<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/NCT02255409</url>
  </required_header>
  <id_info>
    <org_study_id>V118_05E1</org_study_id>
    <secondary_id>2014-002599-95</secondary_id>
    <nct_id>NCT02255409</nct_id>
  </id_info>
  <brief_title>Clinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine (QIV) in Children Previously Vaccinated in Trial V118_05</brief_title>
  <official_title>A Phase III, Randomized, Observer Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Repeated Exposure to an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV), Administered to Subjects Previously Vaccinated in Trial V118_05</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seqirus</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seqirus</source>
  <brief_summary>
    <textblock>
      Safety, Immunogenicity of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared&#xD;
      to Non-Adjuvanted Comparator Influenza Vaccine in Children Previously Vaccinated in Trial&#xD;
      V118_05&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety Endpoint: Number of Subjects With SAEs, AEs Leading to Withdrawal From the Study, NOCDs, AESIs and Medically Attended AEs.</measure>
    <time_frame>Day 1 through Day 356</time_frame>
    <description>Safety was assessed in terms of number of subjects between 12 months and 7 years of age reporting unsolicited events up to 12 months after last vaccination with either aQIV or QIV (comparator): serious adverse events (SAEs), AEs leading to study withdrawal, new onset chronic disease (NOCDs), adverse events of special interest (AESIs) and medically attended AEs after vaccination.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 22)</measure>
    <time_frame>Day 1, Day 22</time_frame>
    <description>The percentage of subjects achieving seroconversion at Day 22 after vaccination is reported for homologous strains; Seroconversion is defined as hemagglutination inhibition (HI) ≥1:40 for subjects negative at baseline [&lt;1:10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI ≥1:10]; Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and and Differences in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Homologous Influenza Strains (Day 22).</measure>
    <time_frame>Day 1, Day 22</time_frame>
    <description>The percentage of subjects achieving HI titer ≥1:40 at Day 22 after vaccination is reported for homologous strains. Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety Endpoint: Number of Subjects With a Diagnosis of Failure to Thrive or Short Stature</measure>
    <time_frame>Day 1 through Day 366 (Day 1, Day 22, Day 181, Day 366)</time_frame>
    <description>Short stature was defined as a height/length that was 2 or more standard deviations below the mean for age and gender within a population and was assessed as being below the 2nd z-score (worse outcome) on the length/height-for-age scale. Failure-to-thrive was defined by inadequate weight gain and physical growth and assessed through 2 or more of the following criteria: height/length-for-age, weight-for-age or weight-for-height/length below the 2nd z-score, a child's growth line crossing a z-score line, a sharp change in growth curve or a curve that remains flat. The observations were made for 2 or more time points each divided by at least 2 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Endpoint: Number of Subjects With Any Unsolicited AEs</measure>
    <time_frame>Day 1 through Day 22</time_frame>
    <description>Safety was assessed in terms of number of subjects between 12 months and 7 years of age reporting unsolicited events up to 12 months after last vaccination with either aQIV or QIV (comparator).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs)</measure>
    <time_frame>Up to 7 days following vaccination</time_frame>
    <description>Safety was assessed in terms of number of subjects between 12 months and 7 years of age reporting solicited local and systemic AEs, day 1 to day 7 after vaccination with either aQIV or QIV (comparator).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 181)</measure>
    <time_frame>Day 1, Day 181</time_frame>
    <description>The percentage of subjects achieving seroconversion at Day 181 after vaccination is reported for homologous strains. Seroconversion is defined as HI ≥1:40 for subjects negative at baseline [&lt;1:10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI ≥1:10]; Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and Difference in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Homologous Influenza Strains (Day 181)</measure>
    <time_frame>Day 1, Day 181</time_frame>
    <description>The percentage of subjects achieving HI titer ≥1:40 at Day 181 after vaccination is reported for homologous strains; Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) and GMT Ratios for Homologous Influenza Strains (Day 1, Day 22, Day 181)</measure>
    <time_frame>Day 1, Day 22, Day 181</time_frame>
    <description>Adjusted GMT, GMR and 95% confidence interval (CI) were analyzed using ANCOVA with study specific covariates. Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains</measure>
    <time_frame>Day 1, Day 22, and Day 181</time_frame>
    <description>The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. Adjusted GMT, GMR and 95% CI were analyzed using ANCOVA with study specific covariates. Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Difference in Percentage of Subjects Achieving Seroconversion for Heterologous Influenza Strains (Day 181)</measure>
    <time_frame>Day 1, Day 181</time_frame>
    <description>The percentage of subjects achieving seroconversion at Day 181 after vaccination is reported for homologous strains. Seroconversion is defined as HI ≥1:40 for subjects negative at baseline [&lt;1:10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI ≥1:10]; Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and Difference in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Heterologous Influenza Strains (Day 181)</measure>
    <time_frame>Day 1, Day 181</time_frame>
    <description>The percentage of subjects achieving HI titer ≥1:40 at Day 181 after vaccination is reported for homologous strains; Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) for Heterologous Influenza Strains (Day 1, Day 22, Day 181)</measure>
    <time_frame>Day 1, Day 22, Day 181</time_frame>
    <description>Adjusted GMT, GMR and 95% CI were analyzed using ANCOVA with study specific covariates. Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Heterologous Influenza Strains</measure>
    <time_frame>Day 1, Day 22, and Day 181</time_frame>
    <description>The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. Adjusted GMT, GMR and 95% CI were analyzed using ANCOVA with study specific covariates. Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">607</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>aQIV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adjuvanted Quadrivalent Subunit Influenza</description>
  </arm_group>
  <arm_group>
    <arm_group_label>QIV</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Non-Adjuvanted Quadrivalent Subunit Influenza</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)</intervention_name>
    <description>1 dose 0.25 ml: ≥6 months to &lt;36 months, 0.5 ml: ≥36 months to &lt;72 months</description>
    <arm_group_label>aQIV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>non-adjuvanted Quadrivalent Influenza Vaccine (QIV)</intervention_name>
    <description>1 dose 0.25 ml: ≥6 months to &lt;36 months, 0.5 ml: ≥36 months to &lt;72 months</description>
    <arm_group_label>QIV</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female subject who has completed their Day 181 clinic visit for non-naïve&#xD;
             subjects or their Day 209 clinic visit for naïve subjects in parent study.&#xD;
&#xD;
          2. Individuals who give written informed consent, who can comply with study procedures,&#xD;
             and who are available for follow-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Individuals recently vaccinated against influenza.&#xD;
&#xD;
          2. Subjects with contraindications to receive influenza vaccine.&#xD;
&#xD;
          3. Please contact the site for additional eligibility criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>84 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Gabriel</city>
        <state>California</state>
        <zip>91706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Melbourne</city>
        <state>Florida</state>
        <zip>32935</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Augusta</city>
        <state>Kansas</state>
        <zip>67010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Newton</city>
        <state>Kansas</state>
        <zip>67114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40291</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bellevue</city>
        <state>Nebraska</state>
        <zip>68005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Binghamton</city>
        <state>New York</state>
        <zip>13901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Angelo</city>
        <state>Texas</state>
        <zip>76904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tomball</city>
        <state>Texas</state>
        <zip>77375</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>West Jordan</city>
        <state>Utah</state>
        <zip>84088</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Espoo</city>
        <zip>02230</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Helsinki</city>
        <zip>00100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Helsinki</city>
        <zip>00930</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Järvenpää</city>
        <zip>04400</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kokkola</city>
        <zip>67100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pori</city>
        <zip>28100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tampere</city>
        <zip>33100</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Turku</city>
        <zip>20520</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Vantaa</city>
        <zip>01300</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <results_first_submitted>August 20, 2020</results_first_submitted>
  <results_first_submitted_qc>March 6, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 15, 2023</results_first_posted>
  <disposition_first_submitted>October 26, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>October 26, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">October 27, 2016</disposition_first_posted>
  <last_update_submitted>March 6, 2023</last_update_submitted>
  <last_update_submitted_qc>March 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were enrolled from 30 sites in 2 countries (Finland and United States)</recruitment_details>
      <pre_assignment_details>All enrolled subjects were included in the trial</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Adjuvanted Quadrivalent Influenza Vaccine (aQIV)</title>
          <description>Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118_05 received aQIV in study V118_05E1.</description>
        </group>
        <group group_id="P2">
          <title>Comparator Quadrivalent Influenza Vaccine (QIV)</title>
          <description>Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118_05 received QIV in study V118_05E1.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="318"/>
                <participants group_id="P2" count="289"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="304"/>
                <participants group_id="P2" count="258"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="31"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Administrative Reason</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Adjuvanted Quadrivalent Influenza Vaccine (aQIV)</title>
          <description>Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118_05 received aQIV in the study V118_05E1.</description>
        </group>
        <group group_id="B2">
          <title>Comparator Quadrivalent Influenza Vaccine (QIV)</title>
          <description>Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118_05 received QIV in study V118_05E1.</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="318"/>
            <count group_id="B2" value="289"/>
            <count group_id="B3" value="607"/>
          </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="44.7" spread="19.04"/>
                    <measurement group_id="B2" value="42.0" spread="17.47"/>
                    <measurement group_id="B3" value="43.4" spread="18.35"/>
                  </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="171"/>
                    <measurement group_id="B2" value="155"/>
                    <measurement group_id="B3" value="326"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="147"/>
                    <measurement group_id="B2" value="134"/>
                    <measurement group_id="B3" value="281"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="112"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="253"/>
                    <measurement group_id="B2" value="241"/>
                    <measurement group_id="B3" value="494"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="140"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="231"/>
                    <measurement group_id="B2" value="209"/>
                    <measurement group_id="B3" value="440"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="269"/>
                    <measurement group_id="B2" value="238"/>
                    <measurement group_id="B3" value="507"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Finland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Safety Endpoint: Number of Subjects With SAEs, AEs Leading to Withdrawal From the Study, NOCDs, AESIs and Medically Attended AEs.</title>
        <description>Safety was assessed in terms of number of subjects between 12 months and 7 years of age reporting unsolicited events up to 12 months after last vaccination with either aQIV or QIV (comparator): serious adverse events (SAEs), AEs leading to study withdrawal, new onset chronic disease (NOCDs), adverse events of special interest (AESIs) and medically attended AEs after vaccination.</description>
        <time_frame>Day 1 through Day 356</time_frame>
        <population>The Unsolicited Safety Set consisting of subjects who received a study vaccination and who had any AE assessments (ie, a subject did not have to have an AE to be included in this population) was used for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>aQIV</title>
            <description>Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118_05 received aQIV in study V118_05E1.</description>
          </group>
          <group group_id="O2">
            <title>Comparator QIV</title>
            <description>Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118_05 received QIV in study V118_05E1.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety Endpoint: Number of Subjects With SAEs, AEs Leading to Withdrawal From the Study, NOCDs, AESIs and Medically Attended AEs.</title>
          <description>Safety was assessed in terms of number of subjects between 12 months and 7 years of age reporting unsolicited events up to 12 months after last vaccination with either aQIV or QIV (comparator): serious adverse events (SAEs), AEs leading to study withdrawal, new onset chronic disease (NOCDs), adverse events of special interest (AESIs) and medically attended AEs after vaccination.</description>
          <population>The Unsolicited Safety Set consisting of subjects who received a study vaccination and who had any AE assessments (ie, a subject did not have to have an AE to be included in this population) was used for analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="317"/>
                <count group_id="O2" value="288"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least possibly related SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>NOCDs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AESIs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medically attended AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="161"/>
                    <measurement group_id="O2" value="141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs leading to withdrawal</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>Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 22)</title>
        <description>The percentage of subjects achieving seroconversion at Day 22 after vaccination is reported for homologous strains; Seroconversion is defined as hemagglutination inhibition (HI) ≥1:40 for subjects negative at baseline [&lt;1:10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI ≥1:10]; Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab</description>
        <time_frame>Day 1, Day 22</time_frame>
        <population>The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (homologous strains) for both before (baseline) and after vaccination (ie, Day 22 and/or Day 181).&#xD;
Day 22 analyses are reported for the 302 and 257 (256 for the A/H3N2 strain) participants in the aQIV and Comparator QIV groups, respectively, who had immunogenicity data at both Day 1 and Day 22.</population>
        <group_list>
          <group group_id="O1">
            <title>aQIV</title>
            <description>Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118_05 received aQIV in study V118_05E1.</description>
          </group>
          <group group_id="O2">
            <title>Comparator QIV</title>
            <description>Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118_05 received QIV in study V118_05E1.</description>
          </group>
        </group_list>
        <measure>
          <title>Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 22)</title>
          <description>The percentage of subjects achieving seroconversion at Day 22 after vaccination is reported for homologous strains; Seroconversion is defined as hemagglutination inhibition (HI) ≥1:40 for subjects negative at baseline [&lt;1:10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI ≥1:10]; Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab</description>
          <population>The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (homologous strains) for both before (baseline) and after vaccination (ie, Day 22 and/or Day 181).&#xD;
Day 22 analyses are reported for the 302 and 257 (256 for the A/H3N2 strain) participants in the aQIV and Comparator QIV groups, respectively, who had immunogenicity data at both Day 1 and Day 22.</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="302"/>
                <count group_id="O2" value="257"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="302"/>
                    <count group_id="O2" value="257"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.9" lower_limit="52.2" upper_limit="63.6"/>
                    <measurement group_id="O2" value="56.4" lower_limit="50.1" upper_limit="62.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="302"/>
                    <count group_id="O2" value="256"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.7" lower_limit="44.9" upper_limit="56.4"/>
                    <measurement group_id="O2" value="56.6" lower_limit="50.3" upper_limit="62.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Yamagata</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="302"/>
                    <count group_id="O2" value="257"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.5" lower_limit="68.2" upper_limit="78.4"/>
                    <measurement group_id="O2" value="57.2" lower_limit="50.9" upper_limit="63.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Victoria</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="302"/>
                    <count group_id="O2" value="257"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72.2" lower_limit="66.8" upper_limit="77.2"/>
                    <measurement group_id="O2" value="58.0" lower_limit="51.7" upper_limit="64.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Vaccine Group Difference (aQIV - QIV) for A/H1N1 at Day 22</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.7</ci_lower_limit>
            <ci_upper_limit>9.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 22</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-6.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-14.2</ci_lower_limit>
            <ci_upper_limit>2.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 22</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>16.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>8.4</ci_lower_limit>
            <ci_upper_limit>24.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Vaccine Group Difference (aQIV - QIV) for B/Victoria at Day 22</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>14.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>6.3</ci_lower_limit>
            <ci_upper_limit>22.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and and Differences in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Homologous Influenza Strains (Day 22).</title>
        <description>The percentage of subjects achieving HI titer ≥1:40 at Day 22 after vaccination is reported for homologous strains. Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab</description>
        <time_frame>Day 1, Day 22</time_frame>
        <population>The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (homologous strains) for both before (baseline) and after vaccination (ie, Day 22 and/or Day 181).&#xD;
Day 22 analyses are reported for the 302 and 257 (256 for the A/H3N2 strain) participants in the aQIV and Comparator QIV groups, respectively, who had immunogenicity data at both Day 1 and Day 22.</population>
        <group_list>
          <group group_id="O1">
            <title>Adjuvanted Quadrivalent Influenza Vaccine (aQIV)</title>
            <description>Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118_05 received aQIV in study V118_05E1.</description>
          </group>
          <group group_id="O2">
            <title>Comparator Quadrivalent Influenza Vaccine (QIV)</title>
            <description>Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118_05 received QIV in the study V118_05E1.</description>
          </group>
        </group_list>
        <measure>
          <title>Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and and Differences in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Homologous Influenza Strains (Day 22).</title>
          <description>The percentage of subjects achieving HI titer ≥1:40 at Day 22 after vaccination is reported for homologous strains. Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab</description>
          <population>The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (homologous strains) for both before (baseline) and after vaccination (ie, Day 22 and/or Day 181).&#xD;
Day 22 analyses are reported for the 302 and 257 (256 for the A/H3N2 strain) participants in the aQIV and Comparator QIV groups, respectively, who had immunogenicity data at both Day 1 and Day 22.</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="302"/>
                <count group_id="O2" value="257"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1, Homologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="302"/>
                    <count group_id="O2" value="257"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="98.8" upper_limit="100.0"/>
                    <measurement group_id="O2" value="99.6" lower_limit="97.9" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2, Homologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="302"/>
                    <count group_id="O2" value="256"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.7" lower_limit="98.2" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="98.6" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Yamagata, Homologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="302"/>
                    <count group_id="O2" value="257"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.7" lower_limit="92.8" upper_limit="97.7"/>
                    <measurement group_id="O2" value="81.3" lower_limit="76.0" upper_limit="85.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Victoria, Homologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="302"/>
                    <count group_id="O2" value="257"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.0" lower_limit="95.7" upper_limit="99.3"/>
                    <measurement group_id="O2" value="72.0" lower_limit="66.1" upper_limit="77.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Vaccine Group Difference (aQIV - QIV) for A/H1N1 at Day 22</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.9</ci_lower_limit>
            <ci_upper_limit>2.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 22</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-0.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.9</ci_lower_limit>
            <ci_upper_limit>1.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 22</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>14.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>9.3</ci_lower_limit>
            <ci_upper_limit>20.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Vaccine Group Difference (aQIV - QIV) for B/Victoria at Day 22</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>26.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>20.6</ci_lower_limit>
            <ci_upper_limit>32.0</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety Endpoint: Number of Subjects With a Diagnosis of Failure to Thrive or Short Stature</title>
        <description>Short stature was defined as a height/length that was 2 or more standard deviations below the mean for age and gender within a population and was assessed as being below the 2nd z-score (worse outcome) on the length/height-for-age scale. Failure-to-thrive was defined by inadequate weight gain and physical growth and assessed through 2 or more of the following criteria: height/length-for-age, weight-for-age or weight-for-height/length below the 2nd z-score, a child's growth line crossing a z-score line, a sharp change in growth curve or a curve that remains flat. The observations were made for 2 or more time points each divided by at least 2 months.</description>
        <time_frame>Day 1 through Day 366 (Day 1, Day 22, Day 181, Day 366)</time_frame>
        <population>The Unsolicited Safety Set consisting of subjects who received a study vaccination and who had any AE assessments (ie, a subject did not have to have an AE to be included in this population) was used for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>aQIV</title>
            <description>Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118_05 received aQIV in study V118_05E1.</description>
          </group>
          <group group_id="O2">
            <title>Comparator QIV</title>
            <description>Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118_05 received QIV in study V118_05E1.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety Endpoint: Number of Subjects With a Diagnosis of Failure to Thrive or Short Stature</title>
          <description>Short stature was defined as a height/length that was 2 or more standard deviations below the mean for age and gender within a population and was assessed as being below the 2nd z-score (worse outcome) on the length/height-for-age scale. Failure-to-thrive was defined by inadequate weight gain and physical growth and assessed through 2 or more of the following criteria: height/length-for-age, weight-for-age or weight-for-height/length below the 2nd z-score, a child's growth line crossing a z-score line, a sharp change in growth curve or a curve that remains flat. The observations were made for 2 or more time points each divided by at least 2 months.</description>
          <population>The Unsolicited Safety Set consisting of subjects who received a study vaccination and who had any AE assessments (ie, a subject did not have to have an AE to be included in this population) was used for analysis.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="317"/>
                <count group_id="O2" value="290"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Subjects with diagnosis of failure to thrive</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>Subjects with diagnosis of short stature</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>Safety Endpoint: Number of Subjects With Any Unsolicited AEs</title>
        <description>Safety was assessed in terms of number of subjects between 12 months and 7 years of age reporting unsolicited events up to 12 months after last vaccination with either aQIV or QIV (comparator).</description>
        <time_frame>Day 1 through Day 22</time_frame>
        <population>The Unsolicited Safety Set consisting of subjects who received a study vaccination and who had any AE assessments (ie, a subject did not have to have an AE to be included in this population) was used for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>aQIV</title>
            <description>Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118_05 received aQIV in study V118_05E1.</description>
          </group>
          <group group_id="O2">
            <title>Comparator QIV</title>
            <description>Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118_05 received QIV in the present study V118_05E1.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety Endpoint: Number of Subjects With Any Unsolicited AEs</title>
          <description>Safety was assessed in terms of number of subjects between 12 months and 7 years of age reporting unsolicited events up to 12 months after last vaccination with either aQIV or QIV (comparator).</description>
          <population>The Unsolicited Safety Set consisting of subjects who received a study vaccination and who had any AE assessments (ie, a subject did not have to have an AE to be included in this population) was used for analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="317"/>
                <count group_id="O2" value="288"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85"/>
                    <measurement group_id="O2" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs)</title>
        <description>Safety was assessed in terms of number of subjects between 12 months and 7 years of age reporting solicited local and systemic AEs, day 1 to day 7 after vaccination with either aQIV or QIV (comparator).</description>
        <time_frame>Up to 7 days following vaccination</time_frame>
        <population>The Solicited Safety Set consisting of subjects who received a study vaccination and had any assessment of local and systemic reactions and/or assessment of any use of analgesics/antipyretics was used for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>aQIV</title>
            <description>Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118_05 received aQIV in study V118_05E1.</description>
          </group>
          <group group_id="O2">
            <title>Comparator QIV</title>
            <description>Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118_05 received QIV in study V118_05E1.</description>
          </group>
        </group_list>
        <measure>
          <title>Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs)</title>
          <description>Safety was assessed in terms of number of subjects between 12 months and 7 years of age reporting solicited local and systemic AEs, day 1 to day 7 after vaccination with either aQIV or QIV (comparator).</description>
          <population>The Solicited Safety Set consisting of subjects who received a study vaccination and had any assessment of local and systemic reactions and/or assessment of any use of analgesics/antipyretics was used for analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="317"/>
                <count group_id="O2" value="288"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Solicited AEs, Any</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="202"/>
                    <measurement group_id="O2" value="148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Solicited Local AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="173"/>
                    <measurement group_id="O2" value="112"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Solicited Systemic AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="127"/>
                    <measurement group_id="O2" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 181)</title>
        <description>The percentage of subjects achieving seroconversion at Day 181 after vaccination is reported for homologous strains. Seroconversion is defined as HI ≥1:40 for subjects negative at baseline [&lt;1:10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI ≥1:10]; Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab.</description>
        <time_frame>Day 1, Day 181</time_frame>
        <population>The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (homologous strains) for both before (baseline) and after vaccination (ie, Day 22 and/or Day 181).&#xD;
Day 181 analyses are reported for the 289 and 251 participants in the aQIV and Comparator QIV groups, respectively, who had immunogenicity data at both Day 1 and Day 181.</population>
        <group_list>
          <group group_id="O1">
            <title>Adjuvanted Quadrivalent Influenza Vaccine (aQIV)</title>
            <description>Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118_05 received aQIV in the study V118_05E1.</description>
          </group>
          <group group_id="O2">
            <title>Comparator Quadrivalent Influenza Vaccine (QIV)</title>
            <description>Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118_05 received QIV in study V118_05E1.</description>
          </group>
        </group_list>
        <measure>
          <title>Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 181)</title>
          <description>The percentage of subjects achieving seroconversion at Day 181 after vaccination is reported for homologous strains. Seroconversion is defined as HI ≥1:40 for subjects negative at baseline [&lt;1:10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI ≥1:10]; Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab.</description>
          <population>The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (homologous strains) for both before (baseline) and after vaccination (ie, Day 22 and/or Day 181).&#xD;
Day 181 analyses are reported for the 289 and 251 participants in the aQIV and Comparator QIV groups, respectively, who had immunogenicity data at both Day 1 and Day 181.</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="289"/>
                <count group_id="O2" value="251"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1, Homologous</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.7" lower_limit="22.6" upper_limit="33.2"/>
                    <measurement group_id="O2" value="21.9" lower_limit="17.0" upper_limit="27.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2, Homologous</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.1" lower_limit="24.9" upper_limit="35.8"/>
                    <measurement group_id="O2" value="27.9" lower_limit="22.4" upper_limit="33.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Yamagata, Homologous</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.6" lower_limit="19.7" upper_limit="29.9"/>
                    <measurement group_id="O2" value="12.7" lower_limit="8.9" upper_limit="17.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Victoria, Homologous</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.5" lower_limit="16.9" upper_limit="26.6"/>
                    <measurement group_id="O2" value="22.7" lower_limit="17.7" upper_limit="28.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Vaccine Group Difference (aQIV - QIV) for A/H1N1 at Day 181</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>5.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-1.6</ci_lower_limit>
            <ci_upper_limit>13.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 181</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>2.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.5</ci_lower_limit>
            <ci_upper_limit>9.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 181</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>11.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.3</ci_lower_limit>
            <ci_upper_limit>18.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Vaccine Group Difference (aQIV - QIV) for B/Victoria at Day 181</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-8.4</ci_lower_limit>
            <ci_upper_limit>5.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and Difference in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Homologous Influenza Strains (Day 181)</title>
        <description>The percentage of subjects achieving HI titer ≥1:40 at Day 181 after vaccination is reported for homologous strains; Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab</description>
        <time_frame>Day 1, Day 181</time_frame>
        <population>The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (homologous strains) for both before (baseline) and after vaccination (ie, Day 22 and/or Day 181).&#xD;
Day 181 analyses are reported for the 289 and 251 participants in the aQIV and Comparator QIV groups, respectively, who had immunogenicity data at both Day 1 and Day 181.</population>
        <group_list>
          <group group_id="O1">
            <title>Adjuvanted Quadrivalent Influenza Vaccine (aQIV)</title>
            <description>Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118_05 received aQIV in study V118_05E1.</description>
          </group>
          <group group_id="O2">
            <title>Comparator Quadrivalent Influenza Vaccine (QIV)</title>
            <description>Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118_05 received QIV in study V118_05E1.</description>
          </group>
        </group_list>
        <measure>
          <title>Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and Difference in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Homologous Influenza Strains (Day 181)</title>
          <description>The percentage of subjects achieving HI titer ≥1:40 at Day 181 after vaccination is reported for homologous strains; Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab</description>
          <population>The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (homologous strains) for both before (baseline) and after vaccination (ie, Day 22 and/or Day 181).&#xD;
Day 181 analyses are reported for the 289 and 251 participants in the aQIV and Comparator QIV groups, respectively, who had immunogenicity data at both Day 1 and Day 181.</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="289"/>
                <count group_id="O2" value="251"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1, Homologous</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.7" lower_limit="98.1" upper_limit="100.0"/>
                    <measurement group_id="O2" value="94.8" lower_limit="91.3" upper_limit="97.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2, Homologous</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.7" lower_limit="98.1" upper_limit="100.0"/>
                    <measurement group_id="O2" value="94.0" lower_limit="90.3" upper_limit="96.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Yamagata, Homologous</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.0" lower_limit="67.5" upper_limit="78.0"/>
                    <measurement group_id="O2" value="39.8" lower_limit="33.7" upper_limit="46.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Victoria, Homologous</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.4" lower_limit="77.5" upper_limit="86.6"/>
                    <measurement group_id="O2" value="45.0" lower_limit="38.8" upper_limit="51.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Vaccine Group Difference (aQIV - QIV) for A/H1N1 at Day 181</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>4.8</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.4</ci_lower_limit>
            <ci_upper_limit>8.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 181</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>5.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.1</ci_lower_limit>
            <ci_upper_limit>9.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 181</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>33.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>25.0</ci_lower_limit>
            <ci_upper_limit>40.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Vaccine Group Difference (aQIV - QIV) for B/Victoria at Day 181</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>37.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>29.6</ci_lower_limit>
            <ci_upper_limit>44.7</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) and GMT Ratios for Homologous Influenza Strains (Day 1, Day 22, Day 181)</title>
        <description>Adjusted GMT, GMR and 95% confidence interval (CI) were analyzed using ANCOVA with study specific covariates. Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab</description>
        <time_frame>Day 1, Day 22, Day 181</time_frame>
        <population>The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (homologous strains) for both before (baseline) and after vaccination (ie, Day 22 and/or Day 181).&#xD;
Day 22 analyses are reported for 302 and 257 (256 for the A/H3N2 strain) participants in the aQIV and Comparator QIV groups, respectively.&#xD;
Day 181 analyses are reported for 289 and 251 participants in the aQIV and Comparator QIV groups, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Adjuvanted Quadrivalent Influenza Vaccine (aQIV)</title>
            <description>Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118_05 received aQIV in study V118_05E1.</description>
          </group>
          <group group_id="O2">
            <title>Comparator Quadrivalent Influenza Vaccine (QIV)</title>
            <description>Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118_05 received QIV in study V118_05E1.</description>
          </group>
        </group_list>
        <measure>
          <title>Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) and GMT Ratios for Homologous Influenza Strains (Day 1, Day 22, Day 181)</title>
          <description>Adjusted GMT, GMR and 95% confidence interval (CI) were analyzed using ANCOVA with study specific covariates. Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab</description>
          <population>The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (homologous strains) for both before (baseline) and after vaccination (ie, Day 22 and/or Day 181).&#xD;
Day 22 analyses are reported for 302 and 257 (256 for the A/H3N2 strain) participants in the aQIV and Comparator QIV groups, respectively.&#xD;
Day 181 analyses are reported for 289 and 251 participants in the aQIV and Comparator QIV groups, respectively.</population>
          <units>titer</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="309"/>
                <count group_id="O2" value="273"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1: A/H1N1, Homologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="309"/>
                    <count group_id="O2" value="273"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="320.27" lower_limit="261.9" upper_limit="391.6"/>
                    <measurement group_id="O2" value="165.23" lower_limit="134.0" upper_limit="203.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22: A/H1N1, Homologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="302"/>
                    <count group_id="O2" value="257"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1036.27" lower_limit="923.2" upper_limit="1163.2"/>
                    <measurement group_id="O2" value="700.78" lower_limit="623.7" upper_limit="787.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 181: A/H1N1, Homologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="251"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="424.00" lower_limit="374.2" upper_limit="480.5"/>
                    <measurement group_id="O2" value="282.31" lower_limit="248.8" upper_limit="320.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: A/H3N2, Homologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="309"/>
                    <count group_id="O2" value="273"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="336.88" lower_limit="268.5" upper_limit="422.7"/>
                    <measurement group_id="O2" value="155.97" lower_limit="123.1" upper_limit="197.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22: A/H3N2, Homologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="302"/>
                    <count group_id="O2" value="256"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1221.47" lower_limit="1093.1" upper_limit="1364.9"/>
                    <measurement group_id="O2" value="908.63" lower_limit="810.0" upper_limit="1019.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 181: A/H3N2, Homologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="251"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="611.09" lower_limit="529.0" upper_limit="705.9"/>
                    <measurement group_id="O2" value="454.46" lower_limit="391.5" upper_limit="527.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: B/Yamagata, Homologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="309"/>
                    <count group_id="O2" value="273"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.36" lower_limit="26.9" upper_limit="38.9"/>
                    <measurement group_id="O2" value="17.78" lower_limit="14.7" upper_limit="21.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22: B/Yamagata, Homologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="302"/>
                    <count group_id="O2" value="257"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="176.04" lower_limit="150.8" upper_limit="205.5"/>
                    <measurement group_id="O2" value="100.80" lower_limit="86.1" upper_limit="181.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 181: B/Yamagata, Homologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="251"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.08" lower_limit="46.6" upper_limit="62.8"/>
                    <measurement group_id="O2" value="29.26" lower_limit="25.1" upper_limit="34.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: B/Victoria, Homologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="309"/>
                    <count group_id="O2" value="273"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.41" lower_limit="38.0" upper_limit="56.6"/>
                    <measurement group_id="O2" value="14.33" lower_limit="11.6" upper_limit="17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22: B/Victoria, Homologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="302"/>
                    <count group_id="O2" value="257"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="244.52" lower_limit="203.6" upper_limit="293.7"/>
                    <measurement group_id="O2" value="163.95" lower_limit="135.6" upper_limit="198.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 181: B/Victoria, Homologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="251"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.85" lower_limit="55.9" upper_limit="77.6"/>
                    <measurement group_id="O2" value="50.88" lower_limit="42.9" upper_limit="60.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The ratio of GMT (GMTr) values between aQIV vs. QIV (ie, GMT[aQIV]:GMT[QIV]) for A/H1N1 at Day 1.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMT Ratio</param_type>
            <param_value>1.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.6</ci_lower_limit>
            <ci_upper_limit>2.4</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>GMTr values between aQIV vs. QIV (ie, GMT[aQIV]:GMT[QIV]) for A/H1N1 at Day 22.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMT Ratio</param_type>
            <param_value>1.48</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.3</ci_lower_limit>
            <ci_upper_limit>1.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>GMTr values between aQIV vs. QIV (ie, GMT[aQIV]:GMT[QIV]) for A/H1N1 at Day 181.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMT Ratio</param_type>
            <param_value>1.50</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.3</ci_lower_limit>
            <ci_upper_limit>1.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>GMTr values between aQIV vs. QIV (ie, GMT[aQIV]:GMT[QIV]) for A/H3N2 at Day 1.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMT Ratio</param_type>
            <param_value>2.16</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.7</ci_lower_limit>
            <ci_upper_limit>2.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>GMTr values between aQIV vs. QIV (ie, GMT[aQIV]:GMT[QIV]) for A/H3N2 at Day 22.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMT Ratio</param_type>
            <param_value>1.34</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.2</ci_lower_limit>
            <ci_upper_limit>1.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>GMTr values between aQIV vs. QIV (ie, GMT[aQIV]:GMT[QIV]) for A/H3N2 at Day 181.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMT Ratio</param_type>
            <param_value>1.34</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.2</ci_lower_limit>
            <ci_upper_limit>1.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>GMTr values between aQIV vs. QIV (ie, GMT[aQIV]:GMT[QIV]) for B/Yamagata at Day 1.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMT Ratio</param_type>
            <param_value>1.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.5</ci_lower_limit>
            <ci_upper_limit>2.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>GMTr values between aQIV vs. QIV (ie, GMT[aQIV]:GMT[QIV]) for B/Yamagata at Day 22.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMT Ratio</param_type>
            <param_value>1.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.5</ci_lower_limit>
            <ci_upper_limit>2.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>GMTr values between aQIV vs. QIV (ie, GMT[aQIV]:GMT[QIV]) for B/Yamagata at Day 181.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMT Ratio</param_type>
            <param_value>1.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.6</ci_lower_limit>
            <ci_upper_limit>2.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>GMTr values between aQIV vs. QIV (ie, GMT[aQIV]:GMT[QIV]) for B/Victoria at Day 1.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMT Ratio</param_type>
            <param_value>3.24</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.7</ci_lower_limit>
            <ci_upper_limit>4.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>GMTr values between aQIV vs. QIV (ie, GMT[aQIV]:GMT[QIV]) for B/Victoria at Day 22.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMT Ratio</param_type>
            <param_value>1.49</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.2</ci_lower_limit>
            <ci_upper_limit>1.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>GMTr values between aQIV vs. QIV (ie, GMT[aQIV]:GMT[QIV]) for B/Victoria at Day 181.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMT Ratio</param_type>
            <param_value>1.29</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.1</ci_lower_limit>
            <ci_upper_limit>1.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains</title>
        <description>The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. Adjusted GMT, GMR and 95% CI were analyzed using ANCOVA with study specific covariates. Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab</description>
        <time_frame>Day 1, Day 22, and Day 181</time_frame>
        <population>The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (homologous strains) for both before (baseline) and after vaccination (ie, Day 22 and/or Day 181).&#xD;
Note: Subjects may be included in the Day 181 analyses but not the Day 22 analyses (and vice versa).</population>
        <group_list>
          <group group_id="O1">
            <title>Adjuvanted Quadrivalent Influenza Vaccine (aQIV)</title>
            <description>Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118_05 received aQIV in study V118_05E1.</description>
          </group>
          <group group_id="O2">
            <title>Comparator Quadrivalent Influenza Vaccine (QIV)</title>
            <description>Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118_05 received QIV in study V118_05E1.</description>
          </group>
        </group_list>
        <measure>
          <title>Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains</title>
          <description>The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. Adjusted GMT, GMR and 95% CI were analyzed using ANCOVA with study specific covariates. Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab</description>
          <population>The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (homologous strains) for both before (baseline) and after vaccination (ie, Day 22 and/or Day 181).&#xD;
Note: Subjects may be included in the Day 181 analyses but not the Day 22 analyses (and vice versa).</population>
          <units>ratio</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="309"/>
                <count group_id="O2" value="273"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22/Day 1: A/H1N1, Homologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="302"/>
                    <count group_id="O2" value="257"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.82" lower_limit="5.2" upper_limit="6.5"/>
                    <measurement group_id="O2" value="3.93" lower_limit="3.5" upper_limit="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 181/Day 1: A/H1N1, Homologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="251"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.40" lower_limit="2.1" upper_limit="2.7"/>
                    <measurement group_id="O2" value="1.60" lower_limit="1.4" upper_limit="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22/Day 1: A/H3N2, Homologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="302"/>
                    <count group_id="O2" value="257"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.41" lower_limit="4.8" upper_limit="6.0"/>
                    <measurement group_id="O2" value="4.03" lower_limit="3.6" upper_limit="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 181/Day 1: A/H3N2, Homologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="251"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.73" lower_limit="2.4" upper_limit="3.2"/>
                    <measurement group_id="O2" value="2.03" lower_limit="1.8" upper_limit="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22/Day 1: B/Yamagata, Homologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="302"/>
                    <count group_id="O2" value="257"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.33" lower_limit="7.1" upper_limit="9.7"/>
                    <measurement group_id="O2" value="4.77" lower_limit="4.1" upper_limit="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 181/Day 1: B/Yamagata, Homologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="251"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.57" lower_limit="2.2" upper_limit="3.0"/>
                    <measurement group_id="O2" value="1.39" lower_limit="1.2" upper_limit="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22/Day 1: B/Victoria, Homologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="302"/>
                    <count group_id="O2" value="257"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.26" lower_limit="7.7" upper_limit="11.1"/>
                    <measurement group_id="O2" value="6.21" lower_limit="5.1" upper_limit="7.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 181/Day 1: B/Victoria, Homologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="289"/>
                    <count group_id="O2" value="251"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.55" lower_limit="2.2" upper_limit="3.0"/>
                    <measurement group_id="O2" value="1.97" lower_limit="1.7" upper_limit="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Difference in Percentage of Subjects Achieving Seroconversion for Heterologous Influenza Strains (Day 181)</title>
        <description>The percentage of subjects achieving seroconversion at Day 181 after vaccination is reported for homologous strains. Seroconversion is defined as HI ≥1:40 for subjects negative at baseline [&lt;1:10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI ≥1:10]; Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab</description>
        <time_frame>Day 1, Day 181</time_frame>
        <population>The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (heterologous strains) for both before (baseline) and after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Adjuvanted Quadrivalent Influenza Vaccine (aQIV)</title>
            <description>Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118_05 received aQIV in study V118_05E1.</description>
          </group>
          <group group_id="O2">
            <title>Comparator Quadrivalent Influenza Vaccine (QIV)</title>
            <description>Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118_05 received QIV in study V118_05E1.</description>
          </group>
        </group_list>
        <measure>
          <title>Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Difference in Percentage of Subjects Achieving Seroconversion for Heterologous Influenza Strains (Day 181)</title>
          <description>The percentage of subjects achieving seroconversion at Day 181 after vaccination is reported for homologous strains. Seroconversion is defined as HI ≥1:40 for subjects negative at baseline [&lt;1:10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI ≥1:10]; Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab</description>
          <population>The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (heterologous strains) for both before (baseline) and after vaccination.</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="155"/>
                <count group_id="O2" value="138"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H3N2, Heterologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="155"/>
                    <count group_id="O2" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.1" lower_limit="28.6" upper_limit="44.2"/>
                    <measurement group_id="O2" value="30.4" lower_limit="22.9" upper_limit="38.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Yamagata, Heterologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="155"/>
                    <count group_id="O2" value="136"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.7" lower_limit="20.9" upper_limit="35.5"/>
                    <measurement group_id="O2" value="13.2" lower_limit="8.0" upper_limit="20.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 181</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>5.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.2</ci_lower_limit>
            <ci_upper_limit>16.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 181</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>14.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>5.3</ci_lower_limit>
            <ci_upper_limit>23.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and Difference in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Heterologous Influenza Strains (Day 181)</title>
        <description>The percentage of subjects achieving HI titer ≥1:40 at Day 181 after vaccination is reported for homologous strains; Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab</description>
        <time_frame>Day 1, Day 181</time_frame>
        <population>The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (heterologous strains) for both before (baseline) and after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Adjuvanted Quadrivalent Influenza Vaccine (aQIV)</title>
            <description>Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118_05 received aQIV in study V118_05E1.</description>
          </group>
          <group group_id="O2">
            <title>Comparator Quadrivalent Influenza Vaccine (QIV)</title>
            <description>Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118_05 received QIV in study V118_05E1.</description>
          </group>
        </group_list>
        <measure>
          <title>Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and Difference in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Heterologous Influenza Strains (Day 181)</title>
          <description>The percentage of subjects achieving HI titer ≥1:40 at Day 181 after vaccination is reported for homologous strains; Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab</description>
          <population>The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (heterologous strains) for both before (baseline) and after vaccination.</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="155"/>
                <count group_id="O2" value="138"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H3N2, Heterologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="155"/>
                    <count group_id="O2" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.8" lower_limit="92.6" upper_limit="98.9"/>
                    <measurement group_id="O2" value="80.4" lower_limit="72.8" upper_limit="86.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Yamagata, Heterologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="155"/>
                    <count group_id="O2" value="136"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.9" lower_limit="77.1" upper_limit="89.3"/>
                    <measurement group_id="O2" value="37.5" lower_limit="29.4" upper_limit="46.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Vaccine Group Difference (aQIV - QIV) for A/H3N2 at Day 181</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>16.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>9.5</ci_lower_limit>
            <ci_upper_limit>24.1</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Vaccine Group Difference (aQIV - QIV) for B/Yamagata at Day 181</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>46.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>35.9</ci_lower_limit>
            <ci_upper_limit>55.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) for Heterologous Influenza Strains (Day 1, Day 22, Day 181)</title>
        <description>Adjusted GMT, GMR and 95% CI were analyzed using ANCOVA with study specific covariates. Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab</description>
        <time_frame>Day 1, Day 22, Day 181</time_frame>
        <population>The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (heterologous strains) for both before (baseline) and after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Adjuvanted Quadrivalent Influenza Vaccine (aQIV)</title>
            <description>Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118_05 received aQIV in study V118_05E1.</description>
          </group>
          <group group_id="O2">
            <title>Comparator Quadrivalent Influenza Vaccine (QIV)</title>
            <description>Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118_05 received QIV in study V118_05E1.</description>
          </group>
        </group_list>
        <measure>
          <title>Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) for Heterologous Influenza Strains (Day 1, Day 22, Day 181)</title>
          <description>Adjusted GMT, GMR and 95% CI were analyzed using ANCOVA with study specific covariates. Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab</description>
          <population>The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (heterologous strains) for both before (baseline) and after vaccination.</population>
          <units>titer</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="155"/>
                <count group_id="O2" value="138"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1: A/H3N2, Heterologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="155"/>
                    <count group_id="O2" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="126.35" lower_limit="83.7" upper_limit="190.8"/>
                    <measurement group_id="O2" value="48.02" lower_limit="31.7" upper_limit="72.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22: A/H3N2, Heterologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="155"/>
                    <count group_id="O2" value="137"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="630.62" lower_limit="515.0" upper_limit="772.2"/>
                    <measurement group_id="O2" value="402.54" lower_limit="328.0" upper_limit="494.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 181: A/H3N2, Heterologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="155"/>
                    <count group_id="O2" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="304.10" lower_limit="229.9" upper_limit="402.3"/>
                    <measurement group_id="O2" value="179.12" lower_limit="134.9" upper_limit="237.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1: B/Yamagata, Heterologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="155"/>
                    <count group_id="O2" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.29" lower_limit="22.8" upper_limit="40.2"/>
                    <measurement group_id="O2" value="15.25" lower_limit="11.5" upper_limit="20.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22: B/Yamagata, Heterologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="137"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="196.27" lower_limit="156.0" upper_limit="246.9"/>
                    <measurement group_id="O2" value="88.92" lower_limit="70.6" upper_limit="112.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 181: B/Yamagata, Heterologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="155"/>
                    <count group_id="O2" value="136"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.60" lower_limit="55.7" upper_limit="87.0"/>
                    <measurement group_id="O2" value="27.27" lower_limit="21.8" upper_limit="34.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>GMTr values between aQIV vs. QIV (ie, GMT[aQIV]:GMT[QIV]) for A/H3N2 at Day 1.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMT Ratio</param_type>
            <param_value>2.63</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.8</ci_lower_limit>
            <ci_upper_limit>3.8</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>GMTr values between aQIV vs. QIV (ie, GMT[aQIV]:GMT[QIV]) for A/H3N2 at Day 22.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMT Ratio</param_type>
            <param_value>1.57</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.3</ci_lower_limit>
            <ci_upper_limit>2.9</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>GMTr values between aQIV vs. QIV (ie, GMT[aQIV]:GMT[QIV]) for A/H3N2 at Day 181.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMT Ratio</param_type>
            <param_value>1.70</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.3</ci_lower_limit>
            <ci_upper_limit>2.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>GMTr values between aQIV vs. QIV (ie, GMT[aQIV]:GMT[QIV]) for B/Yamagata at Day 1.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMT Ratio</param_type>
            <param_value>1.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.5</ci_lower_limit>
            <ci_upper_limit>2.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>GMTr values between aQIV vs. QIV (ie, GMT[aQIV]:GMT[QIV]) for A/H3N2 at Day 22.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMT Ratio</param_type>
            <param_value>2.21</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.8</ci_lower_limit>
            <ci_upper_limit>2.7</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>GMTr values between aQIV vs. QIV (ie, GMT[aQIV]:GMT[QIV]) for A/H3N2 at Day 181.</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>GMT Ratio</param_type>
            <param_value>2.55</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.1</ci_lower_limit>
            <ci_upper_limit>3.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Heterologous Influenza Strains</title>
        <description>The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. Adjusted GMT, GMR and 95% CI were analyzed using ANCOVA with study specific covariates. Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab</description>
        <time_frame>Day 1, Day 22, and Day 181</time_frame>
        <population>The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (heterologous strains) for both before (baseline) and after vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Adjuvanted Quadrivalent Influenza Vaccine (aQIV)</title>
            <description>Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118_05 received aQIV in study V118_05E1.</description>
          </group>
          <group group_id="O2">
            <title>Comparator Quadrivalent Influenza Vaccine (QIV)</title>
            <description>Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118_05 received QIV in study V118_05E1.</description>
          </group>
        </group_list>
        <measure>
          <title>Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Heterologous Influenza Strains</title>
          <description>The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. Adjusted GMT, GMR and 95% CI were analyzed using ANCOVA with study specific covariates. Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab</description>
          <population>The Full Analysis Set for Immunogenicity consisting of all enrolled subjects who received a study vaccination and provided evaluable serum samples (heterologous strains) for both before (baseline) and after vaccination.</population>
          <units>ratio</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="155"/>
                <count group_id="O2" value="138"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 22/Day 1: A/H3N2, Heterologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="137"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.80" lower_limit="6.4" upper_limit="9.6"/>
                    <measurement group_id="O2" value="4.98" lower_limit="4.1" upper_limit="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 181/Day 1: A/H3N2, Heterologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="155"/>
                    <count group_id="O2" value="138"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.72" lower_limit="2.8" upper_limit="4.9"/>
                    <measurement group_id="O2" value="2.19" lower_limit="1.7" upper_limit="2.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22/Day 1: B/Yamagata, Heterologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="154"/>
                    <count group_id="O2" value="137"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.29" lower_limit="7.4" upper_limit="11.7"/>
                    <measurement group_id="O2" value="4.21" lower_limit="3.3" upper_limit="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 181/Day 1: B/Yamagata, Heterologous</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="155"/>
                    <count group_id="O2" value="136"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.31" lower_limit="2.7" upper_limit="4.1"/>
                    <measurement group_id="O2" value="1.30" lower_limit="1.0" upper_limit="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Serious AEs: SAEs were captured from day 1 through day 366. Non Serious AEs: Solicited local and systemic AEs were reported from day 1 through day 7 after vaccination. All unsolicited AEs were captured through day 366.</time_frame>
      <desc>All-cause mortality and non-serious AEs are reported for the Overall Safety Set (all subjects in the Solicited Safety Set and/or in the Unsolicited Safety Set). SAEs are reported for the Unsolicited Safety Set.&#xD;
Note: A total of 318 subjects were assigned to the aQIV arm; however, 1 subject in the aQIV arm incorrectly received QIV instead of aQIV and is included in the Comparator QIV arm for the safety analyses.</desc>
      <group_list>
        <group group_id="E1">
          <title>aQIV</title>
          <description>Subjects approximately ≥12 months to 7 years of age who had received aQIV in the parent study V118_05 received aQIV in study V118_05E1.</description>
        </group>
        <group group_id="E2">
          <title>Comparator QIV</title>
          <description>Subjects approximately ≥12 months to 7 years of age who had received TIV in the parent study V118_05 received QIV in study V118_05E1.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="288"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Immune thrombocytopenic purpura</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="288"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Right ventricle outflow tract obstruction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="288"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="288"/>
              </event>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="288"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="288"/>
              </event>
              <event>
                <sub_title>Pyelonephritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="288"/>
              </event>
              <event>
                <sub_title>Tonsillitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="288"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="288"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Type 1 diabetes mellitus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="288"/>
              </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="317"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="288"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 19.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="253" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="210" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="20" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Influenza like illness</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" subjects_affected="88" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="58" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Injection site haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Injection site induration</sub_title>
                <counts group_id="E1" subjects_affected="58" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="32" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" subjects_affected="147" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="82" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="55" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="37" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" subjects_affected="37" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="38" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="74" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="53" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Eating disorder</sub_title>
                <counts group_id="E1" subjects_affected="55" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="290"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" subjects_affected="83" subjects_at_risk="317"/>
                <counts group_id="E2" subjects_affected="49" subjects_at_risk="290"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Study Disclosure Manager</name_or_title>
      <organization>Seqirus</organization>
      <email>Seqirus.ClinicalTrials@Seqirus.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02255409
org study id: V118_05E1
secondary id: 2014-002599-95
nct id: NCT02255409
lead sponsor: 
Safety, Immunogenicity of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared
      to Non-Adjuvanted Comparator Influenza Vaccine in Children Previously Vaccinated in Trial
      V118_05
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Safety Endpoint: Number of Subjects With SAEs, AEs Leading to Withdrawal From the Study, NOCDs, AESIs and Medically Attended AEs.
time frame: Day 1 through Day 356
description: Safety was assessed in terms of number of subjects between 12 months and 7 years of age reporting unsolicited events up to 12 months after last vaccination with either aQIV or QIV (comparator): serious adverse events (SAEs), AEs leading to study withdrawal, new onset chronic disease (NOCDs), adverse events of special interest (AESIs) and medically attended AEs after vaccination.
measure: Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 22)
time frame: Day 1, Day 22
description: The percentage of subjects achieving seroconversion at Day 22 after vaccination is reported for homologous strains; Seroconversion is defined as hemagglutination inhibition (HI) ≥1:40 for subjects negative at baseline [<1:10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI ≥1:10]; Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab
measure: Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and and Differences in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Homologous Influenza Strains (Day 22).
time frame: Day 1, Day 22
description: The percentage of subjects achieving HI titer ≥1:40 at Day 22 after vaccination is reported for homologous strains. Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab
measure: Safety Endpoint: Number of Subjects With a Diagnosis of Failure to Thrive or Short Stature
time frame: Day 1 through Day 366 (Day 1, Day 22, Day 181, Day 366)
description: Short stature was defined as a height/length that was 2 or more standard deviations below the mean for age and gender within a population and was assessed as being below the 2nd z-score (worse outcome) on the length/height-for-age scale. Failure-to-thrive was defined by inadequate weight gain and physical growth and assessed through 2 or more of the following criteria: height/length-for-age, weight-for-age or weight-for-height/length below the 2nd z-score, a child's growth line crossing a z-score line, a sharp change in growth curve or a curve that remains flat. The observations were made for 2 or more time points each divided by at least 2 months.
measure: Safety Endpoint: Number of Subjects With Any Unsolicited AEs
time frame: Day 1 through Day 22
description: Safety was assessed in terms of number of subjects between 12 months and 7 years of age reporting unsolicited events up to 12 months after last vaccination with either aQIV or QIV (comparator).
measure: Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs)
time frame: Up to 7 days following vaccination
description: Safety was assessed in terms of number of subjects between 12 months and 7 years of age reporting solicited local and systemic AEs, day 1 to day 7 after vaccination with either aQIV or QIV (comparator).
measure: Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 181)
time frame: Day 1, Day 181
description: The percentage of subjects achieving seroconversion at Day 181 after vaccination is reported for homologous strains. Seroconversion is defined as HI ≥1:40 for subjects negative at baseline [<1:10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI ≥1:10]; Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab.
measure: Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and Difference in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Homologous Influenza Strains (Day 181)
time frame: Day 1, Day 181
description: The percentage of subjects achieving HI titer ≥1:40 at Day 181 after vaccination is reported for homologous strains; Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab
measure: Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) and GMT Ratios for Homologous Influenza Strains (Day 1, Day 22, Day 181)
time frame: Day 1, Day 22, Day 181
description: Adjusted GMT, GMR and 95% confidence interval (CI) were analyzed using ANCOVA with study specific covariates. Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab
measure: Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains
time frame: Day 1, Day 22, and Day 181
description: The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. Adjusted GMT, GMR and 95% CI were analyzed using ANCOVA with study specific covariates. Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab
measure: Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Difference in Percentage of Subjects Achieving Seroconversion for Heterologous Influenza Strains (Day 181)
time frame: Day 1, Day 181
description: The percentage of subjects achieving seroconversion at Day 181 after vaccination is reported for homologous strains. Seroconversion is defined as HI ≥1:40 for subjects negative at baseline [<1:10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI ≥1:10]; Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab
measure: Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and Difference in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Heterologous Influenza Strains (Day 181)
time frame: Day 1, Day 181
description: The percentage of subjects achieving HI titer ≥1:40 at Day 181 after vaccination is reported for homologous strains; Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab
measure: Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) for Heterologous Influenza Strains (Day 1, Day 22, Day 181)
time frame: Day 1, Day 22, Day 181
description: Adjusted GMT, GMR and 95% CI were analyzed using ANCOVA with study specific covariates. Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab
measure: Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Heterologous Influenza Strains
time frame: Day 1, Day 22, and Day 181
description: The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. Adjusted GMT, GMR and 95% CI were analyzed using ANCOVA with study specific covariates. Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab
arm group label: aQIV
arm group type: Experimental
description: Adjuvanted Quadrivalent Subunit Influenza
arm group label: QIV
arm group type: Active Comparator
description: Non-Adjuvanted Quadrivalent Subunit Influenza
intervention type: Biological
intervention name: Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
description: 1 dose 0.25 ml: ≥6 months to <36 months, 0.5 ml: ≥36 months to <72 months
arm group label: aQIV
intervention type: Biological
intervention name: non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
description: 1 dose 0.25 ml: ≥6 months to <36 months, 0.5 ml: ≥36 months to <72 months
arm group label: QIV
criteria: 
gender: All
minimum age: 12 Months
maximum age: 84 Months
healthy volunteers: Accepts Healthy Volunteers
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country: Finland
country: United States
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Vaccines
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