<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/NCT01711736</url>
  </required_header>
  <id_info>
    <org_study_id>116926</org_study_id>
    <secondary_id>2013-003155-38</secondary_id>
    <nct_id>NCT01711736</nct_id>
  </id_info>
  <brief_title>Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children 6 to 35 Months of Age</brief_title>
  <official_title>Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) When Administered in Children</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 investigate the immunogenicity, reactogenicity and safety of&#xD;
      the new influenza vaccine GSK2282512A (FLU-Q-QIV) and compare its activity to the marketed&#xD;
      vaccine Fluarix® (TIV) in young children 6 to 35 months of age.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The subjects will be randomized (1:1) in the 2 treatment groups to explore responses to&#xD;
      vaccination in a sub-group analysis based on age (6 to 17 months, 18 to 35 months).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2012</start_date>
  <completion_date type="Actual">June 19, 2013</completion_date>
  <primary_completion_date type="Actual">February 21, 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Quadrivalent Influenza GSK2282512A Vaccine.</measure>
    <time_frame>At Day 28 for primed subjects and at Day 56 for unprimed subjects</time_frame>
    <description>A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (&lt;) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria). This outcome concerns solely subjects in the GSK2282512A Group.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.</measure>
    <time_frame>During the 7-day (Days 0-6) post-vaccination period</time_frame>
    <description>Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 swelling was greater than 100 millimeters (mm) i.e. &gt;100mm.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms (Excluding Fever).</measure>
    <time_frame>During the 7-day (Days 0-6) post-vaccination period</time_frame>
    <description>Solicited general symptoms assessed were drowsiness, irritability/fussiness and loss of appetite. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Subjects Reporting Any, Grade 3 and Related Fever</measure>
    <time_frame>During the 7-day (Days 0-6) post-vaccination period</time_frame>
    <description>Any fever was defined as any fever ≥38.0 degrees Celsius (°C) irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ≥39.0 °C.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains</measure>
    <time_frame>At Day 0 (for all subjects) and 28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)</time_frame>
    <description>HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Fluarix Vaccine</measure>
    <time_frame>At Day 28 for primed subjects and at Day 56 for unprimed subjects</time_frame>
    <description>A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (&lt;) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria). This outcome concerns solely subjects in the Fluarix Group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.</measure>
    <time_frame>At Day 0 (for all subjects) and Day 28 after last vaccine dose (Day 28 for primed subjects and Day 56 for unprimed subjects)</time_frame>
    <description>A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains.</measure>
    <time_frame>28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)</time_frame>
    <description>MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any, Grade 3 and Related Fever</measure>
    <time_frame>During the 4-day (Days 0-3) post-vaccination period</time_frame>
    <description>Any fever was defined as any fever ≥38.0 °C irrespective of intensity and relationship to vaccination. Related was defined as symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ≥39.0 °C.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs)</measure>
    <time_frame>During the entire study period (Day 0 to Day 180)</time_frame>
    <description>MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any Potential Immune-Mediated Diseases (pIMDs)</measure>
    <time_frame>During the entire study period (Day 0 to Day 180)</time_frame>
    <description>Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. Any pIMD was defined as at least one pIMD experienced by the study subject.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).</measure>
    <time_frame>During the 28-day (Days 0-27) post-vaccination period.</time_frame>
    <description>An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)</measure>
    <time_frame>During the entire study period (Day 0 - Day 180)</time_frame>
    <description>A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of 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">606</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>GSK2282512A Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.&#xD;
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fluarix Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.&#xD;
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Quadrivalent influenza GSK2282512A vaccine</intervention_name>
    <description>1 or 2 doses administered intramuscularly (IM) in deltoid muscle or anterolateral thigh on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects) respectively.</description>
    <arm_group_label>GSK2282512A Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fluarix</intervention_name>
    <description>1 or 2 doses administered IM in deltoid muscle or anterolateral thigh, on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects) respectively.</description>
    <arm_group_label>Fluarix Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject's parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion&#xD;
             of the investigator, can and will comply with the requirements of the protocol.&#xD;
&#xD;
          -  A male or female between, and including, 6 and 35 months of age at the time of the&#xD;
             first vaccination.&#xD;
&#xD;
          -  Written informed consent obtained from the parent(s)/LAR(s) of the subject.&#xD;
&#xD;
          -  Subjects in stable health as determined by the investigator's clinical examination and&#xD;
             assessment of subject's medical history.&#xD;
&#xD;
          -  Subjects are eligible regardless of history of administration of influenza vaccine in&#xD;
             a previous season.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of any investigational or non-registered product other than the study vaccine&#xD;
             within 30 days preceding the first dose of study vaccine, or planned use during the&#xD;
             study period. Routine registered childhood vaccinations are permitted.&#xD;
&#xD;
          -  Child in care.&#xD;
&#xD;
          -  Prior receipt of any seasonal or pandemic influenza vaccine within six months&#xD;
             preceding the first dose of study vaccine, or planned use during the study period.&#xD;
&#xD;
          -  Chronic administration of immunosuppressants or other immune-modifying drugs within&#xD;
             six months prior to the first vaccine dosed.&#xD;
&#xD;
          -  Administration of immunoglobulins and/or any blood products within the three months&#xD;
             preceding the first dose of study vaccine or planned administration during the study&#xD;
             period.&#xD;
&#xD;
          -  History of Guillain-Barré syndrome within six weeks of receipt of prior influenza&#xD;
             vaccine.&#xD;
&#xD;
          -  Any known or suspected allergy to any constituent of influenza vaccines; a history of&#xD;
             anaphylactic-type reaction to consumption of eggs; or a history of severe adverse&#xD;
             reaction to a previous influenza vaccine.&#xD;
&#xD;
          -  Acute disease and/or fever at the time of enrolment.&#xD;
&#xD;
          -  Any significant disorder of coagulation or treatment with warfarin derivatives or&#xD;
             heparin.&#xD;
&#xD;
          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on&#xD;
             medical history and physical examination.&#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>6 Months</minimum_age>
    <maximum_age>35 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>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3K 6R8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Brampton</city>
        <state>Ontario</state>
        <zip>L6T 0G1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8L 5G8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sudbury</city>
        <state>Ontario</state>
        <zip>P3E 1H5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Mirabel</city>
        <state>Quebec</state>
        <zip>J7J 2K8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Québec City</city>
        <state>Quebec</state>
        <zip>G1E 7G9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Santo Domingo, Distrito Nacional</city>
        <zip>11201</zip>
        <country>Dominican Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>San Pedro Sula</city>
        <zip>21102</zip>
        <country>Honduras</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Dominican Republic</country>
    <country>Honduras</country>
  </location_countries>
  <link>
    <url>https://www.clinicalstudydatarequest.com</url>
    <description>Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.</description>
  </link>
  <reference>
    <citation>Bekkat-Berkani R, Ray R, Jain VK, Chandrasekaran V, Innis BL. Evidence update: GlaxoSmithKline's inactivated quadrivalent influenza vaccines. Expert Rev Vaccines. 2016;15(2):201-14. doi: 10.1586/14760584.2016.1113878. Epub 2015 Dec 5.</citation>
    <PMID>26641539</PMID>
  </reference>
  <reference>
    <citation>Langley JM, Wang L, Aggarwal N, Bueso A, Chandrasekaran V, Cousin L, Halperin SA, Li P, Liu A, McNeil S, Mendez LP, Rivera L, Innis BL, Jain VK. Immunogenicity and Reactogenicity of an Inactivated Quadrivalent Influenza Vaccine Administered Intramuscularly to Children 6 to 35 Months of Age in 2012-2013: A Randomized, Double-Blind, Controlled, Multicenter, Multicountry, Clinical Trial. J Pediatric Infect Dis Soc. 2015 Sep;4(3):242-51. doi: 10.1093/jpids/piu098. Epub 2014 Oct 20.</citation>
    <PMID>26336604</PMID>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 22, 2012</study_first_posted>
  <results_first_submitted>February 20, 2014</results_first_submitted>
  <results_first_submitted_qc>February 20, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 3, 2014</results_first_posted>
  <last_update_submitted>October 19, 2021</last_update_submitted>
  <last_update_submitted_qc>October 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Immunogenicity</keyword>
  <keyword>Children</keyword>
  <keyword>Safety</keyword>
  <keyword>Seasonal influenza</keyword>
  <keyword>Fluarix</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>116926</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>116926</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>116926</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>116926</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>116926</doc_id>
      <doc_type>Clinical Study Report</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>116926</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_docs>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Primed subjects: Received 2 doses of seasonal influenza vaccine separated by at least one month during the last season or had received at least 1 dose prior to last season. Unprimed subjects: Did not receive any seasonal influenza vaccine in the past or received only 1 dose for the first time in the last influenza season.</recruitment_details>
      <pre_assignment_details>5 subjects enrolled in the study were allocated subject numbers but the study vaccine dose was not administered.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>GSK2282512A Group</title>
          <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.&#xD;
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</description>
        </group>
        <group group_id="P2">
          <title>Fluarix Group</title>
          <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.&#xD;
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="299"/>
                <participants group_id="P2" count="302"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="287">Up to Day 180</participants>
                <participants group_id="P2" count="294">Up to Day 180</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Migrated/moved from study area</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>GSK2282512A Group</title>
          <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.&#xD;
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</description>
        </group>
        <group group_id="B2">
          <title>Fluarix Group</title>
          <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.&#xD;
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</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="299"/>
            <count group_id="B2" value="302"/>
            <count group_id="B3" value="601"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18.2" spread="8.17"/>
                    <measurement group_id="B2" value="18.1" spread="8.34"/>
                    <measurement group_id="B3" value="18.15" spread="8.25"/>
                  </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="155"/>
                    <measurement group_id="B2" value="146"/>
                    <measurement group_id="B3" value="301"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="144"/>
                    <measurement group_id="B2" value="156"/>
                    <measurement group_id="B3" value="300"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Quadrivalent Influenza GSK2282512A Vaccine.</title>
        <description>A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (&lt;) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria). This outcome concerns solely subjects in the GSK2282512A Group.</description>
        <time_frame>At Day 28 for primed subjects and at Day 56 for unprimed subjects</time_frame>
        <population>The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, in terms of antibody response measured by the Haemagglutination Inhibition assay, included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK2282512A Group</title>
            <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.&#xD;
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Quadrivalent Influenza GSK2282512A Vaccine.</title>
          <description>A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (&lt;) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria). This outcome concerns solely subjects in the GSK2282512A Group.</description>
          <population>The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, in terms of antibody response measured by the Haemagglutination Inhibition assay, included all evaluable subjects 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="284"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>[H1N1, Day 28 = primed and Day 56 = unprimed]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="244"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[H3N2, Day 28 = primed and Day 56 = unprimed]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="205"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[Yamagata, Day 28 = primed and Day 56 = unprimed]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="224"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[Victoria, Day 28 = primed and Day 56 = unprimed]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.</title>
        <description>Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 swelling was greater than 100 millimeters (mm) i.e. &gt;100mm.</description>
        <time_frame>During the 7-day (Days 0-6) post-vaccination period</time_frame>
        <population>The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK2282512A Group</title>
            <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.&#xD;
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Group</title>
            <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.&#xD;
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.</title>
          <description>Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 swelling was greater than 100 millimeters (mm) i.e. &gt;100mm.</description>
          <population>The analysis was performed on the Total Vaccinated cohort, which included all vaccinated 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="291"/>
                <count group_id="O2" value="297"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95"/>
                    <measurement group_id="O2" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Redness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Redness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms (Excluding Fever).</title>
        <description>Solicited general symptoms assessed were drowsiness, irritability/fussiness and loss of appetite. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity.</description>
        <time_frame>During the 7-day (Days 0-6) post-vaccination period</time_frame>
        <population>The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK2282512A Group</title>
            <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.&#xD;
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Group</title>
            <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.&#xD;
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms (Excluding Fever).</title>
          <description>Solicited general symptoms assessed were drowsiness, irritability/fussiness and loss of appetite. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity.</description>
          <population>The analysis was performed on the Total Vaccinated cohort, which included all vaccinated 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="290"/>
                <count group_id="O2" value="296"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Drowsiness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93"/>
                    <measurement group_id="O2" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Drowsiness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Drowsiness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79"/>
                    <measurement group_id="O2" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Irritability/fussiness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118"/>
                    <measurement group_id="O2" value="123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Irritability/fussiness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Irritability/fussiness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104"/>
                    <measurement group_id="O2" value="106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Loss of appetite</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Loss of appetite</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Loss of appetite</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84"/>
                    <measurement group_id="O2" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects Reporting Any, Grade 3 and Related Fever</title>
        <description>Any fever was defined as any fever ≥38.0 degrees Celsius (°C) irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ≥39.0 °C.</description>
        <time_frame>During the 7-day (Days 0-6) post-vaccination period</time_frame>
        <population>The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK2282512A Group</title>
            <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.&#xD;
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Group</title>
            <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.&#xD;
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any, Grade 3 and Related Fever</title>
          <description>Any fever was defined as any fever ≥38.0 degrees Celsius (°C) irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ≥39.0 °C.</description>
          <population>The analysis was performed on the Total Vaccinated cohort, which included all vaccinated 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="290"/>
                <count group_id="O2" value="296"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Fever</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fever</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Fever</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains</title>
        <description>HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria)</description>
        <time_frame>At Day 0 (for all subjects) and 28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)</time_frame>
        <population>The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, in terms of antibody response measured by the Haemagglutination Inhibition assay, included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK2282512A Group</title>
            <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.&#xD;
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Group</title>
            <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.&#xD;
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</description>
          </group>
        </group_list>
        <measure>
          <title>Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains</title>
          <description>HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria)</description>
          <population>The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, in terms of antibody response measured by the Haemagglutination Inhibition assay, included all evaluable subjects 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="284"/>
                <count group_id="O2" value="287"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>[H1N1, Day 0]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.6" lower_limit="8.1" upper_limit="11.3"/>
                    <measurement group_id="O2" value="9.8" lower_limit="8.3" upper_limit="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[H1N1, Day 28 = primed and Day 56 = unprimed]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="157.1" lower_limit="132.8" upper_limit="185.9"/>
                    <measurement group_id="O2" value="61.2" lower_limit="49.2" upper_limit="76.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[H3N2, Day 0]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.4" lower_limit="14.1" upper_limit="21.5"/>
                    <measurement group_id="O2" value="13.8" lower_limit="11.4" upper_limit="16.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[H3N2, Day 28 = primed and Day 56 = unprimed]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="159.4" lower_limit="129.4" upper_limit="196.3"/>
                    <measurement group_id="O2" value="103.0" lower_limit="83.7" upper_limit="126.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[Yamagata, Day 0]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7" lower_limit="6.9" upper_limit="8.7"/>
                    <measurement group_id="O2" value="7.2" lower_limit="6.5" upper_limit="8.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[Yamagata, Day 28 = primed and Day 56 = unprimed]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114.2" lower_limit="100.0" upper_limit="130.5"/>
                    <measurement group_id="O2" value="107.2" lower_limit="92.2" upper_limit="124.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[Victoria, Day 0]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.6" lower_limit="9.1" upper_limit="12.4"/>
                    <measurement group_id="O2" value="9.3" lower_limit="8.0" upper_limit="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[Victoria, Day 28 = primed and Day 56 = unprimed]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="111.4" lower_limit="91.9" upper_limit="135.2"/>
                    <measurement group_id="O2" value="15.6" lower_limit="13.3" upper_limit="18.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Fluarix Vaccine</title>
        <description>A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (&lt;) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria). This outcome concerns solely subjects in the Fluarix Group.</description>
        <time_frame>At Day 28 for primed subjects and at Day 56 for unprimed subjects</time_frame>
        <population>The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, in terms of antibody response measured by the Haemagglutination Inhibition assay, included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.</population>
        <group_list>
          <group group_id="O1">
            <title>Fluarix Group</title>
            <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.&#xD;
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Fluarix Vaccine</title>
          <description>A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (&lt;) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria). This outcome concerns solely subjects in the Fluarix Group.</description>
          <population>The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, in terms of antibody response measured by the Haemagglutination Inhibition assay, included all evaluable subjects 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="287"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>[H1N1, Day 28 = primed and Day 56 = unprimed]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[H3N2, Day 28 = primed and Day 56 = unprimed]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[Yamagata, Day 28 = primed and Day 56 = unprimed]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="222"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[Victoria, Day 28 = primed and Day 56 = unprimed]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.</title>
        <description>A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria)</description>
        <time_frame>At Day 0 (for all subjects) and Day 28 after last vaccine dose (Day 28 for primed subjects and Day 56 for unprimed subjects)</time_frame>
        <population>The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, in terms of antibody response measured by the Haemagglutination Inhibition assay, included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK2282512A Group</title>
            <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.&#xD;
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Group</title>
            <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.&#xD;
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.</title>
          <description>A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria)</description>
          <population>The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, in terms of antibody response measured by the Haemagglutination Inhibition assay, included all evaluable subjects 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="284"/>
                <count group_id="O2" value="287"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>[H1N1, Day 0]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[H1N1, Day 28 = primed and Day 56 = unprimed]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="254"/>
                    <measurement group_id="O2" value="169"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[H3N2, Day 0]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93"/>
                    <measurement group_id="O2" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[H3N2, Day 28 = primed and Day 56 = unprimed]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="231"/>
                    <measurement group_id="O2" value="191"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[Yamagata, Day 0]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[Yamagata, Day 28 = primed and Day 56 = unprimed]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="242"/>
                    <measurement group_id="O2" value="229"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[Victoria, Day 0]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                    <measurement group_id="O2" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[Victoria, Day 28 = primed and Day 56 = unprimed]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="216"/>
                    <measurement group_id="O2" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains.</title>
        <description>MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria)</description>
        <time_frame>28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)</time_frame>
        <population>The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, in terms of antibody response measured by the Haemagglutination Inhibition assay, included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK2282512A Group</title>
            <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.&#xD;
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Group</title>
            <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.&#xD;
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains.</title>
          <description>MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria)</description>
          <population>The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, in terms of antibody response measured by the Haemagglutination Inhibition assay, included all evaluable subjects 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="284"/>
                <count group_id="O2" value="287"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>[H1N1, Day 28 = primed and Day 56 = unprimed]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.4" lower_limit="14.3" upper_limit="18.7"/>
                    <measurement group_id="O2" value="6.2" lower_limit="5.3" upper_limit="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[H3N2, Day 28 = primed and Day 56 = unprimed]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.1" lower_limit="8.0" upper_limit="10.5"/>
                    <measurement group_id="O2" value="7.5" lower_limit="6.4" upper_limit="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[Yamagata, Day 28 = primed and Day 56 = unprimed]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.8" lower_limit="12.8" upper_limit="17.1"/>
                    <measurement group_id="O2" value="14.8" lower_limit="12.8" upper_limit="17.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>[Victoria, Day 28 = primed and Day 56 = unprimed]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.5" lower_limit="9.2" upper_limit="11.9"/>
                    <measurement group_id="O2" value="1.7" lower_limit="1.5" upper_limit="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any, Grade 3 and Related Fever</title>
        <description>Any fever was defined as any fever ≥38.0 °C irrespective of intensity and relationship to vaccination. Related was defined as symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ≥39.0 °C.</description>
        <time_frame>During the 4-day (Days 0-3) post-vaccination period</time_frame>
        <population>The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK2282512A Group</title>
            <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.&#xD;
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Group</title>
            <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.&#xD;
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any, Grade 3 and Related Fever</title>
          <description>Any fever was defined as any fever ≥38.0 °C irrespective of intensity and relationship to vaccination. Related was defined as symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ≥39.0 °C.</description>
          <population>The analysis was performed on the Total Vaccinated cohort, which included all vaccinated 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="290"/>
                <count group_id="O2" value="296"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Fever</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fever</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Fever</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs)</title>
        <description>MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).</description>
        <time_frame>During the entire study period (Day 0 to Day 180)</time_frame>
        <population>The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK2282512A Group</title>
            <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.&#xD;
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Group</title>
            <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.&#xD;
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs)</title>
          <description>MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).</description>
          <population>The analysis was performed on the Total Vaccinated cohort, which included all vaccinated 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="299"/>
                <count group_id="O2" value="302"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="156"/>
                    <measurement group_id="O2" value="156"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any Potential Immune-Mediated Diseases (pIMDs)</title>
        <description>Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. Any pIMD was defined as at least one pIMD experienced by the study subject.</description>
        <time_frame>During the entire study period (Day 0 to Day 180)</time_frame>
        <population>The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK2282512A Group</title>
            <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.&#xD;
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Group</title>
            <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.&#xD;
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any Potential Immune-Mediated Diseases (pIMDs)</title>
          <description>Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. Any pIMD was defined as at least one pIMD experienced by the study subject.</description>
          <population>The analysis was performed on the Total Vaccinated cohort, which included all vaccinated 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="299"/>
                <count group_id="O2" value="302"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any pIMD(s)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related pIMD(s)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).</title>
        <description>An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.</description>
        <time_frame>During the 28-day (Days 0-27) post-vaccination period.</time_frame>
        <population>The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK2282512A Group</title>
            <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.&#xD;
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Group</title>
            <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.&#xD;
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).</title>
          <description>An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.</description>
          <population>The analysis was performed on the Total Vaccinated cohort, which included all vaccinated 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="299"/>
                <count group_id="O2" value="302"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Unsolicited AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="142"/>
                    <measurement group_id="O2" value="165"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Unsolicited AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Unsolicited AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="13"/>
                  </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 defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of 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 180)</time_frame>
        <population>The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one vaccine administration documented.</population>
        <group_list>
          <group group_id="O1">
            <title>GSK2282512A Group</title>
            <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.&#xD;
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</description>
          </group>
          <group group_id="O2">
            <title>Fluarix Group</title>
            <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.&#xD;
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)</title>
          <description>A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of 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>The analysis was performed on the Total Vaccinated cohort, which included all vaccinated 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="299"/>
                <count group_id="O2" value="302"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.</time_frame>
      <desc>For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.</desc>
      <group_list>
        <group group_id="E1">
          <title>GSK2282512A Group</title>
          <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.&#xD;
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</description>
        </group>
        <group group_id="E2">
          <title>Fluarix Group</title>
          <description>Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.&#xD;
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects &lt; 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).</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="9" subjects_at_risk="299"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis ulcerative</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="299"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Gastroenteritis rotavirus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Amoebic dysentery</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="299"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Bacterial pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="299"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Blastocystis infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Dengue fever</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="299"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="299"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus bronchiolitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Rotavirus infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="299"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="299"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Febrile convulsion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="299"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Bronchial hyperreactivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="299"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="299"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="302"/>
              </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="200" subjects_at_risk="299"/>
                <counts group_id="E2" subjects_affected="211" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="299"/>
                <counts group_id="E2" subjects_affected="38" subjects_at_risk="302"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="95" subjects_at_risk="299"/>
                <counts group_id="E2" subjects_affected="91" subjects_at_risk="302"/>
              </event>
              <event>
                <sub_title>Drowsiness</sub_title>
                <counts group_id="E1" subjects_affected="93" subjects_at_risk="290"/>
                <counts group_id="E2" subjects_affected="88" subjects_at_risk="296"/>
              </event>
              <event>
                <sub_title>Irritability/fussiness</sub_title>
                <counts group_id="E1" subjects_affected="118" subjects_at_risk="290"/>
                <counts group_id="E2" subjects_affected="123" subjects_at_risk="296"/>
              </event>
              <event>
                <sub_title>Loss of appetite</sub_title>
                <counts group_id="E1" subjects_affected="99" subjects_at_risk="290"/>
                <counts group_id="E2" subjects_affected="100" subjects_at_risk="296"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <description>Assessed during the 7-day (Days 0-6) post-vaccination period</description>
                <counts group_id="E1" subjects_affected="61" subjects_at_risk="290"/>
                <counts group_id="E2" subjects_affected="60" subjects_at_risk="296"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <description>Assessed duringthe 4-day (Days 0-3) post-vaccination period</description>
                <counts group_id="E1" subjects_affected="46" subjects_at_risk="290"/>
                <counts group_id="E2" subjects_affected="42" subjects_at_risk="296"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="78" subjects_at_risk="299"/>
                <counts group_id="E2" subjects_affected="90" subjects_at_risk="302"/>
              </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/NCT01711736
org study id: 116926
secondary id: 2013-003155-38
nct id: NCT01711736
lead sponsor: 
The purpose of this study is to investigate the immunogenicity, reactogenicity and safety of
      the new influenza vaccine GSK2282512A (FLU-Q-QIV) and compare its activity to the marketed
      vaccine Fluarix® (TIV) in young children 6 to 35 months of age.
The subjects will be randomized (1:1) in the 2 treatment groups to explore responses to
      vaccination in a sub-group analysis based on age (6 to 17 months, 18 to 35 months).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Quadrivalent Influenza GSK2282512A Vaccine.
time frame: At Day 28 for primed subjects and at Day 56 for unprimed subjects
description: A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria). This outcome concerns solely subjects in the GSK2282512A Group.
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
time frame: During the 7-day (Days 0-6) post-vaccination period
description: Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 swelling was greater than 100 millimeters (mm) i.e. >100mm.
measure: Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms (Excluding Fever).
time frame: During the 7-day (Days 0-6) post-vaccination period
description: Solicited general symptoms assessed were drowsiness, irritability/fussiness and loss of appetite. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity.
measure: Number of Subjects Reporting Any, Grade 3 and Related Fever
time frame: During the 7-day (Days 0-6) post-vaccination period
description: Any fever was defined as any fever ≥38.0 degrees Celsius (°C) irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ≥39.0 °C.
measure: Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains
time frame: At Day 0 (for all subjects) and 28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)
description: HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria)
measure: Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Fluarix Vaccine
time frame: At Day 28 for primed subjects and at Day 56 for unprimed subjects
description: A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria). This outcome concerns solely subjects in the Fluarix Group.
measure: Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains.
time frame: At Day 0 (for all subjects) and Day 28 after last vaccine dose (Day 28 for primed subjects and Day 56 for unprimed subjects)
description: A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria)
measure: Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains.
time frame: 28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)
description: MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria)
measure: Number of Subjects Reporting Any, Grade 3 and Related Fever
time frame: During the 4-day (Days 0-3) post-vaccination period
description: Any fever was defined as any fever ≥38.0 °C irrespective of intensity and relationship to vaccination. Related was defined as symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ≥39.0 °C.
measure: Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs)
time frame: During the entire study period (Day 0 to Day 180)
description: MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).
measure: Number of Subjects Reporting Any Potential Immune-Mediated Diseases (pIMDs)
time frame: During the entire study period (Day 0 to Day 180)
description: Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. Any pIMD was defined as at least one pIMD experienced by the study subject.
measure: Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
time frame: During the 28-day (Days 0-27) post-vaccination period.
description: An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
measure: Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
time frame: During the entire study period (Day 0 - Day 180)
description: A serious adverse event was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of 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: GSK2282512A Group
arm group type: Experimental
description: Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.
Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).
arm group label: Fluarix Group
arm group type: Active Comparator
description: Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.
Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).
intervention type: Biological
intervention name: Quadrivalent influenza GSK2282512A vaccine
description: 1 or 2 doses administered intramuscularly (IM) in deltoid muscle or anterolateral thigh on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects) respectively.
arm group label: GSK2282512A Group
intervention type: Biological
intervention name: Fluarix
description: 1 or 2 doses administered IM in deltoid muscle or anterolateral thigh, on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects) respectively.
arm group label: Fluarix Group
criteria: 
gender: All
minimum age: 6 Months
maximum age: 35 Months
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
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country: Canada
country: Dominican Republic
country: Honduras
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.
citation: Bekkat-Berkani R, Ray R, Jain VK, Chandrasekaran V, Innis BL. Evidence update: GlaxoSmithKline's inactivated quadrivalent influenza vaccines. Expert Rev Vaccines. 2016;15(2):201-14. doi: 10.1586/14760584.2016.1113878. Epub 2015 Dec 5.
PMID: 26641539
citation: Langley JM, Wang L, Aggarwal N, Bueso A, Chandrasekaran V, Cousin L, Halperin SA, Li P, Liu A, McNeil S, Mendez LP, Rivera L, Innis BL, Jain VK. Immunogenicity and Reactogenicity of an Inactivated Quadrivalent Influenza Vaccine Administered Intramuscularly to Children 6 to 35 Months of Age in 2012-2013: A Randomized, Double-Blind, Controlled, Multicenter, Multicountry, Clinical Trial. J Pediatric Infect Dis Soc. 2015 Sep;4(3):242-51. doi: 10.1093/jpids/piu098. Epub 2014 Oct 20.
PMID: 26336604
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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