<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/NCT01730378</url>
  </required_header>
  <id_info>
    <org_study_id>114695</org_study_id>
    <nct_id>NCT01730378</nct_id>
  </id_info>
  <brief_title>Immunogenicity and Safety of PrepandrixTM in Korean Subjects Aged 18 to 60 Years Old</brief_title>
  <official_title>Immunogenicity and Safety of GlaxoSmithKline Biologicals' (Pre-) Pandemic Influenza Vaccine Prepandrix™ in Korean Subjects Aged 18 to 60 Years Old</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <brief_summary>
    <textblock>
      This study will evaluate the immunogenicity and the safety of PrepandrixTM in Korean&#xD;
      subjects. A second group of subjects will receive FluarixTM vaccine as control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Initially, 124 subjects were planned to be enrolled according to a 1:1 randomisation ratio.&#xD;
      However, by mistake, the randomisation application was set up consistent with the vaccine&#xD;
      supply ratio (2:1) rather than the treatment group randomization ratio (1:1). Subsequently,&#xD;
      the protocol was amended to adjust the sample size and randomisation ratio for the study.&#xD;
&#xD;
      The study will enrol 126 subjects randomised 2:1. 84 subjects will receive Prepandrix™ and 42&#xD;
      subjects will receive Fluarix™.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 5, 2012</start_date>
  <completion_date type="Actual">December 17, 2013</completion_date>
  <primary_completion_date type="Actual">December 17, 2013</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Seroconverted Subjects for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.</measure>
    <time_frame>At Day 42</time_frame>
    <description>A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (&lt;) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.</measure>
    <time_frame>At Day 42</time_frame>
    <description>MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.</measure>
    <time_frame>At Day 42</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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.</measure>
    <time_frame>At Day 0 and Day 42</time_frame>
    <description>Antibody titers were expressed as Geometric mean titers (GMTs).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.</measure>
    <time_frame>At Day 21</time_frame>
    <description>Antibody titers were expressed as Geometric mean titers (GMTs).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Who Were Seroprotected for HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.</measure>
    <time_frame>At Day 0 and Day 21</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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Seroconverted Subjects for HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.</measure>
    <time_frame>At Day 21</time_frame>
    <description>A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (&lt;) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.</measure>
    <time_frame>At Day 21</time_frame>
    <description>MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.</measure>
    <time_frame>At Days 0 and 21</time_frame>
    <description>Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.</measure>
    <time_frame>At Day 21</time_frame>
    <description>A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (&lt;) 1:10 and a post-vaccination titer ≥ 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/Victoria/361/2011 (H3N2)and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Geometric Increase (MGI) for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.</measure>
    <time_frame>At Day 21</time_frame>
    <description>MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.</measure>
    <time_frame>At Day 0 and Day 21</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/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.</measure>
    <time_frame>During the 7-day (Day 0-6) period after each vaccination</time_frame>
    <description>Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities as assessed by inability to attend/do work or school. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. &gt;100mm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.</measure>
    <time_frame>During the 7-day (Days 0-6) post-vaccination period</time_frame>
    <description>Solicited general symptoms assessed were fatigue, headache, joint pain, muscle aches, shivering, increased sweating and fever [axillary temperature above 38.0 degrees Celsius (°C)]. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity as assessed by inability to attend/do work or school, or requires intervention of a physician/healthcare provider. Grade 3 fever = axillary temperature above 39.0°C</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any Potential Immune Mediated Diseases (pIMDs).</measure>
    <time_frame>During the entire study period (From Day 0 to Day 182)</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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Unsolicited Adverse Events (AEs)</measure>
    <time_frame>During the 21 days (Day 0-20) post-vaccination period</time_frame>
    <description>Unsolicited AE covers any AE 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 Unsolicted AEs</measure>
    <time_frame>During the 84-day (Days 0-83) post vaccination period</time_frame>
    <description>Unsolicited AE covers any AE 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 Any Unsolicited AEs</measure>
    <time_frame>During the 63-day (Days 21-83) post-dose 2 in Prepandrix Group</time_frame>
    <description>Unsolicited AE covers any AE 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 Any and Related Serious Adverse Events (SAEs)</measure>
    <time_frame>During the entire study period (From Day 0 to 182)</time_frame>
    <description>A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was 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>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">131</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Prepandrix Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fluarix Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Prepandrix™</intervention_name>
    <description>2 doses administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).</description>
    <arm_group_label>Prepandrix Group</arm_group_label>
    <other_name>GlaxoSmithKline [GSK] Biologicals' A/Indonesia/5/2005 (H5N1) (pre-) pandemic influenza adjuvanted vaccine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fluarix™</intervention_name>
    <description>1 dose administered intramuscularly in the deltoid region of non-dominant arm.</description>
    <arm_group_label>Fluarix Group</arm_group_label>
    <other_name>GSK Biologicals' trivalent inactivated influenza split vaccine (Influsplit SSW® 2012/2013)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who the investigator believes can and will comply with the requirements of&#xD;
             the protocol. Or subjects who the investigator believes that parent(s)/Legally&#xD;
             Acceptable Representative(s) can and will comply with the requirements of the&#xD;
             protocol.&#xD;
&#xD;
          -  Korean male or female subject between, and including, 18 and 60 years of age at the&#xD;
             time of the first vaccination.&#xD;
&#xD;
          -  Written informed consent obtained from the subject/ from the parent(s)/ Legally&#xD;
             Acceptable Representative(s).&#xD;
&#xD;
          -  Healthy subjects or free of acute aggravation of the health status as established by&#xD;
             medical history and clinical examination before entering into the study.&#xD;
&#xD;
          -  Access to a consistent means of telephone contact, which may be either in the home or&#xD;
             at the workplace, land line or mobile, but NOT a pay phone or other multiple-user&#xD;
             device.&#xD;
&#xD;
          -  Female subjects of non-childbearing potential may be enrolled in the study.&#xD;
&#xD;
          -  Female subjects of childbearing potential may be enrolled in the study, if the subject&#xD;
             has practiced adequate contraception for 30 days prior to vaccination, has a negative&#xD;
             pregnancy test on the day of vaccination, and has agreed to continue adequate&#xD;
             contraception during the entire treatment period and for two months after completion&#xD;
             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;
          -  Acute disease and/or fever at the time of enrollment.&#xD;
&#xD;
          -  Subjects with a minor illness without fever may be enrolled at the discretion of the&#xD;
             investigator.&#xD;
&#xD;
          -  Diagnosed with cancer, or treatment for cancer, within the past three years.&#xD;
&#xD;
          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including&#xD;
             history of human immunodeficiency virus (HIV) infection.&#xD;
&#xD;
          -  Family history of congenital or hereditary immunodeficiency.&#xD;
&#xD;
          -  Any significant disorder of coagulation or treatment with warfarin derivatives or&#xD;
             heparin. Persons receiving individual doses of low molecular weight heparin outside of&#xD;
             24 hours prior to vaccination are eligible. Persons receiving prophylactic&#xD;
             antiplatelet medications, e.g., low-dose aspirin, and without any clinically-apparent&#xD;
             bleeding tendency, are eligible.&#xD;
&#xD;
          -  History of any neurological disorders or seizures.&#xD;
&#xD;
          -  An acute evolving neurological disorder or history of Guillan-Barré syndrome.&#xD;
&#xD;
          -  Chronic administration of immunosuppressants or other immune-modifying drugs within&#xD;
             six months prior to the first vaccine dose.&#xD;
&#xD;
          -  Any administration of long-acting immune-modifying drugs within three months before&#xD;
             study start, or a planned administration during the study period.&#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;
          -  Clinically or virologically diagnosed influenza infection within six months preceding&#xD;
             the study start.&#xD;
&#xD;
          -  Administration of any vaccines within 30 days before vaccination, or planned&#xD;
             administration during the study start.&#xD;
&#xD;
          -  Previous vaccination against influenza with any seasonal or pandemic vaccine within&#xD;
             six months preceding the administration of the study vaccine.&#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 product.&#xD;
&#xD;
          -  History of allergy or reactions likely to be exacerbated by any component of the&#xD;
             vaccines, including history of a severe adverse reaction to a previous dose of&#xD;
             influenza vaccine.&#xD;
&#xD;
          -  Female planning to become pregnant or planning to discontinue contraceptive&#xD;
             precautions.&#xD;
&#xD;
          -  Child in care.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</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>Guro Gu</city>
        <zip>152703</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Gyeonggi</city>
        <zip>442-723</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Incheon</city>
        <zip>400-711</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Seoul</city>
        <zip>150-950</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <results_first_submitted>December 15, 2014</results_first_submitted>
  <results_first_submitted_qc>December 15, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 24, 2014</results_first_posted>
  <last_update_submitted>August 9, 2018</last_update_submitted>
  <last_update_submitted_qc>August 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Influenza vaccine</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>Vaccines</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Prepandrix Group</title>
          <description>Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).</description>
        </group>
        <group group_id="P2">
          <title>Fluarix Group</title>
          <description>Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="84"/>
                <participants group_id="P2" count="47"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="83"/>
                <participants group_id="P2" count="47"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Prepandrix Group</title>
          <description>Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).</description>
        </group>
        <group group_id="B2">
          <title>Fluarix Group</title>
          <description>Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.</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="84"/>
            <count group_id="B2" value="47"/>
            <count group_id="B3" value="131"/>
          </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="39.3" spread="10.94"/>
                    <measurement group_id="B2" value="40.4" spread="10.3"/>
                    <measurement group_id="B3" value="39.69" spread="10.69"/>
                  </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="61"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="95"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Seroconverted Subjects for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.</title>
        <description>A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (&lt;) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.</description>
        <time_frame>At Day 42</time_frame>
        <population>Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Prepandrix Group</title>
            <description>Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Seroconverted Subjects for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.</title>
          <description>A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (&lt;) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.</description>
          <population>Analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least 1 study vaccine antigen component after vaccination.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.</title>
        <description>MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0).</description>
        <time_frame>At Day 42</time_frame>
        <population>Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Prepandrix Group</title>
            <description>Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.</title>
          <description>MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0).</description>
          <population>Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.</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="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.0" lower_limit="48.7" upper_limit="69.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.</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.</description>
        <time_frame>At Day 42</time_frame>
        <population>Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Prepandrix Group</title>
            <description>Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.</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.</description>
          <population>Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.</title>
        <description>Antibody titers were expressed as Geometric mean titers (GMTs).</description>
        <time_frame>At Day 0 and Day 42</time_frame>
        <population>Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Prepandrix Group</title>
            <description>Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).</description>
          </group>
        </group_list>
        <measure>
          <title>Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.</title>
          <description>Antibody titers were expressed as Geometric mean titers (GMTs).</description>
          <population>Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.</population>
          <units>Titer</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H5N1, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" lower_limit="5.0" upper_limit="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H5N1, Day 42</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="300.1" lower_limit="254.1" upper_limit="354.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.</title>
        <description>Antibody titers were expressed as Geometric mean titers (GMTs).</description>
        <time_frame>At Day 21</time_frame>
        <population>Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Prepandrix Group</title>
            <description>Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).</description>
          </group>
        </group_list>
        <measure>
          <title>Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.</title>
          <description>Antibody titers were expressed as Geometric mean titers (GMTs).</description>
          <population>Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.</population>
          <units>Titer</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.8" lower_limit="26.2" upper_limit="38.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Who Were Seroprotected for HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.</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.</description>
        <time_frame>At Day 0 and Day 21</time_frame>
        <population>Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Prepandrix Group</title>
            <description>Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Who Were Seroprotected for HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.</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.</description>
          <population>Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H5N1, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H5N1, Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Seroconverted Subjects for HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.</title>
        <description>A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (&lt;) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.</description>
        <time_frame>At Day 21</time_frame>
        <population>Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Prepandrix Group</title>
            <description>Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Seroconverted Subjects for HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.</title>
          <description>A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (&lt;) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.</description>
          <population>Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                  </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 Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.</title>
        <description>MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0).</description>
        <time_frame>At Day 21</time_frame>
        <population>Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Prepandrix Group</title>
            <description>Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.</title>
          <description>MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0).</description>
          <population>Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.</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="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2" lower_limit="5.1" upper_limit="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.</title>
        <description>Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).</description>
        <time_frame>At Days 0 and 21</time_frame>
        <population>Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Group</title>
            <description>Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.</title>
          <description>Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).</description>
          <population>Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.</population>
          <units>Titer</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.3" lower_limit="12.0" upper_limit="27.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="425.9" lower_limit="289.9" upper_limit="625.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.0" lower_limit="14.7" upper_limit="33.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="149.2" lower_limit="108.5" upper_limit="205.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.1" lower_limit="43.0" upper_limit="84.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="367.6" lower_limit="304.7" upper_limit="443.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.</title>
        <description>A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (&lt;) 1:10 and a post-vaccination titer ≥ 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/Victoria/361/2011 (H3N2)and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).</description>
        <time_frame>At Day 21</time_frame>
        <population>Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Group</title>
            <description>Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.</title>
          <description>A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (&lt;) 1:10 and a post-vaccination titer ≥ 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/Victoria/361/2011 (H3N2)and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).</description>
          <population>Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Geometric Increase (MGI) for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.</title>
        <description>MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).</description>
        <time_frame>At Day 21</time_frame>
        <population>Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Group</title>
            <description>Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Geometric Increase (MGI) for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.</title>
          <description>MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).</description>
          <population>Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.</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="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.3" lower_limit="13.7" upper_limit="39.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8" lower_limit="4.3" upper_limit="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1" lower_limit="4.3" upper_limit="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.</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/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).</description>
        <time_frame>At Day 0 and Day 21</time_frame>
        <population>Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Group</title>
            <description>Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.</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/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).</description>
          <population>Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.</title>
        <description>Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities as assessed by inability to attend/do work or school. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. &gt;100mm.</description>
        <time_frame>During the 7-day (Day 0-6) period after each vaccination</time_frame>
        <population>Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Prepandrix Group</title>
            <description>Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Group</title>
            <description>Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.</title>
          <description>Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities as assessed by inability to attend/do work or school. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. &gt;100mm.</description>
          <population>Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data 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="84"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80"/>
                    <measurement group_id="O2" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Redness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Redness</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>Any Swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Swelling</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 Solicited General Symptoms.</title>
        <description>Solicited general symptoms assessed were fatigue, headache, joint pain, muscle aches, shivering, increased sweating and fever [axillary temperature above 38.0 degrees Celsius (°C)]. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity as assessed by inability to attend/do work or school, or requires intervention of a physician/healthcare provider. Grade 3 fever = axillary temperature above 39.0°C</description>
        <time_frame>During the 7-day (Days 0-6) post-vaccination period</time_frame>
        <population>Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Prepandrix Group</title>
            <description>Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Group</title>
            <description>Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.</title>
          <description>Solicited general symptoms assessed were fatigue, headache, joint pain, muscle aches, shivering, increased sweating and fever [axillary temperature above 38.0 degrees Celsius (°C)]. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity as assessed by inability to attend/do work or school, or requires intervention of a physician/healthcare provider. Grade 3 fever = axillary temperature above 39.0°C</description>
          <population>Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data 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="84"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Fatigue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fatigue</title>
              <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 Fatigue</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Headache</title>
              <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 Headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Increased Sweating</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Increased Sweating</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Increased Sweating</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Joint Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Joint Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Joint Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Muscle Aches</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Muscle Aches</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Muscle Aches</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Shivering</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Shivering</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Shivering</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Fever (≥ 38.0°C)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fever (≥ 39.0°C)</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>Related Fever</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <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 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.</description>
        <time_frame>During the entire study period (From Day 0 to Day 182)</time_frame>
        <population>Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Prepandrix Group</title>
            <description>Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Group</title>
            <description>Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any 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.</description>
          <population>Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data 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="84"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <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 Unsolicited Adverse Events (AEs)</title>
        <description>Unsolicited AE covers any AE 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>During the 21 days (Day 0-20) post-vaccination period</time_frame>
        <population>Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Prepandrix Group</title>
            <description>Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Group</title>
            <description>Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Unsolicited Adverse Events (AEs)</title>
          <description>Unsolicited AE covers any AE 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>Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data 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="84"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Unsolicted AEs</title>
        <description>Unsolicited AE covers any AE 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>During the 84-day (Days 0-83) post vaccination period</time_frame>
        <population>Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Prepandrix Group</title>
            <description>Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Group</title>
            <description>Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Unsolicted AEs</title>
          <description>Unsolicited AE covers any AE 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>Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data 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="84"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Any Unsolicited AEs</title>
        <description>Unsolicited AE covers any AE 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>During the 63-day (Days 21-83) post-dose 2 in Prepandrix Group</time_frame>
        <population>Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Prepandrix Group</title>
            <description>Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Any Unsolicited AEs</title>
          <description>Unsolicited AE covers any AE 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>Analysis was performed on the ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome variables were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after vaccination.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="84"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)</title>
        <description>A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was 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>During the entire study period (From Day 0 to 182)</time_frame>
        <population>Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Prepandrix Group</title>
            <description>Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Group</title>
            <description>Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)</title>
          <description>A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was 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>Analysis was performed on the Total Vaccinated cohort included all vaccinated subjects for whom data 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="84"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any SAEs</title>
              <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 SAEs</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_list>

    <reported_events>
      <time_frame>Serious Adverse Events: From Day 0 to Day 182; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 84-day (Day 0-83) post-vaccination period</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Prepandrix Group</title>
          <description>Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).</description>
        </group>
        <group group_id="E2">
          <title>Fluarix Group</title>
          <description>Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-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="1" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Endometriosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
              </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="81" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="40" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="80" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="32" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Redness</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Swelling</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="54" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Increased Sweating</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Joint Pain</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Muscles Aches</sub_title>
                <counts group_id="E1" subjects_affected="62" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="47"/>
              </event>
              <event>
                <sub_title>Shivering</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="47"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="84"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="47"/>
              </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/NCT01730378
org study id: 114695
nct id: NCT01730378
lead sponsor: 
This study will evaluate the immunogenicity and the safety of PrepandrixTM in Korean
      subjects. A second group of subjects will receive FluarixTM vaccine as control.
Initially, 124 subjects were planned to be enrolled according to a 1:1 randomisation ratio.
      However, by mistake, the randomisation application was set up consistent with the vaccine
      supply ratio (2:1) rather than the treatment group randomization ratio (1:1). Subsequently,
      the protocol was amended to adjust the sample size and randomisation ratio for the study.

      The study will enrol 126 subjects randomised 2:1. 84 subjects will receive Prepandrix™ and 42
      subjects will receive Fluarix™.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of Seroconverted Subjects for Serum H5N1 Haemagglutination-inhibition (HI) Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.
time frame: At Day 42
description: A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.
measure: Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.
time frame: At Day 42
description: MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0).
measure: Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.
time frame: At Day 42
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.
measure: Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.
time frame: At Day 0 and Day 42
description: Antibody titers were expressed as Geometric mean titers (GMTs).
measure: Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.
time frame: At Day 21
description: Antibody titers were expressed as Geometric mean titers (GMTs).
measure: Number of Subjects Who Were Seroprotected for HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.
time frame: At Day 0 and Day 21
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.
measure: Number of Seroconverted Subjects for HI Antibodies Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.
time frame: At Day 21
description: A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.
measure: Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Flu A/Indonesia/5/2005 (H5N1) Vaccine Strain in Prepandrix Group.
time frame: At Day 21
description: MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0).
measure: Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.
time frame: At Days 0 and 21
description: Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).
measure: Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.
time frame: At Day 21
description: A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 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/Victoria/361/2011 (H3N2)and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).
measure: Mean Geometric Increase (MGI) for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.
time frame: At Day 21
description: MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).
measure: Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the Three Vaccine Seasonal Influenza Strains in Fluarix Group.
time frame: At Day 0 and Day 21
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/Victoria/361/2011 (H3N2) and Flu B/Hubei-Wujiagang/158/2009 (Yamagata).
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
time frame: During the 7-day (Day 0-6) period after each vaccination
description: Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities as assessed by inability to attend/do work or school. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.
measure: Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
time frame: During the 7-day (Days 0-6) post-vaccination period
description: Solicited general symptoms assessed were fatigue, headache, joint pain, muscle aches, shivering, increased sweating and fever [axillary temperature above 38.0 degrees Celsius (°C)]. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity as assessed by inability to attend/do work or school, or requires intervention of a physician/healthcare provider. Grade 3 fever = axillary temperature above 39.0°C
measure: Number of Subjects Reporting Any Potential Immune Mediated Diseases (pIMDs).
time frame: During the entire study period (From Day 0 to Day 182)
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.
measure: Number of Subjects Reporting Unsolicited Adverse Events (AEs)
time frame: During the 21 days (Day 0-20) post-vaccination period
description: Unsolicited AE covers any AE 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 Unsolicted AEs
time frame: During the 84-day (Days 0-83) post vaccination period
description: Unsolicited AE covers any AE 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 Any Unsolicited AEs
time frame: During the 63-day (Days 21-83) post-dose 2 in Prepandrix Group
description: Unsolicited AE covers any AE 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 Any and Related Serious Adverse Events (SAEs)
time frame: During the entire study period (From Day 0 to 182)
description: A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was 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.
arm group label: Prepandrix Group
arm group type: Experimental
description: Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
arm group label: Fluarix Group
arm group type: Active Comparator
description: Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
intervention type: Biological
intervention name: Prepandrix™
description: 2 doses administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
arm group label: Prepandrix Group
other name: GlaxoSmithKline [GSK] Biologicals' A/Indonesia/5/2005 (H5N1) (pre-) pandemic influenza adjuvanted vaccine
intervention type: Biological
intervention name: Fluarix™
description: 1 dose administered intramuscularly in the deltoid region of non-dominant arm.
arm group label: Fluarix Group
other name: GSK Biologicals' trivalent inactivated influenza split vaccine (Influsplit SSW® 2012/2013)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Vaccines
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 