<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/NCT02255279</url>
  </required_header>
  <id_info>
    <org_study_id>V70_50</org_study_id>
    <nct_id>NCT02255279</nct_id>
  </id_info>
  <brief_title>Safety and Immunogenicity of an Adjuvanted Trivalent Influenza Vaccine in Children 6 to &lt;72 Months of Age in Mexico.</brief_title>
  <official_title>A Phase 3, Observed-Blind, Randomized, Multi-center Study to Evaluate Safety and Immunogenicity of an Adjuvanted Trivalent Influenza Vaccine in Children 6 to &lt;72 Months of Age in Mexico.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Vaccines</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The administration of adjuvanted Trivalent Influenza Vaccine (aTIV) has come to result in a&#xD;
      more immunogenic and effective response compared with conventional influenza vaccines in&#xD;
      elderly and adults.&#xD;
&#xD;
      The aim of this study is to evaluate safety and immunogenicity of Novartis aTIV in children 6&#xD;
      to &lt;72 months of age, Mexican population, in comparison to Fluzone, a non-adjuvanted&#xD;
      trivalent influenza vaccine (TIV).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Naive Subjects 6 to &lt; 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination.</measure>
    <time_frame>From Day 1 to Day 7 by vaccination</time_frame>
    <description>Number of naive subjects 6 to &lt; 36 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after first vaccination and from Day 29 to Day 35 after second vaccination.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Non-naive Subjects 6 to &lt; 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination.</measure>
    <time_frame>From Day 1 to Day 7</time_frame>
    <description>Number of non-naive subjects 6 to &lt; 36 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after vaccination.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Naive Subjects ≥ 36 Months to &lt; 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination.</measure>
    <time_frame>From Day 1 to Day 7 by vaccination</time_frame>
    <description>Number of naive subjects ≥ 36 months to &lt; 72 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after first vaccination and from Day 29 to Day 35 after second vaccination.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Non-naive Subjects ≥36 Months to &lt; 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination.</measure>
    <time_frame>From Day 1 to Day 7</time_frame>
    <description>Number of non-naive subjects ≥36 months to &lt; 72 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after vaccination.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Naive Subjects Aged 6 to &lt; 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50.</measure>
    <time_frame>From Day 1 to Day 50</time_frame>
    <description>Number of naive subjects aged 6 to &lt; 72 months reporting all unsolicited AEs, medically attended AEs, AE leading to study withdrawal and serious AEs (SAEs) from Day 1 to Day 50.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Non-naive Subjects Aged 6 to &lt; 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22</measure>
    <time_frame>From Day 1 to Day 22</time_frame>
    <description>Number of non-naive subjects aged 6 to &lt; 72 months reporting all unsolicited AEs, medically attended AEs, AE leading to study withdrawal and SAEs from Day 1 to Day 22.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to &lt; 72 Months of Age.</measure>
    <time_frame>Day 1 and Day 22 (vaccine non-naïve subjects) or Day 50 (vaccine naïve subjects) post vaccination</time_frame>
    <description>Antibody response was assessed in terms of GMTs in all three homologous virus strains, 21 days after last immunization, in subjects 6 to &lt;72 months of age.&#xD;
The study is considered a success if the 21 days after last immunization GMT ratios of aTIV relative to TIV demonstrate as non-inferior with the lower limit (LL) of the two sided 95% confidence interval (CI) above 0.67 (-0.176 on log10 scale) for each vaccine strain (Center for Biologics Evaluation and Research {CBER} Guideline on Seasonal Vaccines May 2007).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentages of Subjects Achieving Seroconversion in Hemagglutination Inhibition (HI) Titers and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.</measure>
    <time_frame>Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination</time_frame>
    <description>Percentages of subjects with seroconversion in all three homologous virus strains, 21 days after last immunization, in subjects 6 to &lt;72 months of age, defined as: HI ≥ 40 subject with a pre-vaccination HI titer &lt;10; a minimum 4-fold increase HI titer for subjects with a prevaccination HI titer ≥10, on Day 22 (non-naive subjects) or Day 50 (naive subjects), as applicable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Ratios (GMRs) of HI and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.</measure>
    <time_frame>Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination</time_frame>
    <description>GMRs of HI, day 22/day 1 (non-naive subjects) or day 50/day 1 (naive subjects) in all three homologous virus strains, 21 days after last immunization, in subjects 6 to &lt;72 months of age. As the non-inferiority of aTIV to TIV has been established, GMT ratio of aTIV relative to TIV in all three homologous virus strains, 21 days after last immunization in subjects 6 to &lt;72 months of age was evaluated using margins greater than the non-inferiority cut-off of 0.67.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.</measure>
    <time_frame>Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination</time_frame>
    <description>Percentage of subjects with a HI titer ≥ 40, ≥110 and ≥330 on Day 1, Day 22 (non naïve subjects) or Day 50 (naïve subjects), in all three homologous virus strains, 21 days after last immunization, in subjects 6 to &lt;72 months of age.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">287</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>aTIV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>aTIV is a trivalent influenza virus vaccine, adjuvanted with MF59C.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TIV</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TIV is trivalent influenza vaccine licensed in Mexico.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Adjuvanted Trivalent Influenza Vaccine, 1 dose for non-naive subjects (day 1), two doses for naive subjects (day 1 and day 29)</intervention_name>
    <description>A 0.25 mL (for children 6 to &lt;36 months old) and 0.5 mL (for children ≥36 months to &lt; 72 months old) dose of aTIV, a trivalent (surface antigen, formaldehyde-inactivated) influenza virus vaccine, adjuvanted with MF59C.1, administered at day 1 (for all subjects) and day 29 (for naïve subjects).</description>
    <arm_group_label>aTIV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Non-adjuvanted Trivalent Influenza Vaccine, 1 dose for non-naive subjects (day 1), two doses for naive subjects (day 1 and day 29).</intervention_name>
    <description>A 0.25 mL (for children 6 to &lt;36 months old) and 0.5 mL (for children ≥36 months to &lt; 72 months old) dose of TIV , an egg-derived trivalent split influenza vaccine licensed in Mexico, administered at day 1 (for all subjects) and day 29 (for naïve subjects)</description>
    <arm_group_label>TIV</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals of &gt;6 months through &lt;72 months of age on the day of informed consent.&#xD;
&#xD;
          -  Individuals whose parent(s)/legal guardian(s) have voluntarily given written informed&#xD;
             consent after the nature of the study has been explained according to local regulatory&#xD;
             requirements, prior to study entry.&#xD;
&#xD;
          -  Individuals who can comply with study procedures.&#xD;
&#xD;
          -  Willingness to allow for serum samples to be stored beyond the study period, for&#xD;
             potential additional future testing to better characterize immune response.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Progressive, unstable or uncontrolled clinical conditions.&#xD;
&#xD;
          -  Hypersensitivity, including allergy, to any component of vaccines, medicinal products&#xD;
             or medical equipment whose use is foreseen in this study.&#xD;
&#xD;
          -  History of progressive or severe neurologic disorder, seizure disorder or&#xD;
             Guillain-Barré syndrome.&#xD;
&#xD;
          -  Surgery planned during the study period that in the Investigator's opinion would&#xD;
             interfere with the study visits schedule.&#xD;
&#xD;
          -  Known bleeding diathesis, or any condition that may be associated with a prolonged&#xD;
             bleeding time.&#xD;
&#xD;
          -  Any fatal prognosis of an underlying medical condition (&lt;12 month life expectancy).&#xD;
&#xD;
          -  Clinical conditions representing a contraindication to intramuscular vaccination and&#xD;
             blood draws.&#xD;
&#xD;
          -  Abnormal function of the immune system resulting from:&#xD;
&#xD;
               1. Clinical conditions.&#xD;
&#xD;
               2. Systemic administration of corticosteroids (PO/IV/IM) for more than 14&#xD;
                  consecutive days within 90 days prior to informed consent.&#xD;
&#xD;
               3. Administration of antineoplastic and immunomodulating agents or radiotherapy&#xD;
                  within 90 days prior to informed consent.&#xD;
&#xD;
          -  Received immunoglobulins or any blood products within 180 days prior to informed&#xD;
             consent.&#xD;
&#xD;
          -  Received an investigational or non-registered medicinal product within 30 days prior&#xD;
             to informed consent.&#xD;
&#xD;
          -  Study personnel as an immediate family or household member.&#xD;
&#xD;
          -  Any other clinical condition that, in the opinion of the investigator, might interfere&#xD;
             with the results of the study or pose additional risk to the subject due to&#xD;
             participation in the study.&#xD;
&#xD;
          -  Received any influenza vaccine (licensed or investigational) or with laboratory&#xD;
             confirmed influenza within 6 months prior enrollment.&#xD;
&#xD;
          -  Received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for&#xD;
             live vaccines) prior to enrolment in this study or who are planning to receive any&#xD;
             vaccine within 28 days from the study vaccines.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>71 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>03, Centro Médico Universitario</name>
      <address>
        <city>Colonia Chamilpa, Cuernavaca</city>
        <state>Morelos</state>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>02, Unidad de Atencion Medica E Investigacion En Salud S.C (Unamis)</name>
      <address>
        <city>Mérida</city>
        <state>Yucatán</state>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>04, Medical Care and Research S.A. de C.V.</name>
      <address>
        <city>Mérida</city>
        <state>Yucatán</state>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <results_first_submitted>January 4, 2016</results_first_submitted>
  <results_first_submitted_qc>January 4, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 3, 2016</results_first_posted>
  <last_update_submitted>November 30, 2016</last_update_submitted>
  <last_update_submitted_qc>November 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 27, 2017</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 3 study centers in Mexico.</recruitment_details>
      <pre_assignment_details>All enrolled subjects were included in study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>aTIV (6 Months to &lt; 72 Months)</title>
          <description>A 0.25 mL (for children 6 to &lt;36 months old) and 0.5 mL (for children ≥36 months to &lt; 72 months old) dose of aTIV to be administered.</description>
        </group>
        <group group_id="P2">
          <title>TIV (6 Months to &lt; 72 Months)</title>
          <description>A 0.25 mL (for children 6 to &lt;36 months old) and 0.5 mL (for children ≥36 months to &lt; 72 months old) dose of TIV to be administered.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="144"/>
                <participants group_id="P2" count="143"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="139"/>
                <participants group_id="P2" count="134"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>aTIV (6 Months to &lt; 72 Months)</title>
          <description>A 0.25 mL (for children 6 to &lt;36 months old) and 0.5 mL (for children ≥36 months to &lt; 72 months old) dose of aTIV to be administered.</description>
        </group>
        <group group_id="B2">
          <title>TIV (6 Months to &lt; 72 Months)</title>
          <description>A 0.25 mL (for children 6 to &lt;36 months old) and 0.5 mL (for children ≥36 months to &lt; 72 months old) dose of TIV to be administered.</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="144"/>
            <count group_id="B2" value="143"/>
            <count group_id="B3" value="287"/>
          </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="29.5" spread="18.2"/>
                    <measurement group_id="B2" value="30.1" spread="19.1"/>
                    <measurement group_id="B3" value="29.8" spread="18.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</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="68"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="140"/>
                  </measurement_list>
                </category>
                <category>
                  <title>MALE</title>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="147"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Naive Subjects 6 to &lt; 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination.</title>
        <description>Number of naive subjects 6 to &lt; 36 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after first vaccination and from Day 29 to Day 35 after second vaccination.</description>
        <time_frame>From Day 1 to Day 7 by vaccination</time_frame>
        <population>Analysis performed on the Solicited Safety Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Naive_aTIV (6 to &lt;36 Months)</title>
            <description>A 0.25 mL (for children 6 to &lt;36 months old) dose of aTIV to be administered.</description>
          </group>
          <group group_id="O2">
            <title>Naive_TIV (6 to &lt;36 Months)</title>
            <description>A 0.25 mL (for children 6 to &lt;36 months old) dose of TIV to be administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Naive Subjects 6 to &lt; 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination.</title>
          <description>Number of naive subjects 6 to &lt; 36 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after first vaccination and from Day 29 to Day 35 after second vaccination.</description>
          <population>Analysis performed on the Solicited Safety Set.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Local (Vac-1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Local (Vac-2, N= 67,67)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site ecchymosis (Vac-1, N= 65,69)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site ecchymosis (Vac-2, N= 66,67)</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>Injection site induration (Vac-1, N= 66,69)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site induration (Vac-2, N= 66,67)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site swelling (Vac-1, N= 65,69)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site swelling (Vac-2, N= 66,67)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site erythema (Vac-1, N= 64,69)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site erythema (Vac-2, N= 66,67)</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>Injection site tenderness (Vac-1, N= 66,69)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site tenderness (Vac-1, N= 66,66)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Systemic (Vac-1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Systemic (Vac-2, N=67,67)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body Temperature (&gt;=40°C) (Vac-1, N= 67,68)</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>Body Temperature (&gt;=40°C) (Vac-2, N= 67,67)</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>Fever (Vac-1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever (Vac-2, N= 67,67)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in eating habits (Vac-1, N= 67,69)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in eating habits (Vac-2, N= 66,67)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea (Vac-1, N= 67,69)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea (Vac-2, N= 66,67)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Irritability (Vac-1, N= 67,69)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Irritability (Vac-2, N= 66,67)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Persistent Crying (Vac-1, N= 67,69)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Persistent Crying (Vac-2, N= 66,67)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sleepiness (Vac-1, N= 67,68)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sleepiness (Vac-2, N= 65,67)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting (Vac-1, N= 67,68)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting (Vac-2, N= 65,67)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prevention of Pain and or Fever (Vac-1, N= 67,67)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prevention of Pain and or Fever (Vac-2, N= 64,67)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment of Pain and or Fever (Vac-1, N= 67,67)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment of Pain and or Fever (Vac-1, N= 66,67)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Non-naive Subjects 6 to &lt; 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination.</title>
        <description>Number of non-naive subjects 6 to &lt; 36 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after vaccination.</description>
        <time_frame>From Day 1 to Day 7</time_frame>
        <population>Analysis performed on the Solicited Safety Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Non-naive_aTIV (6 to &lt;36 Months)</title>
            <description>A 0.25 mL (for children 6 to &lt;36 months old) dose of aTIV to be administered.</description>
          </group>
          <group group_id="O2">
            <title>Non-naive_TIV (6 to &lt;36 Months)</title>
            <description>A 0.25 mL (for children 6 to &lt;36 months old) dose of TIV to be administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Non-naive Subjects 6 to &lt; 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination.</title>
          <description>Number of non-naive subjects 6 to &lt; 36 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after vaccination.</description>
          <population>Analysis performed on the Solicited Safety Set.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Local</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site ecchymosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site induration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site swelling</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>Injection site erythema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site tenderness (N= 22,21)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Systemic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body Temperature (&gt;= 40.0°C)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in eating habits</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Irritability</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Persistent Crying</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>Sleepiness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting (N= 21,21)</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>Prevention of Pain and or Fever (N= 21,22)</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>Treatment of Pain and or Fever (N= 21,22)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Naive Subjects ≥ 36 Months to &lt; 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination.</title>
        <description>Number of naive subjects ≥ 36 months to &lt; 72 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after first vaccination and from Day 29 to Day 35 after second vaccination.</description>
        <time_frame>From Day 1 to Day 7 by vaccination</time_frame>
        <population>Analysis performed on the Solicited Safety Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Naive_aTIV (≥36 Months to &lt; 72 Months)</title>
            <description>A 0.5 mL (for children ≥36 months to &lt; 72 months old) dose of aTIV to be administered.</description>
          </group>
          <group group_id="O2">
            <title>Naive_TIV (≥36 Months to &lt; 72 Months)</title>
            <description>A 0.5 mL (for children ≥36 months to &lt; 72 months old) dose of TIV to be administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Naive Subjects ≥ 36 Months to &lt; 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination.</title>
          <description>Number of naive subjects ≥ 36 months to &lt; 72 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after first vaccination and from Day 29 to Day 35 after second vaccination.</description>
          <population>Analysis performed on the Solicited Safety Set.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Local (Vac-1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Local (Vac-2, N= 6,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site ecchymosis (Vac-1)</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>Injection site ecchymosis (Vac-2, N= 6,3)</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>Injection site induration (Vac-1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site induration (Vac-2, N= 6,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site swelling (Vac-1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site swelling (Vac-2, N= 6,3)</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>Injection site erythema (Vac-1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site erythema (Vac-2, N= 6,3)</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>Injection site pain (Vac-1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site pain (Vac-2, N= 6,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Systemic (Vac-1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Systemic (Vac-2, N= 6,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue (Vac-1)</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>Fatigue (Vac-2, N= 6,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia (Vac-1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia (Vac-2, N= 6,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Arthralgia (Vac-1)</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>Arthralgia (Vac-2, N= 6,2)</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>Headache (Vac-1)</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>Headache (Vac-2, N= 6,2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body Temperature (&gt;= 40.0°C) (Vac-1)</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>Body Temperature (&gt;= 40.0°C) (Vac-2, N= 6,3)</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>Fever (Vac-1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever (Vac-2, N= 6,3)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chills (Vac-1)</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>Chills (Vac-2, N= 6,3)</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>Change in Eating Habits (Vac-1, N= 5,4)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in Eating Habits (Vac-2, N= 6,3)</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>Diarrhea (Vac-1)</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>Diarrhea (Vac-2, N= 6,3)</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>Vomiting (Vac-1)</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>Vomiting (Vac-2, N= 6,3)</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>Prevention of Pain and or Fever (Vac-1, N= 6,2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prevention of Pain and or Fever (Vac-2, N= 4,2)</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>Treatment of Pain and or Fever (Vac-1, N= 6,2)</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>Treatment of Pain and or Fever (Vac-2, N= 5,2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Non-naive Subjects ≥36 Months to &lt; 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination.</title>
        <description>Number of non-naive subjects ≥36 months to &lt; 72 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after vaccination.</description>
        <time_frame>From Day 1 to Day 7</time_frame>
        <population>Analysis performed on the Solicited Safety Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Non-naive_aTIV (≥36 Months to &lt; 72 Months)</title>
            <description>A 0.5 mL (for children ≥36 months to &lt; 72 months old) dose of aTIV to be administered.</description>
          </group>
          <group group_id="O2">
            <title>Non-naive_TIV (≥36 Months to &lt; 72 Months)</title>
            <description>A 0.5 mL (for children ≥36 months to &lt; 72 months old) dose of TIV to be administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Non-naive Subjects ≥36 Months to &lt; 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination.</title>
          <description>Number of non-naive subjects ≥36 months to &lt; 72 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after vaccination.</description>
          <population>Analysis performed on the Solicited Safety Set.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Local</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site ecchymosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site induration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site erythema (N= 43,40)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site pain (N= 44,40)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site tenderness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Systemic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue (N= 44,40)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia (N= 44,40)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Arthralgia (N= 44,40)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache (N= 44,40)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body Temperature (&gt;= 40.0°C) (N= 44,40)</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>Fever</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chills (N= 44,40)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change in eating habits (N= 44,39)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea (N= 44,39)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting (N= 44,40)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prevention of Pain and or Fever (N= 42,40)</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>Treatment of Pain and or Fever (N=42,40)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Naive Subjects Aged 6 to &lt; 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50.</title>
        <description>Number of naive subjects aged 6 to &lt; 72 months reporting all unsolicited AEs, medically attended AEs, AE leading to study withdrawal and serious AEs (SAEs) from Day 1 to Day 50.</description>
        <time_frame>From Day 1 to Day 50</time_frame>
        <population>Analysis performed on the Unsolicited Safety Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Naive_aTIV (6 Months to &lt; 72 Months)</title>
            <description>A 0.25 mL (for children 6 to &lt;36 months old) and 0.5 mL (for children ≥36 months to &lt; 72 months old) dose of aTIV to be administered.</description>
          </group>
          <group group_id="O2">
            <title>Naive_TIV (6 Months to &lt; 72 Months)</title>
            <description>A 0.25 mL (for children 6 to &lt;36 months old) and 0.5 mL (for children ≥36 months to &lt; 72 months old) dose of TIV to be administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Naive Subjects Aged 6 to &lt; 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50.</title>
          <description>Number of naive subjects aged 6 to &lt; 72 months reporting all unsolicited AEs, medically attended AEs, AE leading to study withdrawal and serious AEs (SAEs) from Day 1 to Day 50.</description>
          <population>Analysis performed on the Unsolicited Safety Set.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="73"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least Possibly related AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAE</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>At least possibly related SAE</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>AE leading to study 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>
              <title>Medically attended AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Non-naive Subjects Aged 6 to &lt; 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22</title>
        <description>Number of non-naive subjects aged 6 to &lt; 72 months reporting all unsolicited AEs, medically attended AEs, AE leading to study withdrawal and SAEs from Day 1 to Day 22.</description>
        <time_frame>From Day 1 to Day 22</time_frame>
        <population>Analysis performed on the Unsolicited Safety Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Non naive_aTIV (6 Months to &lt; 72 Months)</title>
            <description>A 0.25 mL (for children 6 to &lt;36 months old) and 0.5 mL (for children ≥36 months to &lt; 72 months old) dose of aTIV to be administered.</description>
          </group>
          <group group_id="O2">
            <title>Non naive_TIV (6 Months to &lt; 72 Months)</title>
            <description>A 0.25 mL (for children 6 to &lt;36 months old) and 0.5 mL (for children ≥36 months to &lt; 72 months old) dose of TIV to be administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Non-naive Subjects Aged 6 to &lt; 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22</title>
          <description>Number of non-naive subjects aged 6 to &lt; 72 months reporting all unsolicited AEs, medically attended AEs, AE leading to study withdrawal and SAEs from Day 1 to Day 22.</description>
          <population>Analysis performed on the Unsolicited Safety Set.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least Possibly related AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAE</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>At least possibly related SAE</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>AE leading to study 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>
              <title>Medically attended AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Death</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>Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to &lt; 72 Months of Age.</title>
        <description>Antibody response was assessed in terms of GMTs in all three homologous virus strains, 21 days after last immunization, in subjects 6 to &lt;72 months of age.&#xD;
The study is considered a success if the 21 days after last immunization GMT ratios of aTIV relative to TIV demonstrate as non-inferior with the lower limit (LL) of the two sided 95% confidence interval (CI) above 0.67 (-0.176 on log10 scale) for each vaccine strain (Center for Biologics Evaluation and Research {CBER} Guideline on Seasonal Vaccines May 2007).</description>
        <time_frame>Day 1 and Day 22 (vaccine non-naïve subjects) or Day 50 (vaccine naïve subjects) post vaccination</time_frame>
        <population>Analysis performed on the Per Protocol Set.</population>
        <group_list>
          <group group_id="O1">
            <title>aTIV (6 Months to &lt; 72 Months)</title>
            <description>A 0.25 mL (for children 6 to &lt;36 months old) and 0.5 mL (for children ≥36 months to &lt; 72 months old) dose of aTIV to be administered.</description>
          </group>
          <group group_id="O2">
            <title>TIV (6 Months to &lt; 72 Months)</title>
            <description>A 0.25 mL (for children 6 to &lt;36 months old) and 0.5 mL (for children ≥36 months to &lt; 72 months old) dose of TIV to be administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to &lt; 72 Months of Age.</title>
          <description>Antibody response was assessed in terms of GMTs in all three homologous virus strains, 21 days after last immunization, in subjects 6 to &lt;72 months of age.&#xD;
The study is considered a success if the 21 days after last immunization GMT ratios of aTIV relative to TIV demonstrate as non-inferior with the lower limit (LL) of the two sided 95% confidence interval (CI) above 0.67 (-0.176 on log10 scale) for each vaccine strain (Center for Biologics Evaluation and Research {CBER} Guideline on Seasonal Vaccines May 2007).</description>
          <population>Analysis performed on the Per Protocol Set.</population>
          <units>Titers</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1 (Day 1) (N= 113,112)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14" lower_limit="11" upper_limit="19"/>
                    <measurement group_id="O2" value="15" lower_limit="11" upper_limit="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H1N1 (Day 22 or Day 50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="675" lower_limit="536" upper_limit="849"/>
                    <measurement group_id="O2" value="166" lower_limit="132" upper_limit="208"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2 (Day 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59" lower_limit="40" upper_limit="86"/>
                    <measurement group_id="O2" value="55" lower_limit="38" upper_limit="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2 (Day 22 or Day 50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1280" lower_limit="1077" upper_limit="1521"/>
                    <measurement group_id="O2" value="495" lower_limit="417" upper_limit="588"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Day 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.47" lower_limit="6.41" upper_limit="8.71"/>
                    <measurement group_id="O2" value="6.92" lower_limit="5.95" upper_limit="8.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Day 22 or Day 50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76" lower_limit="61" upper_limit="93"/>
                    <measurement group_id="O2" value="16" lower_limit="13" upper_limit="20"/>
                  </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>Geometric mean titers (GMTs), in H1N1 strain of all the tree strains in Subjects 6 to &lt; 72 months of Age.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Hypothesis: Demonstrate non-inferiority (NI) of aTIV to TIV:&#xD;
H0 : μAi - μBi ≤ -0.176 (Null) H1 : μAi - μBi &gt;-0.176 (alternative) (i= H1N1, H3N2, B) μA and μB are means of log10-transformed titers 21 days after last vaccination of the aTIV &amp; TIV vaccine groups respectively. NI is claimed if LL of 95% CI for GMT ratios is &gt;0.67.&#xD;
Significance level is α = 2.5% (1-sided), which needs no further adjustment for multiplicity as to reach NI, above hypothesis needs to be rejected for all 3 strains.</non_inferiority_desc>
            <param_type>Ratio of GMTs</param_type>
            <param_value>4.06</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.00</ci_lower_limit>
            <ci_upper_limit>5.51</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Geometric mean titers (GMTs), in H3N2 strain of all three homologous virus strains in Subjects 6 to &lt; 72 months of Age.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Hypothesis: Demonstrate non-inferiority (NI) of aTIV to TIV:&#xD;
H0 : μAi - μBi ≤ -0.176 (Null) H1 : μAi - μBi &gt;-0.176 (alternative) (i= H1N1, H3N2, B) μA and μB are means of log10-transformed titers 21 days after last vaccination of the aTIV &amp; TIV vaccine groups respectively. NI is claimed if LL of 95% CI for GMT ratios is &gt;0.67.&#xD;
Significance level is α = 2.5% (1-sided), which needs no further adjustment for multiplicity as to reach NI, above hypothesis needs to be rejected for all 3 strains.</non_inferiority_desc>
            <param_type>Ratio of GMTs</param_type>
            <param_value>2.58</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.05</ci_lower_limit>
            <ci_upper_limit>3.25</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Geometric mean titers (GMTs), in B strain of all three homologous virus strains in Subjects 6 to &lt; 72 months of Age.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Hypothesis: Demonstrate non-inferiority (NI) of aTIV to TIV:&#xD;
H0 : μAi - μBi ≤ -0.176 (Null) H1 : μAi - μBi &gt;-0.176 (alternative) (i= H1N1, H3N2, B) μA and μB are means of log10-transformed titers 21 days after last vaccination of the aTIV &amp; TIV vaccine groups respectively. NI is claimed if LL of 95% CI for GMT ratios is &gt;0.67.&#xD;
Significance level is α = 2.5% (1-sided), which needs no further adjustment for multiplicity as to reach NI, above hypothesis needs to be rejected for all 3 strains.</non_inferiority_desc>
            <param_type>Ratio of GMTs</param_type>
            <param_value>4.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.52</ci_lower_limit>
            <ci_upper_limit>6.20</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentages of Subjects Achieving Seroconversion in Hemagglutination Inhibition (HI) Titers and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.</title>
        <description>Percentages of subjects with seroconversion in all three homologous virus strains, 21 days after last immunization, in subjects 6 to &lt;72 months of age, defined as: HI ≥ 40 subject with a pre-vaccination HI titer &lt;10; a minimum 4-fold increase HI titer for subjects with a prevaccination HI titer ≥10, on Day 22 (non-naive subjects) or Day 50 (naive subjects), as applicable.</description>
        <time_frame>Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination</time_frame>
        <population>Analysis performed on the Per Protocol Set.</population>
        <group_list>
          <group group_id="O1">
            <title>aTIV (6 Months to &lt; 72 Months)</title>
            <description>A 0.25 mL (for children 6 to &lt;36 months old) and 0.5 mL (for children ≥36 months to &lt; 72 months old) dose of aTIV to be administered.</description>
          </group>
          <group group_id="O2">
            <title>TIV (6 Months to &lt; 72 Months)</title>
            <description>A 0.25 mL (for children 6 to &lt;36 months old) and 0.5 mL (for children ≥36 months to &lt; 72 months old) dose of TIV to be administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Subjects Achieving Seroconversion in Hemagglutination Inhibition (HI) Titers and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.</title>
          <description>Percentages of subjects with seroconversion in all three homologous virus strains, 21 days after last immunization, in subjects 6 to &lt;72 months of age, defined as: HI ≥ 40 subject with a pre-vaccination HI titer &lt;10; a minimum 4-fold increase HI titer for subjects with a prevaccination HI titer ≥10, on Day 22 (non-naive subjects) or Day 50 (naive subjects), as applicable.</description>
          <population>Analysis performed on the Per Protocol Set.</population>
          <units>Percentages 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="114"/>
                <count group_id="O2" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1 strain (N= 113,112)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90" lower_limit="83.2" upper_limit="95"/>
                    <measurement group_id="O2" value="75" lower_limit="65.9" upper_limit="82.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2 strain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77" lower_limit="68.4" upper_limit="84.5"/>
                    <measurement group_id="O2" value="67" lower_limit="57.4" upper_limit="75.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B strain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78" lower_limit="69.4" upper_limit="85.3"/>
                    <measurement group_id="O2" value="22" lower_limit="15" upper_limit="31.2"/>
                  </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>Percentage of subjects achieving seroconversion in H1N1 strain after last vaccination with aTIV or TIV in naïve and non-naive subjects.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The following hypotheses should be tested to demonstrate non-inferiority of aTIV to TIV:&#xD;
H0i: πi1 &gt; πi2-0.1 vs. H1i: πi1 &gt; πi2- 0.1 where H0i and H1i represent the null and the alternative hypothesis (respectively) of the non- inferiority objective and πi1 and πi2 represent the seroresponse rates 21 days after last immunization of the aTIV and TIV vaccine groups respectively in the i-th strain (H1N1, H3N2, B). The non-inferiority criterion is -0.1 (i.e., -10%).</non_inferiority_desc>
            <param_type>Vaccine Group Differences</param_type>
            <param_value>17</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>8.1</ci_lower_limit>
            <ci_upper_limit>26.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Percentage of subjects achieving seroconversion in H3N2 strain after last vaccination with aTIV or TIV in naive and non-naive subjects.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The following hypotheses should be tested to demonstrate non-inferiority of aTIV to TIV:&#xD;
H0i: πi1 &gt; πi2-0.1 vs. H1i: πi1 &gt; πi2- 0.1 where H0i and H1i represent the null and the alternative hypothesis (respectively) of the non- inferiority objective and πi1 and πi2 represent the seroresponse rates 21 days after last immunization of the aTIV and TIV vaccine groups respectively in the i-th strain (H1N1, H3N2, B). The non-inferiority criterion is -0.1 (i.e., -10%).</non_inferiority_desc>
            <param_type>Vaccine Group Differences</param_type>
            <param_value>10</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>21</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Percentage of subjects achieving seroconversion in B strains after last vaccination with aTIV or TIV in naïve and non naive subjects.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The following hypotheses should be tested to demonstrate non-inferiority of aTIV to TIV:&#xD;
H0i: πi1 &gt; πi2-0.1 vs. H1i: πi1 &gt; πi2- 0.1 where H0i and H1i represent the null and the alternative hypothesis (respectively) of the non- inferiority objective and πi1 and πi2 represent the seroresponse rates 21 days after last immunization of the aTIV and TIV vaccine groups respectively in the i-th strain (H1N1, H3N2, B). The non-inferiority criterion is -0.1 (i.e., -10%).</non_inferiority_desc>
            <param_type>Vaccine Group Differences</param_type>
            <param_value>58</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>47.5</ci_lower_limit>
            <ci_upper_limit>68.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Ratios (GMRs) of HI and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.</title>
        <description>GMRs of HI, day 22/day 1 (non-naive subjects) or day 50/day 1 (naive subjects) in all three homologous virus strains, 21 days after last immunization, in subjects 6 to &lt;72 months of age. As the non-inferiority of aTIV to TIV has been established, GMT ratio of aTIV relative to TIV in all three homologous virus strains, 21 days after last immunization in subjects 6 to &lt;72 months of age was evaluated using margins greater than the non-inferiority cut-off of 0.67.</description>
        <time_frame>Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination</time_frame>
        <population>Analysis performed on the Per Protocol Set.</population>
        <group_list>
          <group group_id="O1">
            <title>aTIV (6 Months to &lt; 72 Months)</title>
            <description>A 0.25 mL (for children 6 to &lt;36 months old) and 0.5 mL (for children ≥36 months to &lt; 72 months old) dose of aTIV to be administered.</description>
          </group>
          <group group_id="O2">
            <title>TIV (6 Months to &lt; 72 Months)</title>
            <description>A 0.25 mL (for children 6 to &lt;36 months old) and 0.5 mL (for children ≥36 months to &lt; 72 months old) dose of TIV to be administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Ratios (GMRs) of HI and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.</title>
          <description>GMRs of HI, day 22/day 1 (non-naive subjects) or day 50/day 1 (naive subjects) in all three homologous virus strains, 21 days after last immunization, in subjects 6 to &lt;72 months of age. As the non-inferiority of aTIV to TIV has been established, GMT ratio of aTIV relative to TIV in all three homologous virus strains, 21 days after last immunization in subjects 6 to &lt;72 months of age was evaluated using margins greater than the non-inferiority cut-off of 0.67.</description>
          <population>Analysis performed on the Per Protocol Set.</population>
          <units>Ratios</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="114"/>
                <count group_id="O2" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1 strain (N=113,112)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46" lower_limit="34" upper_limit="62"/>
                    <measurement group_id="O2" value="11" lower_limit="8.12" upper_limit="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2 strain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21" lower_limit="16" upper_limit="28"/>
                    <measurement group_id="O2" value="8.39" lower_limit="6.26" upper_limit="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B strain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" lower_limit="8.25" upper_limit="13"/>
                    <measurement group_id="O2" value="2.30" lower_limit="1.84" upper_limit="2.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.</title>
        <description>Percentage of subjects with a HI titer ≥ 40, ≥110 and ≥330 on Day 1, Day 22 (non naïve subjects) or Day 50 (naïve subjects), in all three homologous virus strains, 21 days after last immunization, in subjects 6 to &lt;72 months of age.</description>
        <time_frame>Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination</time_frame>
        <population>Analysis performed on the Per Protocol Set.</population>
        <group_list>
          <group group_id="O1">
            <title>aTIV (6 Months to &lt; 72 Months)</title>
            <description>A 0.25 mL (for children 6 to &lt;36 months old) and 0.5 mL (for children ≥36 months to &lt; 72 months old) dose of aTIV to be administered.</description>
          </group>
          <group group_id="O2">
            <title>TIV (6 Months to &lt; 72 Months)</title>
            <description>A 0.25 mL (for children 6 to &lt;36 months old) and 0.5 mL (for children ≥36 months to &lt; 72 months old) dose of TIV to be administered.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.</title>
          <description>Percentage of subjects with a HI titer ≥ 40, ≥110 and ≥330 on Day 1, Day 22 (non naïve subjects) or Day 50 (naïve subjects), in all three homologous virus strains, 21 days after last immunization, in subjects 6 to &lt;72 months of age.</description>
          <population>Analysis performed on the Per Protocol Set.</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="114"/>
                <count group_id="O2" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1 strain (HI titer ≥ 40, Day 1) (N=113,112)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32" lower_limit="23.4" upper_limit="41.3"/>
                    <measurement group_id="O2" value="33" lower_limit="24.4" upper_limit="42.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1 strain (HI titer ≥ 40, Day 22 or Day 50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99" lower_limit="95.2" upper_limit="99.98"/>
                    <measurement group_id="O2" value="88" lower_limit="81" upper_limit="93.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1 strain (HI titer ≥ 110, Day 1) (N=113,112)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19" lower_limit="11.9" upper_limit="27"/>
                    <measurement group_id="O2" value="20" lower_limit="12.7" upper_limit="28.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1 strain (HI titer ≥ 110, Day 22 or Day 50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96" lower_limit="90.1" upper_limit="98.6"/>
                    <measurement group_id="O2" value="68" lower_limit="58.4" upper_limit="76.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1 strain (HI titer ≥ 330, Day 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="1.5" upper_limit="10"/>
                    <measurement group_id="O2" value="7" lower_limit="3.1" upper_limit="13.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1 strain (HI titer ≥ 330, Day 22 or Day 50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78" lower_limit="69.4" upper_limit="85.3"/>
                    <measurement group_id="O2" value="37" lower_limit="27.7" upper_limit="46.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2 strain (HI titer ≥ 40, Day 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56" lower_limit="46.5" upper_limit="65.4"/>
                    <measurement group_id="O2" value="58" lower_limit="48.3" upper_limit="67.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2 strain (HI titer ≥ 40, Day 22 or Day 50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="96.8" upper_limit="100"/>
                    <measurement group_id="O2" value="97" lower_limit="92.4" upper_limit="99.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2 strain (HI titer ≥ 110, Day 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44" lower_limit="34.6" upper_limit="53.5"/>
                    <measurement group_id="O2" value="44" lower_limit="34.4" upper_limit="53.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2 strain (HI titer ≥ 110, Day 22 or Day 50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99" lower_limit="95.2" upper_limit="99.98"/>
                    <measurement group_id="O2" value="84" lower_limit="75.8" upper_limit="90.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2 strain (HI titer ≥ 330, Day 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33" lower_limit="24.8" upper_limit="42.8"/>
                    <measurement group_id="O2" value="30" lower_limit="22" upper_limit="39.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2 strain (HI titer ≥ 330, Day 22 or Day 50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86" lower_limit="78.2" upper_limit="91.8"/>
                    <measurement group_id="O2" value="61" lower_limit="51" upper_limit="69.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B strain (HI titer ≥ 40, Day 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9" lower_limit="4.3" upper_limit="15.5"/>
                    <measurement group_id="O2" value="9" lower_limit="4.4" upper_limit="15.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B strain (HI titer ≥ 40, Day 22 or Day 50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84" lower_limit="76.2" upper_limit="90.4"/>
                    <measurement group_id="O2" value="32" lower_limit="23.6" upper_limit="41.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B strain (HI titer ≥ 110, Day 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="0.21" upper_limit="6.2"/>
                    <measurement group_id="O2" value="1" lower_limit="0.02" upper_limit="4.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B strain (HI titer ≥ 110, Day 22 or Day 50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43" lower_limit="33.7" upper_limit="52.6"/>
                    <measurement group_id="O2" value="6" lower_limit="2.5" upper_limit="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B strain (HI titer ≥ 330, Day 1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="3.2"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B strain (HI titer ≥ 330, Day 22 or Day 50)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" lower_limit="3.7" upper_limit="14.5"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Throughout the study; Day 1 - Day 50 (naive subjects) and Day 1 - Day 22 (non-naive subjects).</time_frame>
      <desc>Solicited AEs were collected by the subject parent(s)/legal guardian(s) for 7 days from the day of vaccination/s (Day 1 &amp; Day 29 for naive; Day 1 for non-naive). Unsolicited AEs were collected from Day 1 to Day 50 for naive, from Day 1 to Day 22 for non-naive.&#xD;
All AEs were monitored until resolution or the investigator assesses them as stable.</desc>
      <group_list>
        <group group_id="E1">
          <title>Naive_aTIV (6 Months to &lt; 72 Months)</title>
          <description>A 0.25 mL (for children 6 to &lt;36 months old) and 0.5 mL (for children ≥36 months to &lt; 72 months old) dose of aTIV to be administered (Naive).</description>
        </group>
        <group group_id="E2">
          <title>Naive_TIV (6 Months to &lt; 72 Months)</title>
          <description>A 0.25 mL (for children 6 to &lt;36 months old) and 0.5 mL (for children ≥36 months to &lt; 72 months old) dose of TIV to be administered (Naive).&#xD;
Enrolled subjects- 79 Exposed subjects- 78 Reason for discrepancy- Before vaccination one subject was withdrawn from study because of the suspected egg allergy.</description>
        </group>
        <group group_id="E3">
          <title>Non-naive_aTIV (6 Months to &lt; 72 Months)</title>
          <description>A 0.25 mL (for children 6 to &lt;36 months old) and 0.5 mL (for children ≥36 months to &lt; 72 months old) dose of aTIV to be administered (Non-naive).</description>
        </group>
        <group group_id="E4">
          <title>Non-naive_TIV (6 Months to &lt; 72 Months)</title>
          <description>A 0.25 mL (for children 6 to &lt;36 months old) and 0.5 mL (for children ≥36 months to &lt; 72 months old) dose of TIV to be administered (Non-naive).</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (19.0)</default_vocab>
        <default_assessment>Non-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="58" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="52" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="35" subjects_at_risk="67"/>
                <counts group_id="E4" subjects_affected="31" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="21" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="67"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="67"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Crying</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="67"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="67"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Injection site induration</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="67"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" subjects_affected="33" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="23" subjects_at_risk="67"/>
                <counts group_id="E4" subjects_affected="20" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Injection site swelling</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="67"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="67"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="67"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="67"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Eating disorder</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="12" subjects_at_risk="67"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="67"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="64"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="64"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="77"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="78"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="64"/>
              </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 terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Posting Director</name_or_title>
      <organization>Novartis Vaccines</organization>
      <email>RegistryContactVaccinesUS@novartis.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/NCT02255279
org study id: V70_50
nct id: NCT02255279
lead sponsor: 
has dmc: No
The administration of adjuvanted Trivalent Influenza Vaccine (aTIV) has come to result in a
      more immunogenic and effective response compared with conventional influenza vaccines in
      elderly and adults.

      The aim of this study is to evaluate safety and immunogenicity of Novartis aTIV in children 6
      to <72 months of age, Mexican population, in comparison to Fluzone, a non-adjuvanted
      trivalent influenza vaccine (TIV).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Number of Naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic Adverse Events (AEs) From Day 1 to Day 7 Following Each Vaccination.
time frame: From Day 1 to Day 7 by vaccination
description: Number of naive subjects 6 to < 36 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after first vaccination and from Day 29 to Day 35 after second vaccination.
measure: Number of Non-naive Subjects 6 to < 36 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 After Vaccination.
time frame: From Day 1 to Day 7
description: Number of non-naive subjects 6 to < 36 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after vaccination.
measure: Number of Naive Subjects ≥ 36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination.
time frame: From Day 1 to Day 7 by vaccination
description: Number of naive subjects ≥ 36 months to < 72 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after first vaccination and from Day 29 to Day 35 after second vaccination.
measure: Number of Non-naive Subjects ≥36 Months to < 72 Months Old Reporting Solicited Local and Systemic AEs From Day 1 to Day 7 Following Each Vaccination.
time frame: From Day 1 to Day 7
description: Number of non-naive subjects ≥36 months to < 72 months old reporting solicited local and systemic AEs from Day 1 to Day 7 after vaccination.
measure: Number of Naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 50.
time frame: From Day 1 to Day 50
description: Number of naive subjects aged 6 to < 72 months reporting all unsolicited AEs, medically attended AEs, AE leading to study withdrawal and serious AEs (SAEs) from Day 1 to Day 50.
measure: Number of Non-naive Subjects Aged 6 to < 72 Months Reporting All Unsolicited AEs From Day 1 to Day 22
time frame: From Day 1 to Day 22
description: Number of non-naive subjects aged 6 to < 72 months reporting all unsolicited AEs, medically attended AEs, AE leading to study withdrawal and SAEs from Day 1 to Day 22.
measure: Geometric Mean Titers (GMTs), in All Three Homologous Virus Strains in Subjects 6 to < 72 Months of Age.
time frame: Day 1 and Day 22 (vaccine non-naïve subjects) or Day 50 (vaccine naïve subjects) post vaccination
description: Antibody response was assessed in terms of GMTs in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age.
The study is considered a success if the 21 days after last immunization GMT ratios of aTIV relative to TIV demonstrate as non-inferior with the lower limit (LL) of the two sided 95% confidence interval (CI) above 0.67 (-0.176 on log10 scale) for each vaccine strain (Center for Biologics Evaluation and Research {CBER} Guideline on Seasonal Vaccines May 2007).
measure: Percentages of Subjects Achieving Seroconversion in Hemagglutination Inhibition (HI) Titers and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.
time frame: Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination
description: Percentages of subjects with seroconversion in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age, defined as: HI ≥ 40 subject with a pre-vaccination HI titer <10; a minimum 4-fold increase HI titer for subjects with a prevaccination HI titer ≥10, on Day 22 (non-naive subjects) or Day 50 (naive subjects), as applicable.
measure: Geometric Mean Ratios (GMRs) of HI and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.
time frame: Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination
description: GMRs of HI, day 22/day 1 (non-naive subjects) or day 50/day 1 (naive subjects) in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age. As the non-inferiority of aTIV to TIV has been established, GMT ratio of aTIV relative to TIV in all three homologous virus strains, 21 days after last immunization in subjects 6 to <72 months of age was evaluated using margins greater than the non-inferiority cut-off of 0.67.
measure: Percentages of Subjects With a HI Titer ≥ 40, ≥110 and ≥330 and Vaccine Group Differences at Day 1 and 21 Days After Last Vaccination With aTIV or TIV in Naive and Non-naive Subjects.
time frame: Day 1 and Day 22 (vaccine non-naive subjects) or Day 50 (vaccine naive subjects) post vaccination
description: Percentage of subjects with a HI titer ≥ 40, ≥110 and ≥330 on Day 1, Day 22 (non naïve subjects) or Day 50 (naïve subjects), in all three homologous virus strains, 21 days after last immunization, in subjects 6 to <72 months of age.
arm group label: aTIV
arm group type: Experimental
description: aTIV is a trivalent influenza virus vaccine, adjuvanted with MF59C.
arm group label: TIV
arm group type: Active Comparator
description: TIV is trivalent influenza vaccine licensed in Mexico.
intervention type: Biological
intervention name: Adjuvanted Trivalent Influenza Vaccine, 1 dose for non-naive subjects (day 1), two doses for naive subjects (day 1 and day 29)
description: A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV, a trivalent (surface antigen, formaldehyde-inactivated) influenza virus vaccine, adjuvanted with MF59C.1, administered at day 1 (for all subjects) and day 29 (for naïve subjects).
arm group label: aTIV
intervention type: Biological
intervention name: Non-adjuvanted Trivalent Influenza Vaccine, 1 dose for non-naive subjects (day 1), two doses for naive subjects (day 1 and day 29).
description: A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV , an egg-derived trivalent split influenza vaccine licensed in Mexico, administered at day 1 (for all subjects) and day 29 (for naïve subjects)
arm group label: TIV
criteria: 
gender: All
minimum age: 6 Months
maximum age: 71 Months
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
country: Mexico
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Vaccines
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 