<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/NCT02242643</url>
  </required_header>
  <id_info>
    <org_study_id>201234</org_study_id>
    <nct_id>NCT02242643</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) Compared to Fluzone® Quadrivalent in Children 6 to 35 Months of Age</brief_title>
  <official_title>Immunogenicity and Safety Study of GSK Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) Compared to Fluzone® Quadrivalent in Children 6 to 35 Months of Age</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals'&#xD;
      quadrivalent influenza vaccine (GSK2282512A) compared to Sanofi Pasteur's Fluzone®&#xD;
      Quadrivalent in children 6 to 35 months of age.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 1, 2014</start_date>
  <completion_date type="Actual">June 23, 2015</completion_date>
  <primary_completion_date type="Actual">March 16, 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, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains</measure>
    <time_frame>28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)</time_frame>
    <description>Antibody titers were expressed as Seroconversion rate (SCR) and SCR difference. SCR was defined as the proportion of vaccinees who had either a pre-vaccination titer &lt; 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.&#xD;
The vaccine strains assessed were Flu A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 (Yamagata) and B/Brisbane/60/2008 (Victoria).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains.</measure>
    <time_frame>At 28 days after the last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)</time_frame>
    <description>HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)</measure>
    <time_frame>At Day 0 and 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)</time_frame>
    <description>Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 (Yamagata) and B/Brisbane/60/2008 (Victoria).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)</measure>
    <time_frame>At Day 0 and 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)</time_frame>
    <description>A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)</measure>
    <time_frame>28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)</time_frame>
    <description>A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (&lt;) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)</measure>
    <time_frame>28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)</time_frame>
    <description>MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)</measure>
    <time_frame>During a 7-day (Day 0 - Day 6) follow-up period after each vaccination</time_frame>
    <description>Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity and all subjects reporting 'Yes' for solicited symptom occurred but with missing values for at least one day during the solicited period. Grade 3 pain = Cried when limb is moved/spontaneously painful. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. &gt;100mm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)</measure>
    <time_frame>During the 7-day (Days 0-6) follow-up period after each vaccination</time_frame>
    <description>Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (&lt; )38°C but with missing values for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (&gt;) 39.0°C.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)</measure>
    <time_frame>During the 7-day (Days 0-6) follow-up period after each vaccination.</time_frame>
    <description>Duration was defined as number of days with any grade of local and general symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any Fever Following Each Dose and Across Doses.</measure>
    <time_frame>During a 2-day (Days 0-1) follow-up period after each vaccination</time_frame>
    <description>Any Fever = all subjects with a documented temperature of ≥38.0°C /100.4°F by axillary route and all subjects reporting temperature &lt; 38.0°C but with missing values for at least one day during the solicited period.&#xD;
Grade 3 fever was defined as temperature greater than (&gt;) 39.0°C.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting the Occurrence of All Medically Attended Events (MAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed).</measure>
    <time_frame>During the entire study period (Days 0 -180)</time_frame>
    <description>MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)</measure>
    <time_frame>During the entire study period (Days 0 -180)</time_frame>
    <description>pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related = symptom assed by the investigator as causally related to the study vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)</measure>
    <time_frame>During a 28-day (Days 0-27 for primed and unprimed subjects and Days 28-56 for unprimed subjects) post-vaccination period</time_frame>
    <description>An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE was defined as an event that prevented normal activity. Related unsolicited AE was defined as an event assessed by the investigator to be causally related to the study vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)</measure>
    <time_frame>During the entire study period (Days 0 -180)</time_frame>
    <description>SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assessed by the investigator as causally related to the study vaccination.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2432</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>FluLaval™ Quadrivalent Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.&#xD;
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fluzone® Quadrivalent Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.&#xD;
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>FluLaval™ Quadrivalent</intervention_name>
    <description>1 or 2 doses administered intramusculary (IM) in deltoid region of non-dominant arm (for subjects ≥12 months of age) or anterolateral region of left thigh (for subjects &lt;12 months of age) on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects), respectively</description>
    <arm_group_label>FluLaval™ Quadrivalent Group</arm_group_label>
    <other_name>FLU Q-QIV (GSK2282512A)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fluzone® Quadrivalent</intervention_name>
    <description>1 or 2 doses administered IM in deltoid region of non-dominant arm (for subjects ≥12 months of age) or anterolateral region of left thigh (for subjects &lt;12 months of age) on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects), respectively</description>
    <arm_group_label>Fluzone® Quadrivalent Group</arm_group_label>
    <other_name>F-QIV</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion&#xD;
             of the investigator, can and will comply with the requirements of the protocol.&#xD;
&#xD;
          -  A male or female between, and including, 6 and 35 months of age at the time of the&#xD;
             first vaccination.&#xD;
&#xD;
          -  Written informed consent obtained from the parent(s)/LAR(s) of the subject.&#xD;
&#xD;
          -  Subjects in stable health as determined by investigator's clinical examination and&#xD;
             assessment of subject's medical history.&#xD;
&#xD;
          -  Subjects are eligible regardless of history of administration of influenza vaccine in&#xD;
             a previous season.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of any investigational or non-registered product (drug or vaccine) other than the&#xD;
             study vaccine within 30 days preceding the first dose of study vaccine, or planned use&#xD;
             during the study period. Routine registered childhood vaccinations are permitted.&#xD;
&#xD;
          -  Child in care.&#xD;
&#xD;
          -  Chronic administration (defined as more than 14 days in total) of immunosuppressants&#xD;
             or other immune-modifying drugs within six months prior to the first vaccine dose. For&#xD;
             corticosteroids, this will mean a dose equivalent to either &gt; 2 mg/kg/day of body&#xD;
             weight, or to ≥ 20 mg/day of prednisone for persons who weigh ≥ 10 kg, when&#xD;
             administered for more than 2 weeks. Inhaled and topical steroids are allowed.&#xD;
&#xD;
          -  Prior receipt of any seasonal or pandemic influenza vaccine (registered or&#xD;
             investigational) within six months preceding the first dose of study vaccine, or&#xD;
             planned use during the study period.&#xD;
&#xD;
          -  Administration of immunoglobulins and/or any blood products within the three months&#xD;
             preceding the first dose of study vaccine or planned administration during the study&#xD;
             period.&#xD;
&#xD;
          -  History of Guillain-Barré syndrome within six weeks of receipt of prior influenza&#xD;
             vaccine.&#xD;
&#xD;
          -  Any known or suspected allergy to any constituent of influenza vaccines (including egg&#xD;
             proteins); a history of anaphylactic-type reaction to consumption of eggs; or a&#xD;
             history of severe adverse reaction to a previous influenza vaccine.&#xD;
&#xD;
          -  Acute disease and/or fever at the time of enrolment.&#xD;
&#xD;
               -  Fever is defined as temperature ≥ 38.0°C/100.4°F by any route.&#xD;
&#xD;
               -  Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory&#xD;
                  infection) without fever may be enrolled at the discretion of the investigator.&#xD;
&#xD;
          -  Any significant disorder of coagulation or treatment with warfarin derivatives or&#xD;
             heparin.&#xD;
&#xD;
          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on&#xD;
             medical history and physical examination.&#xD;
&#xD;
          -  Any other condition which, in the opinion of the investigator, prevents the subject&#xD;
             from participating in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>35 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Dothan</city>
        <state>Alabama</state>
        <zip>36305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85741</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Jonesboro</city>
        <state>Arkansas</state>
        <zip>72401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Chino</city>
        <state>California</state>
        <zip>91710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Daly City</city>
        <state>California</state>
        <zip>94015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93726</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hayward</city>
        <state>California</state>
        <zip>94545</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Paramount</city>
        <state>California</state>
        <zip>90723</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Pleasanton</city>
        <state>California</state>
        <zip>94588</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95823</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Santa Clara</city>
        <state>California</state>
        <zip>95051</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94596</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>West Covina</city>
        <state>California</state>
        <zip>91790</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80922</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lake Mary</city>
        <state>Florida</state>
        <zip>32736</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Nampa</city>
        <state>Idaho</state>
        <zip>83686</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Augusta</city>
        <state>Kansas</state>
        <zip>67010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Newton</city>
        <state>Kansas</state>
        <zip>67114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Topeka</city>
        <state>Kansas</state>
        <zip>66604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40291</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Bossier City</city>
        <state>Louisiana</state>
        <zip>71111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Columbia</city>
        <state>Maryland</state>
        <zip>21045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Woburn</city>
        <state>Massachusetts</state>
        <zip>01801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68516</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Binghamton</city>
        <state>New York</state>
        <zip>13901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Beavercreek</city>
        <state>Ohio</state>
        <zip>45431</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Erie</city>
        <state>Pennsylvania</state>
        <zip>16505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Hermitage</city>
        <state>Pennsylvania</state>
        <zip>16148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Sellersville</city>
        <state>Pennsylvania</state>
        <zip>18960</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Cheraw</city>
        <state>South Carolina</state>
        <zip>29520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Kingsport</city>
        <state>Tennessee</state>
        <zip>37660</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555-1119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Tomball</city>
        <state>Texas</state>
        <zip>77375</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Layton</city>
        <state>Utah</state>
        <zip>84041</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Orem</city>
        <state>Utah</state>
        <zip>84057</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Payson</city>
        <state>Utah</state>
        <zip>84651</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Provo</city>
        <state>Utah</state>
        <zip>84604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Roy</city>
        <state>Utah</state>
        <zip>84067</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>South Jordan</city>
        <state>Utah</state>
        <zip>84095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Ellensburg</city>
        <state>Washington</state>
        <zip>98926</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Marshfield</city>
        <state>Wisconsin</state>
        <zip>54449</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>San Nicolas de los Garza</city>
        <state>Nuevo León</state>
        <zip>66480</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>Mexico city</city>
        <zip>04530</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.clinicalstudydatarequest.com</url>
    <description>Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.</description>
  </link>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 15, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <results_first_submitted>March 14, 2016</results_first_submitted>
  <results_first_submitted_qc>March 14, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 12, 2016</results_first_posted>
  <last_update_submitted>August 9, 2018</last_update_submitted>
  <last_update_submitted_qc>August 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fluzone Quadrivalent</keyword>
  <keyword>Comparator</keyword>
  <keyword>Children</keyword>
  <keyword>Seasonal influenza</keyword>
  <keyword>Safety</keyword>
  <keyword>Immunogenicity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.</ipd_description>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_id>201234</doc_id>
      <doc_type>Clinical Study Report</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>201234</doc_id>
      <doc_type>Individual Participant Data Set</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>201234</doc_id>
      <doc_type>Study Protocol</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>201234</doc_id>
      <doc_type>Informed Consent Form</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>201234</doc_id>
      <doc_type>Dataset Specification</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>201234</doc_id>
      <doc_type>Statistical Analysis Plan</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
    <study_doc>
      <doc_id>201234</doc_id>
      <doc_type>Annotated Case Report Form</doc_type>
      <doc_url>https://www.clinicalstudydatarequest.com</doc_url>
      <doc_comment>For additional information about this study please refer to the GSK Clinical Study Register</doc_comment>
    </study_doc>
  </study_docs>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Primed subjects:Received atleast 2 doses of seasonal influenza vaccine since 1 July 2010 or atleast 1 dose of the 2013-2014 seasonal influenza vaccine. Unprimed subjects:Did not receive any seasonal influenza vaccine or received only 1 dose of seasonal influenza vaccine since 1 July 2010, but did not receive any 2013-2014 seasonal influenza vaccine</recruitment_details>
      <pre_assignment_details>Data has been analyzed in sub-groups by age: 6-17 months and 18-35 months and by priming status.&#xD;
6 subjects were allocated subject numbers but did not receive the study vaccine dose and for 2 subjects the blood samples were withdrawn but they did not participate in the study due to screening failure.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>FluLaval™ Quadrivalent Group</title>
          <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.&#xD;
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
        </group>
        <group group_id="P2">
          <title>Fluzone® Quadrivalent Group</title>
          <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.&#xD;
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1207"/>
                <participants group_id="P2" count="1217"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1132"/>
                <participants group_id="P2" count="1139"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="75"/>
                <participants group_id="P2" count="78"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Migrated/moved from study area</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="54"/>
                <participants group_id="P2" count="61"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Child placed in foster care by family</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-compliance</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Consent withdrawal by parent</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol requirements not followed</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Language barrier</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by subject at Visit 2</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>FluLaval™ Quadrivalent Group</title>
          <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.&#xD;
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
        </group>
        <group group_id="B2">
          <title>Fluzone® Quadrivalent Group</title>
          <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.&#xD;
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1207"/>
            <count group_id="B2" value="1217"/>
            <count group_id="B3" value="2424"/>
          </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="19.4" spread="8.7"/>
                    <measurement group_id="B2" value="19.5" spread="8.9"/>
                    <measurement group_id="B3" value="19.45" spread="8.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="547"/>
                    <measurement group_id="B2" value="582"/>
                    <measurement group_id="B3" value="1129"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="660"/>
                    <measurement group_id="B2" value="635"/>
                    <measurement group_id="B3" value="1295"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains</title>
        <description>Antibody titers were expressed as Seroconversion rate (SCR) and SCR difference. SCR was defined as the proportion of vaccinees who had either a pre-vaccination titer &lt; 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.&#xD;
The vaccine strains assessed were Flu A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 (Yamagata) and B/Brisbane/60/2008 (Victoria).</description>
        <time_frame>28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)</time_frame>
        <population>The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.</population>
        <group_list>
          <group group_id="O1">
            <title>FluLaval™ Quadrivalent Group</title>
            <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.&#xD;
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
          </group>
          <group group_id="O2">
            <title>Fluzone® Quadrivalent Group</title>
            <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.&#xD;
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
          </group>
        </group_list>
        <measure>
          <title>Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains</title>
          <description>Antibody titers were expressed as Seroconversion rate (SCR) and SCR difference. SCR was defined as the proportion of vaccinees who had either a pre-vaccination titer &lt; 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.&#xD;
The vaccine strains assessed were Flu A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 (Yamagata) and B/Brisbane/60/2008 (Victoria).</description>
          <population>The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="974"/>
                <count group_id="O2" value="980"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1 [N=972,980]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="716"/>
                    <measurement group_id="O2" value="660"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2 [N=972,980]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="740"/>
                    <measurement group_id="O2" value="680"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria [N=973,980]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="631"/>
                    <measurement group_id="O2" value="475"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata [N=974,980]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="833"/>
                    <measurement group_id="O2" value="723"/>
                  </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>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority criterion: The upper limit of the two-sided 95% CI for the difference in SCR (Fluzone® Quadrivalent Group minus FluLaval™ Quadrivalent Group) did not exceed 10% for each of the four strains.</non_inferiority_desc>
            <param_type>Seroconversion rate (SCR) Difference (%)</param_type>
            <param_value>-6.32</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.34</ci_lower_limit>
            <ci_upper_limit>-2.27</ci_upper_limit>
            <estimate_desc>For A/California/7/2009 (H1N1) vaccine strain.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority criterion: The upper limit of the two-sided 95% CI for the difference in SCR (Fluzone® Quadrivalent Group minus FluLaval™ Quadrivalent Group) did not exceed 10% for each of the four strains.</non_inferiority_desc>
            <param_type>SCR Difference (%)</param_type>
            <param_value>-6.74</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.68</ci_lower_limit>
            <ci_upper_limit>-2.80</ci_upper_limit>
            <estimate_desc>For A/Texas/50/2012 (H3N2) vaccine strain</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority criterion: The upper limit of the two-sided 95% CI for the difference in SCR (Fluzone® Quadrivalent Group minus FluLaval™ Quadrivalent Group) did not exceed 10% for each of the four strains.</non_inferiority_desc>
            <param_type>SCR Difference (%)</param_type>
            <param_value>-16.38</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-20.68</ci_lower_limit>
            <ci_upper_limit>-12.02</ci_upper_limit>
            <estimate_desc>For B/Massachusetts/2/2012 (Yamagata) vaccine strain</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority criterion: The upper limit of the two-sided 95% CI for the difference in SCR (Fluzone® Quadrivalent Group minus FluLaval™ Quadrivalent Group) did not exceed 10% for each of the four strains.</non_inferiority_desc>
            <param_type>SCR Difference (%)</param_type>
            <param_value>-11.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-15.28</ci_lower_limit>
            <ci_upper_limit>-8.21</ci_upper_limit>
            <estimate_desc>For B/Brisbane/60/2008 (Victoria) vaccine strain.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains.</title>
        <description>HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).</description>
        <time_frame>At 28 days after the last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)</time_frame>
        <population>The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.</population>
        <group_list>
          <group group_id="O1">
            <title>FluLaval™ Quadrivalent Group</title>
            <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.&#xD;
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
          </group>
          <group group_id="O2">
            <title>Fluzone® Quadrivalent Group</title>
            <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.&#xD;
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
          </group>
        </group_list>
        <measure>
          <title>Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains.</title>
          <description>HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).</description>
          <population>The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.</population>
          <units>Titers</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1013"/>
                <count group_id="O2" value="1028"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.8" lower_limit="90.3" upper_limit="108.2"/>
                    <measurement group_id="O2" value="84.4" lower_limit="76.9" upper_limit="92.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.7" lower_limit="90.3" upper_limit="105.7"/>
                    <measurement group_id="O2" value="84.3" lower_limit="77.6" upper_limit="91.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="257.5" lower_limit="240.9" upper_limit="275.3"/>
                    <measurement group_id="O2" value="164.2" lower_limit="151.8" upper_limit="177.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.1" lower_limit="50.8" upper_limit="59.8"/>
                    <measurement group_id="O2" value="33.4" lower_limit="30.6" upper_limit="36.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority criterion: The upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio (Fluzone® Quadrivalent Group/FluLaval™ Quadrivalent Group) did not exceed 1.5 for each of the four strains.</non_inferiority_desc>
            <param_type>Adjusted GMT ratio</param_type>
            <param_value>0.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.77</ci_lower_limit>
            <ci_upper_limit>0.95</ci_upper_limit>
            <estimate_desc>The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority criterion: The upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio (Fluzone® Quadrivalent Group/FluLaval™ Quadrivalent Group) did not exceed 1.5 for each of the four strains.</non_inferiority_desc>
            <param_type>Adjusted GMT Ratio</param_type>
            <param_value>0.85</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.77</ci_lower_limit>
            <ci_upper_limit>0.94</ci_upper_limit>
            <estimate_desc>The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority criterion: The upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio (Fluzone® Quadrivalent Group/FluLaval™ Quadrivalent Group) did not exceed 1.5 for each of the four strains.</non_inferiority_desc>
            <param_type>Adjusted GMT Ratio</param_type>
            <param_value>0.65</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.59</ci_lower_limit>
            <ci_upper_limit>0.71</ci_upper_limit>
            <estimate_desc>The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority criterion: The upper limit of the two-sided 95% confidence interval (CI) for the GMT ratio (Fluzone® Quadrivalent Group/FluLaval™ Quadrivalent Group) did not exceed 1.5 for each of the four strains.</non_inferiority_desc>
            <param_type>Adjusted GMT Ratio</param_type>
            <param_value>0.62</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.56</ci_lower_limit>
            <ci_upper_limit>0.69</ci_upper_limit>
            <estimate_desc>The GMTs were used to calculate the Adjusted GMTs, which in turn were used to calculate the Adjusted GMT ratio with 95% confidence interval (Ancova model: adjustment for baseline titer - pooled variance).</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)</title>
        <description>Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 (Yamagata) and B/Brisbane/60/2008 (Victoria).</description>
        <time_frame>At Day 0 and 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)</time_frame>
        <population>The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.</population>
        <group_list>
          <group group_id="O1">
            <title>FluLaval™ Quadrivalent Group</title>
            <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.&#xD;
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
          </group>
          <group group_id="O2">
            <title>Fluzone® Quadrivalent Group</title>
            <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.&#xD;
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
          </group>
        </group_list>
        <measure>
          <title>Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)</title>
          <description>Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 (Yamagata) and B/Brisbane/60/2008 (Victoria).</description>
          <population>The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.</population>
          <units>Titers</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1013"/>
                <count group_id="O2" value="1028"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.0" lower_limit="10.2" upper_limit="12.0"/>
                    <measurement group_id="O2" value="11.1" lower_limit="10.2" upper_limit="12.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 28/Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.8" lower_limit="90.3" upper_limit="108.2"/>
                    <measurement group_id="O2" value="84.4" lower_limit="76.9" upper_limit="92.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.2" lower_limit="8.6" upper_limit="9.8"/>
                    <measurement group_id="O2" value="9.6" lower_limit="8.9" upper_limit="10.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 28/Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.7" lower_limit="90.3" upper_limit="105.7"/>
                    <measurement group_id="O2" value="84.3" lower_limit="77.6" upper_limit="91.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.3" lower_limit="18.8" upper_limit="22.0"/>
                    <measurement group_id="O2" value="20.6" lower_limit="19.0" upper_limit="22.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 28/Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="257.5" lower_limit="240.9" upper_limit="275.3"/>
                    <measurement group_id="O2" value="164.2" lower_limit="151.8" upper_limit="177.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2" lower_limit="6.0" upper_limit="6.5"/>
                    <measurement group_id="O2" value="6.3" lower_limit="6.0" upper_limit="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 28/Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.1" lower_limit="50.8" upper_limit="59.8"/>
                    <measurement group_id="O2" value="33.4" lower_limit="30.6" upper_limit="36.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, 6-17M, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2" lower_limit="6.5" upper_limit="7.9"/>
                    <measurement group_id="O2" value="7.1" lower_limit="6.5" upper_limit="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, 6-17M, Day 28/Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.7" lower_limit="37.1" upper_limit="49.0"/>
                    <measurement group_id="O2" value="43.2" lower_limit="37.3" upper_limit="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, 18-35M, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.5" lower_limit="13.0" upper_limit="16.2"/>
                    <measurement group_id="O2" value="14.6" lower_limit="13.1" upper_limit="16.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, 18-35M, Day 28/Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="170.9" lower_limit="155.2" upper_limit="188.3"/>
                    <measurement group_id="O2" value="129.6" lower_limit="116.3" upper_limit="144.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, 6-17M, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8" lower_limit="5.5" upper_limit="6.1"/>
                    <measurement group_id="O2" value="6.2" lower_limit="5.8" upper_limit="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, 6-17M, Day 28/Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.9" lower_limit="52.2" upper_limit="66.4"/>
                    <measurement group_id="O2" value="54.8" lower_limit="47.9" upper_limit="62.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, 18-35M, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.3" lower_limit="11.1" upper_limit="13.6"/>
                    <measurement group_id="O2" value="12.5" lower_limit="11.2" upper_limit="13.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, 18-35M, Day 28/Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="136.0" lower_limit="123.7" upper_limit="149.6"/>
                    <measurement group_id="O2" value="111.1" lower_limit="100.6" upper_limit="122.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, 6-17M, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.2" lower_limit="11.1" upper_limit="13.5"/>
                    <measurement group_id="O2" value="13.0" lower_limit="11.8" upper_limit="14.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, 6-17M, Day 28/Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="151.0" lower_limit="137.4" upper_limit="165.9"/>
                    <measurement group_id="O2" value="79.1" lower_limit="70.9" upper_limit="88.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, 18-35M, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.0" lower_limit="25.2" upper_limit="31.0"/>
                    <measurement group_id="O2" value="27.4" lower_limit="24.5" upper_limit="30.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, 18-35M, Day 28/Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="364.8" lower_limit="336.7" upper_limit="395.3"/>
                    <measurement group_id="O2" value="262.1" lower_limit="239.3" upper_limit="287.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, 6-17M, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" lower_limit="5.3" upper_limit="5.7"/>
                    <measurement group_id="O2" value="5.6" lower_limit="5.3" upper_limit="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, 6-17M, Day 28/Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68.7" lower_limit="61.8" upper_limit="76.3"/>
                    <measurement group_id="O2" value="31.9" lower_limit="28.4" upper_limit="35.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, 18-35M, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8" lower_limit="6.4" upper_limit="7.3"/>
                    <measurement group_id="O2" value="6.8" lower_limit="6.3" upper_limit="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, 18-35M, Day 28/Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.8" lower_limit="42.6" upper_limit="53.6"/>
                    <measurement group_id="O2" value="34.4" lower_limit="30.4" upper_limit="38.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Unprimed, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5" lower_limit="6.8" upper_limit="8.4"/>
                    <measurement group_id="O2" value="8.2" lower_limit="7.4" upper_limit="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Unprimed, Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.4" lower_limit="44.7" upper_limit="59.1"/>
                    <measurement group_id="O2" value="56.0" lower_limit="48.4" upper_limit="64.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Primed, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.4" lower_limit="12.9" upper_limit="16.1"/>
                    <measurement group_id="O2" value="13.8" lower_limit="12.3" upper_limit="15.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Primed, Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="158.8" lower_limit="143.3" upper_limit="176.0"/>
                    <measurement group_id="O2" value="115.0" lower_limit="102.6" upper_limit="128.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Unprimed, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4" lower_limit="5.9" upper_limit="7.0"/>
                    <measurement group_id="O2" value="6.9" lower_limit="6.3" upper_limit="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Unprimed, Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.0" lower_limit="66.0" upper_limit="85.3"/>
                    <measurement group_id="O2" value="76.8" lower_limit="66.9" upper_limit="88.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Primed, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8" lower_limit="10.7" upper_limit="13.0"/>
                    <measurement group_id="O2" value="12.2" lower_limit="10.9" upper_limit="13.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Primed, Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="118.4" lower_limit="107.5" upper_limit="130.3"/>
                    <measurement group_id="O2" value="90.4" lower_limit="81.8" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Unprimed, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.4" lower_limit="10.3" upper_limit="12.6"/>
                    <measurement group_id="O2" value="12.4" lower_limit="11.2" upper_limit="13.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Unprimed, Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="179.8" lower_limit="163.7" upper_limit="197.4"/>
                    <measurement group_id="O2" value="98.1" lower_limit="88.1" upper_limit="109.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Primed, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.5" lower_limit="27.6" upper_limit="33.8"/>
                    <measurement group_id="O2" value="30.1" lower_limit="27.0" upper_limit="33.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Primed, Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="334.3" lower_limit="306.4" upper_limit="364.7"/>
                    <measurement group_id="O2" value="242.2" lower_limit="219.1" upper_limit="267.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Unprimed, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6" lower_limit="5.3" upper_limit="5.9"/>
                    <measurement group_id="O2" value="5.6" lower_limit="5.3" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Unprimed, Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.7" lower_limit="83.8" upper_limit="100.3"/>
                    <measurement group_id="O2" value="44.8" lower_limit="40.1" upper_limit="50.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Primed, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" lower_limit="6.3" upper_limit="7.2"/>
                    <measurement group_id="O2" value="6.8" lower_limit="6.4" upper_limit="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Primed, Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.1" lower_limit="34.0" upper_limit="42.8"/>
                    <measurement group_id="O2" value="26.7" lower_limit="23.6" upper_limit="30.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)</title>
        <description>A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).</description>
        <time_frame>At Day 0 and 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)</time_frame>
        <population>The ATP cohort for immunogenicity included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.</population>
        <group_list>
          <group group_id="O1">
            <title>FluLaval™ Quadrivalent Group</title>
            <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.&#xD;
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
          </group>
          <group group_id="O2">
            <title>Fluzone® Quadrivalent Group</title>
            <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.&#xD;
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)</title>
          <description>A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).</description>
          <population>The ATP cohort for immunogenicity included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1013"/>
                <count group_id="O2" value="1028"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="191"/>
                    <measurement group_id="O2" value="190"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Day 28/56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="814"/>
                    <measurement group_id="O2" value="775"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="135"/>
                    <measurement group_id="O2" value="140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Day 28/56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="833"/>
                    <measurement group_id="O2" value="800"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="324"/>
                    <measurement group_id="O2" value="336"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Day 28/56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="983"/>
                    <measurement group_id="O2" value="911"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Day 28/56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="669"/>
                    <measurement group_id="O2" value="512"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, 6-17M, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, 6-17M, Day 28/Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="245"/>
                    <measurement group_id="O2" value="240"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, 18-35M, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="159"/>
                    <measurement group_id="O2" value="165"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, 18-35M, Day 28/Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="569"/>
                    <measurement group_id="O2" value="535"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, 6-17M, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, 6-17M, Day 28/Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="281"/>
                    <measurement group_id="O2" value="272"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, 18-35M, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="123"/>
                    <measurement group_id="O2" value="125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, 18-35M, Day 28/Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="552"/>
                    <measurement group_id="O2" value="528"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, 6-17M, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64"/>
                    <measurement group_id="O2" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, 6-17M, Day 28/Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="377"/>
                    <measurement group_id="O2" value="311"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, 18-35M, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="260"/>
                    <measurement group_id="O2" value="266"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, 18-35M, Day 28/Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="606"/>
                    <measurement group_id="O2" value="600"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, 6-17M, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, 6-17M, Day 28/Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="313"/>
                    <measurement group_id="O2" value="206"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, 18-35M, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, 18-35M, Day 28/Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="356"/>
                    <measurement group_id="O2" value="306"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Unprimed, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Unprimed, Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="282"/>
                    <measurement group_id="O2" value="294"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Primed, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="149"/>
                    <measurement group_id="O2" value="144"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Primed, Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="532"/>
                    <measurement group_id="O2" value="481"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Unprimed, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Unprimed, Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="321"/>
                    <measurement group_id="O2" value="330"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Primed, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108"/>
                    <measurement group_id="O2" value="109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Primed, Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="512"/>
                    <measurement group_id="O2" value="470"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Unprimed, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                    <measurement group_id="O2" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Unprimed, Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="407"/>
                    <measurement group_id="O2" value="362"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Primed, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="259"/>
                    <measurement group_id="O2" value="256"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Primed, Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="576"/>
                    <measurement group_id="O2" value="549"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Unprimed, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Unprimed, Day 56</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="379"/>
                    <measurement group_id="O2" value="277"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Primed, Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Primed, Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="290"/>
                    <measurement group_id="O2" value="235"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)</title>
        <description>A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (&lt;) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).</description>
        <time_frame>28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)</time_frame>
        <population>The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.</population>
        <group_list>
          <group group_id="O1">
            <title>FluLaval™ Quadrivalent Group</title>
            <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
          </group>
          <group group_id="O2">
            <title>Fluzone® Quadrivalent Group</title>
            <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)</title>
          <description>A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (&lt;) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).</description>
          <population>The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity which included all evaluable subjects, who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="974"/>
                <count group_id="O2" value="980"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1 [N=972,980]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="716"/>
                    <measurement group_id="O2" value="660"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2 [N=972,980]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="740"/>
                    <measurement group_id="O2" value="680"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata [N=974,980]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="833"/>
                    <measurement group_id="O2" value="723"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria [N=973,980]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="631"/>
                    <measurement group_id="O2" value="475"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, 6-17M [N=376,375]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="220"/>
                    <measurement group_id="O2" value="216"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, 18-35M [N=596,605]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="496"/>
                    <measurement group_id="O2" value="444"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, 6-17M [N=376,375]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="260"/>
                    <measurement group_id="O2" value="250"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, 18-35M [N=596,605]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="480"/>
                    <measurement group_id="O2" value="430"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, 6-17M [N=376,375]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="299"/>
                    <measurement group_id="O2" value="232"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, 18-35M [N=598,605]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="534"/>
                    <measurement group_id="O2" value="491"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, 6-17M [N=376,375]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="291"/>
                    <measurement group_id="O2" value="189"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, 18-35M [N=597,605]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="340"/>
                    <measurement group_id="O2" value="286"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)</title>
        <description>MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).</description>
        <time_frame>28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)</time_frame>
        <population>The ATP cohort for immunogenicity included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.</population>
        <group_list>
          <group group_id="O1">
            <title>FluLaval™ Quadrivalent Group</title>
            <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
          </group>
          <group group_id="O2">
            <title>Fluzone® Quadrivalent Group</title>
            <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)</title>
          <description>MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).</description>
          <population>The ATP cohort for immunogenicity included all evaluable subjects who received the study vaccine according to their treatment assignment and for whom the assay results for antibodies against at least one study vaccine strain after vaccination were available.</population>
          <units>Fold increase</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="974"/>
                <count group_id="O2" value="980"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H1N1 [N=972,980]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.0" lower_limit="8.4" upper_limit="9.7"/>
                    <measurement group_id="O2" value="7.7" lower_limit="7.1" upper_limit="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2 [N=972,980]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.7" lower_limit="10.0" upper_limit="11.6"/>
                    <measurement group_id="O2" value="8.9" lower_limit="8.2" upper_limit="9.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata [N=974,980]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.7" lower_limit="11.7" upper_limit="13.7"/>
                    <measurement group_id="O2" value="8.1" lower_limit="7.5" upper_limit="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria [N=973,980]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.7" lower_limit="8.1" upper_limit="9.4"/>
                    <measurement group_id="O2" value="5.4" lower_limit="5.0" upper_limit="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, 6-17M [N=376,375]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" lower_limit="5.3" upper_limit="6.8"/>
                    <measurement group_id="O2" value="6.1" lower_limit="5.2" upper_limit="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, 18-35M [N=596,605]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.7" lower_limit="10.7" upper_limit="12.8"/>
                    <measurement group_id="O2" value="8.9" lower_limit="8.1" upper_limit="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, 6-17M [N=376,375]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.2" lower_limit="9.0" upper_limit="11.6"/>
                    <measurement group_id="O2" value="8.8" lower_limit="7.7" upper_limit="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, 18-35M [N=596,605]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.1" lower_limit="10.1" upper_limit="12.1"/>
                    <measurement group_id="O2" value="9.0" lower_limit="8.2" upper_limit="9.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, 6-17M [N=376,375]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.3" lower_limit="10.7" upper_limit="14.3"/>
                    <measurement group_id="O2" value="6.1" lower_limit="5.3" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, 18-35M [N=598,605]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.9" lower_limit="11.8" upper_limit="14.0"/>
                    <measurement group_id="O2" value="9.7" lower_limit="8.9" upper_limit="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, 6-17M [N=376,375]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.3" lower_limit="11.0" upper_limit="13.8"/>
                    <measurement group_id="O2" value="5.7" lower_limit="5.1" upper_limit="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, 18-35M [N=597,605]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.0" lower_limit="6.4" upper_limit="7.7"/>
                    <measurement group_id="O2" value="5.2" lower_limit="4.7" upper_limit="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Unprimed [N=402,417]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.9" lower_limit="6.1" upper_limit="7.8"/>
                    <measurement group_id="O2" value="6.8" lower_limit="5.9" upper_limit="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H1N1, Primed [N=570, 563]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.9" lower_limit="10.0" upper_limit="12.0"/>
                    <measurement group_id="O2" value="8.5" lower_limit="7.7" upper_limit="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Unprimed [N=402,417]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8" lower_limit="10.4" upper_limit="13.4"/>
                    <measurement group_id="O2" value="11.2" lower_limit="9.7" upper_limit="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2, Primed [N=570, 563]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" lower_limit="9.1" upper_limit="10.9"/>
                    <measurement group_id="O2" value="7.6" lower_limit="6.9" upper_limit="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Unprimed [N=402,417]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.0" lower_limit="13.9" upper_limit="18.5"/>
                    <measurement group_id="O2" value="8.0" lower_limit="6.9" upper_limit="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yamagata, Primed [N=572, 563]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.7" lower_limit="9.9" upper_limit="11.6"/>
                    <measurement group_id="O2" value="8.2" lower_limit="7.6" upper_limit="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Unprimed [N=402,417]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.2" lower_limit="14.8" upper_limit="17.8"/>
                    <measurement group_id="O2" value="8.0" lower_limit="7.2" upper_limit="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Victoria, Primed [N=571, 563]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6" lower_limit="5.1" upper_limit="6.1"/>
                    <measurement group_id="O2" value="4.0" lower_limit="3.6" upper_limit="4.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)</title>
        <description>Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity and all subjects reporting 'Yes' for solicited symptom occurred but with missing values for at least one day during the solicited period. Grade 3 pain = Cried when limb is moved/spontaneously painful. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. &gt;100mm.</description>
        <time_frame>During a 7-day (Day 0 - Day 6) follow-up period after each vaccination</time_frame>
        <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.</population>
        <group_list>
          <group group_id="O1">
            <title>FluLaval™ Quadrivalent Group</title>
            <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.&#xD;
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
          </group>
          <group group_id="O2">
            <title>Fluzone® Quadrivalent Group</title>
            <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.&#xD;
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)</title>
          <description>Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity and all subjects reporting 'Yes' for solicited symptom occurred but with missing values for at least one day during the solicited period. Grade 3 pain = Cried when limb is moved/spontaneously painful. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. &gt;100mm.</description>
          <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1156"/>
                <count group_id="O2" value="1151"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Pain, Dose 1 [N=1151,1146]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="464"/>
                    <measurement group_id="O2" value="429"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Pain, Dose 1 [N=1151,1146]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Redness, Dose 1 [N=1151,1146]</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>Grade 3 Redness, Dose 1 [N=1151,1146]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Swelling, Dose 1 [N=1151,1146]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Swelling, Dose 1 [N=1151,1146]</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 Pain, Dose 2 [N=490,493]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="138"/>
                    <measurement group_id="O2" value="147"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Pain, Dose 2 [N=490,493]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Redness, Dose 2 [N=490,493]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Redness, Dose 2 [N=490,493]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Swelling, Dose 2 [N=490,493]</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>Grade 3 Swelling, Dose 2 [N=490,493]</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 Pain, Across doses [N=1156,1151]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="509"/>
                    <measurement group_id="O2" value="462"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Pain, Across doses [N=1156,1151]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Redness, Across doses [N=1156,1151]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Redness, Across doses [N=1156,1151]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Swelling, Across doses [N=1156,1151]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Swelling, Across doses [N=1156,1151]</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 Pain, 6-17M, Dose 1 [N=478,465]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="175"/>
                    <measurement group_id="O2" value="173"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Pain, 6-17M, Dose 1 [N=478,465]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Redness, 6-17M, Dose 1 [N=478,465]</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>Grade 3 Redness, 6-17M, Dose 1 [N=478,465]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Swelling, 6-17M, Dose 1 [N=478,465]</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>Grade 3 Swelling, 6-17M, Dose 1 [N=478,465]</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 Pain, 18-35M, Dose 1 [N=673,681]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="289"/>
                    <measurement group_id="O2" value="256"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Pain, 18-35M, Dose 1 [N=673,681]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Redness, 18-35M, Dose 1 [N=673,681]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Redness, 18-35M, Dose 1 [N=673,681]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Swelling, 18-35M, Dose 1 [N=673,681]</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>Grade 3 Swelling, 18-35M, Dose 1 [N=673,681]</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 Pain, 6-17M, Dose 2 [N=373,372]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103"/>
                    <measurement group_id="O2" value="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Pain, 6-17M, Dose 2 [N=373,372]</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>Any Redness, 6-17M, Dose 2 [N=373,372]</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>Grade 3 Redness, 6-17M, Dose 2 [N=373,372]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Swelling, 6-17M, Dose 2 [N=373,372]</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>Grade 3 Swelling, 6-17M, Dose 2 [N=373,372]</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 Pain, 18-35M, Dose 2 [N=117,121]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Pain, 18-35M, Dose 2 [N=117,121]</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 Redness, 18-35M, Dose 2 [N=117,121]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Redness, 18-35M, Dose 2 [N=117,121]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Swelling, 18-35M, Dose 2 [N=117,121]</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>Grade 3 Swelling, 18-35M, Dose 2 [N=117,121]</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 Pain, 6-17M, Across Doses [N=481,469]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="211"/>
                    <measurement group_id="O2" value="196"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Pain, 6-17M, Across Doses [N=481,469]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Redness, 6-17M, Across Doses [N=481,469]</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>Grade 3 Redness, 6-17M, Across Doses [N=481,469]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Swelling, 6-17M, Across Doses [N=481,469]</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>Grade 3 Swelling, 6-17M, Across Doses [N=481,469]</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 Pain, 18-35M, Across Doses [N=675,682]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="298"/>
                    <measurement group_id="O2" value="266"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Pain, 18-35M, Across Doses [N=675,682]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Redness, 18-35M, Across Doses [N=675,682]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Redness, 18-35M, Across Doses [N=675,682]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Swelling, 18-35M, Across Doses [N=675,682]</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>Grade 3 Swelling, 18-35M, Across Doses [N=675,682]</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 Pain, Unprimed, Dose 1 [N=518,516]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="187"/>
                    <measurement group_id="O2" value="190"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Pain, Unprimed, Dose 1 [N=518,516]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Redness, Unprimed, Dose 1 [N=518,516]</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>Grade 3 Redness, Unprimed, Dose 1 [N=518,516]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Swelling, Unprimed, Dose 1 [N=518,516</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>Grade 3 Swelling, Unprimed, Dose 1 [N=518,516]</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 Pain, Primed, Dose 1 [N=633,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="277"/>
                    <measurement group_id="O2" value="239"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Pain, Primed, Dose 1 [N=633,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Redness, Primed, Dose 1 [N=633,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Redness, Primed, Dose 1 [N=633,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Swelling, Primed, Dose 1 [N=633,630]</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>Grade 3 Swelling, Primed, Dose 1 [N=633,630]</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 Pain, Unprimed, Dose 2 [N=490,493]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="138"/>
                    <measurement group_id="O2" value="147"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Pain, Unprimed, Dose 2 [N=490,493]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Redness, Unprimed, Dose 2 [N=490,493]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Redness, Unprimed, Dose 2 [N=490,493]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Swelling, Unprimed, Dose 2 [N=490,493]</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>Grade 3 Swelling, Unprimed, Dose 2 [N=490,493]</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 Pain, Unprimed, Across Doses [N=523,521]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="232"/>
                    <measurement group_id="O2" value="223"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Pain, Unprimed, Across Doses [N=523,521]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Redness, Unprimed, Across Doses [N=523,521]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Redness, Unprimed, Across Doses[N=523,521]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Swelling, Unprimed, Across Doses [N=523,521]</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>Grade 3 Swelling,Unprimed, Across Doses[N=523,521]</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 Pain, Primed, Across Doses [N=633,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="277"/>
                    <measurement group_id="O2" value="239"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Pain, Primed, Across Doses [N=633,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Redness, Primed, Across Doses [N=633,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Redness, Primed, Across Doses [N=633,630]</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 Sweling, Primed, Across Doses [N=633,630]</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>Grade 3 Swelling, Primed, Across Doses [N=633,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)</title>
        <description>Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (&lt; )38°C but with missing values for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (&gt;) 39.0°C.</description>
        <time_frame>During the 7-day (Days 0-6) follow-up period after each vaccination</time_frame>
        <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.</population>
        <group_list>
          <group group_id="O1">
            <title>FluLaval™ Quadrivalent Group</title>
            <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
          </group>
          <group group_id="O2">
            <title>Fluzone® Quadrivalent Group</title>
            <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)</title>
          <description>Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (&lt; )38°C but with missing values for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (&gt;) 39.0°C.</description>
          <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1159"/>
                <count group_id="O2" value="1152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Drowsiness, Dose 1 [N=1155,1148]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="424"/>
                    <measurement group_id="O2" value="424"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Drowsiness, Dose 1 [N=1155,1148]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Drowsiness, Dose 1 [N=1155,1148]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="365"/>
                    <measurement group_id="O2" value="381"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Fever, Dose 1 [N=1155,1148]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="146"/>
                    <measurement group_id="O2" value="147"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever (≥38.0°C), Dose 1 [N=1155,1148]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                    <measurement group_id="O2" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fever, Dose 1 [N=1155,1148]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Fever, Dose 1 [N=1155,1148]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥38.0°C Related Fever, Dose 1 [N=1155,1148]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Irritability, Dose 1 [N=1155,1148]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="570"/>
                    <measurement group_id="O2" value="527"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Irritability, Dose 1 [N=1155,1148]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44"/>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Irritability, Dose 1 [N=1155,1148]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="499"/>
                    <measurement group_id="O2" value="473"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Loss of Appetite, Dose 1 [N=1155,1148]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="334"/>
                    <measurement group_id="O2" value="328"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Loss of Appetite, Dose 1 [N=1155,1148]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Loss of Appetite, Dose 1 [N=1155,1148]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="280"/>
                    <measurement group_id="O2" value="290"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Drowsiness, Dose 2 [N=490,495]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="157"/>
                    <measurement group_id="O2" value="166"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Drowsiness, Dose 2 [N=490,495]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Drowsiness, Dose 2 [N=490,495]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="133"/>
                    <measurement group_id="O2" value="136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Fever, Dose 2 [N=490,495]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O2" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever (≥38.0°C), Dose 2 [N=490,495]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fever, Dose 2 [N=490,495]</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>Related Fever, Dose 2 [N=490,495]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥38.0°C Related Fever, Dose 2 [N=490,495]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Irritability, Dose 2 [N=490,495]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="211"/>
                    <measurement group_id="O2" value="214"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Irritability, Dose 2 [N=490,495]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Irritability, Dose 2 [N=490,495]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="185"/>
                    <measurement group_id="O2" value="175"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Loss of Appetite, Dose 2 [N=490,495]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110"/>
                    <measurement group_id="O2" value="116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Loss of Appetite, Dose 2 [N=490,495]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Loss of Appetite, Dose 2 [N=490,495]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91"/>
                    <measurement group_id="O2" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Drowsiness, Across Doses [N=1159,1152]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="471"/>
                    <measurement group_id="O2" value="471"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Drowsiness, Across Doses [N=1159,1152]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Drowsiness, Across Doses [N=1159,1152]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="411"/>
                    <measurement group_id="O2" value="425"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Fever, Across Doses [N=1159,1152]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="183"/>
                    <measurement group_id="O2" value="178"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever (≥38.0°C), Across Doses [N=1159,1152</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91"/>
                    <measurement group_id="O2" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fever, Across Doses [N=1159,1152]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Fever, Across Doses [N=1159,1152]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                    <measurement group_id="O2" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥38.0°C Related Fever, Across Doses [N=1159,1152]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O2" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Irritability, Across Doses [N=1159,1152]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="630"/>
                    <measurement group_id="O2" value="582"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Irritability, Across Doses [N=1159,1152]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61"/>
                    <measurement group_id="O2" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Irritability, Across Doses [N=1159,1152]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="558"/>
                    <measurement group_id="O2" value="525"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Loss of Appetite, Across Doses [N=1159,1152]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="391"/>
                    <measurement group_id="O2" value="385"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Loss of Appetite,Across Doses[N=1159,1152</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Loss of Appetite,Across Doses[N=1159,1152]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="328"/>
                    <measurement group_id="O2" value="337"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Drowsiness, 6-17M, Dose 1 [N=478,467]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="200"/>
                    <measurement group_id="O2" value="210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Drowsiness, 6-17M, Dose 1 [N=478,467]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Drowsiness, 6-17M, Dose 1 [N=478,467]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="171"/>
                    <measurement group_id="O2" value="189"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Fever, 6-17M, Dose 1 [N=478,467]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80"/>
                    <measurement group_id="O2" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever (≥38.0°C), 6-17M, Dose 1 [N=478,467]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fever, 6-17M, Dose 1 [N=478,467]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Fever, 6-17M, Dose 1 [N=478,467]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥38.0°C Related Fever, 6-17M, Dose 1 [N=478,467]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Irritability, 6-17M, Dose 1 [N=478,467]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="273"/>
                    <measurement group_id="O2" value="252"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Irritability, 6-17M, Dose 1 [N=478,467]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Irritability, 6-17M, Dose 1 [N=478,467]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="239"/>
                    <measurement group_id="O2" value="227"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Loss of Appetite, 6-17M, Dose 1 [N=478,467]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="141"/>
                    <measurement group_id="O2" value="131"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Loss of Appetite, 6-17M,Dose 1 [N=478,467]</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>Related Loss of Appetite, 6-17M, Dose 1[N=478,467]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="122"/>
                    <measurement group_id="O2" value="115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Drowsiness, 18-35M, Dose 1 [N=677,681]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="224"/>
                    <measurement group_id="O2" value="214"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Drowsiness, 18-35M, Dose 1 [N=677,681]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Drowsiness, 18-35M, Dose 1 [N=677,681]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="194"/>
                    <measurement group_id="O2" value="192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Fever, 18-35M, Dose 1 [N=677,681]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66"/>
                    <measurement group_id="O2" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever (≥38.0°C), 18-35M, Dose 1 [N=677,681]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fever, 18-35M, Dose 1 [N=677,681]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Fever, 18-35M, Dose 1 [N=677,681]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥38.0°C Related Fever, 18-35M, Dose 1 [N=677,681]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Irritability, 18-35M, Dose 1 [N=677,681]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="297"/>
                    <measurement group_id="O2" value="275"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Irritability, 18-35M, Dose 1 [N=677,681]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Irritability, 18-35M, Dose 1 [N=677,681]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="260"/>
                    <measurement group_id="O2" value="246"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Loss of Appetite, 18-35M, Dose 1 [N=677,681]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="193"/>
                    <measurement group_id="O2" value="197"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Loss of Appetite,18-35M,Dose 1 [N=677,681]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Loss of Appetite,18-35M,Dose 1 [N=677,681]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="158"/>
                    <measurement group_id="O2" value="175"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Drowsiness, 6-17M, Dose 2 [N=373,374]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="129"/>
                    <measurement group_id="O2" value="142"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Drowsiness, 6-17M, Dose 2 [N=373,374]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Drowsiness, 6-17M, Dose 2 [N=373,374]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="111"/>
                    <measurement group_id="O2" value="115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Fever, 6-17M, Dose 2 [N=373,374]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever (≥38.0°C), 6-17M, Dose 2 [N=373,374]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fever, 6-17M, Dose 2 [N=373,374]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Fever, 6-17M, Dose 2 [N=373,374]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥38.0°C Related Fever, 6-17M, Dose 2 [N=373,374]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Irritability, 6-17M, Dose 2 [N=373,374]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="168"/>
                    <measurement group_id="O2" value="177"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Irritability, 6-17M, Dose 2 [N=373,374]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Irritability, 6-17M, Dose 2 [N=373,374]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="150"/>
                    <measurement group_id="O2" value="141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Loss of Appetite, 6-17M, Dose 2 [N=373,374]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90"/>
                    <measurement group_id="O2" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Loss of Appetite, 6-17M, Dose 2[N=373,374]</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>Related Loss of Appetite, 6-17M Dose 2[N=373,374]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73"/>
                    <measurement group_id="O2" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Drowsiness, 18-35M, Dose 2 [N=117,121]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Drowsiness, 18-35M, Dose 2 [N=117,121]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Drowsiness, 18-35M, Dose 2 [N=117,121]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Fever, 18-35M, Dose 2 [N=117,121]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever (≥38.0°C), 18-35M, Dose 2 [N=117,121]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fever, 18-35M, Dose 2 [N=117,121]</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>Related Fever, 18-35M, Dose 2 [N=117,121]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥38.0°C Related Fever, 18-35M, Dose 2 [N=117,121]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Irritability, 18-35M, Dose 2 [N=117,121]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Irritability, 18-35M, Dose 2 [N=117,121]</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>Related Irritability, 18-35M, Dose 2 [N=117,121]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Loss of Appetite, 18-35M, Dose 2 [N=117,121]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Loss of Appetite, 18-35M,Dose 2[N=117,121]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Loss of Appetite, 18-35M,Dose 2[N=117,121]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Drowsiness, 6-17M, Across Doses [N=481,470]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="238"/>
                    <measurement group_id="O2" value="248"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Drowsiness, 6-17M, Across Doses[N=481,470]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Drowsiness, 6-17M, Across Doses[N=481,470]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="209"/>
                    <measurement group_id="O2" value="224"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Fever, 6-17M, Across Doses [N=481,470]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109"/>
                    <measurement group_id="O2" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever (≥38.0°C), 6-17M, Across Doses [N=481,470]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O2" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fever, 6-17M, Across Doses [N=481,470]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Fever, 6-17M, Across Doses [N=481,470]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥38.0°CRelated Fever,6-17M,Across Doses[N=481,470]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Irritability, 6-17M, Across Doses [N=481,470]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="315"/>
                    <measurement group_id="O2" value="297"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Irritability,6-17M,Across Doses[N=481,470]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Irritability,6-17M,Across Doses[N=481,470]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="280"/>
                    <measurement group_id="O2" value="269"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Loss of Appetite,6-17M,Across Doses[N=481,470]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="188"/>
                    <measurement group_id="O2" value="175"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade3 LossofAppetite,6-17M,AcrossDoses[N=481,470]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related LossofAppetite,6-17M,AcrossDoses[N=481,470</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="159"/>
                    <measurement group_id="O2" value="148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Drowsiness, 18-35M, Across Doses [N=678,682]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="233"/>
                    <measurement group_id="O2" value="223"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Drowsiness,18-35M, Across Doses[N=678,682]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Drowsiness,18-35M,Across Doses [N=678,682]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="202"/>
                    <measurement group_id="O2" value="201"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Fever, 18-35M, Across Doses [N=678,682]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever (≥38.0°C), 18-35M, Across Doses [N=678,682]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fever, 18-35M, Across Doses [N=678,682]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Fever, 18-35M, Across Doses [N=678,682]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥38.0°CRelated Fever,18-35M,Across Doses[N=678,682</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Irritability, 18-35M, Across Doses [N=678,682]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="315"/>
                    <measurement group_id="O2" value="285"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade3 Irritability,18-35M,Across Doses[N=678,682]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Irritability,18-35M,Across Doses[N=678,682</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="278"/>
                    <measurement group_id="O2" value="256"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Loss ofAppetite,18-35M,Across Doses[N=678,682]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="203"/>
                    <measurement group_id="O2" value="210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade3LossofAppetite,18-35M,AcrossDoses[N=678,682]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RelatedLossofAppetite,18-35M,AcrossDoses[N=678,682</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="169"/>
                    <measurement group_id="O2" value="189"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Drowsiness, Unprimed, Dose 1 [N=520,518]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="212"/>
                    <measurement group_id="O2" value="211"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Drowsiness, Unprimed, Dose 1 [N=520,518]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Drowsiness, Unprimed, Dose 1 [N=520,518]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="182"/>
                    <measurement group_id="O2" value="189"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Fever, Unprimed, Dose 1 [N=520,518]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80"/>
                    <measurement group_id="O2" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever (≥38.0°C), Unprimed, Dose 1 [N=520,518]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fever, Unprimed, Dose 1 [N=520,518]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Fever, Unprimed, Dose 1 [N=520,518]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥38.0°C Related Fever, Unprimed, Dose 1[N=520,518]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Irritability, Unprimed, Dose 1 [N=520,518]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="274"/>
                    <measurement group_id="O2" value="256"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Irritability, Unprimed, Dose 1 [N=520,518]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Irritability, Unprimed, Dose 1 [N=520,518]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="240"/>
                    <measurement group_id="O2" value="227"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Loss of Appetite, Unprimed, Dose 1 [N=520,518]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="154"/>
                    <measurement group_id="O2" value="138"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade3 Loss of Appetite,Unprimed,Dose 1[N=520,518]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Loss of Appetite,Unprimed,Dose1[N=520,518]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="129"/>
                    <measurement group_id="O2" value="119"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Drowsiness, Primed, Dose 1 [N=635,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="212"/>
                    <measurement group_id="O2" value="213"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Drowsiness, Primed, Dose 1 [N=635,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Drowsiness, Primed, Dose 1 [N=635,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="183"/>
                    <measurement group_id="O2" value="192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Fever, Primed, Dose 1 [N=635,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66"/>
                    <measurement group_id="O2" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever (≥38.0°C) Primed, Dose 1 [N=635,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fever, Primed, Dose 1 [N=635,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Fevers, Primed, Dose 1 [N=635,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥38.0°C Related Fever, Primed, Dose 1 [N=635,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Irritability, Primed, Dose 1 [N=635,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="296"/>
                    <measurement group_id="O2" value="271"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Irritability, Primed, Dose 1 [N=635,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Irritability, Primed, Dose 1 [N=635,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="259"/>
                    <measurement group_id="O2" value="246"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Loss of Appetite, Primed, Dose 1 [N=635,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="180"/>
                    <measurement group_id="O2" value="190"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Loss of Appetite, Primed,Dose 1[N=635,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Loss of Appetite,Primed,Dose 1 [N=635,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="151"/>
                    <measurement group_id="O2" value="171"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Drowsiness, Unprimed, Dose 2 [N=490,495]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="157"/>
                    <measurement group_id="O2" value="166"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Drowsiness, Unprimed, Dose 2 [N=490,495]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Drowsiness, Unprimed, Dose 2 [N=490,495]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="133"/>
                    <measurement group_id="O2" value="136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Fever, Unprimed, Dose 2 [N=490,495]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O2" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever (≥38.0°C), Unprimed, Dose 2 [N=490,495]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fever, Unprimed, Dose 2 [N=490,495]</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>Related Fever, Unprimed, Dose 2 [N=490,495]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥38.0°C Related Fever, Unprimed,Dose 2 [N=490,495]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Irritability, Unprimed, Dose 2 [N=490,495]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="211"/>
                    <measurement group_id="O2" value="214"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Irritability, Unprimed, Dose 2 [N=490,495]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Irritability, Unprimed,Dose 2 [N=490,495]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="185"/>
                    <measurement group_id="O2" value="175"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Loss of Appetite, Unprimed, Dose 2 [N=490,495]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110"/>
                    <measurement group_id="O2" value="116"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade3 Loss of Appetite,Unprimed,Dose 2[N=490,495]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Loss of Appetite,Unprimed,Dose 2[N=490,495</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91"/>
                    <measurement group_id="O2" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Drowsiness, Unprimed, Across Doses [N=524,522]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="259"/>
                    <measurement group_id="O2" value="258"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade3 Drowsiness,Unprimed,Across Doses[N=524,522]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RelatedDrowsiness,Unprimed,Across Doses[N=524,522]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="228"/>
                    <measurement group_id="O2" value="233"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Fever, Unprimed, Across Doses [N=524,522]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever (≥38.0°C), Unprimed,Across Doses [N=524,522]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67"/>
                    <measurement group_id="O2" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fever, Unprimed, Across Doses [N=524,522]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Fever, Unprimed, Across Doses [N=524,522]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥38.0°CRelatedFever,Unprimed,AcrossDoses[N=524,522</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Irritability,Unprimed, Across Doses[N=524,522]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="334"/>
                    <measurement group_id="O2" value="311"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade3Irritability,Unprimed,AcrossDoses[N=524,522]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RelatedIrritability,Unprimed,AcrossDoses[N=524,522</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="299"/>
                    <measurement group_id="O2" value="279"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AnyLoss ofAppetite,Unprimed,AcrossDoses[N=524,522]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="211"/>
                    <measurement group_id="O2" value="195"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade3LossofAppetite,Unprimed,AcrossDosesN=524,522</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RelatedLossofAppetite,UnprimedAcrossDosesN=524,522</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="177"/>
                    <measurement group_id="O2" value="166"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Drowsiness, Primed, Across Doses [N=635,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="212"/>
                    <measurement group_id="O2" value="213"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Drowsiness, Primed,Across Doses[N=635,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Drowsiness,Primed,Across Doses[N=635,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="183"/>
                    <measurement group_id="O2" value="192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Fever, Primed, Across Doses [N=635,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66"/>
                    <measurement group_id="O2" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever (≥38.0°C), Primed, Across Doses [N=635,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fever, Primed, Across Doses [N=635,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Fever, Primed, Across Doses [N=635,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥38.0°C RelatedFever,Primed,Across Doses[N=635,630</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Irritability, Primed, Across Doses [N=635,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="296"/>
                    <measurement group_id="O2" value="271"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade3 Irritability,Primed,Across Doses[N=635,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Irritability,Primed,AcrossDoses[N=635,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="259"/>
                    <measurement group_id="O2" value="246"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Loss of Appetite,Primed,AcrossDoses[N=635,630]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="180"/>
                    <measurement group_id="O2" value="190"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade3 LossofAppetite,Primed,AcrossDoses[N=635,630</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RelatedLossofAppetite,Primed,AcrossDoses[N=635,630</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="151"/>
                    <measurement group_id="O2" value="171"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)</title>
        <description>Duration was defined as number of days with any grade of local and general symptoms.</description>
        <time_frame>During the 7-day (Days 0-6) follow-up period after each vaccination.</time_frame>
        <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.</population>
        <group_list>
          <group group_id="O1">
            <title>FluLaval™ Quadrivalent Group</title>
            <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.&#xD;
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
          </group>
          <group group_id="O2">
            <title>Fluzone® Quadrivalent Group</title>
            <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.&#xD;
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)</title>
          <description>Duration was defined as number of days with any grade of local and general symptoms.</description>
          <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.</population>
          <units>Days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="570"/>
                <count group_id="O2" value="527"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Drowsiness, Dose 1 [N=424,424]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="1.5" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drowsiness, Dose 2 [N=157,166]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Irritability, Dose 1 [N=570, 527]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Irritability, Dose 2 [N=211,214]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loss of Appetite, Dose 1 [N=334, 328]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loss of Appetite, Dose 2 [N=110,116]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain, Dose 1 [N=464,429]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain, Dose 2 [N=138,147]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="6.0"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness, Dose 1 [N=15,15]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="4.0"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness, Dose 2 [N=1,2]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                    <measurement group_id="O2" value="1.5" lower_limit="1.0" upper_limit="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling, Dose 1 [N=11,5]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="5.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever, Dose 1 [N=146,147]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever, Dose 2 [N=60,48]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drowsiness, 6-17M, Dose 1 [N=200,210]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drowsiness, 18-35M, Dose 1 [N=224,214]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drowsiness, 6-17M, Dose 2 [N=129,142]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drowsiness, 18-35M, Dose 2 [N=28,24]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Irritability, 6-17M, Dose 1 [N=273,252]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Irritability, 18-35M, Dose 1 [N=297,275]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Irritability, 6-17M, Dose 2 [N=168,177]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Irritability, 18-35M, Dose 2 [N=43,37]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loss of Appetite, 6-17M, Dose 1 [N=141,131]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loss of Appetite, 18-35M, Dose 1 [N=193,197]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loss of Appetite, 6-17M, Dose 2 [N=90,91]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loss of Appetite, 18-35M, Dose 2 [N=20,25]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain, 6-17M, Dose 1 [N=175,173]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain, 18-35M, Dose 1 [N=289,256]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain, 6-17M, Dose 2 [N=103,108]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="6.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain, 18-35M, Dose 2 [N=35,39]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="5.0"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness, 6-17M, Dose 1 [N=2,2]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" lower_limit="1.0" upper_limit="2.0"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness, 18-35M, Dose 1 [N=13,13]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="4.0"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness, 6-17M, Dose 2 [N=1,0]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness, 18-35M, Dose 2 [N=0,2]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" lower_limit="0.0" upper_limit="0.0"/>
                    <measurement group_id="O2" value="1.5" lower_limit="1.0" upper_limit="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling, 6-17M, Dose 1 [N=4,0]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" lower_limit="1.0" upper_limit="2.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling, 18-35M, Dose 1 [N=7,5]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="5.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever, 6-17M, Dose 1 [N=80,70]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever, 18-35M, Dose 1 [N=66,77]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="6.0"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever, 6-17M, Dose 2 [N=47,38]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="1.5" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever, 18-35M, Dose 2 [N=13,10]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="3.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drowsiness, Unprimed, Dose 1 [N=212,211]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drowsiness, Primed, Dose 1 [N=212,213]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drowsiness, Unprimed, Dose 2 [N=157,166]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Irritability, Unprimed, Dose 1 [N=274,256]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Irritability, Primed, Dose 1 [N=296,271]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Irritability, Unprimed, Dose 2 [N=211,214]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loss of Appetite, Unprimed, Dose 1 [N=154,138]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loss of Appetite, Primed, Dose 1 [N=180,190]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loss of Appetite, Unprimed, Dose 2 [N=110,116]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain, Unprimed, Dose 1 [N=187,190]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain, Primed, Dose 1 [N=277,239]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain, Unprimed, Dose 2 [N=138,147]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="6.0"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness, Unprimed, Dose 1 [N=2,2]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" lower_limit="1.0" upper_limit="2.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness, Primed, Dose 1 [N=13,13]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="4.0"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness, Unprimed, Dose 2 [N=1,2]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="1.0"/>
                    <measurement group_id="O2" value="1.5" lower_limit="1.0" upper_limit="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling, Unprimed, Dose 1 [N=4,0]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" lower_limit="1.0" upper_limit="2.0"/>
                    <measurement group_id="O2" value="0.0" lower_limit="0.0" upper_limit="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling, Primed, Dose 1 [N=7,5]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="5.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever, Unprimed, Dose 1 [N=80,69]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever, Primed, Dose 1 [N=66,78]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="1.0" lower_limit="1.0" upper_limit="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever, Unprimed, Dose 2 [N=60,48]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any Fever Following Each Dose and Across Doses.</title>
        <description>Any Fever = all subjects with a documented temperature of ≥38.0°C /100.4°F by axillary route and all subjects reporting temperature &lt; 38.0°C but with missing values for at least one day during the solicited period.&#xD;
Grade 3 fever was defined as temperature greater than (&gt;) 39.0°C.</description>
        <time_frame>During a 2-day (Days 0-1) follow-up period after each vaccination</time_frame>
        <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.</population>
        <group_list>
          <group group_id="O1">
            <title>FluLaval™ Quadrivalent Group</title>
            <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.&#xD;
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
          </group>
          <group group_id="O2">
            <title>Fluzone® Quadrivalent Group</title>
            <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.&#xD;
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any Fever Following Each Dose and Across Doses.</title>
          <description>Any Fever = all subjects with a documented temperature of ≥38.0°C /100.4°F by axillary route and all subjects reporting temperature &lt; 38.0°C but with missing values for at least one day during the solicited period.&#xD;
Grade 3 fever was defined as temperature greater than (&gt;) 39.0°C.</description>
          <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1159"/>
                <count group_id="O2" value="1152"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Fever, Dose 1 [N=1155,1148]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever (≥38.0°C), Dose 1 [N=1155,1148]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fever (&gt;39.0°C), Dose 1 [N=1155,1148]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Fever, Dose 2 [N=490,495]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever (≥38.0°C), Dose 2 [N=490,495]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fever (&gt;39.0°C), Dose 2 [N=490,495]</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 Fever, Across Doses [N=1159,1152]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82"/>
                    <measurement group_id="O2" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever (≥38.0°C), Across Doses [N=1159,1152]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fever (&gt;39.0°C), Across Doses[N=1159,1152]</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_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting the Occurrence of All Medically Attended Events (MAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed).</title>
        <description>MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).</description>
        <time_frame>During the entire study period (Days 0 -180)</time_frame>
        <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.</population>
        <group_list>
          <group group_id="O1">
            <title>FluLaval™ Quadrivalent Group</title>
            <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.&#xD;
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
          </group>
          <group group_id="O2">
            <title>Fluzone® Quadrivalent Group</title>
            <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.&#xD;
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting the Occurrence of All Medically Attended Events (MAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed).</title>
          <description>MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).</description>
          <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1207"/>
                <count group_id="O2" value="1217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any MAE(s) [N=1207,1217]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="727"/>
                    <measurement group_id="O2" value="719"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any MAE(s), 6-17M [N=500,502]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="322"/>
                    <measurement group_id="O2" value="323"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any MAE(s), 18-35M [N=707,715]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="405"/>
                    <measurement group_id="O2" value="396"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any MAE(s), Unprimed [N=550,560]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="344"/>
                    <measurement group_id="O2" value="337"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any MAE(s), Primed [N=657,657]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="383"/>
                    <measurement group_id="O2" value="382"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)</title>
        <description>pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related = symptom assed by the investigator as causally related to the study vaccination.</description>
        <time_frame>During the entire study period (Days 0 -180)</time_frame>
        <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.</population>
        <group_list>
          <group group_id="O1">
            <title>FluLaval™ Quadrivalent Group</title>
            <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.&#xD;
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
          </group>
          <group group_id="O2">
            <title>Fluzone® Quadrivalent Group</title>
            <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.&#xD;
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)</title>
          <description>pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related = symptom assed by the investigator as causally related to the study vaccination.</description>
          <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1207"/>
                <count group_id="O2" value="1217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any pIMD(s) [N=1207,1217]</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>Related pIMD(s) [N=1207,1217]</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 pIMD(s), 6-17M [N=500,502]</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>Related pIMD(s), 6-17M [N=500,502]</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 pIMD(s), 18-35M [N=707,715]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related pIMD(s), 18-35M [N=707,715]</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 pIMD(s), Unprimed [N=550,560]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related pIMD(s), Unprimed [N=550,560]</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 pIMD(s), Primed [N=657,657]</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>Related pIMD(s), Primed [N=657,657]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)</title>
        <description>An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE was defined as an event that prevented normal activity. Related unsolicited AE was defined as an event assessed by the investigator to be causally related to the study vaccination.</description>
        <time_frame>During a 28-day (Days 0-27 for primed and unprimed subjects and Days 28-56 for unprimed subjects) post-vaccination period</time_frame>
        <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.</population>
        <group_list>
          <group group_id="O1">
            <title>FluLaval™ Quadrivalent Group</title>
            <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.&#xD;
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
          </group>
          <group group_id="O2">
            <title>Fluzone® Quadrivalent Group</title>
            <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.&#xD;
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)</title>
          <description>An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE was defined as an event that prevented normal activity. Related unsolicited AE was defined as an event assessed by the investigator to be causally related to the study vaccination.</description>
          <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1207"/>
                <count group_id="O2" value="1217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any Unsolicited AEs [N=1207,1217]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="549"/>
                    <measurement group_id="O2" value="537"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Unsolicited AEs [N=1207,1217]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                    <measurement group_id="O2" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Unsolicited AEs [N=1207,1217]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71"/>
                    <measurement group_id="O2" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Unsolicited AEs, 6-17M [N=500,502]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="268"/>
                    <measurement group_id="O2" value="270"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Unsolicited AEs, 6-17M [N=500,502]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Unsolicited AEs, 6-17M [N=500,502]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Unsolicited AEs, 18-35M [N=707,715]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="281"/>
                    <measurement group_id="O2" value="267"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Unsolicited AEs, 18-35M [N=707,715]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Unsolicited AEs, 18-35M [N=707,715]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Unsolicited AEs, Unprimed [N=550,560]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="310"/>
                    <measurement group_id="O2" value="302"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Unsolicited AEs, Unprimed [N=550,560]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Unsolicited AEs, Unprimed [N=550,560]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Unsolicited AEs, Primed [N=657,657]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="239"/>
                    <measurement group_id="O2" value="235"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Unsolicited AEs, Primed [N=657,657]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related Unsolicited AEs, Primed [N=657,657]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)</title>
        <description>SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assessed by the investigator as causally related to the study vaccination.</description>
        <time_frame>During the entire study period (Days 0 -180)</time_frame>
        <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.</population>
        <group_list>
          <group group_id="O1">
            <title>FluLaval™ Quadrivalent Group</title>
            <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.&#xD;
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
          </group>
          <group group_id="O2">
            <title>Fluzone® Quadrivalent Group</title>
            <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.&#xD;
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)</title>
          <description>SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assessed by the investigator as causally related to the study vaccination.</description>
          <population>The analysis was performed on the Total Vaccinated cohort which included all subjects with at least one vaccine administration documented and for whom data were available.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1207"/>
                <count group_id="O2" value="1217"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any SAE(s) [N=1207,1217]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related SAE(s) [N=1207,1217]</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 SAE(s), 6-17M [N=500,502]</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>Related SAE(s), 6-17M [N=500,502]</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 SAE(s), 18-35M [N=707,715]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related SAE(s), 18-35M [N=707,715]</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 SAE(s), Unprimed [N=550,560]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related SAE(s), Unprimed [N=550,560]</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 SAE(s), Primed [N=657,657]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related SAE(s), Primed [N=657,657]</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period across doses; Unsolicited adverse events: During the 28-day post-vaccination period.</time_frame>
      <desc>For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.</desc>
      <group_list>
        <group group_id="E1">
          <title>FluLaval™ Quadrivalent Group</title>
          <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.&#xD;
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
        </group>
        <group group_id="E2">
          <title>Fluzone® Quadrivalent Group</title>
          <description>Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.&#xD;
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="1217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1217"/>
              </event>
              <event>
                <sub_title>Intussusception</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Developmental delay</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1217"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="1217"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1217"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus bronchiolitis</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1217"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1217"/>
              </event>
              <event>
                <sub_title>Abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1217"/>
              </event>
              <event>
                <sub_title>Croup infectious</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1217"/>
              </event>
              <event>
                <sub_title>Gastroenteritis rotavirus</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1217"/>
              </event>
              <event>
                <sub_title>Groin abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1217"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1217"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1217"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1217"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1217"/>
              </event>
              <event>
                <sub_title>Respiratory syncytial virus infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1217"/>
              </event>
              <event>
                <sub_title>Staphylococcal abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Accidental exposure to product</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1217"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1217"/>
              </event>
              <event>
                <sub_title>Craniocerebral injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1217"/>
              </event>
              <event>
                <sub_title>Multiple injuries</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="1217"/>
              </event>
              <event>
                <sub_title>Failure to thrive</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1217"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>B precursor type acute leukaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Febrile convulsion</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="1217"/>
              </event>
              <event>
                <sub_title>Hemiplegia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1217"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Calculus urinary</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="1217"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1217"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Social circumstances</title>
            <event_list>
              <event>
                <sub_title>Sexual abuse</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Kawasaki's disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1217"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <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="932" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="895" subjects_at_risk="1217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="66" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="53" subjects_at_risk="1217"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Drowsiness</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="471" subjects_at_risk="1159"/>
                <counts group_id="E2" subjects_affected="471" subjects_at_risk="1152"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <assessment>Systematic Assessment</assessment>
                <description>During the 7-day post-vaccination period</description>
                <counts group_id="E1" subjects_affected="183" subjects_at_risk="1159"/>
                <counts group_id="E2" subjects_affected="178" subjects_at_risk="1152"/>
              </event>
              <event>
                <sub_title>Irritability/Fussiness</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="630" subjects_at_risk="1159"/>
                <counts group_id="E2" subjects_affected="582" subjects_at_risk="1152"/>
              </event>
              <event>
                <sub_title>Loss of Appetite</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="391" subjects_at_risk="1159"/>
                <counts group_id="E2" subjects_affected="385" subjects_at_risk="1152"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="509" subjects_at_risk="1156"/>
                <counts group_id="E2" subjects_affected="462" subjects_at_risk="1151"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <assessment>Systematic Assessment</assessment>
                <description>During the 2-day post-vaccination period</description>
                <counts group_id="E1" subjects_affected="82" subjects_at_risk="1159"/>
                <counts group_id="E2" subjects_affected="93" subjects_at_risk="1152"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="111" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="102" subjects_at_risk="1217"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="66" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="54" subjects_at_risk="1217"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" subjects_affected="61" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="49" subjects_at_risk="1217"/>
              </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="70" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="77" subjects_at_risk="1217"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="59" subjects_at_risk="1207"/>
                <counts group_id="E2" subjects_affected="76" subjects_at_risk="1217"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>GSK Response Center</name_or_title>
      <organization>GlaxoSmithKline</organization>
      <phone>866-435-7343</phone>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02242643
org study id: 201234
nct id: NCT02242643
lead sponsor: 
The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals'
      quadrivalent influenza vaccine (GSK2282512A) compared to Sanofi Pasteur's Fluzone®
      Quadrivalent in children 6 to 35 months of age.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains
time frame: 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)
description: Antibody titers were expressed as Seroconversion rate (SCR) and SCR difference. SCR was defined as the proportion of vaccinees who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.
The vaccine strains assessed were Flu A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 (Yamagata) and B/Brisbane/60/2008 (Victoria).
measure: Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains.
time frame: At 28 days after the last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)
description: HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).
measure: Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
time frame: At Day 0 and 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)
description: Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 (Yamagata) and B/Brisbane/60/2008 (Victoria).
measure: Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
time frame: At Day 0 and 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)
description: A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).
measure: Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
time frame: 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)
description: A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).
measure: Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
time frame: 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)
description: MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).
measure: Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
time frame: During a 7-day (Day 0 - Day 6) follow-up period after each vaccination
description: Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity and all subjects reporting 'Yes' for solicited symptom occurred but with missing values for at least one day during the solicited period. Grade 3 pain = Cried when limb is moved/spontaneously painful. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.
measure: Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
time frame: During the 7-day (Days 0-6) follow-up period after each vaccination
description: Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Any fever was defined as subjects with a documented temperature of greater than or equal to (≥) 38°C/100.4°F by any route and all subjects reporting temperature less than (< )38°C but with missing values for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (>) 39.0°C.
measure: Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
time frame: During the 7-day (Days 0-6) follow-up period after each vaccination.
description: Duration was defined as number of days with any grade of local and general symptoms.
measure: Number of Subjects Reporting Any Fever Following Each Dose and Across Doses.
time frame: During a 2-day (Days 0-1) follow-up period after each vaccination
description: Any Fever = all subjects with a documented temperature of ≥38.0°C /100.4°F by axillary route and all subjects reporting temperature < 38.0°C but with missing values for at least one day during the solicited period.
Grade 3 fever was defined as temperature greater than (>) 39.0°C.
measure: Number of Subjects Reporting the Occurrence of All Medically Attended Events (MAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed).
time frame: During the entire study period (Days 0 -180)
description: MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).
measure: Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
time frame: During the entire study period (Days 0 -180)
description: pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related = symptom assed by the investigator as causally related to the study vaccination.
measure: Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
time frame: During a 28-day (Days 0-27 for primed and unprimed subjects and Days 28-56 for unprimed subjects) post-vaccination period
description: An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 unsolicited AE was defined as an event that prevented normal activity. Related unsolicited AE was defined as an event assessed by the investigator to be causally related to the study vaccination.
measure: Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed)
time frame: During the entire study period (Days 0 -180)
description: SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Related = symptom assessed by the investigator as causally related to the study vaccination.
arm group label: FluLaval™ Quadrivalent Group
arm group type: Experimental
description: Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
arm group label: Fluzone® Quadrivalent Group
arm group type: Active Comparator
description: Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.
The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
intervention type: Biological
intervention name: FluLaval™ Quadrivalent
description: 1 or 2 doses administered intramusculary (IM) in deltoid region of non-dominant arm (for subjects ≥12 months of age) or anterolateral region of left thigh (for subjects <12 months of age) on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects), respectively
arm group label: FluLaval™ Quadrivalent Group
other name: FLU Q-QIV (GSK2282512A)
intervention type: Biological
intervention name: Fluzone® Quadrivalent
description: 1 or 2 doses administered IM in deltoid region of non-dominant arm (for subjects ≥12 months of age) or anterolateral region of left thigh (for subjects <12 months of age) on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects), respectively
arm group label: Fluzone® Quadrivalent Group
other name: F-QIV
criteria: 
gender: All
minimum age: 6 Months
maximum age: 35 Months
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
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country: Mexico
country: United States
url: https://www.clinicalstudydatarequest.com
description: Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
responsible party type: Sponsor
mesh term: Influenza, Human
sharing ipd: Yes
ipd description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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