    <measurement group_id="O3" value="17996"/>
                    <measurement group_id="O4" value="24041" lower_limit="14625" upper_limit="39519"/>
                    <measurement group_id="O5" value="7593" lower_limit="4697" upper_limit="12275"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a ≥ 4-fold Increase From Baseline in Serum Anti-H9 Full-length Hemagglutinin IgG Antibodies</title>
        <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H9, the stalk domain of which shares about 59% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H9 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/chicken/Hong Kong/G9/1997 (H9N2) HA.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a ≥ 4-fold Increase From Baseline in Serum Anti-H9 Full-length Hemagglutinin IgG Antibodies</title>
          <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H9, the stalk domain of which shares about 59% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H9 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/chicken/Hong Kong/G9/1997 (H9N2) HA.</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="17.6"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="70.8"/>
                    <measurement group_id="O4" value="40.0" lower_limit="16.3" upper_limit="67.7"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.5" lower_limit="15.2" upper_limit="64.6"/>
                    <measurement group_id="O2" value="7.7" lower_limit="0.2" upper_limit="36.0"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="50.0" lower_limit="23.0" upper_limit="77.0"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1" lower_limit="0.2" upper_limit="33.9"/>
                    <measurement group_id="O2" value="7.7" lower_limit="0.2" upper_limit="36.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="23.1" lower_limit="5.0" upper_limit="53.8"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum Anti-H9 Full-length Hemagglutinin IgG Antibodies</title>
        <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H9, the stalk domain of which shares about 59% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H9 full-length(ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/chicken/Hong Kong/G9/1997 (H9N2) HA.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum Anti-H9 Full-length Hemagglutinin IgG Antibodies</title>
          <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H9, the stalk domain of which shares about 59% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H9 full-length(ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/chicken/Hong Kong/G9/1997 (H9N2) HA.</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="17.6"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="70.8"/>
                    <measurement group_id="O4" value="6.7" lower_limit="0.2" upper_limit="31.9"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3" lower_limit="0.2" upper_limit="30.2"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="7.1" lower_limit="0.2" upper_limit="33.9"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Geometric Increase of Serum Anti-H9 Full-length Hemagglutinin IgG Antibodies</title>
        <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H9, the stalk domain of which shares about 59% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H9 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/chicken/Hong Kong/G9/1997 (H9N2) HA.&#xD;
Mean geometric increase represents the fold-rise in antibody titer from Baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Geometric Increase of Serum Anti-H9 Full-length Hemagglutinin IgG Antibodies</title>
          <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H9, the stalk domain of which shares about 59% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H9 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/chicken/Hong Kong/G9/1997 (H9N2) HA.&#xD;
Mean geometric increase represents the fold-rise in antibody titer from Baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>fold-rise</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0.9" upper_limit="1.1"/>
                    <measurement group_id="O2" value="1.0" lower_limit="0.9" upper_limit="1.1"/>
                    <measurement group_id="O3" value="0.9" lower_limit="0.7" upper_limit="1.1"/>
                    <measurement group_id="O4" value="3.6" lower_limit="2.4" upper_limit="5.5"/>
                    <measurement group_id="O5" value="0.9" lower_limit="0.9" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" lower_limit="2.6" upper_limit="5.6"/>
                    <measurement group_id="O2" value="1.9" lower_limit="1.4" upper_limit="2.6"/>
                    <measurement group_id="O3" value="0.9" lower_limit="0.2" upper_limit="4.0"/>
                    <measurement group_id="O4" value="3.7" lower_limit="2.4" upper_limit="5.8"/>
                    <measurement group_id="O5" value="1.0" lower_limit="0.8" upper_limit="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" lower_limit="1.2" upper_limit="2.0"/>
                    <measurement group_id="O2" value="1.5" lower_limit="1.0" upper_limit="2.1"/>
                    <measurement group_id="O3" value="0.7"/>
                    <measurement group_id="O4" value="2.2" lower_limit="1.6" upper_limit="3.2"/>
                    <measurement group_id="O5" value="1.0" lower_limit="0.7" upper_limit="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Serum Anti-H18 Full-length Hemagglutinin IgG Antibody Seropositivity</title>
        <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin distantly related to the currently circulating influenza A/H1 viruses, subtype H18, the stalk domain of which shares about 65% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H18 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/flat-faced bat/Peru/033/10 (H18N11) HA. Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned.&#xD;
Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 42.3.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Serum Anti-H18 Full-length Hemagglutinin IgG Antibody Seropositivity</title>
          <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin distantly related to the currently circulating influenza A/H1 viruses, subtype H18, the stalk domain of which shares about 65% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H18 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/flat-faced bat/Peru/033/10 (H18N11) HA. Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned.&#xD;
Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 42.3.</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (pre-vaccination)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titer of Serum Anti-H18 Full-length Hemagglutinin IgG Antibodies</title>
        <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin distantly related to the currently circulating influenza A/H1 viruses, H18, the stalk domain of which shares about 65% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H18 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/flat-faced bat/Peru/033/10 (H18N11) HA. Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titer of Serum Anti-H18 Full-length Hemagglutinin IgG Antibodies</title>
          <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin distantly related to the currently circulating influenza A/H1 viruses, H18, the stalk domain of which shares about 65% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H18 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/flat-faced bat/Peru/033/10 (H18N11) HA. Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned.</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>EU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (pre-vaccination)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5764" lower_limit="3981" upper_limit="8345"/>
                    <measurement group_id="O2" value="5266" lower_limit="3463" upper_limit="8007"/>
                    <measurement group_id="O3" value="6142" lower_limit="2841" upper_limit="13276"/>
                    <measurement group_id="O4" value="7585" lower_limit="3822" upper_limit="15052"/>
                    <measurement group_id="O5" value="5315" lower_limit="3444" upper_limit="8201"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6030" lower_limit="4181" upper_limit="8696"/>
                    <measurement group_id="O2" value="5463" lower_limit="3560" upper_limit="8384"/>
                    <measurement group_id="O3" value="5238" lower_limit="2788" upper_limit="9843"/>
                    <measurement group_id="O4" value="30197" lower_limit="19699" upper_limit="46292"/>
                    <measurement group_id="O5" value="4977" lower_limit="3279" upper_limit="7553"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25400" lower_limit="17546" upper_limit="36770"/>
                    <measurement group_id="O2" value="9965" lower_limit="6757" upper_limit="14695"/>
                    <measurement group_id="O3" value="5178" lower_limit="297" upper_limit="90261"/>
                    <measurement group_id="O4" value="30254" lower_limit="20266" upper_limit="45165"/>
                    <measurement group_id="O5" value="5702" lower_limit="3692" upper_limit="8807"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8478" lower_limit="5693" upper_limit="12626"/>
                    <measurement group_id="O2" value="6403" lower_limit="4299" upper_limit="9538"/>
                    <measurement group_id="O3" value="6783"/>
                    <measurement group_id="O4" value="14577" lower_limit="9190" upper_limit="23121"/>
                    <measurement group_id="O5" value="4747" lower_limit="2993" upper_limit="7531"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a ≥ 4-fold Increase From Baseline in Serum Anti-H18 Full-length Hemagglutinin IgG Antibodies</title>
        <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin distantly related to the currently circulating influenza A/H1 viruses, subtype H18, the stalk domain of which shares about 65% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H18 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/flat-faced bat/Peru/033/10 (H18N11) HA.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a ≥ 4-fold Increase From Baseline in Serum Anti-H18 Full-length Hemagglutinin IgG Antibodies</title>
          <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin distantly related to the currently circulating influenza A/H1 viruses, subtype H18, the stalk domain of which shares about 65% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H18 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/flat-faced bat/Peru/033/10 (H18N11) HA.</description>
          <population>Participants in the per-protocol population with available data at each time point. The per protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="17.6"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="70.8"/>
                    <measurement group_id="O4" value="40.0" lower_limit="16.3" upper_limit="67.7"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0" lower_limit="24.7" upper_limit="75.3"/>
                    <measurement group_id="O2" value="15.4" lower_limit="1.9" upper_limit="45.4"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="50.0" lower_limit="23.0" upper_limit="77.0"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O2" value="7.7" lower_limit="0.2" upper_limit="36.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="23.1" lower_limit="5.0" upper_limit="53.8"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum Anti-H18 Full-length Hemagglutinin IgG Antibodies</title>
        <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin distantly related to the currently circulating influenza A/H1 viruses, subtype H18, the stalk domain of which shares about 65% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H18 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/flat-faced bat/Peru/033/10 (H18N11) HA.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum Anti-H18 Full-length Hemagglutinin IgG Antibodies</title>
          <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin distantly related to the currently circulating influenza A/H1 viruses, subtype H18, the stalk domain of which shares about 65% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H18 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/flat-faced bat/Peru/033/10 (H18N11) HA.</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="17.6"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="70.8"/>
                    <measurement group_id="O4" value="13.3" lower_limit="1.7" upper_limit="40.5"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0" lower_limit="7.3" upper_limit="52.4"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="14.3" lower_limit="1.8" upper_limit="42.8"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Geometric Increase of Serum Anti-H18 Full-length Hemagglutinin IgG Antibodies</title>
        <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin distantly related to the currently circulating influenza A/H1 viruses, subtype H18, the stalk domain of which shares about 65% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H18 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/flat-faced bat/Peru/033/10 (H18N11) HA.&#xD;
Mean geometric increase represents the fold-rise in antibody titer from Baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Geometric Increase of Serum Anti-H18 Full-length Hemagglutinin IgG Antibodies</title>
          <description>To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin distantly related to the currently circulating influenza A/H1 viruses, subtype H18, the stalk domain of which shares about 65% amino acid identity with the H1 vaccine stalk domain.&#xD;
Anti-H18 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/flat-faced bat/Peru/033/10 (H18N11) HA.&#xD;
Mean geometric increase represents the fold-rise in antibody titer from Baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>fold-rise</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="1.1"/>
                    <measurement group_id="O3" value="0.9" lower_limit="0.7" upper_limit="1.1"/>
                    <measurement group_id="O4" value="4.0" lower_limit="2.5" upper_limit="6.3"/>
                    <measurement group_id="O5" value="0.9" lower_limit="0.9" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" lower_limit="3.1" upper_limit="6.7"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.5" upper_limit="2.6"/>
                    <measurement group_id="O3" value="0.9" lower_limit="0.3" upper_limit="2.3"/>
                    <measurement group_id="O4" value="3.8" lower_limit="2.4" upper_limit="6.0"/>
                    <measurement group_id="O5" value="1.1" lower_limit="0.9" upper_limit="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" lower_limit="1.1" upper_limit="1.8"/>
                    <measurement group_id="O2" value="1.3" lower_limit="0.9" upper_limit="1.8"/>
                    <measurement group_id="O3" value="0.9"/>
                    <measurement group_id="O4" value="1.8" lower_limit="1.2" upper_limit="2.8"/>
                    <measurement group_id="O5" value="0.9" lower_limit="0.7" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Serum Anti-Human H1N1 Virus Neutralizing Antibody Seropositivity</title>
        <description>This assay was performed to measure the neutralizing potential of antibodies against the currently circulating human H1N1 isolate which is similar to the stalk used in study vaccines.&#xD;
Anti-human H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Singapore/GP1908/2015 (IVR-180).&#xD;
Seropositivity rate was defined as the percentage of participants with an antibody titer of ≥ 1:10.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Serum Anti-Human H1N1 Virus Neutralizing Antibody Seropositivity</title>
          <description>This assay was performed to measure the neutralizing potential of antibodies against the currently circulating human H1N1 isolate which is similar to the stalk used in study vaccines.&#xD;
Anti-human H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Singapore/GP1908/2015 (IVR-180).&#xD;
Seropositivity rate was defined as the percentage of participants with an antibody titer of ≥ 1:10.</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (pre-vaccination)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titer of Serum Anti-Human H1N1 Virus Neutralizing Antibodies</title>
        <description>This assay was performed to measure the neutralizing potential of antibodies against the currently circulating human H1N1 isolate which is similar to the stalk used in study vaccines.&#xD;
Anti-human H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Singapore/GP1908/2015 (IVR-180). The LLOQ for the assay was 1:10.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titer of Serum Anti-Human H1N1 Virus Neutralizing Antibodies</title>
          <description>This assay was performed to measure the neutralizing potential of antibodies against the currently circulating human H1N1 isolate which is similar to the stalk used in study vaccines.&#xD;
Anti-human H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Singapore/GP1908/2015 (IVR-180). The LLOQ for the assay was 1:10.</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>titer</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (pre-vaccination)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="149" lower_limit="79" upper_limit="279"/>
                    <measurement group_id="O2" value="108" lower_limit="46" upper_limit="253"/>
                    <measurement group_id="O3" value="63" lower_limit="NA" upper_limit="881">&lt; LLOQ (1:10)</measurement>
                    <measurement group_id="O4" value="84" lower_limit="47" upper_limit="148"/>
                    <measurement group_id="O5" value="98" lower_limit="38" upper_limit="259"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="172" lower_limit="89" upper_limit="332"/>
                    <measurement group_id="O2" value="113" lower_limit="45" upper_limit="285"/>
                    <measurement group_id="O3" value="50" lower_limit="NA" upper_limit="368">&lt; LLOQ (1:10)</measurement>
                    <measurement group_id="O4" value="175" lower_limit="98" upper_limit="313"/>
                    <measurement group_id="O5" value="80" lower_limit="27" upper_limit="233"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="217" lower_limit="129" upper_limit="365"/>
                    <measurement group_id="O2" value="129" lower_limit="56" upper_limit="301"/>
                    <measurement group_id="O3" value="40" lower_limit="NA" upper_limit="267306">&lt; LLOQ (1:10)</measurement>
                    <measurement group_id="O4" value="226" lower_limit="129" upper_limit="396"/>
                    <measurement group_id="O5" value="106" lower_limit="38" upper_limit="294"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="113" lower_limit="54" upper_limit="239"/>
                    <measurement group_id="O2" value="129" lower_limit="48" upper_limit="347"/>
                    <measurement group_id="O3" value="80"/>
                    <measurement group_id="O4" value="136" lower_limit="75" upper_limit="247"/>
                    <measurement group_id="O5" value="130" lower_limit="54" upper_limit="312"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a ≥ 4-fold Increase in Serum Anti-Human H1N1 Virus Neutralizing Antibodies</title>
        <description>This assay was performed to measure the neutralizing potential of antibodies against the currently circulating human H1N1 isolate which is similar to the stalk used in study vaccines.&#xD;
Anti-human H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Singapore/GP1908/2015 (IVR-180).</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a ≥ 4-fold Increase in Serum Anti-Human H1N1 Virus Neutralizing Antibodies</title>
          <description>This assay was performed to measure the neutralizing potential of antibodies against the currently circulating human H1N1 isolate which is similar to the stalk used in study vaccines.&#xD;
Anti-human H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Singapore/GP1908/2015 (IVR-180).</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3" lower_limit="0.1" upper_limit="26.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="70.8"/>
                    <measurement group_id="O4" value="20.0" lower_limit="4.3" upper_limit="48.1"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.0" lower_limit="7.3" upper_limit="52.4"/>
                    <measurement group_id="O2" value="7.7" lower_limit="0.2" upper_limit="36.0"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="28.6" lower_limit="8.4" upper_limit="58.1"/>
                    <measurement group_id="O5" value="10.0" lower_limit="0.3" upper_limit="44.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O2" value="7.7" lower_limit="0.2" upper_limit="36.0"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="15.4" lower_limit="1.9" upper_limit="45.4"/>
                    <measurement group_id="O5" value="10.0" lower_limit="0.3" upper_limit="44.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum Anti-Human H1N1 Virus Neutralizing Antibodies</title>
        <description>This assay was performed to measure the neutralizing potential of antibodies against the currently circulating human H1N1 isolate which is similar to the stalk used in study vaccines.&#xD;
Anti-human H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Singapore/GP1908/2015 (IVR-180).</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum Anti-Human H1N1 Virus Neutralizing Antibodies</title>
          <description>This assay was performed to measure the neutralizing potential of antibodies against the currently circulating human H1N1 isolate which is similar to the stalk used in study vaccines.&#xD;
Anti-human H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Singapore/GP1908/2015 (IVR-180).</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="17.6"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="70.8"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="21.8"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.3" lower_limit="0.2" upper_limit="30.2"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="7.1" lower_limit="0.2" upper_limit="33.9"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Geometric Increase of Serum Anti-Human H1N1 Virus Neutralizing Antibodies</title>
        <description>This assay was performed to measure the neutralizing potential of antibodies against the currently circulating human H1N1 isolate which is similar to the stalk used in study vaccines.&#xD;
Anti-human H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Singapore/GP1908/2015 (IVR-180).&#xD;
Mean geometric increase represents the fold-rise in antibody titer from Baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Geometric Increase of Serum Anti-Human H1N1 Virus Neutralizing Antibodies</title>
          <description>This assay was performed to measure the neutralizing potential of antibodies against the currently circulating human H1N1 isolate which is similar to the stalk used in study vaccines.&#xD;
Anti-human H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Singapore/GP1908/2015 (IVR-180).&#xD;
Mean geometric increase represents the fold-rise in antibody titer from Baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>fold-rise</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" lower_limit="0.9" upper_limit="1.5"/>
                    <measurement group_id="O2" value="1.1" lower_limit="0.9" upper_limit="1.3"/>
                    <measurement group_id="O3" value="0.8" lower_limit="0.3" upper_limit="2.1"/>
                    <measurement group_id="O4" value="2.1" lower_limit="1.4" upper_limit="3.0"/>
                    <measurement group_id="O5" value="0.8" lower_limit="0.6" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" lower_limit="1.1" upper_limit="2.8"/>
                    <measurement group_id="O2" value="1.3" lower_limit="0.9" upper_limit="1.8"/>
                    <measurement group_id="O3" value="1.0" lower_limit="NA" upper_limit="NA">Confidence interval could not be calculated as the variance was zero</measurement>
                    <measurement group_id="O4" value="2.4" lower_limit="1.6" upper_limit="3.6"/>
                    <measurement group_id="O5" value="1.1" lower_limit="0.6" upper_limit="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0.7" upper_limit="1.3"/>
                    <measurement group_id="O2" value="1.3" lower_limit="0.9" upper_limit="1.9"/>
                    <measurement group_id="O3" value="1.0"/>
                    <measurement group_id="O4" value="1.6" lower_limit="1.0" upper_limit="2.5"/>
                    <measurement group_id="O5" value="1.3" lower_limit="0.7" upper_limit="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Serum Anti-Avian-Swine H1N1 Virus Neutralizing Antibody Seropositivity</title>
        <description>This assay was performed to measure the neutralizing potential of cross-reactive antibodies to a Group 1 influenza against an H1N1 virus isolate that currently circulates in animals and is antigenically different from current human isolates.&#xD;
Anti-avian-swine H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Swine/Jiangsu/40/2011 (asH1N1).&#xD;
Seropositivity rate was defined as the percentage of participants with an antibody titer of ≥ 1:10.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Serum Anti-Avian-Swine H1N1 Virus Neutralizing Antibody Seropositivity</title>
          <description>This assay was performed to measure the neutralizing potential of cross-reactive antibodies to a Group 1 influenza against an H1N1 virus isolate that currently circulates in animals and is antigenically different from current human isolates.&#xD;
Anti-avian-swine H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Swine/Jiangsu/40/2011 (asH1N1).&#xD;
Seropositivity rate was defined as the percentage of participants with an antibody titer of ≥ 1:10.</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (pre-vaccination)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titer of Serum Anti-Avian-Swine H1N1 Virus Neutralizing Antibodies</title>
        <description>This assay was performed to measure the neutralizing potential of cross-reactive antibodies to a Group 1 influenza against an H1N1 virus isolate that currently circulates in animals and is antigenically different from current human isolates.&#xD;
Anti-avian-swine H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Swine/Jiangsu/40/2011 (asH1N1). The LLOQ for the assay was 1:10.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titer of Serum Anti-Avian-Swine H1N1 Virus Neutralizing Antibodies</title>
          <description>This assay was performed to measure the neutralizing potential of cross-reactive antibodies to a Group 1 influenza against an H1N1 virus isolate that currently circulates in animals and is antigenically different from current human isolates.&#xD;
Anti-avian-swine H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Swine/Jiangsu/40/2011 (asH1N1). The LLOQ for the assay was 1:10.</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>titer</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (pre-vaccination)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54" lower_limit="35" upper_limit="83"/>
                    <measurement group_id="O2" value="46" lower_limit="26" upper_limit="84"/>
                    <measurement group_id="O3" value="63" lower_limit="NA" upper_limit="881">&lt; LLOQ (1:10)</measurement>
                    <measurement group_id="O4" value="73" lower_limit="42" upper_limit="128"/>
                    <measurement group_id="O5" value="61" lower_limit="26" upper_limit="142"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56" lower_limit="34" upper_limit="90"/>
                    <measurement group_id="O2" value="54" lower_limit="29" upper_limit="100"/>
                    <measurement group_id="O3" value="63" lower_limit="NA" upper_limit="881">&lt; LLOQ (1:10)</measurement>
                    <measurement group_id="O4" value="127" lower_limit="79" upper_limit="204"/>
                    <measurement group_id="O5" value="46" lower_limit="20" upper_limit="106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="141" lower_limit="95" upper_limit="207"/>
                    <measurement group_id="O2" value="72" lower_limit="40" upper_limit="130"/>
                    <measurement group_id="O3" value="40" lower_limit="NA" upper_limit="267306">&lt; LLOQ (1:10)</measurement>
                    <measurement group_id="O4" value="195" lower_limit="131" upper_limit="290"/>
                    <measurement group_id="O5" value="57" lower_limit="25" upper_limit="128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69" lower_limit="42" upper_limit="114"/>
                    <measurement group_id="O2" value="58" lower_limit="31" upper_limit="109"/>
                    <measurement group_id="O3" value="80"/>
                    <measurement group_id="O4" value="94" lower_limit="61" upper_limit="143"/>
                    <measurement group_id="O5" value="70" lower_limit="34" upper_limit="145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a ≥ 4-fold Increase in Serum Anti-Avian-Swine H1N1 Virus Neutralizing Antibodies</title>
        <description>This assay was performed to measure the neutralizing potential of cross-reactive antibodies to a Group 1 influenza against an H1N1 virus isolate that currently circulates in animals and is antigenically different from current human isolates.&#xD;
Anti-avian-swine H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Swine/Jiangsu/40/2011 (asH1N1).</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a ≥ 4-fold Increase in Serum Anti-Avian-Swine H1N1 Virus Neutralizing Antibodies</title>
          <description>This assay was performed to measure the neutralizing potential of cross-reactive antibodies to a Group 1 influenza against an H1N1 virus isolate that currently circulates in animals and is antigenically different from current human isolates.&#xD;
Anti-avian-swine H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Swine/Jiangsu/40/2011 (asH1N1).</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="17.6"/>
                    <measurement group_id="O2" value="7.1" lower_limit="0.2" upper_limit="33.9"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="70.8"/>
                    <measurement group_id="O4" value="20.0" lower_limit="4.3" upper_limit="48.1"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.5" lower_limit="15.2" upper_limit="64.6"/>
                    <measurement group_id="O2" value="7.7" lower_limit="0.2" upper_limit="36.0"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="28.6" lower_limit="8.4" upper_limit="58.1"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.3" lower_limit="1.8" upper_limit="42.8"/>
                    <measurement group_id="O2" value="15.4" lower_limit="1.9" upper_limit="45.4"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="7.7" lower_limit="0.2" upper_limit="36.0"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a ≥ 10-fold Increase in Serum Anti-Avian-Swine H1N1 Virus Neutralizing Antibodies</title>
        <description>This assay was performed to measure the neutralizing potential of cross-reactive antibodies to a Group 1 influenza against an H1N1 virus isolate that currently circulates in animals and is antigenically different from current human isolates.&#xD;
Anti-avian-swine H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Swine/Jiangsu/40/2011 (asH1N1).</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a ≥ 10-fold Increase in Serum Anti-Avian-Swine H1N1 Virus Neutralizing Antibodies</title>
          <description>This assay was performed to measure the neutralizing potential of cross-reactive antibodies to a Group 1 influenza against an H1N1 virus isolate that currently circulates in animals and is antigenically different from current human isolates.&#xD;
Anti-avian-swine H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Swine/Jiangsu/40/2011 (asH1N1).</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="17.6"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="70.8"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="21.8"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="20.6"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Geometric Increase From Baseline in Serum Anti-Avian-Swine H1N1 Virus Neutralizing Antibodies</title>
        <description>This assay was performed to measure the neutralizing potential of cross-reactive antibodies to a Group 1 influenza against an H1N1 virus isolate that currently circulates in animals and is antigenically different from current human isolates.&#xD;
Anti-avian-swine H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Swine/Jiangsu/40/2011 (asH1N1).&#xD;
Mean geometric increase represents the fold-rise in antibody titer from Baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Geometric Increase From Baseline in Serum Anti-Avian-Swine H1N1 Virus Neutralizing Antibodies</title>
          <description>This assay was performed to measure the neutralizing potential of cross-reactive antibodies to a Group 1 influenza against an H1N1 virus isolate that currently circulates in animals and is antigenically different from current human isolates.&#xD;
Anti-avian-swine H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Swine/Jiangsu/40/2011 (asH1N1).&#xD;
Mean geometric increase represents the fold-rise in antibody titer from Baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>fold-rise</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0.8" upper_limit="1.3"/>
                    <measurement group_id="O2" value="1.2" lower_limit="0.8" upper_limit="1.7"/>
                    <measurement group_id="O3" value="1.0" lower_limit="NA" upper_limit="NA">Confidence interval could not be calculated as the variance was zero</measurement>
                    <measurement group_id="O4" value="1.7" lower_limit="1.3" upper_limit="2.4"/>
                    <measurement group_id="O5" value="0.8" lower_limit="0.6" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" lower_limit="1.8" upper_limit="4.3"/>
                    <measurement group_id="O2" value="1.6" lower_limit="1.1" upper_limit="2.3"/>
                    <measurement group_id="O3" value="1.0" lower_limit="NA" upper_limit="NA">Confidence interval could not be calculated as the variance was zero</measurement>
                    <measurement group_id="O4" value="2.4" lower_limit="1.7" upper_limit="3.5"/>
                    <measurement group_id="O5" value="0.9" lower_limit="0.7" upper_limit="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" lower_limit="1.0" upper_limit="2.0"/>
                    <measurement group_id="O2" value="1.3" lower_limit="0.8" upper_limit="2.0"/>
                    <measurement group_id="O3" value="1.0"/>
                    <measurement group_id="O4" value="1.3" lower_limit="0.9" upper_limit="1.8"/>
                    <measurement group_id="O5" value="1.1" lower_limit="0.8" upper_limit="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Serum Anti-H5N8 Virus Neutralizing Antibody Seropositivity</title>
        <description>This assay was performed to measure the induction of antibodies reactive against the head domain of a group 1 influenza virus with a heterosubtypic hemagglutinin from a recent avian influenza virus. Anti-H5N8 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using a reverse genetics (RG) reassortant virus based on Puerto Rico (PR)/8 for 6 genes with 2 surface proteins: HA and neuraminidase (NA) from A/Gyrfalcon/Washington/41088-6/2014 (H5N8).&#xD;
Seropositivity rate was defined as the percentage of participants with an antibody titer of ≥ 1:10.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Serum Anti-H5N8 Virus Neutralizing Antibody Seropositivity</title>
          <description>This assay was performed to measure the induction of antibodies reactive against the head domain of a group 1 influenza virus with a heterosubtypic hemagglutinin from a recent avian influenza virus. Anti-H5N8 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using a reverse genetics (RG) reassortant virus based on Puerto Rico (PR)/8 for 6 genes with 2 surface proteins: HA and neuraminidase (NA) from A/Gyrfalcon/Washington/41088-6/2014 (H5N8).&#xD;
Seropositivity rate was defined as the percentage of participants with an antibody titer of ≥ 1:10.</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (pre-vaccination)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="100"/>
                    <measurement group_id="O4" value="100"/>
                    <measurement group_id="O5" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titer of Serum Anti-H5N8 Virus Neutralizing Antibodies</title>
        <description>This assay was performed to measure the induction of antibodies reactive against the head domain of a group 1 influenza virus with a heterosubtypic hemagglutinin from a recent avian influenza virus. Anti-H5N8 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using a reverse genetics (RG) reassortant virus based on PR8 for 6 genes with 2 surface proteins: HA and NA from A/Gyrfalcon/Washington/41088-6/2014 (H5N8). The LLOQ for the assay was 1:10.</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titer of Serum Anti-H5N8 Virus Neutralizing Antibodies</title>
          <description>This assay was performed to measure the induction of antibodies reactive against the head domain of a group 1 influenza virus with a heterosubtypic hemagglutinin from a recent avian influenza virus. Anti-H5N8 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using a reverse genetics (RG) reassortant virus based on PR8 for 6 genes with 2 surface proteins: HA and NA from A/Gyrfalcon/Washington/41088-6/2014 (H5N8). The LLOQ for the assay was 1:10.</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>titer</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (pre-vaccination)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37" lower_limit="29" upper_limit="48"/>
                    <measurement group_id="O2" value="30" lower_limit="23" upper_limit="38"/>
                    <measurement group_id="O3" value="40" lower_limit="NA" upper_limit="224">&lt; LLOQ (1:10)</measurement>
                    <measurement group_id="O4" value="35" lower_limit="26" upper_limit="47"/>
                    <measurement group_id="O5" value="28" lower_limit="22" upper_limit="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36" lower_limit="27" upper_limit="47"/>
                    <measurement group_id="O2" value="27" lower_limit="21" upper_limit="35"/>
                    <measurement group_id="O3" value="50" lower_limit="NA" upper_limit="699">&lt; LLOQ (1:10)</measurement>
                    <measurement group_id="O4" value="55" lower_limit="40" upper_limit="76"/>
                    <measurement group_id="O5" value="26" lower_limit="20" upper_limit="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62" lower_limit="43" upper_limit="88"/>
                    <measurement group_id="O2" value="47" lower_limit="37" upper_limit="60"/>
                    <measurement group_id="O3" value="57" lower_limit="NA" upper_limit="30902821">&lt; LLOQ (1:10)</measurement>
                    <measurement group_id="O4" value="66" lower_limit="49" upper_limit="88"/>
                    <measurement group_id="O5" value="30" lower_limit="20" upper_limit="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42" lower_limit="29" upper_limit="61"/>
                    <measurement group_id="O2" value="34" lower_limit="25" upper_limit="46"/>
                    <measurement group_id="O3" value="20"/>
                    <measurement group_id="O4" value="55" lower_limit="38" upper_limit="80"/>
                    <measurement group_id="O5" value="30" lower_limit="20" upper_limit="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a ≥ 4-fold Increase in Serum Anti-H5N8 Virus Neutralizing Antibodies</title>
        <description>This assay was performed to measure the induction of antibodies reactive against the head domain of a group 1 influenza virus with a heterosubtypic hemagglutinin from a recent avian influenza virus. Anti-H5N8 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using a reverse genetics (RG) reassortant virus based on PR8 for 6 genes with 2 surface proteins: HA and NA from A/Gyrfalcon/Washington/41088-6/2014 (H5N8).</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a ≥ 4-fold Increase in Serum Anti-H5N8 Virus Neutralizing Antibodies</title>
          <description>This assay was performed to measure the induction of antibodies reactive against the head domain of a group 1 influenza virus with a heterosubtypic hemagglutinin from a recent avian influenza virus. Anti-H5N8 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using a reverse genetics (RG) reassortant virus based on PR8 for 6 genes with 2 surface proteins: HA and NA from A/Gyrfalcon/Washington/41088-6/2014 (H5N8).</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="17.6"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="70.8"/>
                    <measurement group_id="O4" value="6.7" lower_limit="0.2" upper_limit="31.9"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5" lower_limit="1.6" upper_limit="38.3"/>
                    <measurement group_id="O2" value="15.4" lower_limit="1.9" upper_limit="45.4"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="14.3" lower_limit="1.8" upper_limit="42.8"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O2" value="15.4" lower_limit="1.9" upper_limit="45.4"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a ≥ 10-fold Increase in Serum Anti-H5N8 Virus Neutralizing Antibodies</title>
        <description>This assay was performed to measure the induction of antibodies reactive against the head domain of a group 1 influenza virus with a heterosubtypic hemagglutinin from a recent avian influenza virus. Anti-H5N8 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using a reverse genetics (RG) reassortant virus based on PR8 for 6 genes with 2 surface proteins: HA and NA from A/Gyrfalcon/Washington/41088-6/2014 (H5N8).</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a ≥ 10-fold Increase in Serum Anti-H5N8 Virus Neutralizing Antibodies</title>
          <description>This assay was performed to measure the induction of antibodies reactive against the head domain of a group 1 influenza virus with a heterosubtypic hemagglutinin from a recent avian influenza virus. Anti-H5N8 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using a reverse genetics (RG) reassortant virus based on PR8 for 6 genes with 2 surface proteins: HA and NA from A/Gyrfalcon/Washington/41088-6/2014 (H5N8).</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="17.6"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="70.8"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="21.8"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="20.6"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O3" value="0.0" lower_limit="0.0" upper_limit="84.2"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="23.2"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O3" value="0.0"/>
                    <measurement group_id="O4" value="0.0" lower_limit="0.0" upper_limit="24.7"/>
                    <measurement group_id="O5" value="0.0" lower_limit="0.0" upper_limit="30.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Geometric Increase From Baseline in Serum Anti-H5N8 Virus Neutralizing Antibodies</title>
        <description>This assay was performed to measure the induction of antibodies reactive against the head domain of a group 1 influenza virus with a heterosubtypic hemagglutinin from a recent avian influenza virus. Anti-H5N8 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using a reverse genetics (RG) reassortant virus based on PR8 for 6 genes with 2 surface proteins: HA and NA from A/Gyrfalcon/Washington/41088-6/2014 (H5N8).&#xD;
Mean geometric increase represents the fold-rise in antibody titer from Baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
        <time_frame>Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)</time_frame>
        <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
            <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: Placebo</title>
            <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
            <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: Placebo</title>
            <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Geometric Increase From Baseline in Serum Anti-H5N8 Virus Neutralizing Antibodies</title>
          <description>This assay was performed to measure the induction of antibodies reactive against the head domain of a group 1 influenza virus with a heterosubtypic hemagglutinin from a recent avian influenza virus. Anti-H5N8 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using a reverse genetics (RG) reassortant virus based on PR8 for 6 genes with 2 surface proteins: HA and NA from A/Gyrfalcon/Washington/41088-6/2014 (H5N8).&#xD;
Mean geometric increase represents the fold-rise in antibody titer from Baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).</description>
          <population>Participants in the per-protocol population with available data at each time point. The per-protocol population included all participants who received at least 1 vaccination and with no major deviations, including those considered likely to affect the immune response; data were included up to the time of the observed deviation event.</population>
          <units>fold-rise</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
                <count group_id="O2" value="14"/>
                <count group_id="O3" value="3"/>
                <count group_id="O4" value="15"/>
                <count group_id="O5" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 (28 days post-dose 1)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="14"/>
                    <count group_id="O3" value="3"/>
                    <count group_id="O4" value="15"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="0.8" upper_limit="1.1"/>
                    <measurement group_id="O2" value="0.9" lower_limit="0.8" upper_limit="1.0"/>
                    <measurement group_id="O3" value="1.3" lower_limit="0.5" upper_limit="3.4"/>
                    <measurement group_id="O4" value="1.6" lower_limit="1.3" upper_limit="2.0"/>
                    <measurement group_id="O5" value="0.9" lower_limit="0.8" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 (28 days post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="2"/>
                    <count group_id="O4" value="14"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" lower_limit="1.3" upper_limit="2.3"/>
                    <measurement group_id="O2" value="1.6" lower_limit="1.2" upper_limit="2.2"/>
                    <measurement group_id="O3" value="1.4" lower_limit="0.0" upper_limit="115.6"/>
                    <measurement group_id="O4" value="1.9" lower_limit="1.5" upper_limit="2.4"/>
                    <measurement group_id="O5" value="1.1" lower_limit="0.7" upper_limit="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 15 (12 months post-dose 2)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="14"/>
                    <count group_id="O2" value="13"/>
                    <count group_id="O3" value="1"/>
                    <count group_id="O4" value="13"/>
                    <count group_id="O5" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="0.8" upper_limit="1.4"/>
                    <measurement group_id="O2" value="1.2" lower_limit="0.8" upper_limit="1.8"/>
                    <measurement group_id="O3" value="1.0"/>
                    <measurement group_id="O4" value="1.5" lower_limit="1.2" upper_limit="1.9"/>
                    <measurement group_id="O5" value="1.1" lower_limit="0.8" upper_limit="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All-cause mortality and serious adverse events were recorded through the end of study, 588 days (21 months). Other adverse events were collected through 28 days after each vaccination (Days 1 to 28 and Days 85 to 113)</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + Adjuvant</title>
          <description>Participants received 0.5 mL cH8/1N1 live-attenuated influenza virus vaccine (LAIV) administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 inactivated influenza virus vaccine (IIV) administered as an intramuscular injection on Day 85.</description>
        </group>
        <group group_id="E2">
          <title>Group 2: cH8/1N1 LAIV and cH5/1N1 IIV</title>
          <description>Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
        </group>
        <group group_id="E3">
          <title>Group 3: Placebo</title>
          <description>Participants received 0.5 mL normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.</description>
        </group>
        <group group_id="E4">
          <title>Group 4: cH8/1N1 IIV + Adjuvant and cH5/1N1 IIV + Adjuvant</title>
          <description>Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.</description>
        </group>
        <group group_id="E5">
          <title>Group 5: Placebo</title>
          <description>Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Upper gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Abortion spontaneous</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="5" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymph node pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Photophobia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vision blurred</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacterial vaginosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Cervicitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Vulvovaginal pruritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nasal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Nasal mucosal disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pharyngeal erythema</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Pruritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="15"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Jorge Flores, MD</name_or_title>
      <organization>PATH</organization>
      <phone>(202) 822-0033</phone>
      <email>jeflores@path.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03300050
org study id: CVIA 057 (1082166-1)
nct id: NCT03300050
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The clinical study will evaluate safety and the immune response of a prime- boost regimen
      with a live attenuated influenza vaccine (LAIV) prime and an inactivated split influenza
      vaccine (IIV) boost with or without adjuvant.
This is a prospective, multi-center, randomized, controlled, observer-blind, Phase 1 trial in
      healthy male and female adults 18 through 39 years of age to evaluate safety and the immune
      response of a prime boost regimen with LAIV prime and IIV boost with or without adjuvant.
      Participants will be randomized 4:3:1:3:2 to one of five groups to receive a first dose of
      study cH8/1N1 LAIV (or placebo) or study cH8/1N1 IIV + AS03A adjuvant (or placebo) followed
      three months later by study cH5/1N1 IIV +/- AS03A adjuvant (or placebo).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Eligible enrolled subjects will be randomized to any of the treatment arms (LAIV-IIV, Groups 1, 2, and 3; or IIV-IIV, Groups 4 and 5) under one allocation sequence, stratified by site, to allow comparability between study groups, such as LAIV-IIV vs IIV-IIV regimens (Groups 1 vs 4). Groups 1-3 will be inpatient and receive either LAIV or placebo as nasal drops at Dose 1. Groups 4-5 ill be outpatient and receive either IIV or placebo as an injection at Dose 1.
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
masking description: An unblinded pharmacist will prepare Dose 1 and Dose 2. Participants and study staff will remain blinded to their exact treatment group but will be unblinded to their overall group allocation (inpatient or outpatient).
measure: Number of Participants With Solicited Local Reactions Within 7 Days Following Each Vaccination
time frame: 7 days after each vaccination (Days 1-8 and Days 85-92)
description: Solicited adverse events were assessed by study staff for 60 minutes after each vaccination and and then by study participants daily for 7 days on a a diary card.
Solicited local reactions included:
Post LAIV dose: nasal congestion, rhinorrhea;
Post IIV dose: pain, redness, swelling.
measure: Number of Participants With Solicited General Reactions Within 7 Days Following Each Vaccination
time frame: 7 days after each vaccination (Days 1-8 and Days 85-92)
description: Solicited adverse events were assessed by study staff for 60 minutes after each vaccination and and then by study participants daily for 7 days on a a diary card.
Solicited general reactions included:
abdominal pain
arthralgia
cough
diarrhea
fatigue
fever
headache
myalgia
nausea
shivering
sore throat
vomiting
wheezing
measure: Number of Participants With Unsolicited Adverse Events Within 28 Days Following Any Vaccination
time frame: 28 days after each vaccination (Days 1 to 28 and Days 85 to 113)
description: Unsolicited adverse events (AEs) are any AEs reported spontaneously by the participant, observed by the study personnel during study visits or those identified during review of medical records or source documents, such as diary cards. Participants were asked to record any unsolicited symptoms or other illness description in their diary card during the 28 days after each vaccination.
All AEs, including clinical laboratory test results, were assessed by a study clinician and the study subject (as applicable) to quantify severity using a protocol-defined grading system as mild (mild symptoms, easily tolerated, not interfering with daily activities), moderate (causing some interference with daily activity), or severe (severe symptoms that prevent normal every day activities).
The investigator assessed the relationship between study vaccines and the occurrence of each AE using clinical judgment.
measure: Number of Participants With Grade 2 or Higher Hematological and Biochemical Laboratory Abnormalities From Day 8 to Day 113
time frame: Days 8, 29, 85, 92, and 113
description: Hematological and biochemical parameters assessed included hemoglobin, platelets, red blood cells, white blood cells (WBC), absolute neutrophil count (ANC), lymphocytes, monocytes, eosinophils, basophils, alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, blood urea nitrogen (BUN) and BUN-to-creatinine ratio.
Grading of laboratory parameters was based on the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (severe), or Grade 4 (Potentially life-threatening).
Grade 2 or higher:
BUN: > 26 mg/dL
Creatinine: > 1.7 mg/dL
ALT, AST: > 2.5 × upper limit of normal (ULN)
Hemoglobin: < 11.0 g/dL (females) or < 12.5 g/dL (males) or change from baseline > 1.5 g/dL
WBC: > 15,000 cell/mm³ or < 2,500 cell/mm³
Lymphocytes: < 750 cell/mm³
ANC: < 1,500 cell/mm³
Eosinophils: > 1,500 cell/mm³
Platelets: < 125,000 cell/mm³
measure: Number of Participants With a Medically Attended Event (MAE), Laboratory-Confirmed Influenza-like Illness (LC-ILI), Potential Immune-mediated Disease (pIMD), or Serious Adverse Event (SAE) up to Day 113
time frame: Through Day 113 (28 days post-dose 2)
description: An MAE is an event for which the participant received medical attention such as hospitalization, an emergency room visit, or a visit to or from medical personnel.
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
LC-ILI is defined as at least 1 systemic symptom (fever or myalgia) AND at least 1 respiratory symptom (cough or sore throat), confirmed by polymerase chain reaction (PCR) assay.
An SAE is an AE that met any of the following:
Death
Life threatening
Required inpatient hospitalization or prolongation of existing hospitalization
Results in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
Results in congenital anomaly/birth defect
An important medical event that may jeopardize the well-being of the subject or require medical or surgical intervention to prevent an above outcome.
measure: Number of Participants With Any Grade 2 or Higher Hematological and Biochemical Laboratory Abnormalities From Month 9 to Month 15
time frame: Month 9 (6 months post-dose 2) and Month 15 (12 months post-dose 2)
description: Hematological and biochemical parameters assessed included hemoglobin, platelets, red blood cells, white blood cells (WBC), absolute neutrophil count (ANC), lymphocytes, monocytes, eosinophils, basophils, alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, blood urea nitrogen (BUN) and BUN-to-creatinine ratio.
Grading of laboratory parameters was based on the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (severe), or Grade 4 (Potentially life-threatening).
Grade 2 or higher:
BUN: > 26 mg/dL
Creatinine: > 1.7 mg/dL
ALT, AST: > 2.5 × upper limit of normal (ULN)
Hemoglobin: < 11.0 g/dL (females) or < 12.5 g/dL (males) or change from baseline > 1.5 g/dL
WBC: > 15,000 cell/mm³ or < 2,500 cell/mm³
Lymphocytes: < 750 cell/mm³
ANC: < 1,500 cell/mm³
Eosinophils: > 1,500 cell/mm³
Platelets: < 125,000 cell/mm³
measure: Number of Participants With a Medically Attended Event (MAE), Laboratory-Confirmed Influenza-like Illness (LC-ILI), Potential Immune-mediated Disease (pIMD), or Serious Adverse Event (SAE) up to End of Study
time frame: From first dose to end of study, 588 days (21 months; 18 months post-dose 2)
description: An MAE is an event for which the participant received medical attention such as hospitalization, an emergency room visit, or a visit to or from medical personnel.
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
LC-ILI is defined as at least 1 systemic symptom (fever or myalgia) AND at least 1 respiratory symptom (cough or sore throat), confirmed by PCR assay.
An SAE is an AE that met any of the following:
Death
Life threatening
Required inpatient hospitalization or prolongation of existing hospitalization
Resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions
Resulted in congenital anomaly/birth defect
An important medical event that may jeopardize the well-being of the subject or require medical or surgical intervention to prevent an above outcome.
measure: Number of Participants in Groups 1, 2, and 3 With Detectable Influenza A Virus in Nasal and Oropharyngeal Swabs on Days 1 to 5
time frame: Days 1 to 5
description: To detect viral shedding participants who received LAIV vaccine or intranasal sterile saline as the prime dose had nasal and oropharyngeal swabs collected on Days 1 to 5. Influenza type A virus ribonucleic acid (RNA) was detected using reverse transcription polymerase chain reaction (RT-PCR).
measure: Number of Participants in Groups 1, 2, and 3 With Viable Vaccine Virus in Cell Culture Through 5 Days Post-vaccination
time frame: Days 1 to 5
description: To study virus infectivity, nasal and oropharyngeal swab specimens that tested influenza A positive by RT-PCR were further tested for viability of virus in Madin Darby canine kidney (MDCK) cell culture and stained with monoclonal antibody specific to the cH8/1N1 LAIV virus to confirm detected virus is of vaccine origin.
measure: Percentage of Participants With Serum Anti-H1 Hemagglutinin Stalk Immunoglobulin G Antibody Seropositivity
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), Month 9 (6 months post-dose 2), and Month 15 (12 months post-dose 2)
description: Anti-H1 hemagglutinin (HA) stalk immunoglobulin G (IgG) was quantified using an enzyme-linked immunosorbent assay (ELISA).
The ELISA measured IgG antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .
Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned. Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 65.3 EU/mL.
measure: Geometric Mean Titer of Serum Anti-H1 Hemagglutinin Stalk IgG Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), Month 9 (6 months post-dose 2), and Month 15 (12 months post-dose 2)
description: Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) was quantified using an enzyme-linked immunosorbent assay (ELISA).
The ELISA measured IgG antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .
Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned. The lower limit of quantitation (LLOQ) for the assay was 65.3 EU/mL.
measure: Percentage of Participants With a ≥ 4-fold Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk IgG Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), Month 9 (6 months post-dose 2), and Month 15 (12 months post-dose 2)
description: Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) was quantified using an enzyme-linked immunosorbent assay (ELISA).
The ELISA measured IgG antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .
measure: Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk IgG Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), Month 9 (6 months post-dose 2), and Month 15 (12 months post-dose 2)
description: Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) was quantified using an enzyme-linked immunosorbent assay (ELISA).
The ELISA measured IgG antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .
measure: Mean Geometric Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk IgG Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), Month 9 (6 months post-dose 2), and Month 15 (12 months post-dose 2)
description: Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) was quantified using an enzyme-linked immunosorbent assay (ELISA).
The ELISA measured IgG antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).
Mean geometric increase represents the fold-rise in antibody titer from baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).
measure: Percentage of Participants With Serum Anti-H1 Hemagglutinin Stalk Immunoglobulin A Antibody Seropositivity
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: Anti-H1 hemagglutinin stalk immunoglobulin A (IgA) was quantified using an enzyme-linked immunosorbent assay (ELISA).
The ELISA measured IgA antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .
Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 1:100.
measure: Geometric Mean Titer of Serum Anti-H1 Hemagglutinin Stalk IgA Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: Anti-H1 hemagglutinin stalk immunoglobulin A (IgA) was quantified using an enzyme-linked immunosorbent assay (ELISA).
The ELISA measured IgA antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .
measure: Percentage of Participants With a ≥ 4-fold Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk IgA Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: Anti-H1 hemagglutinin stalk immunoglobulin A (IgA) was quantified using an enzyme-linked immunosorbent assay (ELISA).
The ELISA measured IgA antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .
measure: Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk IgA Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: Anti-H1 hemagglutinin stalk immunoglobulin A (IgA) was quantified using an enzyme-linked immunosorbent assay (ELISA).
The ELISA measured IgA antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .
measure: Mean Geometric Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk IgA Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: Anti-H1 hemagglutinin stalk immunoglobulin A (IgA) was quantified using an enzyme-linked immunosorbent assay (ELISA).
The ELISA measured IgA antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]) .
Mean geometric increase represents the fold-rise in antibody titer from baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).
measure: Percentage of Participants With Serum Anti-H1 Hemagglutinin Stalk Neutralizing Antibody Seropositivity
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: Anti H1 hemagglutinin stalk neutralizing antibodies were quantified using a microneutralization (MN) assay using a virus that expresses a chimeric hemagglutinin that contains an exotic HA head domain (strain A/mallard/Sweden/81/2002 [H6N1]) and the H1 stalk domain (strain A/California/04/2009 [H1N1pandemic]) and an exotic neuraminidase, N5, for which humans are generally naïve (strain: A/mallard/Sweden/86/2003 [H12N5]).
Seropositivity rate was defined as the percentage of participants with an antibody titer of ≥ 1:10.
measure: Geometric Mean Titer of Serum Anti-H1 Hemagglutinin Stalk Neutralizing Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: Anti H1 hemagglutinin stalk neutralizing antibodies were quantified using a microneutralization (MN) assay using a virus that expresses a chimeric hemagglutinin that contains an exotic HA head domain (strain A/mallard/Sweden/81/2002 ([H6N1]) and the H1 stalk domain (strain A/California/04/2009 ([H1N1pandemic]) and an exotic neuraminidase, N5, for which humans are generally naïve (strain: A/mallard/Sweden/86/2003 [H12N5]). The LLOQ for the assay was 1:10.
measure: Percentage of Participants With a ≥ 4-fold Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk Neutralizing Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: Anti H1 hemagglutinin stalk neutralizing antibodies were quantified using a microneutralization (MN) assay using a virus that expresses a chimeric hemagglutinin that contains an exotic HA head domain (strain A/mallard/Sweden/81/2002 ([H6N1]) and the H1 stalk domain (strain A/California/04/2009 ([H1N1pandemic]) and an exotic neuraminidase, N5, for which humans are generally naïve (strain: A/mallard/Sweden/86/2003 [H12N5]).
measure: Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk Neutralizing Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: Anti H1 hemagglutinin stalk neutralizing antibodies were quantified using a microneutralization (MN) assay using a virus that expresses a chimeric hemagglutinin that contains an exotic HA head domain (strain A/mallard/Sweden/81/2002 ([H6N1]) and the H1 stalk domain (strain A/California/04/2009 ([H1N1pandemic]) and an exotic neuraminidase, N5, for which humans are generally naïve (strain: A/mallard/Sweden/86/2003 [H12N5]).
measure: Mean Geometric Increase From Baseline in Serum Anti-H1 Hemagglutinin Stalk Neutralizing Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: Anti H1 hemagglutinin stalk neutralizing antibodies were quantified using a microneutralization (MN) assay using a virus that expresses a chimeric hemagglutinin that contains an exotic HA head domain (strain A/mallard/Sweden/81/2002 [H6N1]) and the H1 stalk domain (strain A/California/04/2009 [H1N1pandemic]) and an exotic neuraminidase, N5, for which humans are generally naïve (strain: A/mallard/Sweden/86/2003 [H12N5]).
Mean geometric increase represents the fold-rise in antibody titer from baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).
measure: Serum Antibody-dependent Cell-mediated Cytotoxicity (ADCC) to the H1 Hemagglutinin Stalk
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: Antibody-dependent cell-mediated cytotoxicity (ADCC) is an immune response leading to lysis of antibody-coated target cells by immune effector cells and is triggered by the interaction between the Fc portion of an antibody and Fc-gamma receptors expressed on immune effector cells.
This bioluminescent assay measured antibodies to a chimeric hemagglutinin (H6 head domain and H1 stalk domain) virus that mediate ADCC activity via the Fc-receptor. ADCC activity was measured in relative luciferase units (RLU) for serial dilutions of serum samples using a plate reader.
ADCC activity was expressed by the area under the curve (AUC) of luminescence (RLU) per serial dilution (X-fold serial dilutions).
measure: Fold-Increase From Baseline in Serum ADCC to the H1 Hemagglutinin Stalk
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: Antibody-dependent cell-mediated cytotoxicity (ADCC) is an immune response leading to lysis of antibody-coated target cells by immune effector cells and is triggered by the interaction between the Fc portion of an antibody and Fc-gamma receptors expressed on immune effector cells.
This bioluminescent assay measured antibodies to a chimeric hemagglutinin (H6 head domain and H1 stalk domain) virus that mediate ADCC activity via the Fc-receptor. ADCC activity was measured by the area under the curve (AUC) of luminescence per serial dilution.
measure: Percentage of Participants With a ≥ 4-fold Increase From Baseline in Serum ADCC to the H1 Hemagglutinin Stalk
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: Antibody-dependent cell-mediated cytotoxicity (ADCC) is an immune response leading to lysis of antibody-coated target cells by immune effector cells and is triggered by the interaction between the Fc portion of an antibody and Fc-gamma receptors expressed on immune effector cells.
This bioluminescent assay measured antibodies to a chimeric hemagglutinin (H6 head domain and H1 stalk domain) virus that mediate ADCC activity via the Fc-receptor. ADCC activity was measured by the area under the curve (AUC) of luminescence per serial dilution.
measure: Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum ADCC to the H1 Hemagglutinin Stalk
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: Antibody-dependent cell-mediated cytotoxicity (ADCC) is an immune response leading to lysis of antibody-coated target cells by immune effector cells and is triggered by the interaction between the Fc portion of an antibody and Fc-gamma receptors expressed on immune effector cells.
This bioluminescent assay measured antibodies to a chimeric hemagglutinin (H6 head domain and H1 stalk domain) virus that mediate ADCC activity via the Fc-receptor. ADCC activity was measured by the area under the curve (AUC) of luminescence per serial dilution.
measure: Percentage of Participants With Anti-H1 Hemagglutinin Stalk Salivary IgG Antibody Seropositivity
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).
The ELISA measured IgG antibodies in saliva against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).
Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 1:10.
measure: Geometric Mean Titer of Anti-H1 Hemagglutinin Stalk Salivary IgG Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).
The ELISA measured IgG antibodies against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]). The LLOQ for the assay was 1:10.
measure: Percentage of Participants With a ≥ 4-fold Increase From Baseline in Anti-H1 Hemagglutinin Stalk Salivary IgG
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).
The ELISA measured IgG antibodies in saliva against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).
measure: Percentage of Participants With a ≥ 10-fold Increase From Baseline in Anti-H1 Hemagglutinin Stalk Salivary IgG
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).
The ELISA measured IgG antibodies in saliva against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).
measure: Mean Geometric Increase of Anti-H1 Hemagglutinin Stalk Salivary IgG Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: Anti-H1 hemagglutinin stalk immunoglobulin G (IgG) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).
The ELISA measured IgG antibodies in saliva against the H1 stalk domain by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).
Mean geometric increase represents the fold-rise in antibody titer from baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).
measure: Percentage of Participants With Anti-H1 Hemagglutinin Stalk Secretory IgA Antibody Seropositivity in Saliva
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: Anti-H1 hemagglutinin stalk secretory immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).
The ELISA measured secretory IgA antibodies antibodies (actively secreted in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).
Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 1:4.
measure: Geometric Mean Titer of Anti-H1 Hemagglutinin Stalk Secretory IgA Antibodies in Saliva
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: Anti-H1 hemagglutinin stalk secretory immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).
The ELISA measured secretory IgA antibodies antibodies (actively secreted in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]). The LLOQ for the assay was 1:4.
measure: Percentage of Participants With a ≥ 4-fold Increase From Baseline in Anti-H1 Hemagglutinin Stalk Secretory IgA Antibodies in Saliva
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: Anti-H1 hemagglutinin stalk secretory immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).
The ELISA measured secretory IgA antibodies (actively secreted in the mucosa) against the H1 stalk domain in saliva by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).
measure: Percentage of Participants With a ≥ 10-fold Increase From Baseline in Anti-H1 Hemagglutinin Stalk Secretory IgA Antibodies in Saliva
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: Anti-H1 hemagglutinin stalk secretory immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).
The ELISA measured secretory IgA antibodies (actively secreted in the mucosa) against the H1 stalk domain in saliva by using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).
measure: Mean Geometric Increase From Baseline in Anti-H1 Hemagglutinin Stalk Secretory IgA in Saliva
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: Anti-H1 hemagglutinin stalk secretory immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).
The ELISA measured secretory IgA antibodies antibodies (actively secreted in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).
Mean geometric increase represents the fold-rise in antibody titer from Baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).
measure: Percentage of Participants With Anti-H1 Hemagglutinin Stalk Total IgA Antibody Seropositivity in Saliva
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: Anti-H1 hemagglutinin stalk total immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).
The ELISA measured total IgA antibodies antibodies (secreted through active and passive transfer processes in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).
Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 1:10.
measure: Geometric Mean Titer of Anti-H1 Hemagglutinin Stalk Total IgA Antibodies in Saliva
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: Anti-H1 hemagglutinin stalk total immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).
The ELISA measured total IgA antibodies antibodies (secreted through active and passive transfer processes in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]). The LLOQ for the assay was 1:10.
measure: Percentage of Participants With a ≥ 4-fold Increase From Baseline in Anti-H1 Hemagglutinin Stalk Total IgA Antibodies in Saliva
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: Anti-H1 hemagglutinin stalk total immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).
The ELISA measured total IgA antibodies antibodies (secreted through active and passive transfer processes in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).
measure: Percentage of Participants With a ≥ 10-fold Increase From Baseline in Anti-H1 Hemagglutinin Stalk Total IgA Antibodies in Saliva
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: Anti-H1 hemagglutinin stalk total immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).
The ELISA measured total IgA antibodies antibodies (secreted through active and passive transfer processes in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).
measure: Mean Geometric Increase From Baseline in Anti-H1 Hemagglutinin Stalk Total IgA Antibodies in Saliva
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: Anti-H1 hemagglutinin stalk total immunoglobulin A (IgA) in saliva was quantified using an enzyme-linked immunosorbent assay (ELISA).
The ELISA measured total IgA antibodies (secreted through active and passive transfer processes in the mucosa) against the H1 stalk domain in saliva using a chimeric protein containing an exotic H6 hemagglutinin head domain that the vaccinees have not previously been exposed to (strain A/mallard/Sweden/81/02 [H6N1]) and the same H1 stalk domain as expressed by the vaccine (strain A/California/04/09 [H1N1]).
Mean geometric increase represents the fold-rise in antibody titer from baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).
measure: Percentage of Participants With Serum Anti-H2 Full-length Hemagglutinin IgG Antibody Seropositivity
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H2, of which the stalk domain shares about 78% amino acid identity with the H1 vaccine stalk domain.
Anti-H2 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on A/mallard/Netherlands/5/1999 (H2N9) HA.
Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned. Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 22.
measure: Geometric Mean Titer of Serum Anti-H2 Full-length Hemagglutinin IgG Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H2, of which the stalk domain shares about 78% amino acid identity with the H1 vaccine stalk domain.
Anti-H2 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on A/mallard/Netherlands/5/1999 (H2N9) HA. Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned.
measure: Percentage of Participants With a ≥ 4-fold Increase From Baseline in Serum Anti-H2 Full-length Hemagglutinin IgG Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H2, of which the stalk domain shares about 78% amino acid identity with the H1 vaccine stalk domain.
Anti-H2 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on A/mallard/Netherlands/5/1999 (H2N9) HA.
measure: Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum Anti-H2 Full-length Hemagglutinin IgG Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H2, of which the stalk domain shares about 78% amino acid identity with the H1 vaccine stalk domain.
Anti-H2 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on A/mallard/Netherlands/5/1999 (H2N9) HA.
measure: Mean Geometric Increase of Serum Anti-H2 Full-length Hemagglutinin IgG Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H2, of which the stalk domain shares about 78% amino acid identity with the H1 vaccine stalk domain.
Anti-H2 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on A/mallard/Netherlands/5/1999 (H2N9) HA.
Mean geometric increase represents the fold-rise in antibody titer from Baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).
measure: Percentage of Participants With Serum Anti-H9 Full-length Hemagglutinin IgG Antibody Seropositivity
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H9, the stalk domain of which shares about 59% amino acid identity with the H1 vaccine stalk domain.
Anti-H9 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/chicken/Hong Kong/G9/1997 (H9N2) HA. Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned.
Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 31.
measure: Geometric Mean Titer of Serum Anti-H9 Full-length Hemagglutinin IgG Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H9, the stalk domain of which shares about 59% amino acid identity with the H1 vaccine stalk domain.
Anti-H9 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/chicken/Hong Kong/G9/1997 (H9N2) HA. Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned. The LLOQ for the assay was 31 EU/mL.
measure: Percentage of Participants With a ≥ 4-fold Increase From Baseline in Serum Anti-H9 Full-length Hemagglutinin IgG Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H9, the stalk domain of which shares about 59% amino acid identity with the H1 vaccine stalk domain.
Anti-H9 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/chicken/Hong Kong/G9/1997 (H9N2) HA.
measure: Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum Anti-H9 Full-length Hemagglutinin IgG Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H9, the stalk domain of which shares about 59% amino acid identity with the H1 vaccine stalk domain.
Anti-H9 full-length(ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/chicken/Hong Kong/G9/1997 (H9N2) HA.
measure: Mean Geometric Increase of Serum Anti-H9 Full-length Hemagglutinin IgG Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin, subtype H9, the stalk domain of which shares about 59% amino acid identity with the H1 vaccine stalk domain.
Anti-H9 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/chicken/Hong Kong/G9/1997 (H9N2) HA.
Mean geometric increase represents the fold-rise in antibody titer from Baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).
measure: Percentage of Participants With Serum Anti-H18 Full-length Hemagglutinin IgG Antibody Seropositivity
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin distantly related to the currently circulating influenza A/H1 viruses, subtype H18, the stalk domain of which shares about 65% amino acid identity with the H1 vaccine stalk domain.
Anti-H18 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/flat-faced bat/Peru/033/10 (H18N11) HA. Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned.
Seropositivity rate was defined as the percentage of participants with an antibody titer of at least the cut-off for the assay; ≥ 42.3.
measure: Geometric Mean Titer of Serum Anti-H18 Full-length Hemagglutinin IgG Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin distantly related to the currently circulating influenza A/H1 viruses, H18, the stalk domain of which shares about 65% amino acid identity with the H1 vaccine stalk domain.
Anti-H18 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/flat-faced bat/Peru/033/10 (H18N11) HA. Titers are expressed as ELISA units (EU) per mL and were calculated on the basis of an internal standard to which units were arbitrarily assigned.
measure: Percentage of Participants With a ≥ 4-fold Increase From Baseline in Serum Anti-H18 Full-length Hemagglutinin IgG Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin distantly related to the currently circulating influenza A/H1 viruses, subtype H18, the stalk domain of which shares about 65% amino acid identity with the H1 vaccine stalk domain.
Anti-H18 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/flat-faced bat/Peru/033/10 (H18N11) HA.
measure: Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum Anti-H18 Full-length Hemagglutinin IgG Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin distantly related to the currently circulating influenza A/H1 viruses, subtype H18, the stalk domain of which shares about 65% amino acid identity with the H1 vaccine stalk domain.
Anti-H18 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/flat-faced bat/Peru/033/10 (H18N11) HA.
measure: Mean Geometric Increase of Serum Anti-H18 Full-length Hemagglutinin IgG Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: To determine antibody breadth, assays were performed to measure the induction of cross-reactive IgG antibodies to a Group 1 influenza A virus with a heterosubtypic hemagglutinin distantly related to the currently circulating influenza A/H1 viruses, subtype H18, the stalk domain of which shares about 65% amino acid identity with the H1 vaccine stalk domain.
Anti-H18 full-length (ecto-domain) hemagglutinin IgG was quantified by ELISA using a recombinant antigen based on Strain A/flat-faced bat/Peru/033/10 (H18N11) HA.
Mean geometric increase represents the fold-rise in antibody titer from Baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).
measure: Percentage of Participants With Serum Anti-Human H1N1 Virus Neutralizing Antibody Seropositivity
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: This assay was performed to measure the neutralizing potential of antibodies against the currently circulating human H1N1 isolate which is similar to the stalk used in study vaccines.
Anti-human H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Singapore/GP1908/2015 (IVR-180).
Seropositivity rate was defined as the percentage of participants with an antibody titer of ≥ 1:10.
measure: Geometric Mean Titer of Serum Anti-Human H1N1 Virus Neutralizing Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: This assay was performed to measure the neutralizing potential of antibodies against the currently circulating human H1N1 isolate which is similar to the stalk used in study vaccines.
Anti-human H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Singapore/GP1908/2015 (IVR-180). The LLOQ for the assay was 1:10.
measure: Percentage of Participants With a ≥ 4-fold Increase in Serum Anti-Human H1N1 Virus Neutralizing Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: This assay was performed to measure the neutralizing potential of antibodies against the currently circulating human H1N1 isolate which is similar to the stalk used in study vaccines.
Anti-human H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Singapore/GP1908/2015 (IVR-180).
measure: Percentage of Participants With a ≥ 10-fold Increase From Baseline in Serum Anti-Human H1N1 Virus Neutralizing Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: This assay was performed to measure the neutralizing potential of antibodies against the currently circulating human H1N1 isolate which is similar to the stalk used in study vaccines.
Anti-human H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Singapore/GP1908/2015 (IVR-180).
measure: Mean Geometric Increase of Serum Anti-Human H1N1 Virus Neutralizing Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: This assay was performed to measure the neutralizing potential of antibodies against the currently circulating human H1N1 isolate which is similar to the stalk used in study vaccines.
Anti-human H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Singapore/GP1908/2015 (IVR-180).
Mean geometric increase represents the fold-rise in antibody titer from Baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).
measure: Percentage of Participants With Serum Anti-Avian-Swine H1N1 Virus Neutralizing Antibody Seropositivity
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: This assay was performed to measure the neutralizing potential of cross-reactive antibodies to a Group 1 influenza against an H1N1 virus isolate that currently circulates in animals and is antigenically different from current human isolates.
Anti-avian-swine H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Swine/Jiangsu/40/2011 (asH1N1).
Seropositivity rate was defined as the percentage of participants with an antibody titer of ≥ 1:10.
measure: Geometric Mean Titer of Serum Anti-Avian-Swine H1N1 Virus Neutralizing Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: This assay was performed to measure the neutralizing potential of cross-reactive antibodies to a Group 1 influenza against an H1N1 virus isolate that currently circulates in animals and is antigenically different from current human isolates.
Anti-avian-swine H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Swine/Jiangsu/40/2011 (asH1N1). The LLOQ for the assay was 1:10.
measure: Percentage of Participants With a ≥ 4-fold Increase in Serum Anti-Avian-Swine H1N1 Virus Neutralizing Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: This assay was performed to measure the neutralizing potential of cross-reactive antibodies to a Group 1 influenza against an H1N1 virus isolate that currently circulates in animals and is antigenically different from current human isolates.
Anti-avian-swine H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Swine/Jiangsu/40/2011 (asH1N1).
measure: Percentage of Participants With a ≥ 10-fold Increase in Serum Anti-Avian-Swine H1N1 Virus Neutralizing Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: This assay was performed to measure the neutralizing potential of cross-reactive antibodies to a Group 1 influenza against an H1N1 virus isolate that currently circulates in animals and is antigenically different from current human isolates.
Anti-avian-swine H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Swine/Jiangsu/40/2011 (asH1N1).
measure: Mean Geometric Increase From Baseline in Serum Anti-Avian-Swine H1N1 Virus Neutralizing Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: This assay was performed to measure the neutralizing potential of cross-reactive antibodies to a Group 1 influenza against an H1N1 virus isolate that currently circulates in animals and is antigenically different from current human isolates.
Anti-avian-swine H1N1 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using Strain A/Swine/Jiangsu/40/2011 (asH1N1).
Mean geometric increase represents the fold-rise in antibody titer from Baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).
measure: Percentage of Participants With Serum Anti-H5N8 Virus Neutralizing Antibody Seropositivity
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: This assay was performed to measure the induction of antibodies reactive against the head domain of a group 1 influenza virus with a heterosubtypic hemagglutinin from a recent avian influenza virus. Anti-H5N8 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using a reverse genetics (RG) reassortant virus based on Puerto Rico (PR)/8 for 6 genes with 2 surface proteins: HA and neuraminidase (NA) from A/Gyrfalcon/Washington/41088-6/2014 (H5N8).
Seropositivity rate was defined as the percentage of participants with an antibody titer of ≥ 1:10.
measure: Geometric Mean Titer of Serum Anti-H5N8 Virus Neutralizing Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: This assay was performed to measure the induction of antibodies reactive against the head domain of a group 1 influenza virus with a heterosubtypic hemagglutinin from a recent avian influenza virus. Anti-H5N8 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using a reverse genetics (RG) reassortant virus based on PR8 for 6 genes with 2 surface proteins: HA and NA from A/Gyrfalcon/Washington/41088-6/2014 (H5N8). The LLOQ for the assay was 1:10.
measure: Percentage of Participants With a ≥ 4-fold Increase in Serum Anti-H5N8 Virus Neutralizing Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: This assay was performed to measure the induction of antibodies reactive against the head domain of a group 1 influenza virus with a heterosubtypic hemagglutinin from a recent avian influenza virus. Anti-H5N8 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using a reverse genetics (RG) reassortant virus based on PR8 for 6 genes with 2 surface proteins: HA and NA from A/Gyrfalcon/Washington/41088-6/2014 (H5N8).
measure: Percentage of Participants With a ≥ 10-fold Increase in Serum Anti-H5N8 Virus Neutralizing Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: This assay was performed to measure the induction of antibodies reactive against the head domain of a group 1 influenza virus with a heterosubtypic hemagglutinin from a recent avian influenza virus. Anti-H5N8 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using a reverse genetics (RG) reassortant virus based on PR8 for 6 genes with 2 surface proteins: HA and NA from A/Gyrfalcon/Washington/41088-6/2014 (H5N8).
measure: Mean Geometric Increase From Baseline in Serum Anti-H5N8 Virus Neutralizing Antibodies
time frame: Baseline (pre-dose 1), Month 1 (28 days post-dose 1), Month 4 (28 days post-dose 2), and Month 15 (12 months post-dose 2)
description: This assay was performed to measure the induction of antibodies reactive against the head domain of a group 1 influenza virus with a heterosubtypic hemagglutinin from a recent avian influenza virus. Anti-H5N8 virus neutralizing antibodies were quantified using a microneutralization (MN) assay using a reverse genetics (RG) reassortant virus based on PR8 for 6 genes with 2 surface proteins: HA and NA from A/Gyrfalcon/Washington/41088-6/2014 (H5N8).
Mean geometric increase represents the fold-rise in antibody titer from Baseline to each post-baseline time point (ratio of post-baseline titer to Baseline titer).
arm group label: Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + adjuvant
arm group type: Experimental
description: Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.
arm group label: Group 2: cH8/1N1 LAIV and cH5/1N1 IIV
arm group type: Experimental
description: Participants received 0.5 mL cH8/1N1 LAIV administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL cH5/1N1 IIV administered as an intramuscular injection on Day 85.
arm group label: Group 3: Placebo
arm group type: Placebo Comparator
description: Participants received 0.5 mL of normal saline administered as 0.25 mL drops per nostril on Day 1 followed by 0.5 mL phosphate buffered saline (PBS) administered as an intramuscular injection on Day 85.
arm group label: Group 4: cH8/1N1 IIV + adjuvant and cH5/1N1 IIV + adjuvant
arm group type: Experimental
description: Participants received 0.5 mL AS03-adjuvanted cH8/1N1 IIV administered as an intramuscular injection on Day 1 followed by 0.5 mL AS03-adjuvanted cH5/1N1 IIV administered as an intramuscular injection on Day 85.
arm group label: Group 5: Placebo
arm group type: Placebo Comparator
description: Participants received 0.5 mL PBS administered as an intramuscular injection on Day 1 followed by 0.5 mL PBS administered as an intramuscular injection on Day 85.
intervention type: Biological
intervention name: cH8/1N1 LAIV
description: Live-attenuated influenza virus vaccine (LAIV) expressing chimeric hemagglutinin (HA) with the H8 head and H1 stalk and neuraminidase (NA) subtype 1 (N1) (cH8/1N1):
HA head, A/mallard/Sweden/24/2002 (H8N4); HA stalk, A/California/04/2009 (H1N1); NA, A/California/04/2009 (H1N1) containing the backbone of the cold-adapted/temperature sensitive of the Russian LAIV A/Leningrad/134/17/1957 (Len17 IDCDCRG46D).
Administered intranasally as drops at a dose of 10⁷·⁵ (plus or minus ⁰·⁵) 50% egg infectious dose (EID50), formulated in a total volume of 0.5 mL sterile saline (0.25 mL per nostril).
arm group label: Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + adjuvant
arm group label: Group 2: cH8/1N1 LAIV and cH5/1N1 IIV
intervention type: Biological
intervention name: AS03-adjuvanted cH5/1N1 IIV
description: Chimeric H5 head with H1 stalk plus N1 (cH5/1N1) split virion inactivated influenza virus vaccine (IIV) plus AS03 adjuvant: HA head, A/Vietnam/1203/2004 (H5N1); HA stalk, A/California/04/2009 (H1N1); NA, A/California/04/2009 (H1N1).
Administered intramuscularly at a dose of 15 μg of hemagglutinin in a volume of 0.5 mL of phosphate buffered saline (PBS).
arm group label: Group 1: cH8/1N1 LAIV and cH5/1N1 IIV + adjuvant
arm group label: Group 4: cH8/1N1 IIV + adjuvant and cH5/1N1 IIV + adjuvant
other name: cH5/1N1 IIV + AS03 adjuvant
intervention type: Biological
intervention name: cH5/1N1 IIV
description: Chimeric H5 head with H1 stalk plus N1 (cH5/1N1) split virion inactivated influenza virus vaccine (IIV):
HA head, A/Vietnam/1203/2004 (H5N1); HA stalk, A/California/04/2009 (H1N1); NA, A/California/04/2009 (H1N1).
Administered intramuscularly at a dose of 15 μg of hemagglutinin in a volume of 0.5 mL of phosphate buffered saline (PBS).
arm group label: Group 2: cH8/1N1 LAIV and cH5/1N1 IIV
intervention type: Biological
intervention name: AS03-adjuvanted cH8/1N1 IIV
description: Chimeric H8 head with H1 stalk plus N1 (cH8/1N1) inactivated influenza vaccine plus AS03 adjuvant: HA head, A/mallard/Sweden/24/2002 (H8N4); HA stalk, A/California/04/2009 (H1N1); NA, A/California/04/2009 (H1N1).
Administered intramuscularly at a dose of 15 μg of hemagglutinin in a volume of 0.5 mL of phosphate buffered saline (PBS).
arm group label: Group 4: cH8/1N1 IIV + adjuvant and cH5/1N1 IIV + adjuvant
other name: cH8/1N1 IIV + AS03 adjuvant
intervention type: Biological
intervention name: Normal saline
description: Administered intranasally as 0.25 mL nasal drops per nostril
arm group label: Group 3: Placebo
intervention type: Biological
intervention name: Phosphate buffered saline (PBS)
description: Administered intramuscularly as 0.5 mL injection
arm group label: Group 3: Placebo
arm group label: Group 5: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 39 Years
healthy volunteers: Accepts Healthy Volunteers
last name: David Bernstein, MD
role: Principal Investigator
affiliation: Children's Hospital Medical Center, Cincinnati
last name: Jeffrey Guptill, MD
role: Principal Investigator
affiliation: Duke University
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Influenza, Human
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 