<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/NCT01702454</url>
  </required_header>
  <id_info>
    <org_study_id>116023</org_study_id>
    <secondary_id>2012-001230-34</secondary_id>
    <nct_id>NCT01702454</nct_id>
  </id_info>
  <brief_title>Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine When Administered in Children Who Previously Participated in Study 115345</brief_title>
  <official_title>Immunogenicity, Safety and Reactogenicity Study of GSK Biologicals' Quadrivalent Seasonal Influenza Candidate Vaccine GSK2321138A, Administered to Children Who Previously Participated in Study 115345</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety and immunogenicity of GSK Biologicals'&#xD;
      investigational vaccine GSK2321138A in children who previously participated in study 115345&#xD;
      (FLU D-QIV-004 PRI) (NCT01439360).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 6, 2012</start_date>
  <completion_date type="Actual">June 5, 2013</completion_date>
  <primary_completion_date type="Actual">May 6, 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine</measure>
    <time_frame>At Day 0 and Day 7</time_frame>
    <description>Antibody titers were expressed as Geometric Mean Titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine</measure>
    <time_frame>At Day 0 and Day 7</time_frame>
    <description>Seropositivity was defined as number of subjects with antibody titers greater than or equal to (≥) 1:10. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</measure>
    <time_frame>At Day 7 post dose 1</time_frame>
    <description>A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 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 included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</measure>
    <time_frame>At Day 7 post dose 1</time_frame>
    <description>MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</measure>
    <time_frame>At Day 0 and Day 7</time_frame>
    <description>Seroprotection rate (SPR) was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer ≥ 1:40 that usually is accepted as indicating protection in adults. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</measure>
    <time_frame>At Day 0 and Day 7</time_frame>
    <description>Antibody titers were expressed as Geometric Mean Titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine</measure>
    <time_frame>At Day 0 and Day 7</time_frame>
    <description>Seropositivity was defined as number of subjects with antibody titers greater than or equal to (≥) 1:10. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</measure>
    <time_frame>At Day 7 post dose 1</time_frame>
    <description>A seroconverted subject was defined as a subject who had either a pre-vaccination titer &lt;1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria)and B/Hubei-Wujiagang/158/2009 (Yamagata )antigens.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Geometric Increase (MGI) for HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</measure>
    <time_frame>At Day 7 post dose 1</time_frame>
    <description>Mean geometric increase was defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</measure>
    <time_frame>At Day 0 and Day 7</time_frame>
    <description>Seroprotection rate was defined as the number of vaccinees with a serum HI titer greater than or equal to(≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008 (Victoria)and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</measure>
    <time_frame>At Day 0 and Day 7</time_frame>
    <description>The cut-off values assessed were less than (&lt;) 1:10, 1:10 to &lt; 1:40 and ≥ 1:40. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine</measure>
    <time_frame>At Day 0 and Day 7</time_frame>
    <description>Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine</measure>
    <time_frame>At Day 0 and Day 7</time_frame>
    <description>Antibody titers were expressed as GMTs. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vaccine Response Rate (VRR) for Neutralising Antibody Titers Against Each of the Four Vaccine Strains.</measure>
    <time_frame>At Day 7 post dose 1</time_frame>
    <description>VRR was defined as the number of vaccinees who had either a pre-vaccination titer &lt;cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</measure>
    <time_frame>At Day 7 post dose 1</time_frame>
    <description>MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains.</measure>
    <time_frame>At Day 7 post dose 1</time_frame>
    <description>VRR was defined as the number of vaccinees who had either a pre-vaccination titer &lt;cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</measure>
    <time_frame>At Day 7 post dose 1</time_frame>
    <description>MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</measure>
    <time_frame>At Day 0 and Day 7</time_frame>
    <description>The cut-off values assessed were less than (&lt;) 1:10, 1:10 to &lt; 1:40,≥ 1:40, ≥1:60 and ≥1:80 . The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</measure>
    <time_frame>At Day 0 and Day 7</time_frame>
    <description>MN antibody titers were expressed as geometric mean titers(GMTs). The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine</measure>
    <time_frame>At Day 0 and Day 7</time_frame>
    <description>NI (Neuraminidase inhibitor) antibody titers were expressed as geometric mean titers(GMTs).The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains</measure>
    <time_frame>At Day 7 post dose 1</time_frame>
    <description>VRR was defined as the number of vaccinees who had either a pre-vaccination titer &lt;cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</measure>
    <time_frame>At Day 7 post dose 1</time_frame>
    <description>MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vaccine Response Rate(VRR) for Anti-neuraminidase Antibodies Against Each of the Four Vaccine Strains.</measure>
    <time_frame>At Day 7 post dose 1</time_frame>
    <description>VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer &lt;cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine</measure>
    <time_frame>At Day 7 post dose 1</time_frame>
    <description>MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.</measure>
    <time_frame>At Day 0 and Day 7</time_frame>
    <description>Antibody titers were expressed as geometric mean titers. The vaccine strains included A/Christchurch/16/2010 (H1N1),A/Victoria/361/2011 (H3N2), A/Victoria/361/2011 and B/Hubei-Wujiagang/158/2009)(Yamagata) antigens. The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata</measure>
    <time_frame>At Day 0 and Day 7</time_frame>
    <description>Antibody titers were expressed as geometric mean titers. The vaccine strains included A/Christchurch/16/2010(H1N1), A/Victoria/361/2011(H3N2),B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009(Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata</measure>
    <time_frame>At Day 7 post dose 1</time_frame>
    <description>VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer &lt;cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008(Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata</measure>
    <time_frame>At Day 7 post dose 1</time_frame>
    <description>MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0.The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.</measure>
    <time_frame>At Day 7 post dose 1</time_frame>
    <description>VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer &lt;cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria /361/2011(H3N2), B/Brisbane /60/2008(Victoria ) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.</measure>
    <time_frame>At Day 7 post dose 1</time_frame>
    <description>MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)</measure>
    <time_frame>During a 7-day (Day 0 to 6) follow-up period after first vaccination</time_frame>
    <description>Solicited local AEs assessed were pain, redness and swelling. Any = any solicited local AE reported irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Solicted Symptoms</measure>
    <time_frame>During the 7-day (Days 0-6) post-vaccination Dose 1 period</time_frame>
    <description>Duration was defined as number of days with any grade of solicted local and/or general symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.</measure>
    <time_frame>During the 7 days (Days 0 - 6) post dose 1 vaccination</time_frame>
    <description>Solicited general symptoms assessed were drowsiness, Irritability/Fussiness, loss of appetite and Temperature. Any Temperature = axillary temperature ≥37.5 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. Grade 3 Irritability/Fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = did not eat at all. Grade 3 temperature = axillary temperature &gt; 39.0°C.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting AEs With Medically Attended Visits (MAV)</measure>
    <time_frame>During the entire study period (Day 0 - Day 179)</time_frame>
    <description>MAVs were defined as an AEs with a medically-attended visits i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAV was defined as at least one MAV experienced. Grade 3 was a MAV that prevented normal activities and related was defined as a MAV assessed by the investigator to be causally related to the study vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs)</measure>
    <time_frame>During the entire study period (Days 0 - 179)</time_frame>
    <description>pIMDs were defined as a subset of AEs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune aetiology. Any pIMDs= Any AEs that occured regardless of the relation with vaccination. Related pIMDs= Any pIMD assessed by the investigator as casually related to the study vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs.</measure>
    <time_frame>Within 28 days (Days 0-27) after first vaccination</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. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study 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 (Day 0 - Day 179)</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">470</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Fluarix Quadrivalent Primed Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fluarix Quadrivalent Unprimed Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fluarix Quadrivalent</intervention_name>
    <description>1 or 2 doses administered intramuscularly (IM) in deltoid region depending on the priming status</description>
    <arm_group_label>Fluarix Quadrivalent Primed Group</arm_group_label>
    <arm_group_label>Fluarix Quadrivalent Unprimed Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who the investigator believes that parent(s)/LAR(s) can and will comply with&#xD;
             the requirements of the protocol.&#xD;
&#xD;
          -  Children, male or female who received a 2-dose vaccination in the study 115345&#xD;
             (NCT01439360).&#xD;
&#xD;
          -  Written informed consent obtained from the parent(s)/LAR(s) of the subject.&#xD;
&#xD;
          -  Subjects in stable health as determined by medical history and clinical examination&#xD;
             before entering into the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child in care.&#xD;
&#xD;
          -  Use of any investigational or non-registered product (drug or vaccine) other than the&#xD;
             study vaccines within 30 days preceding the first dose of study vaccine, or planned&#xD;
             use during the study period.&#xD;
&#xD;
          -  Since the start of study 115345 (NCT01439360), receipt of any seasonal influenza&#xD;
             vaccine other than the study vaccines of study 115345 or planned administration of any&#xD;
             influenza vaccine other than the study vaccine during the study.&#xD;
&#xD;
          -  Administration of any vaccine not foreseen by the study protocol within 4 weeks&#xD;
             preceding the first dose of study vaccine or planned use until Visit 2.&#xD;
&#xD;
          -  Laboratory confirmed influenza infection outside of the 115345 (NCT01439360) study.&#xD;
&#xD;
          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on&#xD;
             medical history and physical examination.&#xD;
&#xD;
          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other&#xD;
             immune-modifying drugs within 6 months prior to enrolment in the study or planned&#xD;
             administration during the study period. Inhaled and topical steroids are allowed.&#xD;
&#xD;
          -  Administration of immunoglobulins and/ or any blood products within 3 months preceding&#xD;
             the first dose of study vaccine or planned administration during the study period.&#xD;
&#xD;
          -  History of any reaction or hypersensitivity likely to be exacerbated by any component&#xD;
             of the vaccine.&#xD;
&#xD;
          -  Any contraindication to intramuscular injection.&#xD;
&#xD;
          -  Acute disease and/or fever at the time of enrollment:&#xD;
&#xD;
               -  Fever is defined as temperature ≥ 37.5°C by any route.&#xD;
&#xD;
               -  Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory&#xD;
                  infection) without fever may be enrolled at the discretion of the investigator.&#xD;
&#xD;
          -  Any other condition which, in the opinion of the Investigator, prevents the subject&#xD;
             from participating in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Months</minimum_age>
    <maximum_age>48 Months</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>Decin</city>
        <zip>405 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Jindrichuv Hradec</city>
        <zip>37701</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lipnik nad Becvou</city>
        <zip>75131</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nachod</city>
        <zip>547 01</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Odolena voda</city>
        <zip>25070</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ostrava - Poruba</city>
        <zip>70800</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pardubice</city>
        <zip>532 03</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Praha 6</city>
        <zip>1600</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tabor</city>
        <zip>390 02</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Debica</city>
        <zip>39-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Katowice</city>
        <zip>40-018</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Siemianowice Slaskie</city>
        <zip>41-103</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Antequera/Málaga</city>
        <zip>29200</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Blanes (Girona)</city>
        <zip>17300</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Castellón</city>
        <zip>12004</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Castellón</city>
        <zip>12530</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Centelles (Barcelona)</city>
        <zip>08540</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Paiporta, Valencia</city>
        <zip>46200</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Quart De Poblet, Valencia</city>
        <zip>46930</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Santiago de Compostela</city>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sevilla</city>
        <zip>41014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Valencia</city>
        <zip>46011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Valencia</city>
        <zip>46024</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>St Austell</city>
        <state>Cornwall</state>
        <zip>PL26 7RL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Coventry</city>
        <state>Warwickshire</state>
        <zip>CV6 4DD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Belfast</city>
        <zip>BT7 2EB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bristol</city>
        <zip>BS2 8AE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Exeter</city>
        <zip>EX2 5DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Gloucester</city>
        <zip>GL1 3NN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>London</city>
        <zip>SW17 0QT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Oxford</city>
        <zip>OX3 7LJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Southampton</city>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <link>
    <url>https://www.clinicalstudydatarequest.com</url>
    <description>Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.</description>
  </link>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>October 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2012</study_first_posted>
  <results_first_submitted>June 5, 2014</results_first_submitted>
  <results_first_submitted_qc>July 10, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 14, 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>GSK Biologicals quadrivalent influenza vaccine</keyword>
  <keyword>Influenza</keyword>
  <keyword>Children</keyword>
  <keyword>Safety</keyword>
  <keyword>Immunogenicity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.</ipd_description>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>116023</doc_id>
      <doc_type>Annotated Case Report Form</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>116023</doc_id>
      <doc_type>Dataset Specification</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>116023</doc_id>
      <doc_type>Informed Consent Form</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>116023</doc_id>
      <doc_type>Statistical Analysis Plan</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>116023</doc_id>
      <doc_type>Study Protocol</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>116023</doc_id>
      <doc_type>Individual Participant Data Set</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>116023</doc_id>
      <doc_type>Clinical Study Report</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
  </study_docs>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Fluarix Quadrivalent Primed Group</title>
          <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
        </group>
        <group group_id="P2">
          <title>Fluarix Quadrivalent Unprimed Group</title>
          <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of 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="241"/>
                <participants group_id="P2" count="229"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="238"/>
                <participants group_id="P2" count="221"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Consent withdrawal</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Migrated/moved from study area</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Fluarix Quadrivalent Primed Group</title>
          <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
        </group>
        <group group_id="B2">
          <title>Fluarix Quadrivalent Unprimed Group</title>
          <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of 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="241"/>
            <count group_id="B2" value="229"/>
            <count group_id="B3" value="470"/>
          </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="33.2" spread="7.54"/>
                    <measurement group_id="B2" value="32.5" spread="7.39"/>
                    <measurement group_id="B3" value="32.8" spread="7.47"/>
                  </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="114"/>
                    <measurement group_id="B2" value="96"/>
                    <measurement group_id="B3" value="210"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="127"/>
                    <measurement group_id="B2" value="133"/>
                    <measurement group_id="B3" value="260"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine</title>
        <description>Antibody titers were expressed as Geometric Mean Titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
        <time_frame>At Day 0 and Day 7</time_frame>
        <population>Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine</title>
          <description>Antibody titers were expressed as Geometric Mean Titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
          <population>Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.</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="224"/>
                <count group_id="O2" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1, Day 0 [N=221,202]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.1" lower_limit="33.8" upper_limit="54.9"/>
                    <measurement group_id="O2" value="14.5" lower_limit="11.5" upper_limit="18.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 7 [N=224,209]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="445.6" lower_limit="376.9" upper_limit="526.7"/>
                    <measurement group_id="O2" value="45.8" lower_limit="32.0" upper_limit="65.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 0 [N=221,202]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.3" lower_limit="10.7" upper_limit="14.1"/>
                    <measurement group_id="O2" value="16.4" lower_limit="13.2" upper_limit="20.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 7 [N=224,209]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="135.3" lower_limit="113.6" upper_limit="161.2"/>
                    <measurement group_id="O2" value="47.5" lower_limit="32.6" upper_limit="69.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 0 [N=221,202]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.5" lower_limit="23.8" upper_limit="34.1"/>
                    <measurement group_id="O2" value="10.0" lower_limit="8.4" upper_limit="11.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 7 [N=224,209]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="193.9" lower_limit="168.7" upper_limit="222.8"/>
                    <measurement group_id="O2" value="47.1" lower_limit="35.2" upper_limit="63.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 0 [N=221,202]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.9" lower_limit="10.6" upper_limit="13.3"/>
                    <measurement group_id="O2" value="6.5" lower_limit="5.9" upper_limit="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7 [N=224,209]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="182.6" lower_limit="159.0" upper_limit="209.6"/>
                    <measurement group_id="O2" value="26.1" lower_limit="20.9" upper_limit="32.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The adjusted GMT of HI antibodies for A/Christchurch strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Criterion: The lower limit (LL) of the two-sided 95% Confidence Interval (CI) for the GMT ratio is above 1</non_inferiority_desc>
            <param_type>Adjusted GMT ratio</param_type>
            <param_value>8.97</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6.21</ci_lower_limit>
            <ci_upper_limit>12.96</ci_upper_limit>
            <estimate_desc>The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The adjusted GMT of HI antibodies for A/Victoria strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Criterion: The lower limit (LL) of the two-sided 95% Confidence Interval (CI) for the GMT ratio is above 1</non_inferiority_desc>
            <param_type>Adjusted GMT ratio</param_type>
            <param_value>2.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.81</ci_lower_limit>
            <ci_upper_limit>4.02</ci_upper_limit>
            <estimate_desc>The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The adjusted GMT of HI antibodies for B/Brisbane strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Criterion: The lower limit (LL) of the two-sided 95% Confidence Interval (CI) for the GMT ratio is above 1</non_inferiority_desc>
            <param_type>Adjusted GMT ratio</param_type>
            <param_value>3.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.89</ci_lower_limit>
            <ci_upper_limit>5.37</ci_upper_limit>
            <estimate_desc>The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The adjusted GMT of HI antibodies for B/Hub-Wuj strain at post-vaccination dose 1, the GMT ratio of Fluarix Quadrivalent Primed Group/Fluarix Quadrivalent Unprimed Group and the 2-sided 95% CI on each GMT ratio were computed after fitting an ANCOVA model on the logarithm10 transformation of the titers, including the vaccine group as fixed effect and the pre-vaccination log-10 titer and age as regressors.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Criterion: The lower limit (LL) of the two-sided 95% Confidence Interval (CI) for the GMT ratio is above 1</non_inferiority_desc>
            <param_type>Adjusted GMT ratio</param_type>
            <param_value>6.71</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.21</ci_lower_limit>
            <ci_upper_limit>8.63</ci_upper_limit>
            <estimate_desc>The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine</title>
        <description>Seropositivity was defined as number of subjects with antibody titers greater than or equal to (≥) 1:10. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
        <time_frame>At Day 0 and Day 7</time_frame>
        <population>Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine</title>
          <description>Seropositivity was defined as number of subjects with antibody titers greater than or equal to (≥) 1:10. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
          <population>Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures 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="224"/>
                <count group_id="O2" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1, Day 0 [N=221,202]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="189"/>
                    <measurement group_id="O2" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 7 [N=224,209]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="220"/>
                    <measurement group_id="O2" value="137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 0 [N=221,202]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="131"/>
                    <measurement group_id="O2" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 7 [N=224,209]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="218"/>
                    <measurement group_id="O2" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 0 [N=221,202]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="187"/>
                    <measurement group_id="O2" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 7 [N=224,209]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="224"/>
                    <measurement group_id="O2" value="174"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 0 [N=221,202]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="134"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7 [N=224,209]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="222"/>
                    <measurement group_id="O2" value="144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</title>
        <description>A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 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 included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
        <time_frame>At Day 7 post dose 1</time_frame>
        <population>Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</title>
          <description>A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 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 included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
          <population>Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures 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="221"/>
                <count group_id="O2" value="202"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="170"/>
                    <measurement group_id="O2" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="180"/>
                    <measurement group_id="O2" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="169"/>
                    <measurement group_id="O2" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="208"/>
                    <measurement group_id="O2" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>To assess the immune response in terms of SCR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>SCR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.</non_inferiority_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>44.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>35.87</ci_lower_limit>
            <ci_upper_limit>52.84</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>To assess the immune response in terms of SCR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>SCR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.</non_inferiority_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>45.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>36.58</ci_lower_limit>
            <ci_upper_limit>53.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>To assess the immune response in terms of SCR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>SCR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.</non_inferiority_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>37.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>28.83</ci_lower_limit>
            <ci_upper_limit>46.26</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>To assess the immune response in terms of SCR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.&#xD;
B/Hu-Wuj = B/Hubei-Wujiagang/158/2009 (Yamagata)</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>SCR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion</non_inferiority_desc>
            <param_type>Difference in percentages</param_type>
            <param_value>56</param_value>
            <ci_percent>95</ci_percent>
            <ci_lower_limit>48.32</ci_lower_limit>
            <ci_upper_limit>63.04</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</title>
        <description>MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
        <time_frame>At Day 7 post dose 1</time_frame>
        <population>Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</title>
          <description>MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
          <population>Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.</population>
          <units>Fold increase</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="221"/>
                <count group_id="O2" value="202"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.3" lower_limit="8.5" upper_limit="12.4"/>
                    <measurement group_id="O2" value="3.2" lower_limit="2.6" upper_limit="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.9" lower_limit="9.4" upper_limit="12.6"/>
                    <measurement group_id="O2" value="2.9" lower_limit="2.4" upper_limit="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" lower_limit="5.9" upper_limit="7.6"/>
                    <measurement group_id="O2" value="4.6" lower_limit="3.8" upper_limit="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.2" lower_limit="13.3" upper_limit="17.3"/>
                    <measurement group_id="O2" value="4.0" lower_limit="3.3" upper_limit="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</title>
        <description>Seroprotection rate (SPR) was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer ≥ 1:40 that usually is accepted as indicating protection in adults. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
        <time_frame>At Day 0 and Day 7</time_frame>
        <population>Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</title>
          <description>Seroprotection rate (SPR) was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer ≥ 1:40 that usually is accepted as indicating protection in adults. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
          <population>Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures 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="224"/>
                <count group_id="O2" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1, Day 0 [N=221,202]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                    <measurement group_id="O2" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 7 [N=224,209]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="217"/>
                    <measurement group_id="O2" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 0 [N=221,202]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 7 [N=224,209]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="193"/>
                    <measurement group_id="O2" value="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 0 [N=221,202]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 7 [N=224,209]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="217"/>
                    <measurement group_id="O2" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 0 [N=221,202]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7 [N=224,209]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="216"/>
                    <measurement group_id="O2" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>To assess the immune response in terms of SPR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>SPR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.</non_inferiority_desc>
            <param_type>Difference in SPR</param_type>
            <param_value>62.43</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>55.27</ci_lower_limit>
            <ci_upper_limit>68.89</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>To assess the immune response in terms of SPR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>SPR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.</non_inferiority_desc>
            <param_type>Difference in SPR</param_type>
            <param_value>47.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>39.08</ci_lower_limit>
            <ci_upper_limit>55.06</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>To assess the immune response in terms of SPR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>SPR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion</non_inferiority_desc>
            <param_type>Difference in SPR</param_type>
            <param_value>56.68</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>49.44</ci_lower_limit>
            <ci_upper_limit>63.43</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>To assess the immune response in terms of SPR difference at Day 7 after one dose of Fluarix Quadrivalent vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all the strains.&#xD;
B/Hu-Wuj = B/Hubei-Wujiagang/158/2009 (Yamagata)</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>SPR difference was calculated using standardized asymptotic 95% CI for the group difference in proportion.</non_inferiority_desc>
            <param_type>Difference in SPR</param_type>
            <param_value>56.72</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>49.41</ci_lower_limit>
            <ci_upper_limit>63.49</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</title>
        <description>Antibody titers were expressed as Geometric Mean Titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
        <time_frame>At Day 0 and Day 7</time_frame>
        <population>Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NC T01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</title>
          <description>Antibody titers were expressed as Geometric Mean Titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
          <population>Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.</population>
          <units>Titers</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="213"/>
                <count group_id="O2" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1, Day 0 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.0" lower_limit="34.2" upper_limit="56.7"/>
                    <measurement group_id="O2" value="14.3" lower_limit="11.2" upper_limit="18.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 7 [N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="442.3" lower_limit="372.0" upper_limit="525.9"/>
                    <measurement group_id="O2" value="42.7" lower_limit="29.0" upper_limit="63.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 0 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.0" lower_limit="9.8" upper_limit="12.5"/>
                    <measurement group_id="O2" value="11.9" lower_limit="9.6" upper_limit="14.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 7 [N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="125.9" lower_limit="105.4" upper_limit="150.4"/>
                    <measurement group_id="O2" value="28.7" lower_limit="19.7" upper_limit="41.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 0 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.8" lower_limit="23.2" upper_limit="33.2"/>
                    <measurement group_id="O2" value="10.3" lower_limit="8.5" upper_limit="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 7 [N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="193.3" lower_limit="167.6" upper_limit="222.8"/>
                    <measurement group_id="O2" value="46.1" lower_limit="33.5" upper_limit="63.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 0 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.9" lower_limit="10.6" upper_limit="13.4"/>
                    <measurement group_id="O2" value="6.5" lower_limit="5.8" upper_limit="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7 [N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="184.1" lower_limit="159.8" upper_limit="212.1"/>
                    <measurement group_id="O2" value="25.2" lower_limit="19.8" upper_limit="32.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine</title>
        <description>Seropositivity was defined as number of subjects with antibody titers greater than or equal to (≥) 1:10. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
        <time_frame>At Day 0 and Day 7</time_frame>
        <population>Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine</title>
          <description>Seropositivity was defined as number of subjects with antibody titers greater than or equal to (≥) 1:10. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
          <population>Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="213"/>
                <count group_id="O2" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1, Day 0 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="178"/>
                    <measurement group_id="O2" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 7 [N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="209"/>
                    <measurement group_id="O2" value="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 0 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="120"/>
                    <measurement group_id="O2" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 7 [N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="207"/>
                    <measurement group_id="O2" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 0[ N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="177"/>
                    <measurement group_id="O2" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 7[ N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="213"/>
                    <measurement group_id="O2" value="145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 0[ N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="127"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7 [N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="211"/>
                    <measurement group_id="O2" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</title>
        <description>A seroconverted subject was defined as a subject who had either a pre-vaccination titer &lt;1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria)and B/Hubei-Wujiagang/158/2009 (Yamagata )antigens.</description>
        <time_frame>At Day 7 post dose 1</time_frame>
        <population>Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</title>
          <description>A seroconverted subject was defined as a subject who had either a pre-vaccination titer &lt;1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria)and B/Hubei-Wujiagang/158/2009 (Yamagata )antigens.</description>
          <population>Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="210"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1, Day 7 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="160"/>
                    <measurement group_id="O2" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 7 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="173"/>
                    <measurement group_id="O2" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 7 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="162"/>
                    <measurement group_id="O2" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="197"/>
                    <measurement group_id="O2" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Geometric Increase (MGI) for HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</title>
        <description>Mean geometric increase was defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
        <time_frame>At Day 7 post dose 1</time_frame>
        <population>Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Geometric Increase (MGI) for HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</title>
          <description>Mean geometric increase was defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
          <population>Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.</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="210"/>
                <count group_id="O2" value="173"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1, Day 7 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" lower_limit="8.1" upper_limit="12.2"/>
                    <measurement group_id="O2" value="3.1" lower_limit="2.5" upper_limit="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 7 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.2" lower_limit="9.7" upper_limit="13.1"/>
                    <measurement group_id="O2" value="2.4" lower_limit="2.0" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 7 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9" lower_limit="6.0" upper_limit="7.8"/>
                    <measurement group_id="O2" value="4.5" lower_limit="3.7" upper_limit="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.2" lower_limit="13.3" upper_limit="17.4"/>
                    <measurement group_id="O2" value="4.0" lower_limit="3.2" upper_limit="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</title>
        <description>Seroprotection rate was defined as the number of vaccinees with a serum HI titer greater than or equal to(≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008 (Victoria)and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
        <time_frame>At Day 0 and Day 7</time_frame>
        <population>Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</title>
          <description>Seroprotection rate was defined as the number of vaccinees with a serum HI titer greater than or equal to(≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008 (Victoria)and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
          <population>Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="213"/>
                <count group_id="O2" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1,Day 0 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87"/>
                    <measurement group_id="O2" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 7 [N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="206"/>
                    <measurement group_id="O2" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 0 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 7 [N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="182"/>
                    <measurement group_id="O2" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 0 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 7 [N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="206"/>
                    <measurement group_id="O2" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 0 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7 [N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="205"/>
                    <measurement group_id="O2" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</title>
        <description>The cut-off values assessed were less than (&lt;) 1:10, 1:10 to &lt; 1:40 and ≥ 1:40. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
        <time_frame>At Day 0 and Day 7</time_frame>
        <population>Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</title>
          <description>The cut-off values assessed were less than (&lt;) 1:10, 1:10 to &lt; 1:40 and ≥ 1:40. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
          <population>Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures 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="224"/>
                <count group_id="O2" value="209"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1 (&lt;1:10), Day 0 [N=221,202]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1 (&lt;1:10), Day 7 [N=224,209]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2 (&lt;1:10), Day 0 [N=221,202]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90"/>
                    <measurement group_id="O2" value="123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2 (&lt;1:10), Day 7 [N=224,209]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="110"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria (&lt;1:10), Day 0 [N=221,202]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria (&lt;1:10), Day 7 [N=224,209]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata (&lt;1:10), Day 0 [N=221,202]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87"/>
                    <measurement group_id="O2" value="166"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata (&lt;1:10), Day 7 [N=224,209]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1 (1:10 to &lt;1:40), Day 0 [N=221,202]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1 (1:10 to &lt;1:40), Day 7 [N=224,209]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2 (1:10 to &lt;1:40), Day 0 [N=221,202]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2 (1:10 to &lt;1:40), Day 7 [N=224,209]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria (1:10 to &lt;1:40), Day 0 [N=221,202]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="115"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria (1:10 to &lt;1:40), Day 7 [N=224,209]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata (1:10 to &lt;1:40), Day 0 [N=221,202]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="107"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata (1:10 to &lt;1:40), Day 7 [N=224,209]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1 (≥1: 40), Day 0 [N=221,202]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                    <measurement group_id="O2" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1 (≥1: 40), Day 7 [N=224,209]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="217"/>
                    <measurement group_id="O2" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2 (≥1: 40), Day 0 [N=221,202]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2 (≥1: 40), Day 7 [N=224,209]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="193"/>
                    <measurement group_id="O2" value="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria (≥1: 40), Day 0 [N=221,202]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria (≥1: 40), Day 7 [N=224,209]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="217"/>
                    <measurement group_id="O2" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata (≥1: 40), Day 0 [N=221,202]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata (≥1: 40), Day 7 [N=224,209]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="216"/>
                    <measurement group_id="O2" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine</title>
        <description>Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
        <time_frame>At Day 0 and Day 7</time_frame>
        <population>Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine</title>
          <description>Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
          <population>Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.</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="107"/>
                <count group_id="O2" value="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1, Day 0 [N=97,90]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="138.2" lower_limit="97.4" upper_limit="196.2"/>
                    <measurement group_id="O2" value="48.3" lower_limit="33.9" upper_limit="68.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 7 [N=107, 96]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1500.9" lower_limit="1172.7" upper_limit="1920.9"/>
                    <measurement group_id="O2" value="139.4" lower_limit="78.8" upper_limit="246.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 0 [N=99,96]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.5" lower_limit="55.9" upper_limit="79.2"/>
                    <measurement group_id="O2" value="82.8" lower_limit="60.6" upper_limit="113.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 7 [N=104,100]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="422.9" lower_limit="342.3" upper_limit="522.4"/>
                    <measurement group_id="O2" value="325.1" lower_limit="187.1" upper_limit="564.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 0 [N=107,109]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.6" lower_limit="29.7" upper_limit="50.3"/>
                    <measurement group_id="O2" value="22.2" lower_limit="18.6" upper_limit="26.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 7 [N=107, 108]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="193.7" lower_limit="154.7" upper_limit="242.6"/>
                    <measurement group_id="O2" value="47.0" lower_limit="30.3" upper_limit="72.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 0 [N=107,107]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.9" lower_limit="34.2" upper_limit="39.8"/>
                    <measurement group_id="O2" value="30.8" lower_limit="29.0" upper_limit="32.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7 [N=107,107]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="182.7" lower_limit="157.7" upper_limit="211.8"/>
                    <measurement group_id="O2" value="51.7" lower_limit="42.2" upper_limit="63.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine</title>
        <description>Antibody titers were expressed as GMTs. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
        <time_frame>At Day 0 and Day 7</time_frame>
        <population>Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine</title>
          <description>Antibody titers were expressed as GMTs. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
          <population>Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.</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="107"/>
                <count group_id="O2" value="109"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1, Day 0 [N=106,106]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.6" lower_limit="25.3" upper_limit="47.3"/>
                    <measurement group_id="O2" value="24.1" lower_limit="18.6" upper_limit="31.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 7 [N=106, 109]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="293.9" lower_limit="247.2" upper_limit="349.3"/>
                    <measurement group_id="O2" value="41.3" lower_limit="28.9" upper_limit="59.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 0 [N=107,106]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.4" lower_limit="33.7" upper_limit="43.7"/>
                    <measurement group_id="O2" value="58.8" lower_limit="47.2" upper_limit="73.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 7 [N=107, 109]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="189.4" lower_limit="155.9" upper_limit="230.2"/>
                    <measurement group_id="O2" value="114.2" lower_limit="84.1" upper_limit="155.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 0 [N=106,106]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.4" lower_limit="14.2" upper_limit="21.3"/>
                    <measurement group_id="O2" value="14.3" lower_limit="12.4" upper_limit="16.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 7 [N=106,109]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.6" lower_limit="74.1" upper_limit="110.8"/>
                    <measurement group_id="O2" value="27.6" lower_limit="19.4" upper_limit="39.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 0 [N=106, 106]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.3" lower_limit="21.6" upper_limit="29.6"/>
                    <measurement group_id="O2" value="15.4" lower_limit="13.2" upper_limit="18.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7 [N=106,109]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="222.0" lower_limit="185.7" upper_limit="265.4"/>
                    <measurement group_id="O2" value="40.6" lower_limit="29.5" upper_limit="55.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Vaccine Response Rate (VRR) for Neutralising Antibody Titers Against Each of the Four Vaccine Strains.</title>
        <description>VRR was defined as the number of vaccinees who had either a pre-vaccination titer &lt;cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
        <time_frame>At Day 7 post dose 1</time_frame>
        <population>Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Vaccine Response Rate (VRR) for Neutralising Antibody Titers Against Each of the Four Vaccine Strains.</title>
          <description>VRR was defined as the number of vaccinees who had either a pre-vaccination titer &lt;cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
          <population>Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures 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="107"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1 [N=97,89]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2 [N=97,94]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                    <measurement group_id="O2" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria [N=107,108]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata [N=107,105]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</title>
        <description>MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
        <time_frame>At Day 7 post dose 1</time_frame>
        <population>Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</title>
          <description>MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
          <population>Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.</population>
          <units>Fold increase</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="108"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1 [N=97, 89]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.6" lower_limit="8.2" upper_limit="13.7"/>
                    <measurement group_id="O2" value="3.1" lower_limit="2.3" upper_limit="4.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2 [N=97, 94]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4" lower_limit="5.4" upper_limit="7.6"/>
                    <measurement group_id="O2" value="4.5" lower_limit="3.2" upper_limit="6.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria [N=107,108]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="4.3" upper_limit="5.8"/>
                    <measurement group_id="O2" value="2.1" lower_limit="1.6" upper_limit="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata [N=107,105]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="4.3" upper_limit="5.7"/>
                    <measurement group_id="O2" value="1.7" lower_limit="1.4" upper_limit="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains.</title>
        <description>VRR was defined as the number of vaccinees who had either a pre-vaccination titer &lt;cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
        <time_frame>At Day 7 post dose 1</time_frame>
        <population>Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains.</title>
          <description>VRR was defined as the number of vaccinees who had either a pre-vaccination titer &lt;cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
          <population>Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures 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="107"/>
                <count group_id="O2" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1 [N=105,106]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2 [N=107,106]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria [N=105,106]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata [N=105,106]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</title>
        <description>MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
        <time_frame>At Day 7 post dose 1</time_frame>
        <population>Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</title>
          <description>MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
          <population>Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available.</population>
          <units>Fold increase</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="106"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1 [N=105,106]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" lower_limit="6.5" upper_limit="10.7"/>
                    <measurement group_id="O2" value="1.8" lower_limit="1.5" upper_limit="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2 [N=105,106]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" lower_limit="4.4" upper_limit="6.0"/>
                    <measurement group_id="O2" value="1.9" lower_limit="1.5" upper_limit="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria [N=105,106]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.8" lower_limit="7.5" upper_limit="10.2"/>
                    <measurement group_id="O2" value="2.7" lower_limit="2.1" upper_limit="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata [N=107,106]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" lower_limit="4.2" upper_limit="5.8"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.7" upper_limit="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</title>
        <description>The cut-off values assessed were less than (&lt;) 1:10, 1:10 to &lt; 1:40,≥ 1:40, ≥1:60 and ≥1:80 . The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
        <time_frame>At Day 0 and Day 7</time_frame>
        <population>Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</title>
          <description>The cut-off values assessed were less than (&lt;) 1:10, 1:10 to &lt; 1:40,≥ 1:40, ≥1:60 and ≥1:80 . The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
          <population>Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="213"/>
                <count group_id="O2" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1, Day 0, &lt;1:10 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="119"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 7, &lt;1:10 [N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 0, 1:10 to &lt;1:40 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="178"/>
                    <measurement group_id="O2" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 7, 1:10 to &lt;1:40 [N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="209"/>
                    <measurement group_id="O2" value="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 0, ≥1:40 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87"/>
                    <measurement group_id="O2" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 7, ≥1:40 [N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="206"/>
                    <measurement group_id="O2" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 0, ≥1:60 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73"/>
                    <measurement group_id="O2" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 7, ≥1:60 [N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="204"/>
                    <measurement group_id="O2" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 0, ≥1:80 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73"/>
                    <measurement group_id="O2" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 7, ≥1:80 [N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="204"/>
                    <measurement group_id="O2" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 0, &lt;1:10 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90"/>
                    <measurement group_id="O2" value="121"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 7, &lt;1:10 [N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 0,1:10 to 1:40 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="120"/>
                    <measurement group_id="O2" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 7,1:10 to 1:40 [N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="207"/>
                    <measurement group_id="O2" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 0, ≥1:40 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 7, ≥1:40 [N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="182"/>
                    <measurement group_id="O2" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 0, ≥1:60 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 7, ≥1:60 [N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="147"/>
                    <measurement group_id="O2" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 0, ≥1:80 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 7, ≥1:80 [N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="147"/>
                    <measurement group_id="O2" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 0, &lt;1:10 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 7, &lt;1:10 [N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 0,1:10 to 1:40 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="177"/>
                    <measurement group_id="O2" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 7,1:10 to 1:40 [N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="213"/>
                    <measurement group_id="O2" value="145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 0, ≥1:40 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 7, ≥1:40 [N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="206"/>
                    <measurement group_id="O2" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 0, ≥1:60 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 7, ≥1:60 [N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="182"/>
                    <measurement group_id="O2" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 0, ≥1:80 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 7, ≥1:80 [N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="182"/>
                    <measurement group_id="O2" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 0, &lt;1:10 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83"/>
                    <measurement group_id="O2" value="142"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7, &lt;1:10 [N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 0,1:10 to 1:40 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="127"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7,1:10 to 1:40 [N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="211"/>
                    <measurement group_id="O2" value="120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 0, ≥1:40 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7, ≥1:40 [N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="205"/>
                    <measurement group_id="O2" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 0, ≥1:60 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7, ≥1:60 [N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="177"/>
                    <measurement group_id="O2" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 0, ≥1:80 [N=210,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7, ≥1:80 [N=213,179]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="177"/>
                    <measurement group_id="O2" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</title>
        <description>MN antibody titers were expressed as geometric mean titers(GMTs). The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
        <time_frame>At Day 0 and Day 7</time_frame>
        <population>Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</title>
          <description>MN antibody titers were expressed as geometric mean titers(GMTs). The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
          <population>Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.</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="100"/>
                <count group_id="O2" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1,Day 0[N=90,72]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="141.4" lower_limit="97.6" upper_limit="205.0"/>
                    <measurement group_id="O2" value="47.3" lower_limit="32.1" upper_limit="69.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1,Day 7[N=100,76]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1461.3" lower_limit="1132.8" upper_limit="1885.1"/>
                    <measurement group_id="O2" value="138.4" lower_limit="71.9" upper_limit="266.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2,Day 0[N=92,76]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.0" lower_limit="51.2" upper_limit="70.4"/>
                    <measurement group_id="O2" value="59.6" lower_limit="42.5" upper_limit="83.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2,Day 7[N=97,80]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="374.6" lower_limit="305.4" upper_limit="459.4"/>
                    <measurement group_id="O2" value="177.7" lower_limit="97.4" upper_limit="324.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria,Day 0[N=100,89]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.1" lower_limit="28.6" upper_limit="48.2"/>
                    <measurement group_id="O2" value="23.5" lower_limit="19.1" upper_limit="28.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria,Day 7[N=100,88]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="189.9" lower_limit="151.2" upper_limit="238.5"/>
                    <measurement group_id="O2" value="52.0" lower_limit="31.3" upper_limit="86.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata,day 0[N=100,87]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.1" lower_limit="34.2" upper_limit="40.2"/>
                    <measurement group_id="O2" value="30.9" lower_limit="28.9" upper_limit="32.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7[N=100,88]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="177.5" lower_limit="154.2" upper_limit="204.5"/>
                    <measurement group_id="O2" value="49.8" lower_limit="40.5" upper_limit="61.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine</title>
        <description>NI (Neuraminidase inhibitor) antibody titers were expressed as geometric mean titers(GMTs).The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
        <time_frame>At Day 0 and Day 7</time_frame>
        <population>Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine</title>
          <description>NI (Neuraminidase inhibitor) antibody titers were expressed as geometric mean titers(GMTs).The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
          <population>Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.</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="100"/>
                <count group_id="O2" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1, Day 0[N=99,86]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.8" lower_limit="25.1" upper_limit="48.1"/>
                    <measurement group_id="O2" value="23.5" lower_limit="17.8" upper_limit="31.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 7[N=99,89]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="287.1" lower_limit="239.8" upper_limit="343.6"/>
                    <measurement group_id="O2" value="38.3" lower_limit="25.7" upper_limit="57.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 0[N=100,86]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.0" lower_limit="31.3" upper_limit="39.1"/>
                    <measurement group_id="O2" value="45.9" lower_limit="36.7" upper_limit="57.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 7[N=100,89]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="175.8" lower_limit="143.9" upper_limit="214.7"/>
                    <measurement group_id="O2" value="84.5" lower_limit="60.7" upper_limit="117.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 0[N=99,86]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.8" lower_limit="13.7" upper_limit="20.7"/>
                    <measurement group_id="O2" value="15.0" lower_limit="12.7" upper_limit="17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 7[N=99,89]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.2" lower_limit="72.5" upper_limit="109.7"/>
                    <measurement group_id="O2" value="29.1" lower_limit="19.6" upper_limit="43.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 0[N=99,86]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.1" lower_limit="21.3" upper_limit="29.5"/>
                    <measurement group_id="O2" value="15.4" lower_limit="12.9" upper_limit="18.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7[N=100,89]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="216.5" lower_limit="180.5" upper_limit="259.6"/>
                    <measurement group_id="O2" value="39.7" lower_limit="27.9" upper_limit="56.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains</title>
        <description>VRR was defined as the number of vaccinees who had either a pre-vaccination titer &lt;cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
        <time_frame>At Day 7 post dose 1</time_frame>
        <population>Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains</title>
          <description>VRR was defined as the number of vaccinees who had either a pre-vaccination titer &lt;cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
          <population>Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1, Day 7[N=90,71]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 7[N=90,74]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 7[N=100,88]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7[N=100,86]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</title>
        <description>MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
        <time_frame>At Day 7 post dose 1</time_frame>
        <population>Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.</title>
          <description>MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
          <population>Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.</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="100"/>
                <count group_id="O2" value="88"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1, Day 7[N=90,71]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" lower_limit="7.7" upper_limit="13.1"/>
                    <measurement group_id="O2" value="3.1" lower_limit="2.2" upper_limit="4.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 7[N=90,74]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2" lower_limit="5.2" upper_limit="7.5"/>
                    <measurement group_id="O2" value="3.4" lower_limit="2.4" upper_limit="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 7[N=100,88]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1" lower_limit="4.4" upper_limit="5.9"/>
                    <measurement group_id="O2" value="2.2" lower_limit="1.6" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7[N=100,86]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.8" lower_limit="4.2" upper_limit="5.4"/>
                    <measurement group_id="O2" value="1.6" lower_limit="1.3" upper_limit="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Vaccine Response Rate(VRR) for Anti-neuraminidase Antibodies Against Each of the Four Vaccine Strains.</title>
        <description>VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer &lt;cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
        <time_frame>At Day 7 post dose 1</time_frame>
        <population>Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Vaccine Response Rate(VRR) for Anti-neuraminidase Antibodies Against Each of the Four Vaccine Strains.</title>
          <description>VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer &lt;cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
          <population>Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1, Day 7[N=98,86]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 7[N=100,86]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 7[N=98,86]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7[N=99,86]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine</title>
        <description>MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
        <time_frame>At Day 7 post dose 1</time_frame>
        <population>Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine</title>
          <description>MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.</description>
          <population>Analyses was performed on According-to-Protocol cohort for immunogenicity (ATP-I) excluding subjects who had an RT-PCR confirmed influenza infection in study 115345 consisted of all evaluable subjects from the ATP-I, excluding subjects who had an RT-PCR confirmed influenza infection in study 115345.</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="100"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1, Day 7[N=98,86]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.1" lower_limit="6.2" upper_limit="10.5"/>
                    <measurement group_id="O2" value="1.7" lower_limit="1.4" upper_limit="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 7[N=100,86]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" lower_limit="4.2" upper_limit="6.0"/>
                    <measurement group_id="O2" value="1.8" lower_limit="1.6" upper_limit="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 7[N=98,86]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" lower_limit="4.5" upper_limit="6.1"/>
                    <measurement group_id="O2" value="1.9" lower_limit="1.5" upper_limit="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7[N=99,86]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7" lower_limit="7.4" upper_limit="10.2"/>
                    <measurement group_id="O2" value="2.6" lower_limit="2.0" upper_limit="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.</title>
        <description>Antibody titers were expressed as geometric mean titers. The vaccine strains included A/Christchurch/16/2010 (H1N1),A/Victoria/361/2011 (H3N2), A/Victoria/361/2011 and B/Hubei-Wujiagang/158/2009)(Yamagata) antigens. The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.</description>
        <time_frame>At Day 0 and Day 7</time_frame>
        <population>Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.</title>
          <description>Antibody titers were expressed as geometric mean titers. The vaccine strains included A/Christchurch/16/2010 (H1N1),A/Victoria/361/2011 (H3N2), A/Victoria/361/2011 and B/Hubei-Wujiagang/158/2009)(Yamagata) antigens. The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.</description>
          <population>Analysis was performed on According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects who received study vaccine according to their treatment assignment, for whom assay results for antibodies against at least 1 study vaccine strain after vaccination and data concerning immunogenicity outcome measures were available</population>
          <units>Titers</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1, Day 0,17-29M[N=47,44]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.8" lower_limit="48.8" upper_limit="120.9"/>
                    <measurement group_id="O2" value="29.0" lower_limit="18.7" upper_limit="44.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 7,17-29M [N=53,48]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1112.0" lower_limit="746.0" upper_limit="1657.8"/>
                    <measurement group_id="O2" value="53.0" lower_limit="26.9" upper_limit="104.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 0,30-48M[N=50,46]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="240.0" lower_limit="146.2" upper_limit="394.1"/>
                    <measurement group_id="O2" value="78.8" lower_limit="46.6" upper_limit="133.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 7,30-48M[N=54,48]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2014.5" lower_limit="1517.5" upper_limit="2674.4"/>
                    <measurement group_id="O2" value="366.9" lower_limit="155.6" upper_limit="865.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2,Day 0,17-29M[N=49,47]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.1" lower_limit="46.3" upper_limit="72.9"/>
                    <measurement group_id="O2" value="74.5" lower_limit="45.8" upper_limit="121.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2,Day 7,17-29M[N=51,50]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="370.5" lower_limit="272.7" upper_limit="503.2"/>
                    <measurement group_id="O2" value="217.5" lower_limit="97.0" upper_limit="488.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2,Day 0,30-48M[N=50,49]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.0" lower_limit="58.2" upper_limit="99.1"/>
                    <measurement group_id="O2" value="91.5" lower_limit="60.8" upper_limit="137.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2,Day 7,30-48M[N=53,50]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="480.3" lower_limit="356.7" upper_limit="646.8"/>
                    <measurement group_id="O2" value="485.8" lower_limit="226.2" upper_limit="1043.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria,Day 0,17-29M[N=53,54]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.2" lower_limit="21.7" upper_limit="39.2"/>
                    <measurement group_id="O2" value="19.8" lower_limit="15.9" upper_limit="24.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria,Day 7,17-29M[N=53,53]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="156.3" lower_limit="119.7" upper_limit="204.2"/>
                    <measurement group_id="O2" value="35.5" lower_limit="20.0" upper_limit="62.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria,Day 0,30-48M[N=54,55]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.9" lower_limit="33.1" upper_limit="78.2"/>
                    <measurement group_id="O2" value="24.7" lower_limit="18.8" upper_limit="32.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria,Day 7,30-48M[N=54,55]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="239.1" lower_limit="166.7" upper_limit="343.0"/>
                    <measurement group_id="O2" value="61.8" lower_limit="31.6" upper_limit="120.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 0,17-29M[N=53,53]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.6" lower_limit="32.3" upper_limit="39.2"/>
                    <measurement group_id="O2" value="29.6" lower_limit="28.0" upper_limit="31.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7,17-29M[N=53,52]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="156.9" lower_limit="129.4" upper_limit="190.3"/>
                    <measurement group_id="O2" value="45.6" lower_limit="33.7" upper_limit="61.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 0,30-48M[N=54,54]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.3" lower_limit="34.0" upper_limit="43.1"/>
                    <measurement group_id="O2" value="32.0" lower_limit="28.9" upper_limit="35.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7,30-48M[N=54,55]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="212.2" lower_limit="170.1" upper_limit="264.7"/>
                    <measurement group_id="O2" value="58.3" lower_limit="44.1" upper_limit="77.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata</title>
        <description>Antibody titers were expressed as geometric mean titers. The vaccine strains included A/Christchurch/16/2010(H1N1), A/Victoria/361/2011(H3N2),B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009(Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.</description>
        <time_frame>At Day 0 and Day 7</time_frame>
        <population>Analyses were performed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata</title>
          <description>Antibody titers were expressed as geometric mean titers. The vaccine strains included A/Christchurch/16/2010(H1N1), A/Victoria/361/2011(H3N2),B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009(Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.</description>
          <population>Analyses were performed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures were available.</population>
          <units>Titers</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1, Day 0,17-29M[N=53,52]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.6" lower_limit="15.0" upper_limit="31.3"/>
                    <measurement group_id="O2" value="15.8" lower_limit="11.9" upper_limit="21.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 7,17-29M[N=53,54]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="246.3" lower_limit="189.1" upper_limit="320.8"/>
                    <measurement group_id="O2" value="22.9" lower_limit="14.9" upper_limit="35.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 0,30-48M[N=53,54]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.5" lower_limit="34.2" upper_limit="89.9"/>
                    <measurement group_id="O2" value="36.1" lower_limit="24.2" upper_limit="53.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 7,30-48M[N=53,55]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="350.7" lower_limit="281.1" upper_limit="437.4"/>
                    <measurement group_id="O2" value="73.7" lower_limit="42.9" upper_limit="126.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 0,17-29M[N=53,52]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.7" lower_limit="29.2" upper_limit="41.2"/>
                    <measurement group_id="O2" value="49.8" lower_limit="35.9" upper_limit="69.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 7,17-29M[N=53,54]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="158.0" lower_limit="117.8" upper_limit="211.8"/>
                    <measurement group_id="O2" value="85.3" lower_limit="55.4" upper_limit="131.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 0,30-48M[N=54,54]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.4" lower_limit="34.9" upper_limit="51.6"/>
                    <measurement group_id="O2" value="69.0" lower_limit="51.1" upper_limit="93.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 7,30-48M[N=54,55]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="226.4" lower_limit="174.9" upper_limit="292.9"/>
                    <measurement group_id="O2" value="152.2" lower_limit="98.5" upper_limit="235.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 0,17-29M[N=53,52]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.2" lower_limit="11.0" upper_limit="16.0"/>
                    <measurement group_id="O2" value="13.1" lower_limit="10.9" upper_limit="15.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 7,17-29M[N=53,54]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.8" lower_limit="53.3" upper_limit="88.9"/>
                    <measurement group_id="O2" value="21.1" lower_limit="13.4" upper_limit="33.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 0,30-48M[N=53,54]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.8" lower_limit="16.0" upper_limit="32.4"/>
                    <measurement group_id="O2" value="15.7" lower_limit="12.6" upper_limit="19.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 7,30-48M[N=53,55]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="119.2" lower_limit="88.2" upper_limit="161.1"/>
                    <measurement group_id="O2" value="35.9" lower_limit="21.0" upper_limit="61.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 0,17-29M[N=53,52]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.5" lower_limit="16.9" upper_limit="24.9"/>
                    <measurement group_id="O2" value="13.2" lower_limit="11.1" upper_limit="15.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7,17-29M[N=53,54]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="181.4" lower_limit="143.3" upper_limit="229.5"/>
                    <measurement group_id="O2" value="29.3" lower_limit="19.5" upper_limit="44.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 0,30-48M[N=53,54]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.1" lower_limit="24.4" upper_limit="39.7"/>
                    <measurement group_id="O2" value="17.9" lower_limit="13.8" upper_limit="23.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7,30-48M[N=53,55]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="271.8" lower_limit="208.6" upper_limit="354.3"/>
                    <measurement group_id="O2" value="55.8" lower_limit="34.4" upper_limit="90.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata</title>
        <description>VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer &lt;cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008(Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.</description>
        <time_frame>At Day 7 post dose 1</time_frame>
        <population>Analyses were perfomed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures were available</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata</title>
          <description>VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer &lt;cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008(Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.</description>
          <population>Analyses were perfomed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures 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="54"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1, Day 7, 17-29M[47,44]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 7, 30-48M[50,45]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 7,17-29M[N=48,46]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 7,30-48M[N=49,48]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 7,17-29M[N=53,53]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 7,30-48M[N=54,55]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7,17-29M[N=53,51]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7,30-48M[N=54,54]</title>
              <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>MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata</title>
        <description>MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0.The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.</description>
        <time_frame>At Day 7 post dose 1</time_frame>
        <population>Analyses were performed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata</title>
          <description>MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0.The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.</description>
          <population>Analyses were performed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures were available.</population>
          <units>Fold Increase</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1, Day 7, 17-29M[N=47,44]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.1" lower_limit="9.2" upper_limit="18.8"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.4" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 7, 30-48M[N=50,45]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7" lower_limit="6.0" upper_limit="12.5"/>
                    <measurement group_id="O2" value="4.7" lower_limit="3.0" upper_limit="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 7,17-29M[N=48,46]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.1" lower_limit="4.8" upper_limit="7.7"/>
                    <measurement group_id="O2" value="3.4" lower_limit="2.1" upper_limit="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 7,30-48M[N=49,48]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" lower_limit="5.1" upper_limit="8.8"/>
                    <measurement group_id="O2" value="5.9" lower_limit="3.8" upper_limit="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 7,17-29M[N=53,53]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.4" lower_limit="4.4" upper_limit="6.5"/>
                    <measurement group_id="O2" value="1.8" lower_limit="1.2" upper_limit="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 7,30-48M[N=54,55]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7" lower_limit="3.8" upper_limit="5.8"/>
                    <measurement group_id="O2" value="2.5" lower_limit="1.6" upper_limit="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7,17-29M[N=53,51]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4" lower_limit="3.8" upper_limit="5.2"/>
                    <measurement group_id="O2" value="1.5" lower_limit="1.2" upper_limit="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7,30-48M[N=54,54]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" lower_limit="4.5" upper_limit="6.9"/>
                    <measurement group_id="O2" value="1.8" lower_limit="1.4" upper_limit="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.</title>
        <description>VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer &lt;cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria /361/2011(H3N2), B/Brisbane /60/2008(Victoria ) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.</description>
        <time_frame>At Day 7 post dose 1</time_frame>
        <population>Analyses were performed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.</title>
          <description>VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer &lt;cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria /361/2011(H3N2), B/Brisbane /60/2008(Victoria ) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.</description>
          <population>Analyses were performed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures 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="54"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1, Day 7,17-29M[N=53,52]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 7,30-48M[N=52,54]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 7,17-29M[N=53,52]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 7,30-48M[N=54,54]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 7,17-29M[N=53,52]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 7,30-48M[N=52,54]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7, 17-29M[N=53,52]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7, 30-48M[N=52,54]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.</title>
        <description>MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.</description>
        <time_frame>At Day 7 post dose 1</time_frame>
        <population>Analyses were performed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures were available</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.</title>
          <description>MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.</description>
          <population>Analyses were performed on the ATP cohort for immunogenicity which included all evaluable subjects who received the study vaccine according to their treatment assignment, for whom the assay results for antibodies against at least one study vaccine strain after vaccination and for whom data concerning immunogenicity outcome measures were available</population>
          <units>Fold Increase</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="54"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1, Day 7,17-29M[53,52]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.4" lower_limit="8.2" upper_limit="15.8"/>
                    <measurement group_id="O2" value="1.5" lower_limit="1.2" upper_limit="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 7,30-48M[N=52,54]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" lower_limit="4.1" upper_limit="8.8"/>
                    <measurement group_id="O2" value="2.1" lower_limit="1.7" upper_limit="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 7,17-29M[N=53,52]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" lower_limit="3.6" upper_limit="5.8"/>
                    <measurement group_id="O2" value="1.7" lower_limit="1.4" upper_limit="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 7,30-48M[N=54,54]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.3" lower_limit="4.2" upper_limit="6.8"/>
                    <measurement group_id="O2" value="2.3" lower_limit="1.9" upper_limit="2.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 7,17-29M[N=53,52]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" lower_limit="4.3" upper_limit="6.3"/>
                    <measurement group_id="O2" value="1.5" lower_limit="1.1" upper_limit="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 7,30-48M[N=52,54]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1" lower_limit="4.1" upper_limit="6.5"/>
                    <measurement group_id="O2" value="2.3" lower_limit="1.6" upper_limit="3.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7, 17-29M[N=53,52]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.8" lower_limit="7.2" upper_limit="10.8"/>
                    <measurement group_id="O2" value="2.2" lower_limit="1.5" upper_limit="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 7, 30-48M[N=52,54]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7" lower_limit="6.9" upper_limit="11.0"/>
                    <measurement group_id="O2" value="3.2" lower_limit="2.3" upper_limit="4.5"/>
                  </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 Adverse Events (AEs)</title>
        <description>Solicited local AEs assessed were pain, redness and swelling. Any = any solicited local AE reported irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).</description>
        <time_frame>During a 7-day (Day 0 to 6) follow-up period after first vaccination</time_frame>
        <population>Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheet completed.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)</title>
          <description>Solicited local AEs assessed were pain, redness and swelling. Any = any solicited local AE reported irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).</description>
          <population>Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheet completed.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="239"/>
                <count group_id="O2" value="228"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96"/>
                    <measurement group_id="O2" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Redness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82"/>
                    <measurement group_id="O2" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Redness</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>Any Swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Swelling</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>Duration of Solicted Symptoms</title>
        <description>Duration was defined as number of days with any grade of solicted local and/or general symptoms</description>
        <time_frame>During the 7-day (Days 0-6) post-vaccination Dose 1 period</time_frame>
        <population>Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Solicted Symptoms</title>
          <description>Duration was defined as number of days with any grade of solicted local and/or general symptoms</description>
          <population>Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Drowsiness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Irritability/fussiness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loss of appetite</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="5.0"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="5.0"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Temperature</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="5.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="6.0"/>
                  </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 drowsiness, Irritability/Fussiness, loss of appetite and Temperature. Any Temperature = axillary temperature ≥37.5 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. Grade 3 Irritability/Fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = did not eat at all. Grade 3 temperature = axillary temperature &gt; 39.0°C.</description>
        <time_frame>During the 7 days (Days 0 - 6) post dose 1 vaccination</time_frame>
        <population>Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheet completed.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of 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 drowsiness, Irritability/Fussiness, loss of appetite and Temperature. Any Temperature = axillary temperature ≥37.5 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. Grade 3 Irritability/Fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = did not eat at all. Grade 3 temperature = axillary temperature &gt; 39.0°C.</description>
          <population>Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented and symptom sheet completed.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="238"/>
                <count group_id="O2" value="224"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Drowsiness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54"/>
                    <measurement group_id="O2" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Drowsiness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Drowsiness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Irritability/Fussiness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77"/>
                    <measurement group_id="O2" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Irritability/Fussiness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Irritability/Fussiness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Loss of appetite</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Loss of appetite</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Loss of appetite</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Temperature</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Temperature</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Temperature</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting AEs With Medically Attended Visits (MAV)</title>
        <description>MAVs were defined as an AEs with a medically-attended visits i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAV was defined as at least one MAV experienced. Grade 3 was a MAV that prevented normal activities and related was defined as a MAV assessed by the investigator to be causally related to the study vaccination.</description>
        <time_frame>During the entire study period (Day 0 - Day 179)</time_frame>
        <population>Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting AEs With Medically Attended Visits (MAV)</title>
          <description>MAVs were defined as an AEs with a medically-attended visits i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAV was defined as at least one MAV experienced. Grade 3 was a MAV that prevented normal activities and related was defined as a MAV assessed by the investigator to be causally related to the study vaccination.</description>
          <population>Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
                <count group_id="O2" value="229"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any MAV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="149"/>
                    <measurement group_id="O2" value="130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 MAV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related MAV</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs)</title>
        <description>pIMDs were defined as a subset of AEs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune aetiology. Any pIMDs= Any AEs that occured regardless of the relation with vaccination. Related pIMDs= Any pIMD assessed by the investigator as casually related to the study vaccination.</description>
        <time_frame>During the entire study period (Days 0 - 179)</time_frame>
        <population>Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs)</title>
          <description>pIMDs were defined as a subset of AEs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune aetiology. Any pIMDs= Any AEs that occured regardless of the relation with vaccination. Related pIMDs= Any pIMD assessed by the investigator as casually related to the study vaccination.</description>
          <population>Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
                <count group_id="O2" value="229"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any pIMD</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 pIMD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any, Grade 3 and Related Unsolicited 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. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.</description>
        <time_frame>Within 28 days (Days 0-27) after first vaccination</time_frame>
        <population>Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any, Grade 3 and Related 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. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.</description>
          <population>Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
                <count group_id="O2" value="229"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Unsolicted AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66"/>
                    <measurement group_id="O2" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Unsolicted AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Unsolicted AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                  </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 (Day 0 - Day 179)</time_frame>
        <population>Analysis was performed on the Total Vaccinated cohort included all subjects with at least one vaccine administration documented.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Quadrivalent Primed Group</title>
            <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Quadrivalent Unprimed Group</title>
            <description>SuSubjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of 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 subjects with at least one vaccine administration documented.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="241"/>
                <count group_id="O2" value="229"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any SAE(s)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related SAE(s)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Serious Adverse Events: From Day 0 to Day 179; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited symptoms: During the 28-day (Day 0-27) post-vaccination period.</time_frame>
      <desc>For the frequent adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.</desc>
      <group_list>
        <group group_id="E1">
          <title>Fluarix Quadrivalent Primed Group</title>
          <description>Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.</description>
        </group>
        <group group_id="E2">
          <title>Fluarix Quadrivalent Unprimed Group</title>
          <description>Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of 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="7" subjects_at_risk="241"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Inguinal hernia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Bronchopneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Lymphadenitis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Rhinitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Adenoidal hypertrophy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="241"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="229"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract inflammation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="241"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="229"/>
              </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="145" subjects_at_risk="241"/>
                <counts group_id="E2" subjects_affected="138" subjects_at_risk="229"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="96" subjects_at_risk="239"/>
                <counts group_id="E2" subjects_affected="61" subjects_at_risk="228"/>
              </event>
              <event>
                <sub_title>Redness</sub_title>
                <counts group_id="E1" subjects_affected="82" subjects_at_risk="239"/>
                <counts group_id="E2" subjects_affected="48" subjects_at_risk="228"/>
              </event>
              <event>
                <sub_title>Swelling</sub_title>
                <counts group_id="E1" subjects_affected="49" subjects_at_risk="239"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="228"/>
              </event>
              <event>
                <sub_title>Drowsiness</sub_title>
                <counts group_id="E1" subjects_affected="54" subjects_at_risk="238"/>
                <counts group_id="E2" subjects_affected="44" subjects_at_risk="224"/>
              </event>
              <event>
                <sub_title>Irritability/Fussiness</sub_title>
                <counts group_id="E1" subjects_affected="77" subjects_at_risk="238"/>
                <counts group_id="E2" subjects_affected="59" subjects_at_risk="224"/>
              </event>
              <event>
                <sub_title>Loss of Appetite</sub_title>
                <counts group_id="E1" subjects_affected="51" subjects_at_risk="238"/>
                <counts group_id="E2" subjects_affected="46" subjects_at_risk="224"/>
              </event>
              <event>
                <sub_title>Temperature</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="238"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="224"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="241"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="229"/>
              </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/NCT01702454
org study id: 116023
secondary id: 2012-001230-34
nct id: NCT01702454
lead sponsor: 
The purpose of this study is to assess the safety and immunogenicity of GSK Biologicals'
      investigational vaccine GSK2321138A in children who previously participated in study 115345
      (FLU D-QIV-004 PRI) (NCT01439360).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
time frame: At Day 0 and Day 7
description: Antibody titers were expressed as Geometric Mean Titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
measure: Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
time frame: At Day 0 and Day 7
description: Seropositivity was defined as number of subjects with antibody titers greater than or equal to (≥) 1:10. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
measure: Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
time frame: At Day 7 post dose 1
description: A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 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 included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
measure: Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
time frame: At Day 7 post dose 1
description: MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
measure: Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
time frame: At Day 0 and Day 7
description: Seroprotection rate (SPR) was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer ≥ 1:40 that usually is accepted as indicating protection in adults. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
measure: Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
time frame: At Day 0 and Day 7
description: Antibody titers were expressed as Geometric Mean Titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
measure: Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine
time frame: At Day 0 and Day 7
description: Seropositivity was defined as number of subjects with antibody titers greater than or equal to (≥) 1:10. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
measure: Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
time frame: At Day 7 post dose 1
description: A seroconverted subject was defined as a subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria)and B/Hubei-Wujiagang/158/2009 (Yamagata )antigens.
measure: Mean Geometric Increase (MGI) for HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
time frame: At Day 7 post dose 1
description: Mean geometric increase was defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
measure: Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
time frame: At Day 0 and Day 7
description: Seroprotection rate was defined as the number of vaccinees with a serum HI titer greater than or equal to(≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008 (Victoria)and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
measure: Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
time frame: At Day 0 and Day 7
description: The cut-off values assessed were less than (<) 1:10, 1:10 to < 1:40 and ≥ 1:40. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
measure: Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
time frame: At Day 0 and Day 7
description: Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
measure: Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
time frame: At Day 0 and Day 7
description: Antibody titers were expressed as GMTs. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
measure: Vaccine Response Rate (VRR) for Neutralising Antibody Titers Against Each of the Four Vaccine Strains.
time frame: At Day 7 post dose 1
description: VRR was defined as the number of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
measure: MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
time frame: At Day 7 post dose 1
description: MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
measure: Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains.
time frame: At Day 7 post dose 1
description: VRR was defined as the number of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
measure: MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
time frame: At Day 7 post dose 1
description: MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
measure: Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
time frame: At Day 0 and Day 7
description: The cut-off values assessed were less than (<) 1:10, 1:10 to < 1:40,≥ 1:40, ≥1:60 and ≥1:80 . The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
measure: Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
time frame: At Day 0 and Day 7
description: MN antibody titers were expressed as geometric mean titers(GMTs). The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
measure: Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
time frame: At Day 0 and Day 7
description: NI (Neuraminidase inhibitor) antibody titers were expressed as geometric mean titers(GMTs).The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
measure: Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains
time frame: At Day 7 post dose 1
description: VRR was defined as the number of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
measure: MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
time frame: At Day 7 post dose 1
description: MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
measure: Vaccine Response Rate(VRR) for Anti-neuraminidase Antibodies Against Each of the Four Vaccine Strains.
time frame: At Day 7 post dose 1
description: VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
measure: MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
time frame: At Day 7 post dose 1
description: MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
measure: Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.
time frame: At Day 0 and Day 7
description: Antibody titers were expressed as geometric mean titers. The vaccine strains included A/Christchurch/16/2010 (H1N1),A/Victoria/361/2011 (H3N2), A/Victoria/361/2011 and B/Hubei-Wujiagang/158/2009)(Yamagata) antigens. The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.
measure: Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata
time frame: At Day 0 and Day 7
description: Antibody titers were expressed as geometric mean titers. The vaccine strains included A/Christchurch/16/2010(H1N1), A/Victoria/361/2011(H3N2),B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009(Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.
measure: Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata
time frame: At Day 7 post dose 1
description: VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008(Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.
measure: MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata
time frame: At Day 7 post dose 1
description: MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0.The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.
measure: Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.
time frame: At Day 7 post dose 1
description: VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria /361/2011(H3N2), B/Brisbane /60/2008(Victoria ) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.
measure: MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.
time frame: At Day 7 post dose 1
description: MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
time frame: During a 7-day (Day 0 to 6) follow-up period after first vaccination
description: Solicited local AEs assessed were pain, redness and swelling. Any = any solicited local AE reported irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).
measure: Duration of Solicted Symptoms
time frame: During the 7-day (Days 0-6) post-vaccination Dose 1 period
description: Duration was defined as number of days with any grade of solicted local and/or general symptoms
measure: Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
time frame: During the 7 days (Days 0 - 6) post dose 1 vaccination
description: Solicited general symptoms assessed were drowsiness, Irritability/Fussiness, loss of appetite and Temperature. Any Temperature = axillary temperature ≥37.5 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. Grade 3 Irritability/Fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = did not eat at all. Grade 3 temperature = axillary temperature > 39.0°C.
measure: Number of Subjects Reporting AEs With Medically Attended Visits (MAV)
time frame: During the entire study period (Day 0 - Day 179)
description: MAVs were defined as an AEs with a medically-attended visits i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAV was defined as at least one MAV experienced. Grade 3 was a MAV that prevented normal activities and related was defined as a MAV assessed by the investigator to be causally related to the study vaccination.
measure: Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs)
time frame: During the entire study period (Days 0 - 179)
description: pIMDs were defined as a subset of AEs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune aetiology. Any pIMDs= Any AEs that occured regardless of the relation with vaccination. Related pIMDs= Any pIMD assessed by the investigator as casually related to the study vaccination.
measure: Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs.
time frame: Within 28 days (Days 0-27) after first vaccination
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. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
measure: Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
time frame: During the entire study period (Day 0 - Day 179)
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: Fluarix Quadrivalent Primed Group
arm group type: Experimental
description: Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
arm group label: Fluarix Quadrivalent Unprimed Group
arm group type: Experimental
description: Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
intervention type: Biological
intervention name: Fluarix Quadrivalent
description: 1 or 2 doses administered intramuscularly (IM) in deltoid region depending on the priming status
arm group label: Fluarix Quadrivalent Primed Group
arm group label: Fluarix Quadrivalent Unprimed Group
criteria: 
gender: All
minimum age: 17 Months
maximum age: 48 Months
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
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country: Czechia
country: Poland
country: Spain
country: United Kingdom
country: Czech Republic
url: https://www.clinicalstudydatarequest.com
description: Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
responsible party type: Sponsor
mesh term: Influenza, Human
sharing ipd: Yes
ipd description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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