<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/NCT03301051</url>
  </required_header>
  <id_info>
    <org_study_id>CP-PRO-QVLP-012</org_study_id>
    <nct_id>NCT03301051</nct_id>
  </id_info>
  <brief_title>Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent Virus-Like Particles (VLPs) Influenza Vaccine in Adults</brief_title>
  <official_title>A Randomized, Observer-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy, Safety, and Immunogenicity of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Adults 18-64 Years of Age</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medicago</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medicago</source>
  <oversight_info>
    <has_dmc>No</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>
      This Phase 3 study is intended to assess the efficacy of the Quadrivalent VLP Influenza&#xD;
      Vaccine during the 2017-2018 influenza season in healthy adults 18 to 64 years of age. One&#xD;
      dose of Quadrivalent VLP Influenza Vaccine (30 μg/strain) or of placebo will be administered&#xD;
      to approximately 10,000 participants&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomized, observer-blind, placebo-controlled multicenter, Phase 3 study will be&#xD;
      conducted at multiple sites. The composition of the Quadrivalent VLP Influenza Vaccine to be&#xD;
      used in this study includes a mix of recombinant H1, H3, and two B hemagglutinin proteins&#xD;
      expressed as VLPs for the 2017-2018 influenza virus strains.&#xD;
&#xD;
      Approximately 10,000 healthy male and female participants aged 18 to 64 years will be&#xD;
      randomized in a 1:1 ratio into one of two parallel treatment groups, such that approximately&#xD;
      5,000 participants will receive the Quadrivalent VLP Influenza Vaccine at a dose of 30&#xD;
      μg/strain and approximately 5,000 participants will receive the placebo. Within the two&#xD;
      treatment groups, participants will be stratified by site and two age groups (18-49 years of&#xD;
      age and 50-64 years of age in a 1:1 ratio).&#xD;
&#xD;
      Participants will participate in this study for approximately eight to ten months, during&#xD;
      which a first visit will be scheduled on Day 0 for screening and vaccine administration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 31, 2017</start_date>
  <completion_date type="Actual">May 9, 2018</completion_date>
  <primary_completion_date type="Actual">May 2, 2018</primary_completion_date>
  <phase>Phase 3</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Observer-blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Occurrences of Protocol-Defined Respiratory Illness Caused by Vaccine-Matched Influenza Strains</measure>
    <time_frame>Day 14 (post-vaccination) up to ~8 months</time_frame>
    <description>Occurrences of protocol-defined respiratory illness caused by vaccine-matched influenza strains were assessed. The vaccine-matched strains included: H1N1 (A/Michigan/45/2015); H3N2 (A/Hong Kong/4801/2014); B/Brisbane (B/Brisbane/60/2008); and B/Phuket (B/Phuket/3073/2013A). The protocol-defined respiratory illness was determined by the occurrence of at least 1 of the following respiratory symptoms: sneezing, stuffy nose, sore throat, cough, sputum production, wheezing, or difficulty breathing. Occurrences of all matched strains are reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Occurrences of Protocol-Defined Respiratory Illness Cases Caused by Any Laboratory Confirmed Influenza Strain</measure>
    <time_frame>Day 14 (post-vaccination) up to ~8 months</time_frame>
    <description>Occurrences of protocol-defined respiratory illness due to laboratory-confirmed influenza strain (matched, mismatched, and un-typed) were assessed. A protocol-defined respiratory illness was determined by the occurrence of at least 1 of the following respiratory symptoms: sneezing, stuffy nose, sore throat, cough, sputum production, wheezing, or difficulty breathing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Occurrences of Laboratory-Confirmed Protocol-Defined Influenza-Like Illness (ILI) Caused by Vaccine-Matched Influenza Strains</measure>
    <time_frame>Day 14 (post-vaccination) up to ~8 months</time_frame>
    <description>Occurrences of protocol-defined ILI due to laboratory-confirmed influenza caused by influenza viral types/subtypes that are matched (and/or antigenically similar) to the strains covered in the vaccine formulation were assessed. A participant is considered to have protocol-defined ILI if the participant met at least one of the following pre-defined respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing AND at least one of the following systemic symptoms: fever (defined as a temperature &gt; 37.2 °C or &gt; 99.0 °F), chills, tiredness, headache or myalgia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Occurrences of Laboratory-Confirmed ILI Caused by Any Influenza Strain</measure>
    <time_frame>Day 14 (post-vaccination) up to ~8 months</time_frame>
    <description>Occurrences of laboratory-confirmed ILI caused by any influenza viral strains were assessed. A participant is considered to have protocol-defined ILI if the participant met at least one of the following pre-defined respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing AND at least one of the following systemic symptoms: fever (defined as a temperature &gt; 37.2 °C or &gt; 99.0 °F), chills, tiredness, headache or myalgia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Occurrences of Protocol-Defined ILI Cases</measure>
    <time_frame>Day 14 (post-vaccination) up to ~8 months</time_frame>
    <description>Occurrences of protocol-defined ILI cases (confirmed or not) were assessed. A participant is considered to have protocol-defined ILI if the participant met at least one of the following pre-defined respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing AND at least one of the following systemic symptoms: fever (defined as a temperature &gt; 37.2 °C or &gt; 99.0 °F), chills, tiredness, headache or myalgia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With at Least One Immediate Complaint</measure>
    <time_frame>15 minutes post vaccination</time_frame>
    <description>Immediate complaints were defined as any solicited local or systemic reactions. Solicited local reactions included: erythema, swelling, and pain at the injection site and solicited systemic reactions included: fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With at Least One Solicited Local and Systemic Reactions</measure>
    <time_frame>Day 0 (post-vaccination) up to Day 7</time_frame>
    <description>Participants were monitored for both solicited local reactions (erythema, swelling, and pain at the injection site) and solicited systemic reactions (fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck). Any solicited local or systemic immediate complaint was also included.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With ≥ Severe Solicited Local and Systemic Reactions</measure>
    <time_frame>Day 0 (post-vaccination) up to Day 7</time_frame>
    <description>Participants were monitored for both solicited local reactions (erythema, swelling, and pain at the injection site) and solicited systemic reactions (fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck). Any solicited local or systemic immediate complaint was also included. The intensity of the solicited reactions was graded as mild (1)-easily tolerated and does not interfere with usual activity; moderate (2)-interferes with daily activity, but the participant is still able to function; severe (3)-incapacitating and the participant is unable to work or complete usual activity or potentially life threatening; (4)-likely to be life-threatening if not treated in a timely manner, according to the Food and Drug Administration (FDA) Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With ≥ Severe Related Solicited Reactions</measure>
    <time_frame>Day 0 (post-vaccination) up to Day 7</time_frame>
    <description>Participants were monitored for both solicited local reactions (erythema, swelling, and pain at the injection site) and solicited systemic reactions (fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck). The intensity of the solicited reactions was graded according to the FDA Toxicity Grading Scale: mild (1), moderate (2), severe (3) or potentially life threatening (4). The causal relationship with the study vaccine was assessed as &quot;definitely not related&quot; (clearly not related), &quot;probably not related&quot; (no medical evidence), &quot;possibly related&quot; (reasonable possibility of cause and effect), &quot;probably related&quot; (plausible biologic mechanism and temporal relationship) or &quot;definitely related&quot; (direct cause and effect relationship). The ≥ severe events included &quot;severe&quot; and &quot;potentially life-threatening&quot; and the related category included &quot;possibly related&quot;, &quot;probably related&quot;, and &quot;definitely related.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Unsolicited Treatment-Emergent Adverse Events (TEAEs)</measure>
    <time_frame>Day 0 (post-vaccination) up to Day 21</time_frame>
    <description>Participants were monitored for unsolicited TEAEs (e.g., nasopharyngitis, upper respiratory tract infection, headache, and oropharyngeal pain). An adverse event (AE) or adverse experience was defined as any untoward medical occurrence in a participant or clinical investigation participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. An AE was considered treatment-emergent if it began on or after the date and time of Study Day 0 vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With ≥ Severe Unsolicited TEAEs</measure>
    <time_frame>Day 0 (post-vaccination) up to Day 21</time_frame>
    <description>The intensity of the unsolicited TEAEs was graded as mild (1)-easily tolerated and does not interfere with usual activity; moderate (2)-interferes with daily activity, but the participant is still able to function; severe (3)-incapacitating and the participant is unable to work or complete usual activity or potentially life threatening; (4)-likely to be life-threatening if not treated in a timely manner, according to the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. The ≥ Severe events included severe and potentially life-threatening events. AE and TEAEs are defined in outcome measure #10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With ≥ Severe Related Unsolicited Reactions</measure>
    <time_frame>Day 0 (post-vaccination) up to Day 21</time_frame>
    <description>The intensity of the solicited local and systemic reactions was graded as: mild (1), moderate (2), severe (3) or potentially life threatening (4). The causal relationship with the study vaccine was assessed as &quot;definitely not related&quot; (clearly not related), &quot;probably not related&quot; (no medical evidence), &quot;possibly related&quot; (reasonable possibility of cause and effect), &quot;probably related&quot; (plausible biologic mechanism and temporal relationship) or &quot;definitely related&quot; (direct cause and effect relationship). The ≥ severe events included &quot;severe&quot; and &quot;potentially life-threatening&quot; and the related category included &quot;possibly related&quot;, &quot;probably related&quot;, and &quot;definitely related.&quot; AE and TEAEs are defined in outcome measure #10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With an Occurrence of Death</measure>
    <time_frame>Day 0 up to ~8 months</time_frame>
    <description>The number of participants in each treatment group with an occurrence of death was assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With at Least One Serious TEAE</measure>
    <time_frame>Day 0 up to ~8 months</time_frame>
    <description>A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. An SAE was considered treatment-emergent if it was aggravated in severity or frequency following the administration of the study vaccine, up to and including the last visit of the study. AE is defined in outcome measure #10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With at Least One AE Leading to Withdrawal</measure>
    <time_frame>Day 0 up to ~8 months</time_frame>
    <description>An AE or adverse experience was defined as any untoward medical occurrence in a participant or clinical investigation participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. The number of participants with at least one adverse event leading to withdrawal was assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With at Least One New Onset Chronic Diseases (NOCDs)</measure>
    <time_frame>Day 0 up to ~8 months</time_frame>
    <description>All NOCDs that may plausibly have an allergic, autoimmune or inflammatory component were assessed and reported. Plausibility should be interpreted broadly; the only clear exceptions are degenerative conditions such as osteoarthritis, age-related physiologic changes and life-style diseases In this context, most cancers, cardiac conditions and kidney diseases should be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous and Heterologous Influenza Strain</measure>
    <time_frame>Day 0 (pre-vaccination), Day 21</time_frame>
    <description>The GMTs in each treatment group were measured using a HI assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013, and the heterologous strains: A/Brisbane/59/2007 (IVR-148) (HIN1), A/Uruguay/716/2007 (H3N2), B/Florida/4/2006, B/Malaysia/2506/2004.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous and Heterologous Strain</measure>
    <time_frame>Day 0 (pre-vaccination) up to Day 21</time_frame>
    <description>Seroconversion rate: the percentage of participants in a given treatment group with either a ≥ 4-fold increase in reciprocal HI titers between Day 0 and Day 21 or a rise of undetectable HI titer (i.e. &lt; 10) pre-vaccination (Day 0) to an HI titer of ≥ 40 on Day 21 was measured using an HI assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013, and the heterologous strains: A/Brisbane/59/2007 (IVR-148) (HIN1), A/Uruguay/716/2007 (H3N2), B/Florida/4/2006, B/Malaysia/2506/2004.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous and Heterologous Strain</measure>
    <time_frame>Day 0 (pre-vaccination) up to Day 21</time_frame>
    <description>Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥ 40 on Day 21 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) was measured using an HI assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013, and the heterologous strains: A/Brisbane/59/2007 (IVR-148) (HIN1), A/Uruguay/716/2007 (H3N2), B/Florida/4/2006, B/Malaysia/2506/2004.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Fold Ratio (GMFR) of HI Antibody Response for Each Homologous and Heterologous Strain</measure>
    <time_frame>Day 0 (pre-vaccination), Day 21</time_frame>
    <description>GMFR, the geometric mean of the ratio of GMTs (Day 21/Day 0) in each treatment group was measured using an HI assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013, and the heterologous strains: A/Brisbane/59/2007 (IVR-148) (HIN1), A/Uruguay/716/2007 (H3N2), B/Florida/4/2006, B/Malaysia/2506/2004.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GMTs of Microneutralization (MN) Antibody Response for Each Homologous Strain</measure>
    <time_frame>Day 0 (pre-vaccination), Day 21</time_frame>
    <description>The GMTs in each treatment group were measured using an MN assay for homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Strain</measure>
    <time_frame>Day 0 (pre-vaccination) up to Day 21</time_frame>
    <description>Seroconversion rate: the percentage of participants in a given treatment group with either a ≥ 4-fold increase in reciprocal MN titers between Day 0 and Day 21 or a rise of undetectable MN titer (i.e. 7.1) pre-vaccination (Day 0) to an MN titer of ≥ 28.3 at Day 21 post-vaccination were measured using an MN assay for homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GMFR of MN Antibody Response for Each Homologous Strain</measure>
    <time_frame>Day 0 (pre-vaccination), Day 21</time_frame>
    <description>GMFR, the geometric mean of the ratio of GMTs (Day 21/Day 0) was measured in each treatment group using an MN assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, and B/Phuket/3073/2013.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Area (GMA) of Single Radial Hemolysis (SRH) Antibody Response for Each Homologous Strain</measure>
    <time_frame>Day 0 (pre-vaccination), Day 21</time_frame>
    <description>The GMA in each treatment group were measured using an SRH assay for homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013. The GMA calculations were performed by taking the anti-log of the mean of the log titer transformations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Seroconversion Measured by SRH Antibody Response for Each Homologous Strain</measure>
    <time_frame>Day 0 (pre-vaccination) up to Day 21</time_frame>
    <description>Seroconversion rate: the percentage of participants in a given treatment group showing at least 50 % increase in GMA between Days 0 and 21 were measured using a SRH assay for homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Seroprotection Measured by SRH Antibody Response for Each Homologous Strain</measure>
    <time_frame>Day 0 (pre-vaccination) up to Day 21</time_frame>
    <description>Seroprotection rate: the percentage of participants in a given treatment group attaining an area ≥ 25 mm^2 following vaccination (Day 21) were measured using an SRH assay for homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GMFR of SRH Antibody Response for Each Homologous Strain</measure>
    <time_frame>Day 0 (pre-vaccination), Day 21</time_frame>
    <description>GMFR, the geometric mean of the ratio of GMTs (Day 21/Day 0) was measured in each treatment group using an SRH assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, and B/Phuket/3073/2013.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10160</enrollment>
  <condition>Virus Diseases</condition>
  <condition>RNA Virus Infections</condition>
  <condition>Respiratory Tract Diseases</condition>
  <condition>Respiratory Tract Infections</condition>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Quadrivalent VLP Vaccine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received one intramuscular (IM) injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received one IM injection of 0.5 mL of placebo on Day 0.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Quadrivalent VLP Vaccine</intervention_name>
    <description>Single dose of a 30 µg/strain of Quadrivalent VLP Vaccine</description>
    <arm_group_label>Quadrivalent VLP Vaccine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Single dose of a Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
        Participants must meet all of the following inclusion criteria to be eligible for&#xD;
        participation in this study; no protocol waivers are allowed:&#xD;
&#xD;
          1. Participants must have a body mass index (BMI) below 40 kg/m^2;&#xD;
&#xD;
          2. Participants are considered by the Investigator to be reliable and likely to cooperate&#xD;
             with the assessment procedures and be available for the duration of the study;&#xD;
&#xD;
          3. Participants must be in good general health prior to study participation, with no&#xD;
             clinically relevant abnormalities that could jeopardize participant safety or&#xD;
             interfere with study assessments, as assessed by the Principal Investigator or&#xD;
             sub-Investigator (thereafter referred as Investigator) and determined by medical&#xD;
             history, physical examination, and vital signs; Note: Participants with a pre-existing&#xD;
             chronic disease will be allowed to participate if the disease is stable and, according&#xD;
             to the Investigator's judgment, the condition is unlikely to confound the results of&#xD;
             the study or pose additional risk to the participant by participating in the study.&#xD;
             Stable disease is generally defined as no new onset or exacerbation of pre-existing&#xD;
             chronic disease three months prior to vaccination. Based on the Investigator's&#xD;
             judgment, a participant with more recent stabilization of a disease could also be&#xD;
             eligible.&#xD;
&#xD;
          4. Female participants must have a negative urine pregnancy test result at the&#xD;
             Screening/Vaccination visit (Visit 1).&#xD;
&#xD;
          5. Female participants of childbearing potential must use an effective method of&#xD;
             contraception for one month prior to vaccination and agree to continue employing&#xD;
             adequate birth control measures for at least 60 days post-vaccination. Moreover,&#xD;
             female participants must have no plan to become pregnant for at least two months&#xD;
             post-vaccination. Abstinent participants should be asked what method(s) they would use&#xD;
             should their circumstances change, and participants without a well-defined plan should&#xD;
             be excluded. The following relationship or methods of contraception are considered to&#xD;
             be effective:&#xD;
&#xD;
               -  Hormonal contraceptives (e.g. oral, injectable, topical [patch], or estrogenic&#xD;
                  vaginal ring);&#xD;
&#xD;
               -  Intra-uterine device with or without hormonal release;&#xD;
&#xD;
               -  Male partner using a condom plus spermicide or sterilized partner (at least one&#xD;
                  year prior to vaccination);&#xD;
&#xD;
               -  Credible self-reported history of heterosexual vaginal intercourse abstinence&#xD;
                  until at least 60 days post-vaccination;&#xD;
&#xD;
               -  Female partner;&#xD;
&#xD;
          6. Non-childbearing females are defined as:&#xD;
&#xD;
               -  Surgically-sterile (defined as bilateral tubal ligation, hysterectomy or&#xD;
                  bilateral oophorectomy performed more than one month prior to vaccination); or&#xD;
&#xD;
               -  Post-menopausal (absence of menses for 24 consecutive months and age consistent&#xD;
                  with natural cessation of ovulation).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants who meet any of the following criteria will be excluded from participating in&#xD;
        this study; no protocol waivers are allowed:&#xD;
&#xD;
          1. Any participant whose medical condition(s) is sufficiently severe that annual&#xD;
             influenza vaccination would be routinely recommended in the jurisdiction of&#xD;
             recruitment, as per the Investigator's judgement;&#xD;
&#xD;
          2. According to the Investigator's opinion, history of significant acute or chronic,&#xD;
             uncontrolled medical or neuropsychiatric illness. 'Uncontrolled' is defined as:&#xD;
&#xD;
               -  Requiring a new medical or surgical treatment during the three months prior to&#xD;
                  study vaccine administration unless the criteria outlined in inclusion criterion&#xD;
                  no. 5 can be met (i.e. the Investigator can justify inclusion based upon the&#xD;
                  innocuous nature of medical/surgical events and/or treatments);&#xD;
&#xD;
               -  Requiring any significant change in a chronic medication (i.e. drug, dose,&#xD;
                  frequency) during the three months prior to study vaccine administration due to&#xD;
                  uncontrolled symptoms or drug toxicity unless the innocuous nature of the&#xD;
                  medication change meets the criteria outlined in inclusion criterion no. 5 and is&#xD;
                  appropriately justified by the Investigator.&#xD;
&#xD;
          3. Any medical or neuropsychiatric condition or any history of excessive alcohol use or&#xD;
             drug abuse which, in the Investigator's opinion, would render the participant unable&#xD;
             to provide informed consent or unable to provide valid safety observations and&#xD;
             reporting;&#xD;
&#xD;
          4. Any autoimmune disease other than hypothyroidism on stable replacement therapy&#xD;
             (including, but not limited to rheumatoid arthritis, systemic lupus erythematosus,&#xD;
             Crohn's disease, and inflammatory bowel disease) or any confirmed or suspected&#xD;
             immunosuppressive condition or immunodeficiency including known or suspected human&#xD;
             immunodeficiency virus (HIV), Hepatitis B or C infection, the presence of&#xD;
             lymphoproliferative disease;&#xD;
&#xD;
          5. History of chronic pulmonary (including asthma, bronchopulmonary dysplasia, and cystic&#xD;
             fibrosis) or cardiovascular (except isolated hypertension), renal, hepatic,&#xD;
             neurologic, hematologic (including anemia and hemoglobinopathy), or metabolic&#xD;
             disorders (including diabetes mellitus);&#xD;
&#xD;
          6. Because this is a placebo-controlled study, any participants in close contact with&#xD;
             individuals considered to be at high risk for developing influenza-related&#xD;
             complications (individuals considered at high risk for complications include adults&#xD;
             and children who have chronic pulmonary or cardiovascular [except isolated&#xD;
             hypertension], renal, hepatic, neurologic, hematologic, or metabolic disorders&#xD;
             [including diabetes mellitus]).&#xD;
&#xD;
          7. Administration or planned administration of any non-influenza vaccine within 30 days&#xD;
             prior to randomization up to blood sampling on Day 21. Immunization on an emergency&#xD;
             basis will be evaluated case-by-case by the Investigator;&#xD;
&#xD;
          8. Administration of any adjuvanted or investigational influenza vaccine within one year&#xD;
             prior to randomization or planned administration prior to the completion of the study;&#xD;
&#xD;
          9. Administration of any 'standard', non-adjuvanted influenza vaccine (e.g. live&#xD;
             attenuated trivalent/quadrivalent inactivated influenza vaccine or split&#xD;
             trivalent/quadrivalent inactivated influenza vaccine administered by intranasal,&#xD;
             intradermal, or intramuscular route) within six months prior to randomization and up&#xD;
             to completion of the study;&#xD;
&#xD;
         10. Use of any investigational or non-registered product within 30 days or five&#xD;
             half-lives, whichever is longer, prior to randomization or planned use during the&#xD;
             study period. Participants may not participate in any other investigational or&#xD;
             marketed drug study while participating in this study until after the study;&#xD;
&#xD;
         11. Treatment with systemic glucocorticoids at a dose exceeding 10 mg of prednisone (or&#xD;
             equivalent) per day for more than seven consecutive days or for 10 or more days in&#xD;
             total, within one month of study vaccine administration; any other cytotoxic or&#xD;
             immunosuppressant drug, or any immunoglobulin preparation within three months of&#xD;
             vaccination and until the completion of the study. Low doses of nasal or inhaled&#xD;
             glucocorticoids are allowed. Topical steroids are permitted;&#xD;
&#xD;
         12. Any significant disorder of coagulation including, but not limited to, treatment with&#xD;
             warfarin derivatives or heparin. Persons receiving prophylactic anti-platelet&#xD;
             medications (e.g. low-dose aspirin [no more than 325 mg/day]), and without a&#xD;
             clinically apparent bleeding tendency are eligible. Participants treated with new&#xD;
             generation drugs that do not increase the risk of intramuscular bleeding (e.g.&#xD;
             clopidogrel) are also eligible;&#xD;
&#xD;
         13. History of allergy to any of the constituents of the Quadrivalent VLP Influenza&#xD;
             Vaccine or tobacco;&#xD;
&#xD;
         14. History of anaphylactic allergic reactions to plants or plants components;&#xD;
&#xD;
         15. Use of antihistamines with systemic absorption for more than 14 days in the four weeks&#xD;
             prior to vaccination or use of antihistamines 48 hours prior to study vaccination (the&#xD;
             use of topical antihistamines and nasal or inhaled steroids is acceptable);&#xD;
&#xD;
         16. Use of prophylactic medications (e.g. acetaminophen/paracetamol, aspirin, naproxen, or&#xD;
             ibuprofen) within 24 hours of randomization to prevent or pre-empt symptoms due to&#xD;
             vaccination. Any participant discovered to have taken a prophylactic medication to&#xD;
             prevent or pre-empt symptoms due to vaccination within the 24 hours prior to planned&#xD;
             randomization must be delayed until at least the 24 hours period is met;&#xD;
&#xD;
         17. Planned use of influenza antiviral treatment medication before the collection of&#xD;
             nasopharyngeal swabs (e.g. oseltamivir, zanamivir, rapivab);&#xD;
&#xD;
         18. Have a rash, dermatological condition, tattoos, muscle mass, or any other&#xD;
             abnormalities at the injection site that may interfere with injection site reaction&#xD;
             rating;&#xD;
&#xD;
         19. Participants who have received a blood transfusion within 90 days prior to study&#xD;
             vaccination;&#xD;
&#xD;
         20. Any female participant who has a positive or doubtful pregnancy test result prior to&#xD;
             vaccination or who is lactating;&#xD;
&#xD;
         21. Participants with abnormal vital signs (systolic blood pressure [BP] &gt; 140 mmHg and/or&#xD;
             diastolic BP ≥ 90 mmHg, heart rate ≤ 45 beats/min and ≥ 100 beats/min) evaluated by an&#xD;
             Investigator to be clinically significant. A participant with abnormal vital signs&#xD;
             results may be included in the study based on Investigator's judgment (e.g. a resting&#xD;
             hear rate ≤ 45 in highly trained athletes);&#xD;
&#xD;
         22. Presence of any febrile illness (including an oral temperature ≥ 38.0 ˚C within 24&#xD;
             hours prior to vaccination. Such participants may be re-evaluated for enrolment after&#xD;
             resolution of illness;&#xD;
&#xD;
         23. Cancer or treatment for cancer within three years prior to study vaccine&#xD;
             administration.&#xD;
&#xD;
             Persons with a history of cancer who are disease-free without treatment for three&#xD;
             years or more are eligible. However, individuals with conditions such as treated and&#xD;
             uncomplicated basal cell carcinoma of the skin or non-treated, non-disseminated local&#xD;
             prostate cancer may be eligible;&#xD;
&#xD;
         24. Participants identified as an Investigator or employee of the Investigator or clinical&#xD;
             site with direct involvement in the proposed study, or identified as an immediate&#xD;
             family member (i.e. parent, spouse, natural or adopted child) of the Investigator or&#xD;
             employee with direct involvement in the proposed study or any employee of Medicago;&#xD;
&#xD;
         25. Participants with a history of Guillain-Barré Syndrome.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Medicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site 222</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 210</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 223</name>
      <address>
        <city>Milford</city>
        <state>Connecticut</state>
        <zip>06460</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 217</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 220</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 212</name>
      <address>
        <city>South Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 203</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 218</name>
      <address>
        <city>Stockbridge</city>
        <state>Georgia</state>
        <zip>30281</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 206</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 202</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 225</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 224</name>
      <address>
        <city>Norfolk</city>
        <state>Nebraska</state>
        <zip>68701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 208</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>63134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 213</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 205</name>
      <address>
        <city>Binghamton</city>
        <state>New York</state>
        <zip>13901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 228</name>
      <address>
        <city>Endwell</city>
        <state>New York</state>
        <zip>13760</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 216</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 221</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28277</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 227</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 201</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 207</name>
      <address>
        <city>Dakota Dunes</city>
        <state>South Dakota</state>
        <zip>57049</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 209</name>
      <address>
        <city>Bristol</city>
        <state>Tennessee</state>
        <zip>37260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 204</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 229</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78745</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 226</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 219</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 214</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 211</name>
      <address>
        <city>West Jordan</city>
        <state>Utah</state>
        <zip>84088</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 230</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 105</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 106</name>
      <address>
        <city>Truro</city>
        <state>Nova Scotia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 107</name>
      <address>
        <city>Brampton</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 110</name>
      <address>
        <city>Sudbury</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 108</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 109</name>
      <address>
        <city>Mirabel</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 103</name>
      <address>
        <city>Pierrefonds</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 101</name>
      <address>
        <city>Quebec City</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 102</name>
      <address>
        <city>Quebec City</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 104</name>
      <address>
        <city>Sherbrooke</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 306</name>
      <address>
        <city>Espoo</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 305</name>
      <address>
        <city>Helsinki</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 310</name>
      <address>
        <city>Helsinki</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 304</name>
      <address>
        <city>Jarvenpaa</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 309</name>
      <address>
        <city>Kokkola</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 307</name>
      <address>
        <city>Oulu</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 303</name>
      <address>
        <city>Pori</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 308</name>
      <address>
        <city>Seinäjoki</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 301</name>
      <address>
        <city>Tampere</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 302</name>
      <address>
        <city>Turku</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 402</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 403</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 406</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 401</name>
      <address>
        <city>Essen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 404</name>
      <address>
        <city>Essen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 405</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 701</name>
      <address>
        <city>Manila</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 703</name>
      <address>
        <city>Manila</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 702</name>
      <address>
        <city>Muntinlupa</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 704</name>
      <address>
        <city>Muntinlupa</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 705</name>
      <address>
        <city>Muntinlupa</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 706</name>
      <address>
        <city>Pasay</city>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 605</name>
      <address>
        <city>Bangkok Noi</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 601</name>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 603</name>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 604</name>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 606</name>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 607</name>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 602</name>
      <address>
        <city>Chiang Mai</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 510</name>
      <address>
        <city>Corby</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 507</name>
      <address>
        <city>Gillingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 506</name>
      <address>
        <city>Northwood</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 508</name>
      <address>
        <city>Romford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 509</name>
      <address>
        <city>Shipley</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Finland</country>
    <country>Germany</country>
    <country>Philippines</country>
    <country>Thailand</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Ward BJ, Makarkov A, Seguin A, Pillet S, Trepanier S, Dhaliwall J, Libman MD, Vesikari T, Landry N. Efficacy, immunogenicity, and safety of a plant-derived, quadrivalent, virus-like particle influenza vaccine in adults (18-64 years) and older adults (&gt;/=65 years): two multicentre, randomised phase 3 trials. Lancet. 2020 Nov 7;396(10261):1491-1503. doi: 10.1016/S0140-6736(20)32014-6. Epub 2020 Oct 13.</citation>
    <PMID>33065035</PMID>
  </results_reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 4, 2017</study_first_posted>
  <results_first_submitted>May 29, 2023</results_first_submitted>
  <results_first_submitted_qc>July 17, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">August 14, 2023</results_first_posted>
  <disposition_first_submitted>October 31, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>July 17, 2023</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 14, 2023</disposition_first_posted>
  <last_update_submitted>July 17, 2023</last_update_submitted>
  <last_update_submitted_qc>July 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Influenza</keyword>
  <keyword>Human</keyword>
  <keyword>RNA Virus Infections</keyword>
  <keyword>Efficacy</keyword>
  <keyword>Immunologic</keyword>
  <keyword>Immunogenic Factors</keyword>
  <keyword>Physiological Effects of Drug</keyword>
  <keyword>Virus Diseases</keyword>
  <keyword>Orthomyxoviridae Infections</keyword>
  <keyword>Infection</keyword>
  <keyword>Vaccine</keyword>
  <keyword>Safety</keyword>
  <keyword>Plant-made</keyword>
  <keyword>Virus-like Particle</keyword>
  <keyword>Hemagglutinin</keyword>
  <keyword>Quadrivalent Influenza Vaccine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Virus Diseases</mesh_term>
    <mesh_term>Influenza, Human</mesh_term>
    <mesh_term>Respiratory Tract Infections</mesh_term>
    <mesh_term>RNA Virus Infections</mesh_term>
    <mesh_term>Respiratory Tract Diseases</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>September 13, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/51/NCT03301051/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>June 27, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/51/NCT03301051/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were randomized in a 1:1 ratio to receive the Quadrivalent virus-like particle (VLP) Influenza Vaccine at a dose of 30 μg/strain or the placebo.</recruitment_details>
      <pre_assignment_details>Participants were healthy adults 18 to 64 years of age assessed during the 2017-2018 influenza season.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Quadrivalent VLP Vaccine</title>
          <description>Participants received one intramuscular (IM) injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Participants received one IM injection of 0.5 mL of placebo on Day 0.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5077"/>
                <participants group_id="P2" count="5083"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Analysis Set</title>
              <participants_list>
                <participants group_id="P1" count="5064"/>
                <participants group_id="P2" count="5072"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Vaccinated</title>
              <participants_list>
                <participants group_id="P1" count="5065">1 participant randomized to placebo fraudulently received doses at 2 different sites. Placebo (first site) and vaccine (second site).</participants>
                <participants group_id="P2" count="5072"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4731"/>
                <participants group_id="P2" count="4711"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="346"/>
                <participants group_id="P2" count="372"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="59"/>
                <participants group_id="P2" count="65"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="263"/>
                <participants group_id="P2" count="282"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Miscellaneous</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Randomized, not vaccinated</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The Safety Analysis Set (SAS) was defined as all participants who received either the Quadrivalent VLP Influenza Vaccine or the placebo.</population>
      <group_list>
        <group group_id="B1">
          <title>Quadrivalent VLP Vaccine</title>
          <description>Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Participants received one IM injection of 0.5 mL of placebo on Day 0.</description>
        </group>
        <group group_id="B3">
          <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="5064"/>
            <count group_id="B2" value="5072"/>
            <count group_id="B3" value="10136"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5064"/>
                    <measurement group_id="B2" value="5072"/>
                    <measurement group_id="B3" value="10136"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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="3051"/>
                    <measurement group_id="B2" value="3034"/>
                    <measurement group_id="B3" value="6085"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2013"/>
                    <measurement group_id="B2" value="2038"/>
                    <measurement group_id="B3" value="4051"/>
                  </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="293"/>
                    <measurement group_id="B2" value="326"/>
                    <measurement group_id="B3" value="619"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4769"/>
                    <measurement group_id="B2" value="4740"/>
                    <measurement group_id="B3" value="9509"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="8"/>
                  </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="20"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1192"/>
                    <measurement group_id="B2" value="1185"/>
                    <measurement group_id="B3" value="2377"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="646"/>
                    <measurement group_id="B2" value="620"/>
                    <measurement group_id="B3" value="1266"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3168"/>
                    <measurement group_id="B2" value="3214"/>
                    <measurement group_id="B3" value="6382"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Occurrences of Protocol-Defined Respiratory Illness Caused by Vaccine-Matched Influenza Strains</title>
        <description>Occurrences of protocol-defined respiratory illness caused by vaccine-matched influenza strains were assessed. The vaccine-matched strains included: H1N1 (A/Michigan/45/2015); H3N2 (A/Hong Kong/4801/2014); B/Brisbane (B/Brisbane/60/2008); and B/Phuket (B/Phuket/3073/2013A). The protocol-defined respiratory illness was determined by the occurrence of at least 1 of the following respiratory symptoms: sneezing, stuffy nose, sore throat, cough, sputum production, wheezing, or difficulty breathing. Occurrences of all matched strains are reported.</description>
        <time_frame>Day 14 (post-vaccination) up to ~8 months</time_frame>
        <population>The Per Protocol (PP) set consisted of the participants who participated in the study until at least the end of the peak period or for at least five months or until the end of the surveillance period.</population>
        <group_list>
          <group group_id="O1">
            <title>Quadrivalent VLP Vaccine</title>
            <description>Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received one IM injection of 0.5 mL of placebo on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Occurrences of Protocol-Defined Respiratory Illness Caused by Vaccine-Matched Influenza Strains</title>
          <description>Occurrences of protocol-defined respiratory illness caused by vaccine-matched influenza strains were assessed. The vaccine-matched strains included: H1N1 (A/Michigan/45/2015); H3N2 (A/Hong Kong/4801/2014); B/Brisbane (B/Brisbane/60/2008); and B/Phuket (B/Phuket/3073/2013A). The protocol-defined respiratory illness was determined by the occurrence of at least 1 of the following respiratory symptoms: sneezing, stuffy nose, sore throat, cough, sputum production, wheezing, or difficulty breathing. Occurrences of all matched strains are reported.</description>
          <population>The Per Protocol (PP) set consisted of the participants who participated in the study until at least the end of the peak period or for at least five months or until the end of the surveillance period.</population>
          <units>Number of cases</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4814"/>
                <count group_id="O2" value="4812"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110"/>
                    <measurement group_id="O2" value="169"/>
                  </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>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Vaccine Efficacy (VE) of VLP vaccine versus placebo = (1 - attack rate in vaccinated participants [ARV]/attack rate in unvaccinated participants [ARU]) x 100%.</non_inferiority_desc>
            <param_type>Vaccine Efficacy</param_type>
            <param_value>34.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>17.6</ci_lower_limit>
            <ci_upper_limit>48.6</ci_upper_limit>
            <estimate_desc>The VE success criterion is defined as a &gt;40% lower limit of the two-sided 95% confidence interval (CI).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Occurrences of Protocol-Defined Respiratory Illness Cases Caused by Any Laboratory Confirmed Influenza Strain</title>
        <description>Occurrences of protocol-defined respiratory illness due to laboratory-confirmed influenza strain (matched, mismatched, and un-typed) were assessed. A protocol-defined respiratory illness was determined by the occurrence of at least 1 of the following respiratory symptoms: sneezing, stuffy nose, sore throat, cough, sputum production, wheezing, or difficulty breathing.</description>
        <time_frame>Day 14 (post-vaccination) up to ~8 months</time_frame>
        <population>PP Set</population>
        <group_list>
          <group group_id="O1">
            <title>Quadrivalent VLP Vaccine</title>
            <description>Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received one IM injection of 0.5 mL of placebo on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Occurrences of Protocol-Defined Respiratory Illness Cases Caused by Any Laboratory Confirmed Influenza Strain</title>
          <description>Occurrences of protocol-defined respiratory illness due to laboratory-confirmed influenza strain (matched, mismatched, and un-typed) were assessed. A protocol-defined respiratory illness was determined by the occurrence of at least 1 of the following respiratory symptoms: sneezing, stuffy nose, sore throat, cough, sputum production, wheezing, or difficulty breathing.</description>
          <population>PP Set</population>
          <units>Number of cases</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4814"/>
                <count group_id="O2" value="4812"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="213"/>
                    <measurement group_id="O2" value="347"/>
                  </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>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>VE of VLP vaccine versus placebo = (1 - ARV/ARU) x 100%.</non_inferiority_desc>
            <param_type>Vaccine Efficacy</param_type>
            <param_value>38.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>27.6</ci_lower_limit>
            <ci_upper_limit>48.0</ci_upper_limit>
            <estimate_desc>The VE success criterion is defined as a &gt;40% lower limit of the two-sided 95% CI.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Occurrences of Laboratory-Confirmed Protocol-Defined Influenza-Like Illness (ILI) Caused by Vaccine-Matched Influenza Strains</title>
        <description>Occurrences of protocol-defined ILI due to laboratory-confirmed influenza caused by influenza viral types/subtypes that are matched (and/or antigenically similar) to the strains covered in the vaccine formulation were assessed. A participant is considered to have protocol-defined ILI if the participant met at least one of the following pre-defined respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing AND at least one of the following systemic symptoms: fever (defined as a temperature &gt; 37.2 °C or &gt; 99.0 °F), chills, tiredness, headache or myalgia.</description>
        <time_frame>Day 14 (post-vaccination) up to ~8 months</time_frame>
        <population>PP Set</population>
        <group_list>
          <group group_id="O1">
            <title>Quadrivalent VLP Vaccine</title>
            <description>Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received one IM injection of 0.5 mL of placebo on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Occurrences of Laboratory-Confirmed Protocol-Defined Influenza-Like Illness (ILI) Caused by Vaccine-Matched Influenza Strains</title>
          <description>Occurrences of protocol-defined ILI due to laboratory-confirmed influenza caused by influenza viral types/subtypes that are matched (and/or antigenically similar) to the strains covered in the vaccine formulation were assessed. A participant is considered to have protocol-defined ILI if the participant met at least one of the following pre-defined respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing AND at least one of the following systemic symptoms: fever (defined as a temperature &gt; 37.2 °C or &gt; 99.0 °F), chills, tiredness, headache or myalgia.</description>
          <population>PP Set</population>
          <units>Number of cases</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4814"/>
                <count group_id="O2" value="4812"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98"/>
                    <measurement group_id="O2" value="148"/>
                  </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>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>VE of VLP vaccine versus placebo = (1 - ARV/ARU) x 100%.</non_inferiority_desc>
            <param_type>Vaccine Efficacy</param_type>
            <param_value>33.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>14.9</ci_lower_limit>
            <ci_upper_limit>48.5</ci_upper_limit>
            <estimate_desc>The VE success criterion is defined as a &gt;40% lower limit of the two-sided 95% CI.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Occurrences of Laboratory-Confirmed ILI Caused by Any Influenza Strain</title>
        <description>Occurrences of laboratory-confirmed ILI caused by any influenza viral strains were assessed. A participant is considered to have protocol-defined ILI if the participant met at least one of the following pre-defined respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing AND at least one of the following systemic symptoms: fever (defined as a temperature &gt; 37.2 °C or &gt; 99.0 °F), chills, tiredness, headache or myalgia.</description>
        <time_frame>Day 14 (post-vaccination) up to ~8 months</time_frame>
        <population>PP Set</population>
        <group_list>
          <group group_id="O1">
            <title>Quadrivalent VLP Vaccine</title>
            <description>Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received one IM injection of 0.5 mL of placebo on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Occurrences of Laboratory-Confirmed ILI Caused by Any Influenza Strain</title>
          <description>Occurrences of laboratory-confirmed ILI caused by any influenza viral strains were assessed. A participant is considered to have protocol-defined ILI if the participant met at least one of the following pre-defined respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing AND at least one of the following systemic symptoms: fever (defined as a temperature &gt; 37.2 °C or &gt; 99.0 °F), chills, tiredness, headache or myalgia.</description>
          <population>PP Set</population>
          <units>Number of cases</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4814"/>
                <count group_id="O2" value="4812"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="178"/>
                    <measurement group_id="O2" value="285"/>
                  </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>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>VE of VLP vaccine versus placebo = (1 - ARV/ARU) x 100%.</non_inferiority_desc>
            <param_type>Vaccine Efficacy</param_type>
            <param_value>37.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>25.1</ci_lower_limit>
            <ci_upper_limit>48.0</ci_upper_limit>
            <estimate_desc>The VE success criterion is defined as a &gt;40% lower limit of the two-sided 95% CI.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Occurrences of Protocol-Defined ILI Cases</title>
        <description>Occurrences of protocol-defined ILI cases (confirmed or not) were assessed. A participant is considered to have protocol-defined ILI if the participant met at least one of the following pre-defined respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing AND at least one of the following systemic symptoms: fever (defined as a temperature &gt; 37.2 °C or &gt; 99.0 °F), chills, tiredness, headache or myalgia.</description>
        <time_frame>Day 14 (post-vaccination) up to ~8 months</time_frame>
        <population>PP Set</population>
        <group_list>
          <group group_id="O1">
            <title>Quadrivalent VLP Vaccine</title>
            <description>Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received one IM injection of 0.5 mL of placebo on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Occurrences of Protocol-Defined ILI Cases</title>
          <description>Occurrences of protocol-defined ILI cases (confirmed or not) were assessed. A participant is considered to have protocol-defined ILI if the participant met at least one of the following pre-defined respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing AND at least one of the following systemic symptoms: fever (defined as a temperature &gt; 37.2 °C or &gt; 99.0 °F), chills, tiredness, headache or myalgia.</description>
          <population>PP Set</population>
          <units>Number of cases</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4814"/>
                <count group_id="O2" value="4812"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1576"/>
                    <measurement group_id="O2" value="1679"/>
                  </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>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>VE of VLP vaccine versus placebo = (1 - ARV/ARU) x 100%.</non_inferiority_desc>
            <param_type>Vaccine Efficacy</param_type>
            <param_value>6.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.8</ci_lower_limit>
            <ci_upper_limit>11.3</ci_upper_limit>
            <estimate_desc>The VE success criterion is defined as a &gt;40% lower limit of the two-sided 95% CI.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With at Least One Immediate Complaint</title>
        <description>Immediate complaints were defined as any solicited local or systemic reactions. Solicited local reactions included: erythema, swelling, and pain at the injection site and solicited systemic reactions included: fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck.</description>
        <time_frame>15 minutes post vaccination</time_frame>
        <population>SAS</population>
        <group_list>
          <group group_id="O1">
            <title>Quadrivalent VLP Vaccine</title>
            <description>Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received one IM injection of 0.5 mL of placebo on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With at Least One Immediate Complaint</title>
          <description>Immediate complaints were defined as any solicited local or systemic reactions. Solicited local reactions included: erythema, swelling, and pain at the injection site and solicited systemic reactions included: fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck.</description>
          <population>SAS</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5064"/>
                <count group_id="O2" value="5072"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="441"/>
                    <measurement group_id="O2" value="377"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With at Least One Solicited Local and Systemic Reactions</title>
        <description>Participants were monitored for both solicited local reactions (erythema, swelling, and pain at the injection site) and solicited systemic reactions (fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck). Any solicited local or systemic immediate complaint was also included.</description>
        <time_frame>Day 0 (post-vaccination) up to Day 7</time_frame>
        <population>SAS</population>
        <group_list>
          <group group_id="O1">
            <title>Quadrivalent VLP Vaccine</title>
            <description>Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received one IM injection of 0.5 mL of placebo on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With at Least One Solicited Local and Systemic Reactions</title>
          <description>Participants were monitored for both solicited local reactions (erythema, swelling, and pain at the injection site) and solicited systemic reactions (fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck). Any solicited local or systemic immediate complaint was also included.</description>
          <population>SAS</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5064"/>
                <count group_id="O2" value="5072"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2776"/>
                    <measurement group_id="O2" value="1723"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With ≥ Severe Solicited Local and Systemic Reactions</title>
        <description>Participants were monitored for both solicited local reactions (erythema, swelling, and pain at the injection site) and solicited systemic reactions (fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck). Any solicited local or systemic immediate complaint was also included. The intensity of the solicited reactions was graded as mild (1)-easily tolerated and does not interfere with usual activity; moderate (2)-interferes with daily activity, but the participant is still able to function; severe (3)-incapacitating and the participant is unable to work or complete usual activity or potentially life threatening; (4)-likely to be life-threatening if not treated in a timely manner, according to the Food and Drug Administration (FDA) Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.</description>
        <time_frame>Day 0 (post-vaccination) up to Day 7</time_frame>
        <population>SAS</population>
        <group_list>
          <group group_id="O1">
            <title>Quadrivalent VLP Vaccine</title>
            <description>Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received one IM injection of 0.5 mL of placebo on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With ≥ Severe Solicited Local and Systemic Reactions</title>
          <description>Participants were monitored for both solicited local reactions (erythema, swelling, and pain at the injection site) and solicited systemic reactions (fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck). Any solicited local or systemic immediate complaint was also included. The intensity of the solicited reactions was graded as mild (1)-easily tolerated and does not interfere with usual activity; moderate (2)-interferes with daily activity, but the participant is still able to function; severe (3)-incapacitating and the participant is unable to work or complete usual activity or potentially life threatening; (4)-likely to be life-threatening if not treated in a timely manner, according to the Food and Drug Administration (FDA) Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.</description>
          <population>SAS</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5064"/>
                <count group_id="O2" value="5072"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75"/>
                    <measurement group_id="O2" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With ≥ Severe Related Solicited Reactions</title>
        <description>Participants were monitored for both solicited local reactions (erythema, swelling, and pain at the injection site) and solicited systemic reactions (fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck). The intensity of the solicited reactions was graded according to the FDA Toxicity Grading Scale: mild (1), moderate (2), severe (3) or potentially life threatening (4). The causal relationship with the study vaccine was assessed as &quot;definitely not related&quot; (clearly not related), &quot;probably not related&quot; (no medical evidence), &quot;possibly related&quot; (reasonable possibility of cause and effect), &quot;probably related&quot; (plausible biologic mechanism and temporal relationship) or &quot;definitely related&quot; (direct cause and effect relationship). The ≥ severe events included &quot;severe&quot; and &quot;potentially life-threatening&quot; and the related category included &quot;possibly related&quot;, &quot;probably related&quot;, and &quot;definitely related.&quot;</description>
        <time_frame>Day 0 (post-vaccination) up to Day 7</time_frame>
        <population>SAS</population>
        <group_list>
          <group group_id="O1">
            <title>Quadrivalent VLP Vaccine</title>
            <description>Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received one IM injection of 0.5 mL of placebo on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With ≥ Severe Related Solicited Reactions</title>
          <description>Participants were monitored for both solicited local reactions (erythema, swelling, and pain at the injection site) and solicited systemic reactions (fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck). The intensity of the solicited reactions was graded according to the FDA Toxicity Grading Scale: mild (1), moderate (2), severe (3) or potentially life threatening (4). The causal relationship with the study vaccine was assessed as &quot;definitely not related&quot; (clearly not related), &quot;probably not related&quot; (no medical evidence), &quot;possibly related&quot; (reasonable possibility of cause and effect), &quot;probably related&quot; (plausible biologic mechanism and temporal relationship) or &quot;definitely related&quot; (direct cause and effect relationship). The ≥ severe events included &quot;severe&quot; and &quot;potentially life-threatening&quot; and the related category included &quot;possibly related&quot;, &quot;probably related&quot;, and &quot;definitely related.&quot;</description>
          <population>SAS</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5064"/>
                <count group_id="O2" value="5072"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                    <measurement group_id="O2" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Unsolicited Treatment-Emergent Adverse Events (TEAEs)</title>
        <description>Participants were monitored for unsolicited TEAEs (e.g., nasopharyngitis, upper respiratory tract infection, headache, and oropharyngeal pain). An adverse event (AE) or adverse experience was defined as any untoward medical occurrence in a participant or clinical investigation participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. An AE was considered treatment-emergent if it began on or after the date and time of Study Day 0 vaccination.</description>
        <time_frame>Day 0 (post-vaccination) up to Day 21</time_frame>
        <population>SAS</population>
        <group_list>
          <group group_id="O1">
            <title>Quadrivalent VLP Vaccine</title>
            <description>Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received one IM injection of 0.5 mL of placebo on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Unsolicited Treatment-Emergent Adverse Events (TEAEs)</title>
          <description>Participants were monitored for unsolicited TEAEs (e.g., nasopharyngitis, upper respiratory tract infection, headache, and oropharyngeal pain). An adverse event (AE) or adverse experience was defined as any untoward medical occurrence in a participant or clinical investigation participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. An AE was considered treatment-emergent if it began on or after the date and time of Study Day 0 vaccination.</description>
          <population>SAS</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5064"/>
                <count group_id="O2" value="5072"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="661"/>
                    <measurement group_id="O2" value="639"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With ≥ Severe Unsolicited TEAEs</title>
        <description>The intensity of the unsolicited TEAEs was graded as mild (1)-easily tolerated and does not interfere with usual activity; moderate (2)-interferes with daily activity, but the participant is still able to function; severe (3)-incapacitating and the participant is unable to work or complete usual activity or potentially life threatening; (4)-likely to be life-threatening if not treated in a timely manner, according to the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. The ≥ Severe events included severe and potentially life-threatening events. AE and TEAEs are defined in outcome measure #10.</description>
        <time_frame>Day 0 (post-vaccination) up to Day 21</time_frame>
        <population>SAS</population>
        <group_list>
          <group group_id="O1">
            <title>Quadrivalent VLP Vaccine</title>
            <description>Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received one IM injection of 0.5 mL of placebo on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With ≥ Severe Unsolicited TEAEs</title>
          <description>The intensity of the unsolicited TEAEs was graded as mild (1)-easily tolerated and does not interfere with usual activity; moderate (2)-interferes with daily activity, but the participant is still able to function; severe (3)-incapacitating and the participant is unable to work or complete usual activity or potentially life threatening; (4)-likely to be life-threatening if not treated in a timely manner, according to the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. The ≥ Severe events included severe and potentially life-threatening events. AE and TEAEs are defined in outcome measure #10.</description>
          <population>SAS</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5064"/>
                <count group_id="O2" value="5072"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With ≥ Severe Related Unsolicited Reactions</title>
        <description>The intensity of the solicited local and systemic reactions was graded as: mild (1), moderate (2), severe (3) or potentially life threatening (4). The causal relationship with the study vaccine was assessed as &quot;definitely not related&quot; (clearly not related), &quot;probably not related&quot; (no medical evidence), &quot;possibly related&quot; (reasonable possibility of cause and effect), &quot;probably related&quot; (plausible biologic mechanism and temporal relationship) or &quot;definitely related&quot; (direct cause and effect relationship). The ≥ severe events included &quot;severe&quot; and &quot;potentially life-threatening&quot; and the related category included &quot;possibly related&quot;, &quot;probably related&quot;, and &quot;definitely related.&quot; AE and TEAEs are defined in outcome measure #10.</description>
        <time_frame>Day 0 (post-vaccination) up to Day 21</time_frame>
        <population>SAS</population>
        <group_list>
          <group group_id="O1">
            <title>Quadrivalent VLP Vaccine</title>
            <description>Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received one IM injection of 0.5 mL of placebo on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With ≥ Severe Related Unsolicited Reactions</title>
          <description>The intensity of the solicited local and systemic reactions was graded as: mild (1), moderate (2), severe (3) or potentially life threatening (4). The causal relationship with the study vaccine was assessed as &quot;definitely not related&quot; (clearly not related), &quot;probably not related&quot; (no medical evidence), &quot;possibly related&quot; (reasonable possibility of cause and effect), &quot;probably related&quot; (plausible biologic mechanism and temporal relationship) or &quot;definitely related&quot; (direct cause and effect relationship). The ≥ severe events included &quot;severe&quot; and &quot;potentially life-threatening&quot; and the related category included &quot;possibly related&quot;, &quot;probably related&quot;, and &quot;definitely related.&quot; AE and TEAEs are defined in outcome measure #10.</description>
          <population>SAS</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5064"/>
                <count group_id="O2" value="5072"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With an Occurrence of Death</title>
        <description>The number of participants in each treatment group with an occurrence of death was assessed.</description>
        <time_frame>Day 0 up to ~8 months</time_frame>
        <population>SAS</population>
        <group_list>
          <group group_id="O1">
            <title>Quadrivalent VLP Vaccine</title>
            <description>Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received one IM injection of 0.5 mL of placebo on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With an Occurrence of Death</title>
          <description>The number of participants in each treatment group with an occurrence of death was assessed.</description>
          <population>SAS</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5064"/>
                <count group_id="O2" value="5072"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With at Least One Serious TEAE</title>
        <description>A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. An SAE was considered treatment-emergent if it was aggravated in severity or frequency following the administration of the study vaccine, up to and including the last visit of the study. AE is defined in outcome measure #10.</description>
        <time_frame>Day 0 up to ~8 months</time_frame>
        <population>SAS</population>
        <group_list>
          <group group_id="O1">
            <title>Quadrivalent VLP Vaccine</title>
            <description>Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received one IM injection of 0.5 mL of placebo on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With at Least One Serious TEAE</title>
          <description>A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. An SAE was considered treatment-emergent if it was aggravated in severity or frequency following the administration of the study vaccine, up to and including the last visit of the study. AE is defined in outcome measure #10.</description>
          <population>SAS</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5064"/>
                <count group_id="O2" value="5072"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55"/>
                    <measurement group_id="O2" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With at Least One AE Leading to Withdrawal</title>
        <description>An AE or adverse experience was defined as any untoward medical occurrence in a participant or clinical investigation participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. The number of participants with at least one adverse event leading to withdrawal was assessed.</description>
        <time_frame>Day 0 up to ~8 months</time_frame>
        <population>SAS</population>
        <group_list>
          <group group_id="O1">
            <title>Quadrivalent VLP Vaccine</title>
            <description>Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received one IM injection of 0.5 mL of placebo on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With at Least One AE Leading to Withdrawal</title>
          <description>An AE or adverse experience was defined as any untoward medical occurrence in a participant or clinical investigation participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. The number of participants with at least one adverse event leading to withdrawal was assessed.</description>
          <population>SAS</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5064"/>
                <count group_id="O2" value="5072"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With at Least One New Onset Chronic Diseases (NOCDs)</title>
        <description>All NOCDs that may plausibly have an allergic, autoimmune or inflammatory component were assessed and reported. Plausibility should be interpreted broadly; the only clear exceptions are degenerative conditions such as osteoarthritis, age-related physiologic changes and life-style diseases In this context, most cancers, cardiac conditions and kidney diseases should be reported.</description>
        <time_frame>Day 0 up to ~8 months</time_frame>
        <population>SAS</population>
        <group_list>
          <group group_id="O1">
            <title>Quadrivalent VLP Vaccine</title>
            <description>Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received one IM injection of 0.5 mL of placebo on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With at Least One New Onset Chronic Diseases (NOCDs)</title>
          <description>All NOCDs that may plausibly have an allergic, autoimmune or inflammatory component were assessed and reported. Plausibility should be interpreted broadly; the only clear exceptions are degenerative conditions such as osteoarthritis, age-related physiologic changes and life-style diseases In this context, most cancers, cardiac conditions and kidney diseases should be reported.</description>
          <population>SAS</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5064"/>
                <count group_id="O2" value="5072"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous and Heterologous Influenza Strain</title>
        <description>The GMTs in each treatment group were measured using a HI assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013, and the heterologous strains: A/Brisbane/59/2007 (IVR-148) (HIN1), A/Uruguay/716/2007 (H3N2), B/Florida/4/2006, B/Malaysia/2506/2004.</description>
        <time_frame>Day 0 (pre-vaccination), Day 21</time_frame>
        <population>Immunogenicity Per Protocol (IPP) Set consisted of a subset of participants who participated in the immunogenicity portion of the study, who had a Day 21 immunogenicity sample collection.</population>
        <group_list>
          <group group_id="O1">
            <title>Quadrivalent VLP Vaccine</title>
            <description>Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received one IM injection of 0.5 mL of placebo on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous and Heterologous Influenza Strain</title>
          <description>The GMTs in each treatment group were measured using a HI assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013, and the heterologous strains: A/Brisbane/59/2007 (IVR-148) (HIN1), A/Uruguay/716/2007 (H3N2), B/Florida/4/2006, B/Malaysia/2506/2004.</description>
          <population>Immunogenicity Per Protocol (IPP) Set consisted of a subset of participants who participated in the immunogenicity portion of the study, who had a Day 21 immunogenicity sample collection.</population>
          <units>Titers</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="278"/>
                <count group_id="O2" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Homologous (HIN1): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.2" lower_limit="20.7" upper_limit="28.3"/>
                    <measurement group_id="O2" value="30.0" lower_limit="22.9" upper_limit="39.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (HIN1): Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.8" lower_limit="71.4" upper_limit="100.8"/>
                    <measurement group_id="O2" value="27.8" lower_limit="21.6" upper_limit="35.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (H3N2): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.2" lower_limit="21.8" upper_limit="31.4"/>
                    <measurement group_id="O2" value="29.0" lower_limit="21.9" upper_limit="38.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (H3N2): Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="144.9" lower_limit="121.9" upper_limit="172.4"/>
                    <measurement group_id="O2" value="28.0" lower_limit="20.9" upper_limit="37.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Brisbane/60/2008): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.8" lower_limit="11.3" upper_limit="14.4"/>
                    <measurement group_id="O2" value="12.9" lower_limit="10.6" upper_limit="15.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Brisbane/60/2008): Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.1" lower_limit="24.8" upper_limit="31.9"/>
                    <measurement group_id="O2" value="12.1" lower_limit="10.0" upper_limit="14.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Phuket/3073/2013): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.8" lower_limit="24.5" upper_limit="33.9"/>
                    <measurement group_id="O2" value="28.1" lower_limit="21.7" upper_limit="36.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Phuket/3073/2013): Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.8" lower_limit="74.3" upper_limit="103.9"/>
                    <measurement group_id="O2" value="26.4" lower_limit="20.4" upper_limit="34.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heterologous (HIN1): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.5" lower_limit="12.7" upper_limit="16.6"/>
                    <measurement group_id="O2" value="14.5" lower_limit="12.0" upper_limit="17.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heterologous (HIN1): Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.4" lower_limit="14.4" upper_limit="18.8"/>
                    <measurement group_id="O2" value="14.4" lower_limit="11.8" upper_limit="17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heterologous (H3N2): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.2" lower_limit="14.7" upper_limit="20.2"/>
                    <measurement group_id="O2" value="19.7" lower_limit="15.4" upper_limit="25.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heterologous (H3N2): Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.1" lower_limit="37.1" upper_limit="52.3"/>
                    <measurement group_id="O2" value="17.7" lower_limit="13.9" upper_limit="22.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heterologous (B/Florida/4/2006): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.8" lower_limit="22.8" upper_limit="31.6"/>
                    <measurement group_id="O2" value="31.5" lower_limit="24.2" upper_limit="41.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heterologous (B/Florida/4/2006): Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.3" lower_limit="55.8" upper_limit="76.5"/>
                    <measurement group_id="O2" value="26.0" lower_limit="20.1" upper_limit="33.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heterologous (B/Malaysia/2506/2004): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.5" lower_limit="10.2" upper_limit="12.9"/>
                    <measurement group_id="O2" value="10.7" lower_limit="8.8" upper_limit="13.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heterologous (B/Malaysia/2506/2004): Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.6" lower_limit="21.6" upper_limit="27.9"/>
                    <measurement group_id="O2" value="10.6" lower_limit="8.7" upper_limit="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous and Heterologous Strain</title>
        <description>Seroconversion rate: the percentage of participants in a given treatment group with either a ≥ 4-fold increase in reciprocal HI titers between Day 0 and Day 21 or a rise of undetectable HI titer (i.e. &lt; 10) pre-vaccination (Day 0) to an HI titer of ≥ 40 on Day 21 was measured using an HI assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013, and the heterologous strains: A/Brisbane/59/2007 (IVR-148) (HIN1), A/Uruguay/716/2007 (H3N2), B/Florida/4/2006, B/Malaysia/2506/2004.</description>
        <time_frame>Day 0 (pre-vaccination) up to Day 21</time_frame>
        <population>IPP Set</population>
        <group_list>
          <group group_id="O1">
            <title>Quadrivalent VLP Vaccine</title>
            <description>Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received one IM injection of 0.5 mL of placebo on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous and Heterologous Strain</title>
          <description>Seroconversion rate: the percentage of participants in a given treatment group with either a ≥ 4-fold increase in reciprocal HI titers between Day 0 and Day 21 or a rise of undetectable HI titer (i.e. &lt; 10) pre-vaccination (Day 0) to an HI titer of ≥ 40 on Day 21 was measured using an HI assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013, and the heterologous strains: A/Brisbane/59/2007 (IVR-148) (HIN1), A/Uruguay/716/2007 (H3N2), B/Florida/4/2006, B/Malaysia/2506/2004.</description>
          <population>IPP Set</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="278"/>
                <count group_id="O2" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Homologous (HIN1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.1" lower_limit="31.4" upper_limit="43.0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (H3N2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.4" lower_limit="40.4" upper_limit="52.5"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Brisbane/60/2008)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.6" lower_limit="13.3" upper_limit="22.6"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Phuket/3073/2013)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.7" lower_limit="26.2" upper_limit="37.5"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heterologous (HIN1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="1.0" upper_limit="5.1"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heterologous (H3N2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.0" lower_limit="18.2" upper_limit="28.4"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heterologous (B/Florida/4/2006)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.0" lower_limit="21.9" upper_limit="32.6"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heterologous (B/Malaysia/2506/2004)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.3" lower_limit="14.0" upper_limit="23.4"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous and Heterologous Strain</title>
        <description>Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥ 40 on Day 21 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) was measured using an HI assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013, and the heterologous strains: A/Brisbane/59/2007 (IVR-148) (HIN1), A/Uruguay/716/2007 (H3N2), B/Florida/4/2006, B/Malaysia/2506/2004.</description>
        <time_frame>Day 0 (pre-vaccination) up to Day 21</time_frame>
        <population>IPP Set</population>
        <group_list>
          <group group_id="O1">
            <title>Quadrivalent VLP Vaccine</title>
            <description>Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received one IM injection of 0.5 mL of placebo on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous and Heterologous Strain</title>
          <description>Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥ 40 on Day 21 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) was measured using an HI assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013, and the heterologous strains: A/Brisbane/59/2007 (IVR-148) (HIN1), A/Uruguay/716/2007 (H3N2), B/Florida/4/2006, B/Malaysia/2506/2004.</description>
          <population>IPP Set</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="278"/>
                <count group_id="O2" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Homologous (HIN1): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.6" lower_limit="34.8" upper_limit="46.7"/>
                    <measurement group_id="O2" value="47.4" lower_limit="37.2" upper_limit="57.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (HIN1): Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.8" lower_limit="69.3" upper_limit="79.8"/>
                    <measurement group_id="O2" value="39.2" lower_limit="29.4" upper_limit="49.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (H3N2): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.4" lower_limit="40.4" upper_limit="52.5"/>
                    <measurement group_id="O2" value="46.4" lower_limit="36.2" upper_limit="56.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (H3N2): Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.3" lower_limit="80.5" upper_limit="89.2"/>
                    <measurement group_id="O2" value="48.5" lower_limit="38.2" upper_limit="58.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Brisbane/60/2008): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.4" lower_limit="14.9" upper_limit="24.6"/>
                    <measurement group_id="O2" value="20.6" lower_limit="13.1" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Brisbane/60/2008: Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.0" lower_limit="35.2" upper_limit="47.0"/>
                    <measurement group_id="O2" value="15.5" lower_limit="8.9" upper_limit="24.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Phuket/3073/2013): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.5" lower_limit="41.5" upper_limit="53.5"/>
                    <measurement group_id="O2" value="46.4" lower_limit="36.2" upper_limit="56.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Phuket/3073/2013): Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.3" lower_limit="70.8" upper_limit="81.1"/>
                    <measurement group_id="O2" value="43.3" lower_limit="33.3" upper_limit="53.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heterologous (HIN1): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.4" lower_limit="18.5" upper_limit="28.8"/>
                    <measurement group_id="O2" value="16.5" lower_limit="9.7" upper_limit="25.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heterologous (HIN1): Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.0" lower_limit="21.9" upper_limit="32.6"/>
                    <measurement group_id="O2" value="16.5" lower_limit="9.7" upper_limit="25.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heterologous (H3N2): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.3" lower_limit="25.9" upper_limit="37.1"/>
                    <measurement group_id="O2" value="34.0" lower_limit="24.7" upper_limit="44.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heterologous (H3N2): Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.6" lower_limit="52.6" upper_limit="64.5"/>
                    <measurement group_id="O2" value="29.9" lower_limit="21.0" upper_limit="40.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heterologous (B/Florida/4/2006): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.8" lower_limit="40.8" upper_limit="52.8"/>
                    <measurement group_id="O2" value="48.5" lower_limit="38.2" upper_limit="58.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heterologous (B/Florida/4/2006): Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.9" lower_limit="65.1" upper_limit="76.1"/>
                    <measurement group_id="O2" value="46.4" lower_limit="36.2" upper_limit="56.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heterologous (B/Malaysia/2506/2004): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.1" lower_limit="15.6" upper_limit="25.3"/>
                    <measurement group_id="O2" value="15.5" lower_limit="8.9" upper_limit="24.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heterologous (B/Malaysia/2506/2004): Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.2" lower_limit="37.3" upper_limit="49.2"/>
                    <measurement group_id="O2" value="13.4" lower_limit="7.3" upper_limit="21.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Fold Ratio (GMFR) of HI Antibody Response for Each Homologous and Heterologous Strain</title>
        <description>GMFR, the geometric mean of the ratio of GMTs (Day 21/Day 0) in each treatment group was measured using an HI assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013, and the heterologous strains: A/Brisbane/59/2007 (IVR-148) (HIN1), A/Uruguay/716/2007 (H3N2), B/Florida/4/2006, B/Malaysia/2506/2004.</description>
        <time_frame>Day 0 (pre-vaccination), Day 21</time_frame>
        <population>IPP Set</population>
        <group_list>
          <group group_id="O1">
            <title>Quadrivalent VLP Vaccine</title>
            <description>Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received one IM injection of 0.5 mL of placebo on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Fold Ratio (GMFR) of HI Antibody Response for Each Homologous and Heterologous Strain</title>
          <description>GMFR, the geometric mean of the ratio of GMTs (Day 21/Day 0) in each treatment group was measured using an HI assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013, and the heterologous strains: A/Brisbane/59/2007 (IVR-148) (HIN1), A/Uruguay/716/2007 (H3N2), B/Florida/4/2006, B/Malaysia/2506/2004.</description>
          <population>IPP Set</population>
          <units>Ratio</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="278"/>
                <count group_id="O2" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Homologous (HIN1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" lower_limit="3.0" upper_limit="3.9"/>
                    <measurement group_id="O2" value="1.0" lower_limit="0.8" upper_limit="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (H3N2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" lower_limit="4.7" upper_limit="6.3"/>
                    <measurement group_id="O2" value="1.0" lower_limit="0.8" upper_limit="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Brisbane/60/2008)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" lower_limit="2.0" upper_limit="2.4"/>
                    <measurement group_id="O2" value="0.9" lower_limit="0.8" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Phuket/3073/2013)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" lower_limit="2.7" upper_limit="3.4"/>
                    <measurement group_id="O2" value="0.9" lower_limit="0.8" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heterologous (HIN1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" lower_limit="1.1" upper_limit="1.2"/>
                    <measurement group_id="O2" value="1.0" lower_limit="0.9" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heterologous (H3N2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="2.3" upper_limit="2.9"/>
                    <measurement group_id="O2" value="0.9" lower_limit="0.8" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heterologous (B/Florida/4/2006)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" lower_limit="2.2" upper_limit="2.7"/>
                    <measurement group_id="O2" value="0.9" lower_limit="0.7" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heterologous (B/Malaysia/2506/2004)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" lower_limit="2.0" upper_limit="2.4"/>
                    <measurement group_id="O2" value="1.0" lower_limit="0.8" upper_limit="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>GMTs of Microneutralization (MN) Antibody Response for Each Homologous Strain</title>
        <description>The GMTs in each treatment group were measured using an MN assay for homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013.</description>
        <time_frame>Day 0 (pre-vaccination), Day 21</time_frame>
        <population>IPP Set</population>
        <group_list>
          <group group_id="O1">
            <title>Quadrivalent VLP Vaccine</title>
            <description>Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received one IM injection of 0.5 mL of placebo on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>GMTs of Microneutralization (MN) Antibody Response for Each Homologous Strain</title>
          <description>The GMTs in each treatment group were measured using an MN assay for homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013.</description>
          <population>IPP Set</population>
          <units>Titers</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="278"/>
                <count group_id="O2" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Homologous (HIN1): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.1" lower_limit="76.7" upper_limit="101.1"/>
                    <measurement group_id="O2" value="112.3" lower_limit="91.1" upper_limit="138.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (HIN1): Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="366.1" lower_limit="316.1" upper_limit="424.1"/>
                    <measurement group_id="O2" value="135.7" lower_limit="110.4" upper_limit="166.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (H3N2): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.7" lower_limit="41.9" upper_limit="52.1"/>
                    <measurement group_id="O2" value="62.1" lower_limit="53.1" upper_limit="72.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (H3N2): Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="120.3" lower_limit="108.9" upper_limit="132.9"/>
                    <measurement group_id="O2" value="67.2" lower_limit="57.0" upper_limit="79.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Brisbane/60/2008): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.2" lower_limit="13.8" upper_limit="16.7"/>
                    <measurement group_id="O2" value="14.9" lower_limit="12.9" upper_limit="17.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Brisbane/60/2008): Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.2" lower_limit="34.3" upper_limit="42.7"/>
                    <measurement group_id="O2" value="16.0" lower_limit="13.7" upper_limit="18.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Phuket/3073/2013): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.2" lower_limit="16.3" upper_limit="20.4"/>
                    <measurement group_id="O2" value="18.9" lower_limit="16.0" upper_limit="22.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Phuket/3073/2013): Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.0" lower_limit="46.1" upper_limit="58.6"/>
                    <measurement group_id="O2" value="21.3" lower_limit="18.0" upper_limit="25.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Strain</title>
        <description>Seroconversion rate: the percentage of participants in a given treatment group with either a ≥ 4-fold increase in reciprocal MN titers between Day 0 and Day 21 or a rise of undetectable MN titer (i.e. 7.1) pre-vaccination (Day 0) to an MN titer of ≥ 28.3 at Day 21 post-vaccination were measured using an MN assay for homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013.</description>
        <time_frame>Day 0 (pre-vaccination) up to Day 21</time_frame>
        <population>IPP Set</population>
        <group_list>
          <group group_id="O1">
            <title>Quadrivalent VLP Vaccine</title>
            <description>Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received one IM injection of 0.5 mL of placebo on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Strain</title>
          <description>Seroconversion rate: the percentage of participants in a given treatment group with either a ≥ 4-fold increase in reciprocal MN titers between Day 0 and Day 21 or a rise of undetectable MN titer (i.e. 7.1) pre-vaccination (Day 0) to an MN titer of ≥ 28.3 at Day 21 post-vaccination were measured using an MN assay for homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013.</description>
          <population>IPP Set</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="278"/>
                <count group_id="O2" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Homologous (HIN1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.7" lower_limit="35.9" upper_limit="47.8"/>
                    <measurement group_id="O2" value="2.1" lower_limit="0.3" upper_limit="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (H3N2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.1" lower_limit="22.9" upper_limit="33.7"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Brisbane/60/2008)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.6" lower_limit="25.2" upper_limit="36.4"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Phuket/3073/2013)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.3" lower_limit="25.9" upper_limit="37.1"/>
                    <measurement group_id="O2" value="1.0" lower_limit="0.0" upper_limit="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>GMFR of MN Antibody Response for Each Homologous Strain</title>
        <description>GMFR, the geometric mean of the ratio of GMTs (Day 21/Day 0) was measured in each treatment group using an MN assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, and B/Phuket/3073/2013.</description>
        <time_frame>Day 0 (pre-vaccination), Day 21</time_frame>
        <population>IPP Set</population>
        <group_list>
          <group group_id="O1">
            <title>Quadrivalent VLP Vaccine</title>
            <description>Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received one IM injection of 0.5 mL of placebo on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>GMFR of MN Antibody Response for Each Homologous Strain</title>
          <description>GMFR, the geometric mean of the ratio of GMTs (Day 21/Day 0) was measured in each treatment group using an MN assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, and B/Phuket/3073/2013.</description>
          <population>IPP Set</population>
          <units>Ratio</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="278"/>
                <count group_id="O2" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Homologous (HIN1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="3.6" upper_limit="4.6"/>
                    <measurement group_id="O2" value="1.3" lower_limit="1.1" upper_limit="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (H3N2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="2.2" upper_limit="2.7"/>
                    <measurement group_id="O2" value="1.2" lower_limit="1.1" upper_limit="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Brisbane/60/2008)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="2.3" upper_limit="2.8"/>
                    <measurement group_id="O2" value="1.1" lower_limit="0.9" upper_limit="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Phuket/3073/2013)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" lower_limit="2.6" upper_limit="3.1"/>
                    <measurement group_id="O2" value="1.1" lower_limit="1.0" upper_limit="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Area (GMA) of Single Radial Hemolysis (SRH) Antibody Response for Each Homologous Strain</title>
        <description>The GMA in each treatment group were measured using an SRH assay for homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013. The GMA calculations were performed by taking the anti-log of the mean of the log titer transformations.</description>
        <time_frame>Day 0 (pre-vaccination), Day 21</time_frame>
        <population>IPP Set</population>
        <group_list>
          <group group_id="O1">
            <title>Quadrivalent VLP Vaccine</title>
            <description>Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received one IM injection of 0.5 mL of placebo on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Area (GMA) of Single Radial Hemolysis (SRH) Antibody Response for Each Homologous Strain</title>
          <description>The GMA in each treatment group were measured using an SRH assay for homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013. The GMA calculations were performed by taking the anti-log of the mean of the log titer transformations.</description>
          <population>IPP Set</population>
          <units>mm^2</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="278"/>
                <count group_id="O2" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Homologous (HIN1): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.3" lower_limit="8.7" upper_limit="12.1"/>
                    <measurement group_id="O2" value="15.4" lower_limit="12.0" upper_limit="19.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (HIN1): Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.4" lower_limit="27.6" upper_limit="35.7"/>
                    <measurement group_id="O2" value="20.9" lower_limit="16.4" upper_limit="26.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (H3N2): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.6" lower_limit="12.9" upper_limit="18.8"/>
                    <measurement group_id="O2" value="19.3" lower_limit="14.2" upper_limit="26.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (H3N2): Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.0" lower_limit="50.2" upper_limit="62.5"/>
                    <measurement group_id="O2" value="28.4" lower_limit="21.2" upper_limit="38.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Brisbane/60/2008): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.2" lower_limit="6.9" upper_limit="9.9"/>
                    <measurement group_id="O2" value="6.8" lower_limit="5.0" upper_limit="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Brisbane/60/2008): Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.9" lower_limit="27.4" upper_limit="37.1"/>
                    <measurement group_id="O2" value="9.3" lower_limit="6.7" upper_limit="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Phuket/3073/2013): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.4" lower_limit="9.5" upper_limit="13.7"/>
                    <measurement group_id="O2" value="11.7" lower_limit="8.8" upper_limit="15.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Phuket/3073/2013): Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.7" lower_limit="31.9" upper_limit="42.1"/>
                    <measurement group_id="O2" value="15.5" lower_limit="11.5" upper_limit="20.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Seroconversion Measured by SRH Antibody Response for Each Homologous Strain</title>
        <description>Seroconversion rate: the percentage of participants in a given treatment group showing at least 50 % increase in GMA between Days 0 and 21 were measured using a SRH assay for homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013.</description>
        <time_frame>Day 0 (pre-vaccination) up to Day 21</time_frame>
        <population>IPP Set</population>
        <group_list>
          <group group_id="O1">
            <title>Quadrivalent VLP Vaccine</title>
            <description>Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received one IM injection of 0.5 mL of placebo on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Seroconversion Measured by SRH Antibody Response for Each Homologous Strain</title>
          <description>Seroconversion rate: the percentage of participants in a given treatment group showing at least 50 % increase in GMA between Days 0 and 21 were measured using a SRH assay for homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013.</description>
          <population>IPP Set</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="278"/>
                <count group_id="O2" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Homologous (HIN1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.6" lower_limit="47.5" upper_limit="59.6"/>
                    <measurement group_id="O2" value="14.4" lower_limit="8.1" upper_limit="23.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (H3N2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.2" lower_limit="42.2" upper_limit="54.2"/>
                    <measurement group_id="O2" value="14.4" lower_limit="8.1" upper_limit="23.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Brisbane/60/2008)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.7" lower_limit="39.7" upper_limit="51.7"/>
                    <measurement group_id="O2" value="9.3" lower_limit="4.3" upper_limit="16.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Phuket/3073/2013)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.1" lower_limit="41.1" upper_limit="53.2"/>
                    <measurement group_id="O2" value="12.4" lower_limit="6.6" upper_limit="20.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Seroprotection Measured by SRH Antibody Response for Each Homologous Strain</title>
        <description>Seroprotection rate: the percentage of participants in a given treatment group attaining an area ≥ 25 mm^2 following vaccination (Day 21) were measured using an SRH assay for homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013.</description>
        <time_frame>Day 0 (pre-vaccination) up to Day 21</time_frame>
        <population>IPP Set</population>
        <group_list>
          <group group_id="O1">
            <title>Quadrivalent VLP Vaccine</title>
            <description>Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received one IM injection of 0.5 mL of placebo on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Seroprotection Measured by SRH Antibody Response for Each Homologous Strain</title>
          <description>Seroprotection rate: the percentage of participants in a given treatment group attaining an area ≥ 25 mm^2 following vaccination (Day 21) were measured using an SRH assay for homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013.</description>
          <population>IPP Set</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="278"/>
                <count group_id="O2" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Homologous (HIN1): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.3" lower_limit="30.7" upper_limit="42.3"/>
                    <measurement group_id="O2" value="42.3" lower_limit="32.3" upper_limit="52.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (HIN1): Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.9" lower_limit="70.4" upper_limit="80.8"/>
                    <measurement group_id="O2" value="57.7" lower_limit="47.3" upper_limit="67.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (H3N2): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.7" lower_limit="48.6" upper_limit="60.6"/>
                    <measurement group_id="O2" value="57.7" lower_limit="47.3" upper_limit="67.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (H3N2): Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.1" lower_limit="88.3" upper_limit="95.0"/>
                    <measurement group_id="O2" value="74.2" lower_limit="64.3" upper_limit="82.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Brisbane/60/2008): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.3" lower_limit="34.5" upper_limit="46.3"/>
                    <measurement group_id="O2" value="37.1" lower_limit="27.5" upper_limit="47.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Brisbane/60/2008): Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.3" lower_limit="76.2" upper_limit="85.7"/>
                    <measurement group_id="O2" value="45.4" lower_limit="35.2" upper_limit="55.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Phuket/3073/2013): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.5" lower_limit="41.5" upper_limit="53.5"/>
                    <measurement group_id="O2" value="44.3" lower_limit="34.2" upper_limit="54.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Phuket/3073/2013): Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81.7" lower_limit="76.6" upper_limit="86.0"/>
                    <measurement group_id="O2" value="54.6" lower_limit="44.2" upper_limit="64.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>GMFR of SRH Antibody Response for Each Homologous Strain</title>
        <description>GMFR, the geometric mean of the ratio of GMTs (Day 21/Day 0) was measured in each treatment group using an SRH assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, and B/Phuket/3073/2013.</description>
        <time_frame>Day 0 (pre-vaccination), Day 21</time_frame>
        <population>IPP Set</population>
        <group_list>
          <group group_id="O1">
            <title>Quadrivalent VLP Vaccine</title>
            <description>Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Participants received one IM injection of 0.5 mL of placebo on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>GMFR of SRH Antibody Response for Each Homologous Strain</title>
          <description>GMFR, the geometric mean of the ratio of GMTs (Day 21/Day 0) was measured in each treatment group using an SRH assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, and B/Phuket/3073/2013.</description>
          <population>IPP Set</population>
          <units>Ratio</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="278"/>
                <count group_id="O2" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Homologous (HIN1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" lower_limit="2.6" upper_limit="3.2"/>
                    <measurement group_id="O2" value="1.6" lower_limit="1.3" upper_limit="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (H3N2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" lower_limit="3.1" upper_limit="3.9"/>
                    <measurement group_id="O2" value="1.6" lower_limit="1.4" upper_limit="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Brisbane/60/2008)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="3.5" upper_limit="4.5"/>
                    <measurement group_id="O2" value="1.3" lower_limit="1.0" upper_limit="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Homologous (B/Phuket/3073/2013)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" lower_limit="2.9" upper_limit="3.6"/>
                    <measurement group_id="O2" value="1.3" lower_limit="1.1" upper_limit="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Day 0 (post-vaccination) up to ~8 months</time_frame>
      <desc>SAS. The unsolicited serious adverse events (SAEs), unsolicited non-serious adverse events (NSAEs), and all deaths were reported.</desc>
      <group_list>
        <group group_id="E1">
          <title>Quadrivalent VLP Vaccine</title>
          <description>Participants received one IM injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine or placebo on Day 0.</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Participants received one IM injection of 0.5 mL of placebo on Day 0.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA V20.1</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="1" subjects_at_risk="5064"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="55" subjects_at_risk="5064"/>
                <counts group_id="E2" subjects_affected="51" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Haemorrhagic anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Coronary artery occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Extrasystoles</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Meniere's disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Large intestine perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Large intestine polyp</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Volvulus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Complication associated with device</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess limb</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Anorectal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Myelitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="5064"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Pulmonary tuberculosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Abdominal wound dehiscence</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Cervical vertebral fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Comminuted fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Facial bones fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Intentional overdose</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Lumbar vertebral fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Meniscus injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Snake bite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood potassium decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Intervertebral disc degeneration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Osteochondrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Osteonecrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Spinal column stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Spondylolisthesis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Breast cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Breast cancer metastatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Gastrointestinal stromal cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Invasive ductal breast carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Malignant pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Transient ischaemic attack</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </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" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Pre-eclampsia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Premature delivery</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Alcohol withdrawal syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Borderline personality disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Completed suicide</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Drug abuse</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Suicide attempt</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>End stage renal disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Renal artery stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Stag horn calculus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Ureterolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Menorrhagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Uterine polyp</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Pulmonary mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic dissection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Peripheral artery thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Peripheral venous disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA V20.1</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="930" subjects_at_risk="5064"/>
                <counts group_id="E2" subjects_affected="918" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Lymph node pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Lymphadenitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Cardiac flutter</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Cerumen impaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="5064"/>
                <counts group_id="E2" events="8" subjects_affected="5" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Excessive cerumen production</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>External ear inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Hypoacusis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Tympanic membrane perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="5064"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Vertigo positional</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Hypogonadism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Thyroid cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Conjunctival haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Corneal opacity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Dry eye</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Eye discharge</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Eye irritation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Eye paraesthesia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Eye pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Eye swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Glaucoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Keratitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Lacrimation increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Ocular hyperaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Photokeratitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Retinal detachment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Visual impairment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="5064"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Acid peptic disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Barrett's oesophagus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Coeliac disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Dental caries</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="5064"/>
                <counts group_id="E2" events="22" subjects_affected="20" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Enteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Food poisoning</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Gastric ulcer perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Gastrointestinal inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="5064"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Gingival swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Glossodynia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Haemorrhoids</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia oral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Irritable bowel syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Mouth ulceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="21" subjects_affected="21" subjects_at_risk="5064"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Noninfective gingivitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Odynophagia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Paraesthesia oral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Proctalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Rectal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Tooth impacted</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="5064"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Uvulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="5064"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Axillary pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Chest discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="19" subjects_affected="19" subjects_at_risk="5064"/>
                <counts group_id="E2" events="13" subjects_affected="13" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Discomfort</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Drug withdrawal syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Facial pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="32" subjects_affected="28" subjects_at_risk="5064"/>
                <counts group_id="E2" events="29" subjects_affected="29" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Feeling hot</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Hangover</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" events="102" subjects_affected="82" subjects_at_risk="5064"/>
                <counts group_id="E2" events="122" subjects_affected="87" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Injection site bruising</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Injection site haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Injection site hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Injection site hypoaesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Injection site inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Injection site oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="29" subjects_affected="29" subjects_at_risk="5064"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Injection site pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Injection site swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Injection site warmth</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Injury associated with device</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="5064"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="5064"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Peripheral swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="5064"/>
                <counts group_id="E2" events="14" subjects_affected="13" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Swelling</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="5064"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Vaccination site haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergy to animal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Allergy to arthropod bite</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Allergy to arthropod sting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Food allergy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Seasonal allergy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess limb</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Abscess of eyelid</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Acarodermatitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Acute sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Atypical pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Bacterial infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Bacterial vaginosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Bacterial vulvovaginitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Balanitis candida</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="5064"/>
                <counts group_id="E2" events="25" subjects_affected="25" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Bullous impetigo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Carbuncle</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Chronic sinusitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Clostridium difficile infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="5064"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Conjunctivitis bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Diarrhoea infectious</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="5064"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Epididymitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Eye infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Fungal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Fungal skin infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Furuncle</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="5064"/>
                <counts group_id="E2" events="21" subjects_affected="20" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Gastrointestinal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Gastrointestinal viral infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Gingivitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Gonorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Hepatitis infectious mononucleosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Herpes simplex</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Hordeolum</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Impetigo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Infectious mononucleosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="5064"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Kidney infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Labyrinthitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Localised infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="5064"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Mastitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Measles</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="57" subjects_affected="56" subjects_at_risk="5064"/>
                <counts group_id="E2" events="57" subjects_affected="55" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Oral herpes</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Oral infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Oropharyngeal candidiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Otitis externa</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="5064"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Pericoronitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Pelvic inflammatory disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Periodontitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="5064"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="5064"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Pharyngotonsillitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Pilonidal cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="5064"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Pulmonary tuberculosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Rash pustular</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection viral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" events="38" subjects_affected="31" subjects_at_risk="5064"/>
                <counts group_id="E2" events="32" subjects_affected="27" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="26" subjects_affected="24" subjects_at_risk="5064"/>
                <counts group_id="E2" events="18" subjects_affected="18" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Skin candida</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Staphylococcal infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Systemic viral infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="5064"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Tooth abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="5064"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="139" subjects_affected="126" subjects_at_risk="5064"/>
                <counts group_id="E2" events="126" subjects_affected="117" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection bacterial</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="14" subjects_affected="12" subjects_at_risk="5064"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Vaginal infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Varicella zoster virus infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Viral pharyngitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Viral sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Vulvovaginal mycotic infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Viral tonsilitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Animal bite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Animal scratch</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Arthropod bite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Arthropod sting</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Back injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Burns second degree</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="7" subjects_affected="5" subjects_at_risk="5064"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Eye injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Foot fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Foreign body in eye</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Hand fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Jaw fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Joint dislocation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Ligament sprain</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="5064"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Limb injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Mucosal excoriation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Multiple injuries</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="5064"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Periorbital haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Post procedural swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Post-traumatic pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Postoperative fever</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Procedural nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="5064"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Radius fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Rib fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Skin abrasion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Soft tissue injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Superficial injury of eye</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Tooth fracture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Wound</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood cholesterol increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Blood iron decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Blood magnesium decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Blood oestrogen decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Blood pressure decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Blood pressure diastolic increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Body temperature increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Cardiac murmur</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Electrocardiogram QT prolonged</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Glomerular filtration rate decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Influenza B virus test positive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Progesterone decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Respiratory rate increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Vitamin B12 decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Vitamin D decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Gout</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Hypercholesterolaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Hyperlipidaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Hyperuricaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Hypoglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Obesity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Type 2 diabetes mellitus</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="5064"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Vitamin D deficiency</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="19" subjects_affected="17" subjects_at_risk="5064"/>
                <counts group_id="E2" events="17" subjects_affected="17" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Arthritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="23" subjects_affected="22" subjects_at_risk="5064"/>
                <counts group_id="E2" events="18" subjects_affected="18" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Bursa disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Costochondritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Fibromyalgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Flank pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Gouty arthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Intervertebral disc degeneration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Intervertebral disc protrusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Joint instability</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Limb mass</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Muscle disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Muscular weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Musculoskeletal discomfort</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="5064"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="28" subjects_affected="28" subjects_at_risk="5064"/>
                <counts group_id="E2" events="28" subjects_affected="28" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Myalgia intercostal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Myofascial pain syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="5064"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Osteoporosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="15" subjects_affected="13" subjects_at_risk="5064"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Pain in jaw</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Periarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Plantar fasciitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Psoriatic arthropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Rotator cuff syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Spinal osteoarthritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Spinal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Synovial cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Tendon disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Tendonitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Torticollis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Large intestine benign neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Uterine leiomyoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Amnesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Aphonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Burning sensation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Carpal tunnel syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="5064"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Facial paralysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="132" subjects_affected="113" subjects_at_risk="5064"/>
                <counts group_id="E2" events="127" subjects_affected="111" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Hyperaesthesia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Intercostal neuralgia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Loss of consciousness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="5064"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Muscle contractions involuntary</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Retinal migraine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Sciatica</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Sensory loss</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Tension headache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Affect lability</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="5064"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Attention deficit/hyperactivity disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Bipolar disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="5064"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="5064"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Major depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Panic attack</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Sleep disorder</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Hypertonic bladder</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Renal cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Amenorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Bartholin's cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="5064"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Genital rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Menopausal symptoms</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Menorrhagia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Metrorrhagia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Nipple pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Prostatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Testicular torsion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Allergic cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Allergic sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="5064"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="39" subjects_affected="39" subjects_at_risk="5064"/>
                <counts group_id="E2" events="43" subjects_affected="41" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Dry throat</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="5064"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="5064"/>
                <counts group_id="E2" events="6" subjects_affected="4" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Increased upper airway secretion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="51" subjects_affected="49" subjects_at_risk="5064"/>
                <counts group_id="E2" events="29" subjects_affected="28" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Nasal discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Nasal pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Nasal septum deviation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Organising pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Oropharyngeal discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="56" subjects_affected="54" subjects_at_risk="5064"/>
                <counts group_id="E2" events="61" subjects_affected="57" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Painful respiration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Paranasal sinus discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Pharyngeal erythema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Pharyngeal ulceration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Pleurisy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="5064"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Rales</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Respiratory disorder</sub_title>
                <counts group_id="E1" events="25" subjects_affected="24" subjects_at_risk="5064"/>
                <counts group_id="E2" events="28" subjects_affected="28" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Respiratory symptom</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Respiratory tract congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Rhinitis allergic</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="5064"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="42" subjects_affected="40" subjects_at_risk="5064"/>
                <counts group_id="E2" events="40" subjects_affected="39" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Sinus pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" events="27" subjects_affected="26" subjects_at_risk="5064"/>
                <counts group_id="E2" events="18" subjects_affected="18" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Sputum discoloured</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Sputum increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Tonsillar disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract congestion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Pharyngeal paraesthesia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Acne</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Actinic keratosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Cold urticaria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Dermal cyst</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Dermatitis allergic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Guttate psoriasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Hidradenitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Ingrown hair</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Pityriasis rosea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Pruritus generalised</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="5064"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Rash generalised</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Rash macular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Skin exfoliation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Skin lesion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Swelling face</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="5064"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Sexual abuse</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Circulatory collapse</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Haematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="18" subjects_affected="18" subjects_at_risk="5064"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Hypertensive crisis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Lymphoedema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Peripheral coldness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Peripheral venous disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="5064"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="5072"/>
              </event>
              <event>
                <sub_title>Vasculitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5064"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="5072"/>
              </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>The Investigator understands that the information in the protocol is confidential and should not be disclosed, other than to those directly involved in the execution or the ethical review of the study, without prior written authorization from the Sponsor. It is, however, permissible to discuss information contained in the protocol with a participant in order to obtain consent once Institutional Review Board (IRB) approval is obtained.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Director</name_or_title>
      <organization>Medicago</organization>
      <phone>+1 418-658-9393</phone>
      <email>clinicaltrialinquiries@medicago.com</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/NCT03301051
org study id: CP-PRO-QVLP-012
nct id: NCT03301051
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This Phase 3 study is intended to assess the efficacy of the Quadrivalent VLP Influenza
      Vaccine during the 2017-2018 influenza season in healthy adults 18 to 64 years of age. One
      dose of Quadrivalent VLP Influenza Vaccine (30 μg/strain) or of placebo will be administered
      to approximately 10,000 participants
This randomized, observer-blind, placebo-controlled multicenter, Phase 3 study will be
      conducted at multiple sites. The composition of the Quadrivalent VLP Influenza Vaccine to be
      used in this study includes a mix of recombinant H1, H3, and two B hemagglutinin proteins
      expressed as VLPs for the 2017-2018 influenza virus strains.

      Approximately 10,000 healthy male and female participants aged 18 to 64 years will be
      randomized in a 1:1 ratio into one of two parallel treatment groups, such that approximately
      5,000 participants will receive the Quadrivalent VLP Influenza Vaccine at a dose of 30
      μg/strain and approximately 5,000 participants will receive the placebo. Within the two
      treatment groups, participants will be stratified by site and two age groups (18-49 years of
      age and 50-64 years of age in a 1:1 ratio).

      Participants will participate in this study for approximately eight to ten months, during
      which a first visit will be scheduled on Day 0 for screening and vaccine administration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Observer-blind
measure: Number of Occurrences of Protocol-Defined Respiratory Illness Caused by Vaccine-Matched Influenza Strains
time frame: Day 14 (post-vaccination) up to ~8 months
description: Occurrences of protocol-defined respiratory illness caused by vaccine-matched influenza strains were assessed. The vaccine-matched strains included: H1N1 (A/Michigan/45/2015); H3N2 (A/Hong Kong/4801/2014); B/Brisbane (B/Brisbane/60/2008); and B/Phuket (B/Phuket/3073/2013A). The protocol-defined respiratory illness was determined by the occurrence of at least 1 of the following respiratory symptoms: sneezing, stuffy nose, sore throat, cough, sputum production, wheezing, or difficulty breathing. Occurrences of all matched strains are reported.
measure: Number of Occurrences of Protocol-Defined Respiratory Illness Cases Caused by Any Laboratory Confirmed Influenza Strain
time frame: Day 14 (post-vaccination) up to ~8 months
description: Occurrences of protocol-defined respiratory illness due to laboratory-confirmed influenza strain (matched, mismatched, and un-typed) were assessed. A protocol-defined respiratory illness was determined by the occurrence of at least 1 of the following respiratory symptoms: sneezing, stuffy nose, sore throat, cough, sputum production, wheezing, or difficulty breathing.
measure: Number of Occurrences of Laboratory-Confirmed Protocol-Defined Influenza-Like Illness (ILI) Caused by Vaccine-Matched Influenza Strains
time frame: Day 14 (post-vaccination) up to ~8 months
description: Occurrences of protocol-defined ILI due to laboratory-confirmed influenza caused by influenza viral types/subtypes that are matched (and/or antigenically similar) to the strains covered in the vaccine formulation were assessed. A participant is considered to have protocol-defined ILI if the participant met at least one of the following pre-defined respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing AND at least one of the following systemic symptoms: fever (defined as a temperature > 37.2 °C or > 99.0 °F), chills, tiredness, headache or myalgia.
measure: Number of Occurrences of Laboratory-Confirmed ILI Caused by Any Influenza Strain
time frame: Day 14 (post-vaccination) up to ~8 months
description: Occurrences of laboratory-confirmed ILI caused by any influenza viral strains were assessed. A participant is considered to have protocol-defined ILI if the participant met at least one of the following pre-defined respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing AND at least one of the following systemic symptoms: fever (defined as a temperature > 37.2 °C or > 99.0 °F), chills, tiredness, headache or myalgia.
measure: Number of Occurrences of Protocol-Defined ILI Cases
time frame: Day 14 (post-vaccination) up to ~8 months
description: Occurrences of protocol-defined ILI cases (confirmed or not) were assessed. A participant is considered to have protocol-defined ILI if the participant met at least one of the following pre-defined respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing AND at least one of the following systemic symptoms: fever (defined as a temperature > 37.2 °C or > 99.0 °F), chills, tiredness, headache or myalgia.
measure: Number of Participants With at Least One Immediate Complaint
time frame: 15 minutes post vaccination
description: Immediate complaints were defined as any solicited local or systemic reactions. Solicited local reactions included: erythema, swelling, and pain at the injection site and solicited systemic reactions included: fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck.
measure: Number of Participants With at Least One Solicited Local and Systemic Reactions
time frame: Day 0 (post-vaccination) up to Day 7
description: Participants were monitored for both solicited local reactions (erythema, swelling, and pain at the injection site) and solicited systemic reactions (fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck). Any solicited local or systemic immediate complaint was also included.
measure: Number of Participants With ≥ Severe Solicited Local and Systemic Reactions
time frame: Day 0 (post-vaccination) up to Day 7
description: Participants were monitored for both solicited local reactions (erythema, swelling, and pain at the injection site) and solicited systemic reactions (fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck). Any solicited local or systemic immediate complaint was also included. The intensity of the solicited reactions was graded as mild (1)-easily tolerated and does not interfere with usual activity; moderate (2)-interferes with daily activity, but the participant is still able to function; severe (3)-incapacitating and the participant is unable to work or complete usual activity or potentially life threatening; (4)-likely to be life-threatening if not treated in a timely manner, according to the Food and Drug Administration (FDA) Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials.
measure: Number of Participants With ≥ Severe Related Solicited Reactions
time frame: Day 0 (post-vaccination) up to Day 7
description: Participants were monitored for both solicited local reactions (erythema, swelling, and pain at the injection site) and solicited systemic reactions (fever, headache, fatigue, muscle aches, joint aches, chills, a feeling of general discomfort, swelling in the axilla, and swelling in the neck). The intensity of the solicited reactions was graded according to the FDA Toxicity Grading Scale: mild (1), moderate (2), severe (3) or potentially life threatening (4). The causal relationship with the study vaccine was assessed as "definitely not related" (clearly not related), "probably not related" (no medical evidence), "possibly related" (reasonable possibility of cause and effect), "probably related" (plausible biologic mechanism and temporal relationship) or "definitely related" (direct cause and effect relationship). The ≥ severe events included "severe" and "potentially life-threatening" and the related category included "possibly related", "probably related", and "definitely related."
measure: Number of Participants With Unsolicited Treatment-Emergent Adverse Events (TEAEs)
time frame: Day 0 (post-vaccination) up to Day 21
description: Participants were monitored for unsolicited TEAEs (e.g., nasopharyngitis, upper respiratory tract infection, headache, and oropharyngeal pain). An adverse event (AE) or adverse experience was defined as any untoward medical occurrence in a participant or clinical investigation participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. An AE was considered treatment-emergent if it began on or after the date and time of Study Day 0 vaccination.
measure: Number of Participants With ≥ Severe Unsolicited TEAEs
time frame: Day 0 (post-vaccination) up to Day 21
description: The intensity of the unsolicited TEAEs was graded as mild (1)-easily tolerated and does not interfere with usual activity; moderate (2)-interferes with daily activity, but the participant is still able to function; severe (3)-incapacitating and the participant is unable to work or complete usual activity or potentially life threatening; (4)-likely to be life-threatening if not treated in a timely manner, according to the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. The ≥ Severe events included severe and potentially life-threatening events. AE and TEAEs are defined in outcome measure #10.
measure: Number of Participants With ≥ Severe Related Unsolicited Reactions
time frame: Day 0 (post-vaccination) up to Day 21
description: The intensity of the solicited local and systemic reactions was graded as: mild (1), moderate (2), severe (3) or potentially life threatening (4). The causal relationship with the study vaccine was assessed as "definitely not related" (clearly not related), "probably not related" (no medical evidence), "possibly related" (reasonable possibility of cause and effect), "probably related" (plausible biologic mechanism and temporal relationship) or "definitely related" (direct cause and effect relationship). The ≥ severe events included "severe" and "potentially life-threatening" and the related category included "possibly related", "probably related", and "definitely related." AE and TEAEs are defined in outcome measure #10.
measure: Number of Participants With an Occurrence of Death
time frame: Day 0 up to ~8 months
description: The number of participants in each treatment group with an occurrence of death was assessed.
measure: Number of Participants With at Least One Serious TEAE
time frame: Day 0 up to ~8 months
description: A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, or is another important medical event. An SAE was considered treatment-emergent if it was aggravated in severity or frequency following the administration of the study vaccine, up to and including the last visit of the study. AE is defined in outcome measure #10.
measure: Number of Participants With at Least One AE Leading to Withdrawal
time frame: Day 0 up to ~8 months
description: An AE or adverse experience was defined as any untoward medical occurrence in a participant or clinical investigation participant who was administered a pharmaceutical product, with or without a causal relationship with the treatment. An AE can be any favorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to a medicinal product. The number of participants with at least one adverse event leading to withdrawal was assessed.
measure: Number of Participants With at Least One New Onset Chronic Diseases (NOCDs)
time frame: Day 0 up to ~8 months
description: All NOCDs that may plausibly have an allergic, autoimmune or inflammatory component were assessed and reported. Plausibility should be interpreted broadly; the only clear exceptions are degenerative conditions such as osteoarthritis, age-related physiologic changes and life-style diseases In this context, most cancers, cardiac conditions and kidney diseases should be reported.
measure: Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Response for Each Homologous and Heterologous Influenza Strain
time frame: Day 0 (pre-vaccination), Day 21
description: The GMTs in each treatment group were measured using a HI assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013, and the heterologous strains: A/Brisbane/59/2007 (IVR-148) (HIN1), A/Uruguay/716/2007 (H3N2), B/Florida/4/2006, B/Malaysia/2506/2004.
measure: Percentage of Participants With Seroconversion Measured by HI Antibody Response for Each Homologous and Heterologous Strain
time frame: Day 0 (pre-vaccination) up to Day 21
description: Seroconversion rate: the percentage of participants in a given treatment group with either a ≥ 4-fold increase in reciprocal HI titers between Day 0 and Day 21 or a rise of undetectable HI titer (i.e. < 10) pre-vaccination (Day 0) to an HI titer of ≥ 40 on Day 21 was measured using an HI assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013, and the heterologous strains: A/Brisbane/59/2007 (IVR-148) (HIN1), A/Uruguay/716/2007 (H3N2), B/Florida/4/2006, B/Malaysia/2506/2004.
measure: Percentage of Participants With Seroprotection Measured by HI Antibody Response for Each Homologous and Heterologous Strain
time frame: Day 0 (pre-vaccination) up to Day 21
description: Seroprotection rate: the percentage of participants in a given treatment group attaining a reciprocal HI titer of ≥ 40 on Day 21 (the percentage of vaccine recipients with a serum HI titer of at least 1:40 following vaccination) was measured using an HI assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013, and the heterologous strains: A/Brisbane/59/2007 (IVR-148) (HIN1), A/Uruguay/716/2007 (H3N2), B/Florida/4/2006, B/Malaysia/2506/2004.
measure: Geometric Mean Fold Ratio (GMFR) of HI Antibody Response for Each Homologous and Heterologous Strain
time frame: Day 0 (pre-vaccination), Day 21
description: GMFR, the geometric mean of the ratio of GMTs (Day 21/Day 0) in each treatment group was measured using an HI assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013, and the heterologous strains: A/Brisbane/59/2007 (IVR-148) (HIN1), A/Uruguay/716/2007 (H3N2), B/Florida/4/2006, B/Malaysia/2506/2004.
measure: GMTs of Microneutralization (MN) Antibody Response for Each Homologous Strain
time frame: Day 0 (pre-vaccination), Day 21
description: The GMTs in each treatment group were measured using an MN assay for homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013.
measure: Percentage of Participants With Seroconversion Measured by MN Antibody Response for Each Homologous Strain
time frame: Day 0 (pre-vaccination) up to Day 21
description: Seroconversion rate: the percentage of participants in a given treatment group with either a ≥ 4-fold increase in reciprocal MN titers between Day 0 and Day 21 or a rise of undetectable MN titer (i.e. 7.1) pre-vaccination (Day 0) to an MN titer of ≥ 28.3 at Day 21 post-vaccination were measured using an MN assay for homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013.
measure: GMFR of MN Antibody Response for Each Homologous Strain
time frame: Day 0 (pre-vaccination), Day 21
description: GMFR, the geometric mean of the ratio of GMTs (Day 21/Day 0) was measured in each treatment group using an MN assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, and B/Phuket/3073/2013.
measure: Geometric Mean Area (GMA) of Single Radial Hemolysis (SRH) Antibody Response for Each Homologous Strain
time frame: Day 0 (pre-vaccination), Day 21
description: The GMA in each treatment group were measured using an SRH assay for homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013. The GMA calculations were performed by taking the anti-log of the mean of the log titer transformations.
measure: Percentage of Participants With Seroconversion Measured by SRH Antibody Response for Each Homologous Strain
time frame: Day 0 (pre-vaccination) up to Day 21
description: Seroconversion rate: the percentage of participants in a given treatment group showing at least 50 % increase in GMA between Days 0 and 21 were measured using a SRH assay for homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013.
measure: Percentage of Participants With Seroprotection Measured by SRH Antibody Response for Each Homologous Strain
time frame: Day 0 (pre-vaccination) up to Day 21
description: Seroprotection rate: the percentage of participants in a given treatment group attaining an area ≥ 25 mm^2 following vaccination (Day 21) were measured using an SRH assay for homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, B/Phuket/3073/2013.
measure: GMFR of SRH Antibody Response for Each Homologous Strain
time frame: Day 0 (pre-vaccination), Day 21
description: GMFR, the geometric mean of the ratio of GMTs (Day 21/Day 0) was measured in each treatment group using an SRH assay for the homologous strains: H1 A/Michigan/45/2015 (H1N1), A/Hong Kong/4801/2014 (H3N2), B/Brisbane/60/2008, and B/Phuket/3073/2013.
arm group label: Quadrivalent VLP Vaccine
arm group type: Experimental
description: Participants received one intramuscular (IM) injection of 0.5 mL of 30 μg/strain of the Quadrivalent VLP Influenza Vaccine on Day 0.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants received one IM injection of 0.5 mL of placebo on Day 0.
intervention type: Biological
intervention name: Quadrivalent VLP Vaccine
description: Single dose of a 30 µg/strain of Quadrivalent VLP Vaccine
arm group label: Quadrivalent VLP Vaccine
intervention type: Biological
intervention name: Placebo
description: Single dose of a Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Medicago
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: Finland
country: Germany
country: Philippines
country: Thailand
country: United Kingdom
country: United States
citation: Ward BJ, Makarkov A, Seguin A, Pillet S, Trepanier S, Dhaliwall J, Libman MD, Vesikari T, Landry N. Efficacy, immunogenicity, and safety of a plant-derived, quadrivalent, virus-like particle influenza vaccine in adults (18-64 years) and older adults (>/=65 years): two multicentre, randomised phase 3 trials. Lancet. 2020 Nov 7;396(10261):1491-1503. doi: 10.1016/S0140-6736(20)32014-6. Epub 2020 Oct 13.
PMID: 33065035
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Virus Diseases
mesh term: Influenza, Human
mesh term: Respiratory Tract Infections
mesh term: RNA Virus Infections
mesh term: Respiratory Tract Diseases
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 