<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/NCT02218697</url>
  </required_header>
  <id_info>
    <org_study_id>117276</org_study_id>
    <secondary_id>2014-001118-24</secondary_id>
    <nct_id>NCT02218697</nct_id>
  </id_info>
  <brief_title>Evaluation of the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine Influsplit™ Tetra (Fluarix™ Tetra) (GSK2321138A) When Co-administered With Pneumovax™ 23 in Adults 50 Years of Age and Older</brief_title>
  <official_title>Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Split Virion Influenza Vaccine 2014/2015 Influsplit™ Tetra (Fluarix™ Tetra) (GSK2321138A) When Co-administered With Pneumovax™ 23 in Adults 50 Years of Age and Older</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the immunogenicity and safety when GSK&#xD;
      Biologicals' influenza vaccine Influsplit™ Tetra (Fluarix™ Tetra) is co-administered with&#xD;
      Merck &amp; Co. Inc.'s pneumococcal vaccine (Pneumovax™23/Pneumovax) in adults 50 years of age&#xD;
      and older at risk for complications from influenza and pneumococcal infections.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2014</start_date>
  <completion_date type="Actual">May 4, 2015</completion_date>
  <primary_completion_date type="Actual">January 14, 2015</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>
  </study_design_info>
  <primary_outcome>
    <measure>Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies Titers Against the 4 Vaccine Strains.</measure>
    <time_frame>At Day 28 post Influsplit™ Tetra vaccination</time_frame>
    <description>HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios (Control Group/Co-Ad Group). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/2/2012 (Yamagata).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 6 Pneumococcal Serotypes (1, 3, 4, 7F, 14 and 19A).</measure>
    <time_frame>At 28 days after Pneumovax™ 23 vaccination</time_frame>
    <description>Anti-pneumococcal antibody concentrations were expressed as adjusted geometric mean concentrations (GMCs) and adjusted GMC ratio (Control Group/Co-Ad Group).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Solicited Local Adverse Events (AEs)</measure>
    <time_frame>Within 7 days (Days 0 - 6) after each dose and across doses.</time_frame>
    <description>Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 50 millimeters (mm) i.e. &gt; 100mm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Solicited General Adverse Events (AEs)</measure>
    <time_frame>Within 7 days (Days 0 - 6) after each dose and across doses.</time_frame>
    <description>Solicited general symptoms assessed were fatigue, gastrointestinal symptoms*, headache, joint pain, muscle aches, shivering, sweating and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 was defined as symptoms that prevented normal everyday activities. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as temperature greater than (&gt;)39.0°C.&#xD;
*Gastrointestinal (GI) symptoms included nausea, vomiting, diarrhoea and/or abdominal pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Local Adverse Events</measure>
    <time_frame>During the 7-day (Days 0-6) post-vaccination period</time_frame>
    <description>Duration was defined as number of days with any grade of local symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Solicited General AEs.</measure>
    <time_frame>During the 7-day (Days 0-6) post-vaccination period</time_frame>
    <description>Duration was defined as number of days with any grade of general symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting the Occurrence of Medically Attended Adverse Events (MAEs)</measure>
    <time_frame>Throughout the study period (Days 0-180)</time_frame>
    <description>MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s) regardless of intensity grade or relationship to vaccination. Related was defined as MAE assessed by the investigator to be causally related to the study vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting the Occurrence of Potential Immune Mediated Diseases (pIMDs)</measure>
    <time_frame>During the entire study period (Days 0-180)</time_frame>
    <description>Potential immune-mediated diseases (pIMDs) were defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.&#xD;
Any was defined as any occurrence of pIMD(s) regardless of intensity grade or relationship to vaccination. Related was defined as pIMD assessed by the investigator to be causally related to the study vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).</measure>
    <time_frame>Within the 28-day (Days 0-27) post-vaccination period</time_frame>
    <description>An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Serious Adverse Events (SAEs)</measure>
    <time_frame>Throughout the study period (Days 0-180)</time_frame>
    <description>SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Influenza Vaccine Strains</measure>
    <time_frame>At Day 0 and Day 28</time_frame>
    <description>HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.</measure>
    <time_frame>At Day 0 and Day 28</time_frame>
    <description>A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/2/2012 (Yamagata).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Seroconverted Subjects for Anti-Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.</measure>
    <time_frame>At Day 28</time_frame>
    <description>A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (&lt;) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains.</measure>
    <time_frame>At Day 28</time_frame>
    <description>MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F</measure>
    <time_frame>At Days 0 (Co-Ad group only), 28 (both groups), and 56 (Control group only)</time_frame>
    <description>The pneumococcal antigen testing was performed, as determined by ELISA cut-offs of ≥0.05 µg/mL and a seroprotection cut-off of ≥ 0.2 µg/ml.&#xD;
PRE = Pre-vaccination i.e. at Day 0 for Co-Ad Group and at Day 28 for Control Group.&#xD;
POST = Post-vaccination i.e. at Day 28 for Co-Ad Group and at Day 56 for Control Group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F)</measure>
    <time_frame>At Days 0 (Co-Ad group only), 28 (both groups), and 56 (Control group only)</time_frame>
    <description>Anti-pneumococcal antibody concentrations were expressed as adjusted geometric mean concentrations (GMCs) PRE = Pre -vaccination i.e. at Day 0 for Co-Ad Group and at Day 28 for Control Group.&#xD;
POST = Post-vaccination i.e. at Day 28 for Co-Ad Group and at Day 56 for Control Group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects.</measure>
    <time_frame>At 28 days post-vaccination with Pneumovax™ 23</time_frame>
    <description>Fold antibody concentration increases post-vaccination/pre-vaccination ≥ 2 and ≥ 4.&#xD;
The anti-pneumococcal serotypes assessed were 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">357</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Co-Ad Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Influsplit™ Tetra (Fluarix™ Tetra)</intervention_name>
    <description>Intramuscular injection, 1 dose each in Control and Co-Ad groups.</description>
    <arm_group_label>Co-Ad Group</arm_group_label>
    <arm_group_label>Control Group</arm_group_label>
    <other_name>D-QIV</other_name>
    <other_name>GSK2321138A</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Pneumovax™ 23</intervention_name>
    <description>Intramuscular injection, 1 dose each in Control and Co-Ad groups.</description>
    <arm_group_label>Co-Ad Group</arm_group_label>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo (Saline)</intervention_name>
    <description>Intramuscular injection, 1 dose each in Control and Co-Ad groups.</description>
    <arm_group_label>Co-Ad Group</arm_group_label>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who, in the opinion of the investigator, can and will comply with the&#xD;
             requirements of the protocol (e.g. completion of the diary cards, return for follow-up&#xD;
             visits).&#xD;
&#xD;
          -  A male or female aged 50 years or above at the time of the first vaccination at risk&#xD;
             for complications from influenza and/or pneumococcal infections, meeting their&#xD;
             respective countries' recommendations for vaccination against influenza and&#xD;
             pneumococcal disease.&#xD;
&#xD;
               -  At risk subjects include adults with chronic respiratory, heart, kidney, liver or&#xD;
                  neurological disease; human immunodeficiency virus (HIV) disease on combination&#xD;
                  antiretroviral therapy (cART) with cluster of differentiation 4 (CD4) T-cell&#xD;
                  counts greater than 350 cells/mm3; sickle cell disease or coeliac syndrome that&#xD;
                  may lead to splenic dysfunction (all other asplenics are excluded). The decision&#xD;
                  to enrol should be based on the investigators clinical judgement.&#xD;
&#xD;
          -  Written informed consent obtained from the subject.&#xD;
&#xD;
          -  Female subjects of non-childbearing potential may be enrolled in the study.&#xD;
&#xD;
               -  Non-childbearing potential is defined as pre-menarche, current tubal ligation,&#xD;
                  hysterectomy, ovariectomy or post-menopause.&#xD;
&#xD;
          -  Female subjects of childbearing potential may be enrolled in the study, if the&#xD;
             subject:&#xD;
&#xD;
               -  has practiced adequate contraception for 30 days prior to vaccination, and&#xD;
&#xD;
               -  has a negative pregnancy test on the day of vaccination, and&#xD;
&#xD;
               -  has agreed to continue adequate contraception during the entire treatment period&#xD;
                  and for 2 months after completion of the vaccination series.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of any investigational or non-registered product other than the study vaccines&#xD;
             within 30 days preceding the first dose of study vaccine, or planned use during the&#xD;
             study period.&#xD;
&#xD;
          -  Chronic administration (defined as more than 14 days in total) of immunosuppressants&#xD;
             or other immune-modifying drugs within six months prior to the first vaccine dose.&#xD;
             Inhaled, topical and low-dose intra-articular steroids are allowed.&#xD;
&#xD;
          -  Planned administration/administration of a vaccine not foreseen by the study protocol&#xD;
             within the period starting 30 days before the first dose and 30 days after the last&#xD;
             dose of vaccine.&#xD;
&#xD;
          -  Administration of such a vaccine has to be documented in the &quot;Concomitant vaccination&quot;&#xD;
             of the electronic Case Report Form (eCRF).&#xD;
&#xD;
          -  Administration of long-acting immune-modifying drugs/treatment within six months prior&#xD;
             to the first vaccine dose or expected administration at any time during the study&#xD;
             period. These immunosuppressant drugs/treatment/Biologics include:&#xD;
&#xD;
               -  Methotrexate&#xD;
&#xD;
               -  Leflunomide&#xD;
&#xD;
               -  Azathioprine and 6-mercaptopurine&#xD;
&#xD;
               -  Cyclosporin A&#xD;
&#xD;
               -  Cyclophosphamide&#xD;
&#xD;
               -  Tacrolimus, everolimus, sirolimus, temsirolimus&#xD;
&#xD;
               -  Mycophenolate mofetil&#xD;
&#xD;
               -  Antilymfocytaire immunoglobulins&#xD;
&#xD;
               -  Tumor Necrosis Factor (TNF) inhibitors: Adalimumab (Humira®), certolizumab&#xD;
                  (Cimzia®), etanercept (Enbrel®), golimumab (Simponi®) and infliximab(Remicade®)&#xD;
&#xD;
               -  Monoclonal antibodies and other biologicals: Rituximab (Mabthera®), Abatacept&#xD;
                  (Orencia®), tocilizumab (RoActemra®), basiliximab (Simulect®), Natalizumab&#xD;
                  (Tysabri®) cluster of differentiation 3 (CD3), …&#xD;
&#xD;
               -  Antitumor agents: alkylating agents, antimetabolites, antitumor antibiotics,&#xD;
                  topoisomerase inhibitors, microtubule inhibitors and other anti-tumor agents&#xD;
&#xD;
               -  Lenalidomide Revlimid®&#xD;
&#xD;
               -  Tasonermin: Beromun®&#xD;
&#xD;
               -  Proleukin® (aldesleukin; Novartis, …)&#xD;
&#xD;
               -  Tyrosine kinase inhibitor (Glivec®)Omalizumab Xolair®&#xD;
&#xD;
               -  Eculizumab Soliris® The above list is compiled from: [Federal Public Service&#xD;
                  Belgium: Health, Food Chain Safety and Environment].&#xD;
&#xD;
               -  Any immunosuppressive treatment which in the opinion of the investigator will not&#xD;
                  allow an adequate immune response. Inhaled, topical and low-dose intra-articular&#xD;
                  steroids are allowed.&#xD;
&#xD;
          -  Concurrently participating in another clinical study, at any time during the study&#xD;
             period, in which the subject has been or will be exposed to an investigational or a&#xD;
             non-investigational vaccine/product.&#xD;
&#xD;
          -  Previous vaccination with a pneumococcal vaccine within the last five years.&#xD;
&#xD;
          -  Previous vaccination with an influenza vaccine within the last six months.&#xD;
&#xD;
          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on&#xD;
             medical history and physical examination. HIV infected subjects on cART with CD4&#xD;
             T-cell counts above 350 cells/mm3 can be enrolled.&#xD;
&#xD;
          -  History of any reaction or hypersensitivity likely to be exacerbated by any component&#xD;
             of the vaccines.&#xD;
&#xD;
          -  Acute disease and/or fever at the time of enrolment.&#xD;
&#xD;
               -  Fever is defined as temperature ≥ 38.0°C (100.4°F). The preferred route for&#xD;
                  recording temperature in this study will be axillary.&#xD;
&#xD;
               -  Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory&#xD;
                  infection) without fever [≥ 38.0°C (100.4°F)] may be enrolled at the discretion&#xD;
                  of the investigator.&#xD;
&#xD;
          -  Administration of immunoglobulins and/or any blood products within the three months&#xD;
             preceding the first dose of study vaccine or planned administration during the study&#xD;
             period.&#xD;
&#xD;
          -  Pregnant or lactating female.&#xD;
&#xD;
          -  Female planning to become pregnant or planning to discontinue contraceptive&#xD;
             precautions.&#xD;
&#xD;
          -  Any condition which, in the opinion of the investigator, prevents the subject from&#xD;
             participating in the study or would make intramuscular (IM) injection unsafe.&#xD;
&#xD;
          -  Asplenia or dysfunction of the spleen. This excludes homozygous sickle cell disease or&#xD;
             coeliac syndrome that may lead to splenic dysfunction.&#xD;
&#xD;
          -  Acute clinically significant (i.e. a medically significant change from baseline&#xD;
             condition in the past 30 days) pulmonary, cardiovascular, hepatic or renal functional&#xD;
             abnormality, as determined by physical examination or laboratory screening tests.&#xD;
&#xD;
          -  History of chronic alcohol consumption and/or drug abuse.&#xD;
&#xD;
          -  History of Guillain-Barré syndrome.&#xD;
&#xD;
          -  A history of anaphylaxis following ANY vaccination.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Angers</city>
        <zip>49000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Laval</city>
        <zip>53000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nantes cedex 2</city>
        <zip>44277</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saint Cyr sur Loire</city>
        <zip>37540</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tours</city>
        <zip>37100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
  </location_countries>
  <link>
    <url>https://www.clinicalstudydatarequest.com</url>
    <description>Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.</description>
  </link>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <results_first_submitted>November 30, 2016</results_first_submitted>
  <results_first_submitted_qc>January 16, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 9, 2017</results_first_posted>
  <disposition_first_submitted>January 14, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>January 14, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">February 8, 2016</disposition_first_posted>
  <last_update_submitted>March 8, 2018</last_update_submitted>
  <last_update_submitted_qc>March 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Immunogenicity</keyword>
  <keyword>Influsplit Tetra (Fluarix Tetra) 2014/2015 season</keyword>
  <keyword>Safety</keyword>
  <keyword>Adults</keyword>
  <keyword>Pneumovax 23/Pneumovax</keyword>
  <keyword>Co-administration</keyword>
  <keyword>Elderly</keyword>
  <keyword>Seasonal influenza</keyword>
  <keyword>Pneumococcal infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heptavalent Pneumococcal Conjugate Vaccine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.</ipd_description>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>117276</doc_id>
      <doc_type>Dataset Specification</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>117276</doc_id>
      <doc_type>Clinical Study Report</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>117276</doc_id>
      <doc_type>Statistical Analysis Plan</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>117276</doc_id>
      <doc_type>Study Protocol</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>117276</doc_id>
      <doc_type>Informed Consent Form</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>117276</doc_id>
      <doc_type>Individual Participant Data Set</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>117276</doc_id>
      <doc_type>Annotated Case Report Form</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
  </study_docs>

  <clinical_results>

    <participant_flow>
      <recruitment_details>In the Control Group, 2 subjects withdrew at Day 0. In the Co-Ad Group, 4 subjects withdrew at Day 0, 1 subject withdrew at Day 28 and 1 subject withdrew at Day 56.</recruitment_details>
      <pre_assignment_details>Of the 357 subjects enrolled, 1 subject failed to meet the inclusion criteria hence he/she was excluded from study start.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Control Group</title>
          <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.</description>
        </group>
        <group group_id="P2">
          <title>Co-Ad Group</title>
          <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="179"/>
                <participants group_id="P2" count="177"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="177"/>
                <participants group_id="P2" count="171"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="6"/>
              </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="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Unwilling to be vaccinated in left arm</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Control Group</title>
          <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.</description>
        </group>
        <group group_id="B2">
          <title>Co-Ad Group</title>
          <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.</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="179"/>
            <count group_id="B2" value="177"/>
            <count group_id="B3" value="356"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68.4" spread="9.4"/>
                    <measurement group_id="B2" value="68.1" spread="9.0"/>
                    <measurement group_id="B3" value="68.3" spread="9.2"/>
                  </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="77"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="153"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="102"/>
                    <measurement group_id="B2" value="101"/>
                    <measurement group_id="B3" value="203"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>African Heritage / African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White - Arabic / North African Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White - Caucasian / European Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="175"/>
                    <measurement group_id="B2" value="172"/>
                    <measurement group_id="B3" value="347"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mixed Origin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies Titers Against the 4 Vaccine Strains.</title>
        <description>HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios (Control Group/Co-Ad Group). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/2/2012 (Yamagata).</description>
        <time_frame>At Day 28 post Influsplit™ Tetra vaccination</time_frame>
        <population>Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.</description>
          </group>
          <group group_id="O2">
            <title>Co-Ad Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies Titers Against the 4 Vaccine Strains.</title>
          <description>HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios (Control Group/Co-Ad Group). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/2/2012 (Yamagata).</description>
          <population>Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.</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="170"/>
                <count group_id="O2" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="253.2" lower_limit="205.3" upper_limit="312.1"/>
                    <measurement group_id="O2" value="235.5" lower_limit="195.0" upper_limit="284.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.6" lower_limit="62.1" upper_limit="87.1"/>
                    <measurement group_id="O2" value="78.6" lower_limit="65.2" upper_limit="94.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="178.7" lower_limit="154.9" upper_limit="206.2"/>
                    <measurement group_id="O2" value="157.9" lower_limit="136.4" upper_limit="182.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="346.5" lower_limit="302.3" upper_limit="397.1"/>
                    <measurement group_id="O2" value="353.8" lower_limit="310.5" upper_limit="403.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The adjusted GMT of HI antibodies for H1N1 strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0.</non_inferiority_desc>
            <param_type>Adjusted GMT ratio</param_type>
            <param_value>1.13</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.88</ci_lower_limit>
            <ci_upper_limit>1.46</ci_upper_limit>
            <estimate_desc>The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The adjusted GMT of HI antibodies for H3N2 strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0.</non_inferiority_desc>
            <param_type>Adjusted GMT ratio</param_type>
            <param_value>0.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.78</ci_lower_limit>
            <ci_upper_limit>1.21</ci_upper_limit>
            <estimate_desc>The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The adjusted GMT of HI antibodies for Victoria strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0.</non_inferiority_desc>
            <param_type>Adjusted GMT ratio</param_type>
            <param_value>1.17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.98</ci_lower_limit>
            <ci_upper_limit>1.40</ci_upper_limit>
            <estimate_desc>The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The adjusted GMT of HI antibodies for Yamagata strain at Day 28 post Influsplit™ Tetra vaccination, the GMT ratio of Control group/Co-Ad group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination titer as covariate.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority criterion (for each of the 4 strains): UL of the 95% CI for the GMT ratio (Control Group / Co-Ad Group) does not exceed 2.0.</non_inferiority_desc>
            <param_type>Adjusted GMT ratio</param_type>
            <param_value>0.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.84</ci_lower_limit>
            <ci_upper_limit>1.16</ci_upper_limit>
            <estimate_desc>The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 6 Pneumococcal Serotypes (1, 3, 4, 7F, 14 and 19A).</title>
        <description>Anti-pneumococcal antibody concentrations were expressed as adjusted geometric mean concentrations (GMCs) and adjusted GMC ratio (Control Group/Co-Ad Group).</description>
        <time_frame>At 28 days after Pneumovax™ 23 vaccination</time_frame>
        <population>Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.</description>
          </group>
          <group group_id="O2">
            <title>Co-Ad Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 6 Pneumococcal Serotypes (1, 3, 4, 7F, 14 and 19A).</title>
          <description>Anti-pneumococcal antibody concentrations were expressed as adjusted geometric mean concentrations (GMCs) and adjusted GMC ratio (Control Group/Co-Ad Group).</description>
          <population>Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.</population>
          <units>ug per ml</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="169"/>
                <count group_id="O2" value="162"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Polysaccharide 01 IgG</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="169"/>
                    <count group_id="O2" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" lower_limit="4.3" upper_limit="7.0"/>
                    <measurement group_id="O2" value="4.9" lower_limit="3.9" upper_limit="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 03 IgG</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="169"/>
                    <count group_id="O2" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" lower_limit="1.4" upper_limit="2.1"/>
                    <measurement group_id="O2" value="1.7" lower_limit="1.4" upper_limit="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 04 IgG</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="169"/>
                    <count group_id="O2" value="161"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" lower_limit="1.8" upper_limit="2.9"/>
                    <measurement group_id="O2" value="1.7" lower_limit="1.4" upper_limit="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 7F IgG</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="169"/>
                    <count group_id="O2" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0" lower_limit="6.9" upper_limit="11.8"/>
                    <measurement group_id="O2" value="8.1" lower_limit="6.2" upper_limit="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 14 IgG</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="169"/>
                    <count group_id="O2" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.2" lower_limit="16.0" upper_limit="25.6"/>
                    <measurement group_id="O2" value="14.1" lower_limit="11.3" upper_limit="17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 19A IgG</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="169"/>
                    <count group_id="O2" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.2" lower_limit="7.1" upper_limit="11.9"/>
                    <measurement group_id="O2" value="7.7" lower_limit="6.1" upper_limit="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Anti-pneumococcal antibody concentrations for Polysaccharide 01 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>1.14</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.86</ci_lower_limit>
            <ci_upper_limit>1.50</ci_upper_limit>
            <estimate_desc>The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Anti-pneumococcal antibody concentrations for Polysaccharide 03 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>1.18</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.96</ci_lower_limit>
            <ci_upper_limit>1.45</ci_upper_limit>
            <estimate_desc>The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Anti-pneumococcal antibody concentrations for Polysaccharide 04 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>1.26</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.98</ci_lower_limit>
            <ci_upper_limit>1.62</ci_upper_limit>
            <estimate_desc>The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Anti-pneumococcal antibody concentrations for Polysaccharide 7F serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>1.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.95</ci_lower_limit>
            <ci_upper_limit>1.63</ci_upper_limit>
            <estimate_desc>The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Anti-pneumococcal antibody concentrations for Polysaccharide 14 serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>1.20</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.91</ci_lower_limit>
            <ci_upper_limit>1.57</ci_upper_limit>
            <estimate_desc>The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Anti-pneumococcal antibody concentrations for Polysaccharide 19A serotype at Day 28 post Pneumovax™ 23 vaccination, the GMC ratio of Control Group/Co-Ad Group and the two sided 95% CI were computed by fitting an ANCOVA model on the logarithm10 transformation of the titres/concentrations, including the vaccine group as fixed effect and the pre-vaccination titre/concentration as covariate.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority criterion (for each of six pneumococcal serotypes): UL of the 95% CI for the geometric mean concentration (GMC) ratio (Control group over Co-Ad group) does not exceed 2.0.</non_inferiority_desc>
            <param_type>Adjusted GMC ratio</param_type>
            <param_value>1.34</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.05</ci_lower_limit>
            <ci_upper_limit>1.70</ci_upper_limit>
            <estimate_desc>The GMCs were used to calculate the Adjusted GMCs, which in turn were used to calculate the Adjusted GMC ratio with 95% confidence interval.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Solicited Local Adverse Events (AEs)</title>
        <description>Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 50 millimeters (mm) i.e. &gt; 100mm.</description>
        <time_frame>Within 7 days (Days 0 - 6) after each dose and across doses.</time_frame>
        <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.</description>
          </group>
          <group group_id="O2">
            <title>Co-Ad Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Solicited Local Adverse Events (AEs)</title>
          <description>Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 50 millimeters (mm) i.e. &gt; 100mm.</description>
          <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="177"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Pain, Dose 1 (Influsplit™ Tetra)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Pain,Dose 1(Influsplit™ Tetra)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Pain, Dose 1 (Placebo)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Pain, Dose 1 (Placebo)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Pain, Dose 1 (Pneumovax™ 23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Pain, Dose 1 (Pneumovax™ 23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Redness, Dose 1 (Influsplit™ Tetra)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade3 Redness,Dose 1(Influsplit™ Tetra)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Redness, Dose 1 (Placebo)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Redness, Dose 1 (Placebo)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Redness, Dose 1 (Pneumovax™ 23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Redness, Dose 1 (Pneumovax™ 23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Swelling, Dose1 (Influsplit™ Tetra)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade3 Swelling,Dose1(Influsplit™ Tetra)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Swelling, Dose 1 (Placebo)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Swelling, Dose 1 (Placebo)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Swelling, Dose 1 (Pneumovax™ 23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Swelling,Dose 1 (Pneumovax™ 23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Pain, Dose 2 (Influsplit™ Tetra)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Grade 3 Pain, Dose 2 (Influsplit™ Tetra)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Any Pain, Dose 2 (Placebo)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Pain, Dose 2 (Placebo)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Pain, Dose 2 (Pneumovax™ 23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Pain, Dose 2 (Pneumovax™ 23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Redness, Dose 2 (Influsplit™ Tetra)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Grade 3 Redness,Dose 2(Influsplit™ Tetra)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Any Redness, Dose 2 (Placebo)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Redness, Dose 2 (Placebo)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Redness, Dose 2 (Pneumovax™ 23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Redness, Dose 2 (Pneumovax™ 23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Swelling, Dose 2 (Influsplit™ Tetra)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Grade 3 Swelling,Dose 2 (Influsplit™ Tetra)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
            <class>
              <title>Any Swelling, Dose 2 (Placebo)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Swelling, Dose 2 (Placebo)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Swelling, Dose 2 (Pneumovax™ 23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Swelling, Dose 2 (Pneumovax™ 23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Pain, Across Doses (Influsplit™ Tetra)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Pain, Across Doses (Influsplit™Tetra)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Pain, Across Doses (Placebo)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Pain, Across Doses (Placebo)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Pain, Across Doses (Pneumovax™ 23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Pain, Across Doses (Pneumovax™ 23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Redness, Across Doses (Influsplit™Tetra)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Redness, Across Doses (Influsplit™ Tetra)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Redness, Across Doses (Placebo)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Redness, Across Doses (Placebo)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Redness, Across Doses (Pneumovax™ 23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Redness, Across Doses (Pneumovax™23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Swelling, Across Doses (Influsplit™Tetra)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Swelling, Across Doses (Influsplit™Tetra)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Swelling, Across Doses (Placebo)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Swelling, Across Doses (Placebo)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Swelling, Across Doses (Pneumovax™23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Swelling, Across Doses (Pneumovax™23)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Solicited General Adverse Events (AEs)</title>
        <description>Solicited general symptoms assessed were fatigue, gastrointestinal symptoms*, headache, joint pain, muscle aches, shivering, sweating and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 was defined as symptoms that prevented normal everyday activities. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as temperature greater than (&gt;)39.0°C.&#xD;
*Gastrointestinal (GI) symptoms included nausea, vomiting, diarrhoea and/or abdominal pain</description>
        <time_frame>Within 7 days (Days 0 - 6) after each dose and across doses.</time_frame>
        <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.</description>
          </group>
          <group group_id="O2">
            <title>Co-Ad Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Solicited General Adverse Events (AEs)</title>
          <description>Solicited general symptoms assessed were fatigue, gastrointestinal symptoms*, headache, joint pain, muscle aches, shivering, sweating and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 was defined as symptoms that prevented normal everyday activities. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as temperature greater than (&gt;)39.0°C.&#xD;
*Gastrointestinal (GI) symptoms included nausea, vomiting, diarrhoea and/or abdominal pain</description>
          <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="178"/>
                <count group_id="O2" value="175"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Fatigue, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fatigue, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Fatigue, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any GI symptoms, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 GI symptoms, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related GI symptoms, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Headache, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Headache, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Headache, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Joint pain, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Joint pain, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Joint pain, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Muscle aches, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Muscle aches, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Muscle aches, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Shivering, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Shivering, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Shivering, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Sweating, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Sweating, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Sweating, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Fever, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fever, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Fever, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="176"/>
                    <count group_id="O2" value="173"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Fatigue, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fatigue, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Fatigue, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any GI symptoms, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 GI symptoms, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related GI symptoms, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Headache, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Headache, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Headache, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Joint pain, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Joint pain, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Joint pain, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Muscle aches, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Muscle aches, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Muscle aches, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Shivering, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Shivering, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Shivering, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Sweating, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Sweating, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Sweating, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Fever, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fever, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Fever, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="177"/>
                    <count group_id="O2" value="171"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Fatigue, Across Doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fatigue, Across Doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Fatigue, Across Doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any GI symptoms, Across Doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 GI symptoms, Across Doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related GI symptoms, Across Doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Headache, Across Doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Headache, Across Doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Headache, Across Doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Joint pain, Across Doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Joint pain, Across Doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Joint pain, Across Doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Muscle aches, Across Doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Muscle aches, Across Doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Muscle aches, Across Doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Shivering, Across Doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Shivering, Across Doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Shivering, Across Doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Sweating, Across Doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Sweating, Across Doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Sweating, Across Doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Fever, Across Doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fever, Across Doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Fever, Across Doses</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="178"/>
                    <count group_id="O2" value="175"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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>Duration of Local Adverse Events</title>
        <description>Duration was defined as number of days with any grade of local symptoms.</description>
        <time_frame>During the 7-day (Days 0-6) post-vaccination period</time_frame>
        <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.</description>
          </group>
          <group group_id="O2">
            <title>Co-Ad Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Local Adverse Events</title>
          <description>Duration was defined as number of days with any grade of local symptoms.</description>
          <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pain, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="3.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="63"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="3.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" lower_limit="3.0" upper_limit="4.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="2.0" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="1"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="2.5"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="2"/>
                    <count group_id="O2" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" lower_limit="4.0" upper_limit="5.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="2.0" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="5"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="1.0" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Solicited General AEs.</title>
        <description>Duration was defined as number of days with any grade of general symptoms.</description>
        <time_frame>During the 7-day (Days 0-6) post-vaccination period</time_frame>
        <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.</description>
          </group>
          <group group_id="O2">
            <title>Co-Ad Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Solicited General AEs.</title>
          <description>Duration was defined as number of days with any grade of general symptoms.</description>
          <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="39"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Fatigue, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="39"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="3.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="2.0" upper_limit="4.0"/>
                    <measurement group_id="O2" value="3.5" lower_limit="1.5" upper_limit="6.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gastrointestinal symptoms, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="4.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Gastrointestinal symptoms, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="2.0" upper_limit="3.0"/>
                    <measurement group_id="O2" value="3.0" lower_limit="2.0" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="2.0"/>
                    <measurement group_id="O2" value="1.5" lower_limit="1.0" upper_limit="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="18"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="3.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Joint pain, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="3.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Joint pain, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="2.0" upper_limit="3.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Muscle aches, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="15"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="3.0"/>
                    <measurement group_id="O2" value="3.0" lower_limit="1.5" upper_limit="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Muscle aches, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="12"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="3.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sweating, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="11"/>
                    <count group_id="O2" value="16"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="6.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sweating, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="10"/>
                    <count group_id="O2" value="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="5.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.5" upper_limit="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Shivering, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="6"/>
                    <count group_id="O2" value="10"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="2.0"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Shivering, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="8"/>
                    <count group_id="O2" value="5"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="2.0"/>
                    <measurement group_id="O2" value="3.0" lower_limit="1.0" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever, Dose 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="2"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever, Dose 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting the Occurrence of Medically Attended Adverse Events (MAEs)</title>
        <description>MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s) regardless of intensity grade or relationship to vaccination. Related was defined as MAE assessed by the investigator to be causally related to the study vaccination.</description>
        <time_frame>Throughout the study period (Days 0-180)</time_frame>
        <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.</description>
          </group>
          <group group_id="O2">
            <title>Co-Ad Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting the Occurrence of Medically Attended Adverse Events (MAEs)</title>
          <description>MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s) regardless of intensity grade or relationship to vaccination. Related was defined as MAE assessed by the investigator to be causally related to the study vaccination.</description>
          <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="179"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any MAE(s)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related MAE(s)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting the Occurrence of Potential Immune Mediated Diseases (pIMDs)</title>
        <description>Potential immune-mediated diseases (pIMDs) were defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.&#xD;
Any was defined as any occurrence of pIMD(s) regardless of intensity grade or relationship to vaccination. Related was defined as pIMD assessed by the investigator to be causally related to the study vaccination.</description>
        <time_frame>During the entire study period (Days 0-180)</time_frame>
        <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.</description>
          </group>
          <group group_id="O2">
            <title>Co-Ad Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting the Occurrence of Potential Immune Mediated Diseases (pIMDs)</title>
          <description>Potential immune-mediated diseases (pIMDs) were defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.&#xD;
Any was defined as any occurrence of pIMD(s) regardless of intensity grade or relationship to vaccination. Related was defined as pIMD assessed by the investigator to be causally related to the study vaccination.</description>
          <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="179"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any pIMD(s)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related pIMD(s)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).</title>
        <description>An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.</description>
        <time_frame>Within the 28-day (Days 0-27) post-vaccination period</time_frame>
        <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.</description>
          </group>
          <group group_id="O2">
            <title>Co-Ad Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).</title>
          <description>An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.</description>
          <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="179"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Unsolicited AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Unsolicited AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Unsolicited AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Serious Adverse Events (SAEs)</title>
        <description>SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.</description>
        <time_frame>Throughout the study period (Days 0-180)</time_frame>
        <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.</description>
          </group>
          <group group_id="O2">
            <title>Co-Ad Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Serious Adverse Events (SAEs)</title>
          <description>SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.</description>
          <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="179"/>
                <count group_id="O2" value="177"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any SAE(s)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related SAE(s)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatal SAE(s)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Fatal SAE(s)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Influenza Vaccine Strains</title>
        <description>HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata).</description>
        <time_frame>At Day 0 and Day 28</time_frame>
        <population>Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.</description>
          </group>
          <group group_id="O2">
            <title>Co-Ad Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Influenza Vaccine Strains</title>
          <description>HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata).</description>
          <population>Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.</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="171"/>
                <count group_id="O2" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1, Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="171"/>
                    <count group_id="O2" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.4" lower_limit="26.3" upper_limit="39.9"/>
                    <measurement group_id="O2" value="253.2" lower_limit="205.3" upper_limit="312.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="170"/>
                    <count group_id="O2" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.0" lower_limit="27.8" upper_limit="41.7"/>
                    <measurement group_id="O2" value="235.5" lower_limit="195.0" upper_limit="284.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="171"/>
                    <count group_id="O2" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.8" lower_limit="17.5" upper_limit="24.9"/>
                    <measurement group_id="O2" value="21.8" lower_limit="18.2" upper_limit="26.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="170"/>
                    <count group_id="O2" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.6" lower_limit="62.1" upper_limit="87.1"/>
                    <measurement group_id="O2" value="78.6" lower_limit="65.2" upper_limit="94.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="171"/>
                    <count group_id="O2" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48.7" lower_limit="41.6" upper_limit="57.1"/>
                    <measurement group_id="O2" value="51.5" lower_limit="43.9" upper_limit="60.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="170"/>
                    <count group_id="O2" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="178.7" lower_limit="154.9" upper_limit="206.2"/>
                    <measurement group_id="O2" value="157.9" lower_limit="136.4" upper_limit="182.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="171"/>
                    <count group_id="O2" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="120.7" lower_limit="104.3" upper_limit="139.8"/>
                    <measurement group_id="O2" value="119.9" lower_limit="103.0" upper_limit="139.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="170"/>
                    <count group_id="O2" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="346.5" lower_limit="302.3" upper_limit="397.1"/>
                    <measurement group_id="O2" value="353.8" lower_limit="310.5" upper_limit="403.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.</title>
        <description>A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/2/2012 (Yamagata).</description>
        <time_frame>At Day 0 and Day 28</time_frame>
        <population>Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.</description>
          </group>
          <group group_id="O2">
            <title>Co-Ad Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.</title>
          <description>A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/2/2012 (Yamagata).</description>
          <population>Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="171"/>
                <count group_id="O2" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1, Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="171"/>
                    <count group_id="O2" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83"/>
                    <measurement group_id="O2" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="170"/>
                    <count group_id="O2" value="163"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="160"/>
                    <measurement group_id="O2" value="157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="171"/>
                    <count group_id="O2" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                    <measurement group_id="O2" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="170"/>
                    <count group_id="O2" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="131"/>
                    <measurement group_id="O2" value="128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="171"/>
                    <count group_id="O2" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106"/>
                    <measurement group_id="O2" value="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="170"/>
                    <count group_id="O2" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="167"/>
                    <measurement group_id="O2" value="154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="171"/>
                    <count group_id="O2" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="159"/>
                    <measurement group_id="O2" value="146"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="170"/>
                    <count group_id="O2" value="162"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="169"/>
                    <measurement group_id="O2" value="162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Seroconverted Subjects for Anti-Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.</title>
        <description>A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (&lt;) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata).</description>
        <time_frame>At Day 28</time_frame>
        <population>Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.</description>
          </group>
          <group group_id="O2">
            <title>Co-Ad Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Seroconverted Subjects for Anti-Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.</title>
          <description>A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (&lt;) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata).</description>
          <population>Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="162"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110"/>
                    <measurement group_id="O2" value="101"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                    <measurement group_id="O2" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73"/>
                    <measurement group_id="O2" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O2" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains.</title>
        <description>MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata).</description>
        <time_frame>At Day 28</time_frame>
        <population>Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.</description>
          </group>
          <group group_id="O2">
            <title>Co-Ad Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains.</title>
          <description>MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata).</description>
          <population>Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.</population>
          <units>Fold increase</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="170"/>
                <count group_id="O2" value="162"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7" lower_limit="6.1" upper_limit="9.7"/>
                    <measurement group_id="O2" value="6.9" lower_limit="5.5" upper_limit="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" lower_limit="3.0" upper_limit="4.2"/>
                    <measurement group_id="O2" value="3.6" lower_limit="3.0" upper_limit="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" lower_limit="3.1" upper_limit="4.3"/>
                    <measurement group_id="O2" value="3.1" lower_limit="2.6" upper_limit="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" lower_limit="2.5" upper_limit="3.3"/>
                    <measurement group_id="O2" value="3.0" lower_limit="2.5" upper_limit="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F</title>
        <description>The pneumococcal antigen testing was performed, as determined by ELISA cut-offs of ≥0.05 µg/mL and a seroprotection cut-off of ≥ 0.2 µg/ml.&#xD;
PRE = Pre-vaccination i.e. at Day 0 for Co-Ad Group and at Day 28 for Control Group.&#xD;
POST = Post-vaccination i.e. at Day 28 for Co-Ad Group and at Day 56 for Control Group.</description>
        <time_frame>At Days 0 (Co-Ad group only), 28 (both groups), and 56 (Control group only)</time_frame>
        <population>Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.</description>
          </group>
          <group group_id="O2">
            <title>Co-Ad Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F</title>
          <description>The pneumococcal antigen testing was performed, as determined by ELISA cut-offs of ≥0.05 µg/mL and a seroprotection cut-off of ≥ 0.2 µg/ml.&#xD;
PRE = Pre-vaccination i.e. at Day 0 for Co-Ad Group and at Day 28 for Control Group.&#xD;
POST = Post-vaccination i.e. at Day 28 for Co-Ad Group and at Day 56 for Control Group.</description>
          <population>Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="170"/>
                <count group_id="O2" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Polysaccharide 01 Ab.IgG (≥ 0.05 µg/ml) (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="162"/>
                    <measurement group_id="O2" value="152"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 01 Ab.IgG (≥ 0.05 µg/ml) (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="169"/>
                    <measurement group_id="O2" value="162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 01 Ab.IgG (≥ 0.2 µg/ml) (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="112"/>
                    <measurement group_id="O2" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 01 Ab.IgG (≥ 0.2 µg/ml) (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="167"/>
                    <measurement group_id="O2" value="159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 03 Ab.IgG (≥ 0.05 µg/ml) (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="158"/>
                    <measurement group_id="O2" value="149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 03 Ab.IgG (≥ 0.05 µg/ml) (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="167"/>
                    <measurement group_id="O2" value="161"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 03 Ab.IgG (≥ 0.2 µg/ml) (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114"/>
                    <measurement group_id="O2" value="121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 03 Ab.IgG (≥ 0.2 µg/ml) (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="158"/>
                    <measurement group_id="O2" value="153"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 04 Ab.IgG (≥ 0.05 µg/ml) (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="138"/>
                    <measurement group_id="O2" value="129"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 04 Ab.IgG (≥ 0.05 µg/ml) (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="167"/>
                    <measurement group_id="O2" value="158"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 04 Ab.IgG (≥ 0.2 µg/ml) (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77"/>
                    <measurement group_id="O2" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 04 Ab.IgG (≥ 0.2 µg/ml) (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="158"/>
                    <measurement group_id="O2" value="149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 05 Ab.IgG5 (≥ 0.05 µg/ml) (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="165"/>
                    <measurement group_id="O2" value="159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 05 Ab.IgG5 (≥ 0.05 µg/ml) (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="169"/>
                    <measurement group_id="O2" value="162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 05 Ab.IgG5 (≥ 0.2 µg/ml) (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="130"/>
                    <measurement group_id="O2" value="115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 05 Ab.IgG5 (≥ 0.2 µg/ml) (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="163"/>
                    <measurement group_id="O2" value="155"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 6B Ab.IgG (≥ 0.05 µg/ml) (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="158"/>
                    <measurement group_id="O2" value="149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 6B Ab.IgG (≥ 0.05 µg/ml) (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="164"/>
                    <measurement group_id="O2" value="160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 6B Ab.IgG (≥ 0.2 µg/ml) (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106"/>
                    <measurement group_id="O2" value="110"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 6B Ab.IgG (≥ 0.2 µg/ml) (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="157"/>
                    <measurement group_id="O2" value="147"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 7F Ab.IgG (≥ 0.05 µg/ml) (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="159"/>
                    <measurement group_id="O2" value="154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 7F Ab.IgG (≥ 0.05 µg/ml) (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="169"/>
                    <measurement group_id="O2" value="162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 7F Ab.IgG (≥ 0.2 µg/ml) (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="127"/>
                    <measurement group_id="O2" value="130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 7F Ab.IgG (≥ 0.2 µg/ml) (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="165"/>
                    <measurement group_id="O2" value="161"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 9V Ab.IgG (≥ 0.05 µg/ml) (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="165"/>
                    <measurement group_id="O2" value="150"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 9V Ab.IgG (≥ 0.05 µg/ml) (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="168"/>
                    <measurement group_id="O2" value="160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 9V Ab.IgG (≥ 0.2 µg/ml) (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="123"/>
                    <measurement group_id="O2" value="117"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 9V Ab.IgG (≥ 0.2 µg/ml) (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="166"/>
                    <measurement group_id="O2" value="157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 14 Ab.IgG (≥ 0.05 µg/ml) (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="170"/>
                    <measurement group_id="O2" value="163"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 14 Ab.IgG (≥ 0.05 µg/ml) (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="169"/>
                    <measurement group_id="O2" value="162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 14 Ab.IgG (≥ 0.2 µg/ml) (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="168"/>
                    <measurement group_id="O2" value="160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 14 Ab.IgG (≥ 0.2 µg/ml) (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="168"/>
                    <measurement group_id="O2" value="162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 18C Ab.IgG (≥ 0.05 µg/ml) (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="166"/>
                    <measurement group_id="O2" value="161"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 18C Ab.IgG (≥ 0.05 µg/ml) (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="169"/>
                    <measurement group_id="O2" value="162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 18C Ab.IgG (≥ 0.2 µg/ml) (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="154"/>
                    <measurement group_id="O2" value="148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 18C Ab.IgG (≥ 0.2 µg/ml) (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="168"/>
                    <measurement group_id="O2" value="159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 19A Ab.IgG (≥ 0.05 µg/ml) (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="168"/>
                    <measurement group_id="O2" value="160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 19A Ab.IgG (≥ 0.05 µg/ml) (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="169"/>
                    <measurement group_id="O2" value="161"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 19A Ab.IgG (≥ 0.2 µg/ml) (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="146"/>
                    <measurement group_id="O2" value="148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 19A Ab.IgG (≥ 0.2 µg/ml) (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="165"/>
                    <measurement group_id="O2" value="158"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 19F Ab.IgG (≥ 0.05 µg/ml) (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="169"/>
                    <measurement group_id="O2" value="160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 19F Ab.IgG (≥ 0.05 µg/ml) (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="169"/>
                    <measurement group_id="O2" value="162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 19F Ab.IgG (≥ 0.2 µg/ml) (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="151"/>
                    <measurement group_id="O2" value="152"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 19F Ab.IgG (≥ 0.2 µg/ml) (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="169"/>
                    <measurement group_id="O2" value="161"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 23F Ab.IgG (≥ 0.05 µg/ml) (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="151"/>
                    <measurement group_id="O2" value="151"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 23F Ab.IgG (≥ 0.05 µg/ml) (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="165"/>
                    <measurement group_id="O2" value="159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 23F Ab.IgG (≥ 0.2 µg/ml) (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="112"/>
                    <measurement group_id="O2" value="125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 23F Ab.IgG (≥ 0.2 µg/ml) (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="155"/>
                    <measurement group_id="O2" value="147"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F)</title>
        <description>Anti-pneumococcal antibody concentrations were expressed as adjusted geometric mean concentrations (GMCs) PRE = Pre -vaccination i.e. at Day 0 for Co-Ad Group and at Day 28 for Control Group.&#xD;
POST = Post-vaccination i.e. at Day 28 for Co-Ad Group and at Day 56 for Control Group.</description>
        <time_frame>At Days 0 (Co-Ad group only), 28 (both groups), and 56 (Control group only)</time_frame>
        <population>Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.</description>
          </group>
          <group group_id="O2">
            <title>Co-Ad Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F)</title>
          <description>Anti-pneumococcal antibody concentrations were expressed as adjusted geometric mean concentrations (GMCs) PRE = Pre -vaccination i.e. at Day 0 for Co-Ad Group and at Day 28 for Control Group.&#xD;
POST = Post-vaccination i.e. at Day 28 for Co-Ad Group and at Day 56 for Control Group.</description>
          <population>Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.</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="170"/>
                <count group_id="O2" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Polysaccharide 01 Ab.IgG (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" lower_limit="0.3" upper_limit="0.5"/>
                    <measurement group_id="O2" value="0.4" lower_limit="0.3" upper_limit="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 01 Ab.IgG (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" lower_limit="4.3" upper_limit="7.0"/>
                    <measurement group_id="O2" value="4.9" lower_limit="3.9" upper_limit="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 03 Ab.IgG (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" lower_limit="0.3" upper_limit="0.5"/>
                    <measurement group_id="O2" value="0.5" lower_limit="0.4" upper_limit="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 03 Ab.IgG (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" lower_limit="1.4" upper_limit="2.1"/>
                    <measurement group_id="O2" value="1.7" lower_limit="1.4" upper_limit="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 04 Ab.IgG (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" lower_limit="0.2" upper_limit="0.3"/>
                    <measurement group_id="O2" value="0.2" lower_limit="0.2" upper_limit="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 04 Ab.IgG (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" lower_limit="1.8" upper_limit="2.9"/>
                    <measurement group_id="O2" value="1.7" lower_limit="1.4" upper_limit="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 05 Ab.IgG5 (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" lower_limit="0.5" upper_limit="0.7"/>
                    <measurement group_id="O2" value="0.5" lower_limit="0.4" upper_limit="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 05 Ab.IgG5 (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.8" lower_limit="5.9" upper_limit="10.4"/>
                    <measurement group_id="O2" value="5.7" lower_limit="4.3" upper_limit="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 6B Ab.IgG (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" lower_limit="0.3" upper_limit="0.6"/>
                    <measurement group_id="O2" value="0.4" lower_limit="0.3" upper_limit="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 6B Ab.IgG (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" lower_limit="2.9" upper_limit="5.1"/>
                    <measurement group_id="O2" value="3.1" lower_limit="2.3" upper_limit="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 7F Ab.IgG (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" lower_limit="0.5" upper_limit="0.8"/>
                    <measurement group_id="O2" value="0.7" lower_limit="0.6" upper_limit="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 7F Ab.IgG (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0" lower_limit="6.9" upper_limit="11.8"/>
                    <measurement group_id="O2" value="8.1" lower_limit="6.2" upper_limit="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 9V Ab.IgG (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" lower_limit="0.4" upper_limit="0.7"/>
                    <measurement group_id="O2" value="0.5" lower_limit="0.4" upper_limit="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 9V Ab.IgG (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9" lower_limit="4.8" upper_limit="7.4"/>
                    <measurement group_id="O2" value="4.4" lower_limit="3.6" upper_limit="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 14 Ab.IgG (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" lower_limit="3.1" upper_limit="4.6"/>
                    <measurement group_id="O2" value="2.9" lower_limit="2.4" upper_limit="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 14 Ab.IgG (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.2" lower_limit="16.0" upper_limit="25.6"/>
                    <measurement group_id="O2" value="14.1" lower_limit="11.3" upper_limit="17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 18C Ab.IgG (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" lower_limit="1.1" upper_limit="1.7"/>
                    <measurement group_id="O2" value="1.2" lower_limit="1.0" upper_limit="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 18C Ab.IgG (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.5" lower_limit="10.7" upper_limit="16.8"/>
                    <measurement group_id="O2" value="11.1" lower_limit="9.0" upper_limit="13.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 19A Ab.IgG (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" lower_limit="1.0" upper_limit="1.6"/>
                    <measurement group_id="O2" value="1.5" lower_limit="1.2" upper_limit="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 19A Ab.IgG (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.2" lower_limit="7.1" upper_limit="11.9"/>
                    <measurement group_id="O2" value="7.7" lower_limit="6.1" upper_limit="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 19F Ab.IgG (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" lower_limit="1.1" upper_limit="1.7"/>
                    <measurement group_id="O2" value="1.4" lower_limit="1.2" upper_limit="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 19F Ab.IgG (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.9" lower_limit="9.3" upper_limit="15.2"/>
                    <measurement group_id="O2" value="10.6" lower_limit="8.4" upper_limit="13.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 23F Ab.IgG (PRE)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" lower_limit="0.3" upper_limit="0.6"/>
                    <measurement group_id="O2" value="0.5" lower_limit="0.4" upper_limit="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 23F Ab.IgG (POST)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" lower_limit="2.3" upper_limit="4.1"/>
                    <measurement group_id="O2" value="2.9" lower_limit="2.2" upper_limit="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects.</title>
        <description>Fold antibody concentration increases post-vaccination/pre-vaccination ≥ 2 and ≥ 4.&#xD;
The anti-pneumococcal serotypes assessed were 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.</description>
        <time_frame>At 28 days post-vaccination with Pneumovax™ 23</time_frame>
        <population>Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Control Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.</description>
          </group>
          <group group_id="O2">
            <title>Co-Ad Group</title>
            <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects.</title>
          <description>Fold antibody concentration increases post-vaccination/pre-vaccination ≥ 2 and ≥ 4.&#xD;
The anti-pneumococcal serotypes assessed were 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.</description>
          <population>Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="169"/>
                <count group_id="O2" value="163"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Polysaccharide 01 Ab.IgG (≥ 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="149"/>
                    <measurement group_id="O2" value="144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 01 Ab.IgG (≥ 4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="134"/>
                    <measurement group_id="O2" value="126"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 03 Ab.IgG (≥ 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="121"/>
                    <measurement group_id="O2" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 03 Ab.IgG (≥ 4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80"/>
                    <measurement group_id="O2" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 04 Ab.IgG (≥ 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="149"/>
                    <measurement group_id="O2" value="137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 04 Ab.IgG (≥ 4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="127"/>
                    <measurement group_id="O2" value="112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 05 Ab.IgG5 (≥ 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="156"/>
                    <measurement group_id="O2" value="138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 05 Ab.IgG5 (≥ 4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="127"/>
                    <measurement group_id="O2" value="114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 14 Ab.IgG (≥ 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="123"/>
                    <measurement group_id="O2" value="102"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 14 Ab.IgG (≥ 4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90"/>
                    <measurement group_id="O2" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 18C Ab.IgG (≥ 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="149"/>
                    <measurement group_id="O2" value="133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 18C Ab.IgG (≥ 4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="123"/>
                    <measurement group_id="O2" value="116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 19A Ab.IgG (≥ 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="133"/>
                    <measurement group_id="O2" value="123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 19A Ab.IgG (≥ 4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="111"/>
                    <measurement group_id="O2" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 19F Ab.IgG (≥ 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="146"/>
                    <measurement group_id="O2" value="141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 19F Ab.IgG (≥ 4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="111"/>
                    <measurement group_id="O2" value="109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 23F Ab.IgG (≥ 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="133"/>
                    <measurement group_id="O2" value="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 23F Ab.IgG (≥ 4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108"/>
                    <measurement group_id="O2" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 6B Ab.IgG (≥ 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="141"/>
                    <measurement group_id="O2" value="127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 6B Ab.IgG (≥ 4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="113"/>
                    <measurement group_id="O2" value="109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 7F Ab.IgG (≥ 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="155"/>
                    <measurement group_id="O2" value="144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 7F Ab.IgG (≥ 4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="138"/>
                    <measurement group_id="O2" value="119"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 9V Ab.IgG (≥ 2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="146"/>
                    <measurement group_id="O2" value="140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Polysaccharide 9V Ab.IgG (≥ 4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="131"/>
                    <measurement group_id="O2" value="121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Serious Adverse Events: During the entire study period (Day 0 to 180); Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.</time_frame>
      <desc>For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.</desc>
      <group_list>
        <group group_id="E1">
          <title>Control Group</title>
          <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.</description>
        </group>
        <group group_id="E2">
          <title>Co-Ad Group</title>
          <description>Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="177"/>
              </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="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="177"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="177"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="177"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="177"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="177"/>
              </event>
              <event>
                <sub_title>Coronary artery stenosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="179"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="177"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="177"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Intestinal malrotation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="177"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Intestinal ischaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="177"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Calcinosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="177"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="177"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="177"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="177"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="177"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus inadequate control</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="177"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="177"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="177"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Colon cancer metastatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="177"/>
              </event>
              <event>
                <sub_title>Renal cancer stage ii</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="177"/>
              </event>
              <event>
                <sub_title>Squamous cell carcinoma of the oral cavity</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="179"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="177"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="177"/>
              </event>
              <event>
                <sub_title>Cerebral thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="177"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="177"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="177"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="177"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="177"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="179"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="177"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <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="117" subjects_at_risk="179"/>
                <counts group_id="E2" subjects_affected="127" subjects_at_risk="177"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal disorder</sub_title>
                <counts group_id="E1" events="27" subjects_affected="23" subjects_at_risk="179"/>
                <counts group_id="E2" events="19" subjects_affected="17" subjects_at_risk="177"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="14" subjects_affected="13" subjects_at_risk="179"/>
                <counts group_id="E2" events="15" subjects_affected="14" subjects_at_risk="177"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="55" subjects_affected="43" subjects_at_risk="179"/>
                <counts group_id="E2" events="51" subjects_affected="43" subjects_at_risk="177"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="98" subjects_affected="76" subjects_at_risk="179"/>
                <counts group_id="E2" events="98" subjects_affected="92" subjects_at_risk="177"/>
              </event>
              <event>
                <sub_title>Swelling</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="179"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="177"/>
              </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="28" subjects_affected="25" subjects_at_risk="179"/>
                <counts group_id="E2" events="30" subjects_affected="25" subjects_at_risk="177"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="36" subjects_affected="32" subjects_at_risk="179"/>
                <counts group_id="E2" events="32" subjects_affected="28" subjects_at_risk="177"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="41" subjects_affected="31" subjects_at_risk="179"/>
                <counts group_id="E2" events="30" subjects_affected="27" subjects_at_risk="177"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="14" subjects_affected="13" subjects_at_risk="179"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="177"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="21" subjects_affected="16" subjects_at_risk="179"/>
                <counts group_id="E2" events="24" subjects_affected="19" subjects_at_risk="177"/>
              </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>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
    </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/NCT02218697
org study id: 117276
secondary id: 2014-001118-24
nct id: NCT02218697
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to investigate the immunogenicity and safety when GSK
      Biologicals' influenza vaccine Influsplit™ Tetra (Fluarix™ Tetra) is co-administered with
      Merck & Co. Inc.'s pneumococcal vaccine (Pneumovax™23/Pneumovax) in adults 50 years of age
      and older at risk for complications from influenza and pneumococcal infections.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies Titers Against the 4 Vaccine Strains.
time frame: At Day 28 post Influsplit™ Tetra vaccination
description: HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios (Control Group/Co-Ad Group). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), FluA/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/2/2012 (Yamagata).
measure: Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 6 Pneumococcal Serotypes (1, 3, 4, 7F, 14 and 19A).
time frame: At 28 days after Pneumovax™ 23 vaccination
description: Anti-pneumococcal antibody concentrations were expressed as adjusted geometric mean concentrations (GMCs) and adjusted GMC ratio (Control Group/Co-Ad Group).
measure: Number of Subjects Reporting Solicited Local Adverse Events (AEs)
time frame: Within 7 days (Days 0 - 6) after each dose and across doses.
description: Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = significant pain at rest and pain that prevented normal everyday activities. Grade 3 redness and swelling = greater than 50 millimeters (mm) i.e. > 100mm.
measure: Number of Subjects Reporting Solicited General Adverse Events (AEs)
time frame: Within 7 days (Days 0 - 6) after each dose and across doses.
description: Solicited general symptoms assessed were fatigue, gastrointestinal symptoms*, headache, joint pain, muscle aches, shivering, sweating and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 was defined as symptoms that prevented normal everyday activities. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as temperature greater than (>)39.0°C.
*Gastrointestinal (GI) symptoms included nausea, vomiting, diarrhoea and/or abdominal pain
measure: Duration of Local Adverse Events
time frame: During the 7-day (Days 0-6) post-vaccination period
description: Duration was defined as number of days with any grade of local symptoms.
measure: Duration of Solicited General AEs.
time frame: During the 7-day (Days 0-6) post-vaccination period
description: Duration was defined as number of days with any grade of general symptoms.
measure: Number of Subjects Reporting the Occurrence of Medically Attended Adverse Events (MAEs)
time frame: Throughout the study period (Days 0-180)
description: MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s) regardless of intensity grade or relationship to vaccination. Related was defined as MAE assessed by the investigator to be causally related to the study vaccination.
measure: Number of Subjects Reporting the Occurrence of Potential Immune Mediated Diseases (pIMDs)
time frame: During the entire study period (Days 0-180)
description: Potential immune-mediated diseases (pIMDs) were defined as a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Any was defined as any occurrence of pIMD(s) regardless of intensity grade or relationship to vaccination. Related was defined as pIMD assessed by the investigator to be causally related to the study vaccination.
measure: Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
time frame: Within the 28-day (Days 0-27) post-vaccination period
description: An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
measure: Number of Subjects Reporting Serious Adverse Events (SAEs)
time frame: Throughout the study period (Days 0-180)
description: SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
measure: Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies in Subjects by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Influenza Vaccine Strains
time frame: At Day 0 and Day 28
description: HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata).
measure: Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.
time frame: At Day 0 and Day 28
description: A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/2/2012 (Yamagata).
measure: Number of Seroconverted Subjects for Anti-Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.
time frame: At Day 28
description: A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata).
measure: Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains.
time frame: At Day 28
description: MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2), Flu B/Brisbane/60/2008 (Victoria) and Flu B/Massachusetts/02/2012 (Yamagata).
measure: Number of Subjects With Anti-pneumococcal Antibody Concentrations for the Following Serotypes: 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F
time frame: At Days 0 (Co-Ad group only), 28 (both groups), and 56 (Control group only)
description: The pneumococcal antigen testing was performed, as determined by ELISA cut-offs of ≥0.05 µg/mL and a seroprotection cut-off of ≥ 0.2 µg/ml.
PRE = Pre-vaccination i.e. at Day 0 for Co-Ad Group and at Day 28 for Control Group.
POST = Post-vaccination i.e. at Day 28 for Co-Ad Group and at Day 56 for Control Group.
measure: Pneumococcal Vaccine Response in Terms of Anti-pneumococcal Antibody Concentrations Against 12 Pneumococcal Serotypes (1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F)
time frame: At Days 0 (Co-Ad group only), 28 (both groups), and 56 (Control group only)
description: Anti-pneumococcal antibody concentrations were expressed as adjusted geometric mean concentrations (GMCs) PRE = Pre -vaccination i.e. at Day 0 for Co-Ad Group and at Day 28 for Control Group.
POST = Post-vaccination i.e. at Day 28 for Co-Ad Group and at Day 56 for Control Group.
measure: Number of Subjects Whose N Antibody Titers Were at Least 2 or 4-fold Higher Than Their Pre-vaccination Titer by Anti-pneumococcal Serotype Subjects.
time frame: At 28 days post-vaccination with Pneumovax™ 23
description: Fold antibody concentration increases post-vaccination/pre-vaccination ≥ 2 and ≥ 4.
The anti-pneumococcal serotypes assessed were 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
arm group label: Co-Ad Group
arm group type: Experimental
description: Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
arm group label: Control Group
arm group type: Experimental
description: Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
intervention type: Biological
intervention name: Influsplit™ Tetra (Fluarix™ Tetra)
description: Intramuscular injection, 1 dose each in Control and Co-Ad groups.
arm group label: Co-Ad Group
arm group label: Control Group
other name: D-QIV
other name: GSK2321138A
intervention type: Biological
intervention name: Pneumovax™ 23
description: Intramuscular injection, 1 dose each in Control and Co-Ad groups.
arm group label: Co-Ad Group
arm group label: Control Group
intervention type: Biological
intervention name: Placebo (Saline)
description: Intramuscular injection, 1 dose each in Control and Co-Ad groups.
arm group label: Co-Ad Group
arm group label: Control Group
criteria: 
gender: All
minimum age: 50 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
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country: Belgium
country: France
url: https://www.clinicalstudydatarequest.com
description: Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Heptavalent Pneumococcal Conjugate Vaccine
sharing ipd: Yes
ipd description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
study doc: 
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participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 