<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/NCT02222870</url>
  </required_header>
  <id_info>
    <org_study_id>GRC56</org_study_id>
    <secondary_id>U1111-1143-8966</secondary_id>
    <nct_id>NCT02222870</nct_id>
  </id_info>
  <brief_title>Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent, Influenza Vaccine</brief_title>
  <official_title>Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent, Influenza Vaccine (2014-2015 Formulation)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi Pasteur, a Sanofi Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will evaluate the safety and immunogenicity of the 2014-2015 formulation of Fluzone&#xD;
      Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with the&#xD;
      Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6 months to&#xD;
      &lt; 9 years of age.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
        -  To describe the safety of the 2014-2015 formulation of Fluzone Quadrivalent vaccine,&#xD;
           administered in a 1- or 2-dose schedule, in accordance with ACIP recommendations, in&#xD;
           children 6 months to &lt; 9 years of age.&#xD;
&#xD;
      Observational objectives:&#xD;
&#xD;
        -  To describe the immunogenicity of the 2014-2015 formulation of Fluzone Quadrivalent&#xD;
           vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP&#xD;
           recommendations, in children 6 months to &lt; 9 years of age.&#xD;
&#xD;
        -  To submit available sera from each subject to Center for Biologics Evaluation and&#xD;
           Research (CBER) for further analysis by the WHO, the Centers for Disease Control and&#xD;
           Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation&#xD;
           recommendations for subsequent influenza vaccines.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be assigned to the appropriate age group based on the age at the time of&#xD;
      enrollment. Participants will receive a dose of Fluzone Quadrivalent vaccine, those for whom&#xD;
      2 doses of influenza vaccine are recommended per ACIP guidance, will receive a second dose&#xD;
      during Visit 2 (28 days after Visit 1).&#xD;
&#xD;
      Solicited adverse event (AE) information will be collected for 7 days after each vaccination,&#xD;
      unsolicited AE information will be collected from Visit 1 to Visit 2, or to Visit 3 for those&#xD;
      subjects receiving 2 doses. Serious adverse event (SAE) information will be collected the&#xD;
      study. Immunogenicity will be evaluated in all participants prior to vaccination and at Day&#xD;
      28 after the final vaccination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine</measure>
    <time_frame>Day 0 up to Day 7 post-any injection</time_frame>
    <description>Solicited Injection-site: 6 to &lt; 36 months - Tenderness, Erythema, and Swelling; 3 to &lt; 9 years - Pain, Erythema, and Swelling. Solicited systemic reactions: 6 to &lt; 36 months - Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability; 3 to &lt; 9 years - Fever, Headache, Malaise, and Myalgia.&#xD;
Grade 3: Fever, &gt; 39.5˚C (6 to &lt; 36 months), ≥ 39.0˚C (3 to &lt; 9 years); Vomiting, ≥ 6 episodes/24 hours or requires parenteral hydration; Crying abnormal, &gt; 3 hours; Drowsiness, Sleeping often/difficult to wake; Appetite lost, Refuses ≥ 3 or most meals; Irritability, Inconsolable; Headache, Malaise, and Myalgia, Significant, prevents daily activity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine</measure>
    <time_frame>Day 0 (pre-vaccination) and Day 28 post-final vaccination</time_frame>
    <description>Geometric titers of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine</measure>
    <time_frame>Day 0 (pre-vaccination) and Day 28 post-final vaccination</time_frame>
    <description>Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (l/dil) at pre-vaccination and at 28 days after the final vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine</measure>
    <time_frame>Day 28 post-final vaccination</time_frame>
    <description>Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroconversion is defined as either a pre-vaccination HAI titer &lt; 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine</measure>
    <time_frame>Day 28 post-final vaccination</time_frame>
    <description>Geometric titer ratios of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Fluzone Study Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants at 6 months to &lt; 36 months age at enrollment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fluzone Study Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants at 3 years to &lt; 9 years of age at enrollment</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fluzone® Quadrivalent Influenza Vaccine, No Preservative</intervention_name>
    <description>0.25 mL, Intramuscular (Pediatric Dose, 2014-2015 formulation)</description>
    <arm_group_label>Fluzone Study Group 1</arm_group_label>
    <other_name>Fluzone® Quadrivalent, No Preservative</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fluzone® Quadrivalent Influenza Vaccine, No Preservative</intervention_name>
    <description>0.5 mL, Intramuscular (2014-2015 formulation)</description>
    <arm_group_label>Fluzone Study Group 2</arm_group_label>
    <other_name>Fluzone® Quadrivalent, No Preservative</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is 6 months to &lt; 9 years of age on the day of first study vaccination (study&#xD;
             product administration)&#xD;
&#xD;
          -  Subject and parent/legally acceptable representative are willing and able to attend&#xD;
             scheduled visits and to comply with the study procedures during the entire duration of&#xD;
             the study.&#xD;
&#xD;
          -  Assent form has been signed and dated by subjects 7 to &lt; 9 years of age, and informed&#xD;
             consent form has been signed and dated by parent(s) or another legally acceptable&#xD;
             representative for subjects 6 months to &lt; 9 years of age.&#xD;
&#xD;
          -  For subjects 6 months to &lt; 12 months of age, born at full term of pregnancy (≥ 37&#xD;
             weeks) and with a birth weight ≥ 2.5 kg (5.5 lbs).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine&#xD;
             components, or a history of a life-threatening reaction to Fluzone Quadrivalent&#xD;
             vaccine or to a vaccine containing any of the same substances (the complete list of&#xD;
             vaccine components is included in the Prescribing Information).&#xD;
&#xD;
          -  History of serious adverse reaction to any influenza vaccine.&#xD;
&#xD;
          -  Receipt of any vaccine within 30 days before receiving study vaccine, or plans to&#xD;
             receive another vaccine before Visit 2 for subjects receiving 1 dose of influenza&#xD;
             vaccine or Visit 3 for subjects receiving 2 doses of influenza vaccine.&#xD;
&#xD;
          -  Participation in another interventional clinical trial investigating a vaccine, drug,&#xD;
             medical device, or medical procedure in the 30 days preceding the first study&#xD;
             vaccination or during the course of the study unless no intervention for the other&#xD;
             study occurred within the 30 days prior to the first study vaccination and none are&#xD;
             planned before the subject would complete safety surveillance for the present study.&#xD;
&#xD;
          -  Prior vaccination with any formulation of 2014-2015 influenza vaccine.&#xD;
&#xD;
          -  Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion,&#xD;
             which may be a contraindication for intramuscular vaccination, at the discretion of&#xD;
             the Investigator.&#xD;
&#xD;
          -  Thrombocytopenia, which may be a contraindication for intramuscular vaccination, at&#xD;
             the discretion of the Investigator.&#xD;
&#xD;
          -  Any condition that in the opinion of the Investigator would pose a health risk to the&#xD;
             subject if enrolled or could interfere with the evaluation of the vaccine.&#xD;
&#xD;
          -  Personal history of Guillain-Barré Syndrome.&#xD;
&#xD;
          -  Known or suspected congenital or acquired immunodeficiency; or receipt of&#xD;
             immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within&#xD;
             the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or&#xD;
             equivalent for more than 2 consecutive weeks within the past 3 months).&#xD;
&#xD;
          -  Personal history of clinically significant developmental delay (at the discretion of&#xD;
             the Investigator), neurologic disorder, or seizure disorder.&#xD;
&#xD;
          -  Chronic illness that, in the opinion of the Investigator, is at a stage where it might&#xD;
             interfere with trial conduct or completion.&#xD;
&#xD;
          -  Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C.&#xD;
&#xD;
          -  Moderate or severe acute illness/infection (according to Investigator judgment) on the&#xD;
             day of vaccination or febrile illness (temperature ≥ 100.4°F). A prospective subject&#xD;
             should not be included in the study until the condition has resolved or the febrile&#xD;
             event has subsided.&#xD;
&#xD;
          -  Receipt of immune globulins, blood, or blood-derived products in the past 3 months.&#xD;
&#xD;
          -  Identified as a natural or adopted child of the Investigator or an employee with&#xD;
             direct involvement in the proposed study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi Pasteur Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Bardstown</city>
        <state>Kentucky</state>
        <zip>40040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.sanofipasteur.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <results_first_submitted>September 16, 2015</results_first_submitted>
  <results_first_submitted_qc>September 16, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 19, 2015</results_first_posted>
  <last_update_submitted>September 16, 2015</last_update_submitted>
  <last_update_submitted_qc>September 16, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 19, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Influenza</keyword>
  <keyword>Influenza virus vaccine</keyword>
  <keyword>Quadrivalent Influenza Virus Vaccine (No Preservative)</keyword>
  <keyword>Fluzone®</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Study participants were enrolled from 19 August 2014 to 06 November 2014 at 2 clinical sites in the United States.</recruitment_details>
      <pre_assignment_details>A total of 60 participants who met all of the inclusion criteria and none of the exclusion criteria were enrolled and vaccinated in the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>6 to &lt; 36 Months of Age</title>
          <description>Participants 6 to &lt; 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.</description>
        </group>
        <group group_id="P2">
          <title>3 to &lt; 9 Years of Age</title>
          <description>Participants 3 to &lt; 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>6 to &lt; 36 Months of Age</title>
          <description>Participants 6 to &lt; 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.</description>
        </group>
        <group group_id="B2">
          <title>3 to &lt; 9 Years of Age</title>
          <description>Participants 3 to &lt; 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.</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="30"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="60"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>Months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Age Continuous</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.0" spread="8.3"/>
                    <measurement group_id="B2" value="66.9" spread="21.8"/>
                    <measurement group_id="B3" value="45.9" spread="26.7"/>
                  </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="15"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine</title>
        <description>Solicited Injection-site: 6 to &lt; 36 months - Tenderness, Erythema, and Swelling; 3 to &lt; 9 years - Pain, Erythema, and Swelling. Solicited systemic reactions: 6 to &lt; 36 months - Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability; 3 to &lt; 9 years - Fever, Headache, Malaise, and Myalgia.&#xD;
Grade 3: Fever, &gt; 39.5˚C (6 to &lt; 36 months), ≥ 39.0˚C (3 to &lt; 9 years); Vomiting, ≥ 6 episodes/24 hours or requires parenteral hydration; Crying abnormal, &gt; 3 hours; Drowsiness, Sleeping often/difficult to wake; Appetite lost, Refuses ≥ 3 or most meals; Irritability, Inconsolable; Headache, Malaise, and Myalgia, Significant, prevents daily activity.</description>
        <time_frame>Day 0 up to Day 7 post-any injection</time_frame>
        <population>Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>6 to &lt; 36 Months of Age</title>
            <description>Participants 6 to &lt; 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.</description>
          </group>
          <group group_id="O2">
            <title>3 to &lt; 9 Years of Age</title>
            <description>Participants 3 to &lt; 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine</title>
          <description>Solicited Injection-site: 6 to &lt; 36 months - Tenderness, Erythema, and Swelling; 3 to &lt; 9 years - Pain, Erythema, and Swelling. Solicited systemic reactions: 6 to &lt; 36 months - Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability; 3 to &lt; 9 years - Fever, Headache, Malaise, and Myalgia.&#xD;
Grade 3: Fever, &gt; 39.5˚C (6 to &lt; 36 months), ≥ 39.0˚C (3 to &lt; 9 years); Vomiting, ≥ 6 episodes/24 hours or requires parenteral hydration; Crying abnormal, &gt; 3 hours; Drowsiness, Sleeping often/difficult to wake; Appetite lost, Refuses ≥ 3 or most meals; Irritability, Inconsolable; Headache, Malaise, and Myalgia, Significant, prevents daily activity.</description>
          <population>Solicited injection-site and systemic reactions were assessed in the Safety Analysis Set.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Injection-site Tenderness (N=30, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.0"/>
                    <measurement group_id="O2" value="NA">Event was not assessed in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Injection-site Tenderness (N=30, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3"/>
                    <measurement group_id="O2" value="NA">Event was not assessed in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Pain (N=0, 30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Event was not assessed in this group</measurement>
                    <measurement group_id="O2" value="73.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Injection site Pain (N=0, 30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Event was not assessed in this group</measurement>
                    <measurement group_id="O2" value="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection-site Erythema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.0"/>
                    <measurement group_id="O2" value="66.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Injection-site Erythema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection-site Swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.3"/>
                    <measurement group_id="O2" value="43.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Injection site Swelling (6 to &lt;36 months)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.7"/>
                    <measurement group_id="O2" value="3.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fever</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting (N=30, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7"/>
                    <measurement group_id="O2" value="NA">Event was not assessed in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Vomiting (N=30, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="NA">Event was not assessed in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Crying abnormal (N=30, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.3"/>
                    <measurement group_id="O2" value="NA">Event was not assessed in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Crying abnormal (N=30, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="NA">Event was not assessed in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drowsiness (N=30, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.0"/>
                    <measurement group_id="O2" value="NA">Event was not assessed in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Drowsiness (N=30, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="NA">Event was not assessed in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Appetite lost (N=30, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.7"/>
                    <measurement group_id="O2" value="NA">Event was not assessed in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Appetite lost</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="NA">Event was not assessed in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Irritability (N=30, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.3"/>
                    <measurement group_id="O2" value="NA">Event was not assessed in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Irritability (N=30, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0"/>
                    <measurement group_id="O2" value="NA">Event was not assessed in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache (N=0, 30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Event was not assessed in this group</measurement>
                    <measurement group_id="O2" value="10.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Headache (N=0, 30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Event was not assessed in this group</measurement>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise (N=0, 30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Event was not assessed in this group</measurement>
                    <measurement group_id="O2" value="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Malaise (N=0, 30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Event was not assessed in this group</measurement>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia (N=0, 30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Event was not assessed in this group</measurement>
                    <measurement group_id="O2" value="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Myalgia (N=0, 30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Event was not assessed in this group</measurement>
                    <measurement group_id="O2" value="0.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine</title>
        <description>Geometric titers of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.</description>
        <time_frame>Day 0 (pre-vaccination) and Day 28 post-final vaccination</time_frame>
        <population>Geometric mean titers were assessed in the Per-Protocol Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>6 to &lt; 36 Months of Age</title>
            <description>Participants 6 to &lt; 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.</description>
          </group>
          <group group_id="O2">
            <title>3 to &lt; 9 Years of Age</title>
            <description>Participants 3 to &lt; 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine</title>
          <description>Geometric titers of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.</description>
          <population>Geometric mean titers were assessed in the Per-Protocol Analysis Set.</population>
          <units>Titers (1/dilutions)</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="29"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1; Pre-vaccination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.6" lower_limit="16.4" upper_limit="64.9"/>
                    <measurement group_id="O2" value="361" lower_limit="179" upper_limit="727"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H1N1; Post-vaccination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="447" lower_limit="254" upper_limit="787"/>
                    <measurement group_id="O2" value="1235" lower_limit="793" upper_limit="1924"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2; Pre-vaccination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.9" lower_limit="25.7" upper_limit="121"/>
                    <measurement group_id="O2" value="277" lower_limit="162" upper_limit="473"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2; Post-vaccination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="696" lower_limit="416" upper_limit="1165"/>
                    <measurement group_id="O2" value="1250" lower_limit="861" upper_limit="1814"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Yamagata); Pre-vaccination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.6" lower_limit="30.3" upper_limit="106"/>
                    <measurement group_id="O2" value="281" lower_limit="158" upper_limit="497"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Yamagata); Post-vaccination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="617" lower_limit="342" upper_limit="1115"/>
                    <measurement group_id="O2" value="1425" lower_limit="972" upper_limit="2090"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Victoria); Pre-vaccination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5" lower_limit="6.88" upper_limit="22.9"/>
                    <measurement group_id="O2" value="156" lower_limit="85.9" upper_limit="284"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Victoria); Post-vaccination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="352" lower_limit="203" upper_limit="612"/>
                    <measurement group_id="O2" value="1136" lower_limit="706" upper_limit="1828"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine</title>
        <description>Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (l/dil) at pre-vaccination and at 28 days after the final vaccination.</description>
        <time_frame>Day 0 (pre-vaccination) and Day 28 post-final vaccination</time_frame>
        <population>Seroprotection was assessed in the Per-Protocol Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>6 to &lt; 36 Months of Age</title>
            <description>Participants 6 to &lt; 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.</description>
          </group>
          <group group_id="O2">
            <title>3 to &lt; 9 Years of Age</title>
            <description>Participants 3 to &lt; 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine</title>
          <description>Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (l/dil) at pre-vaccination and at 28 days after the final vaccination.</description>
          <population>Seroprotection was assessed in the Per-Protocol Analysis Set.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1; Pre-vaccination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.8"/>
                    <measurement group_id="O2" value="86.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H1N1; Post-vaccination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.1"/>
                    <measurement group_id="O2" value="96.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2; Pre-vaccination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.1"/>
                    <measurement group_id="O2" value="93.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2; Post-vaccination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.6"/>
                    <measurement group_id="O2" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Yamagata); Pre-vaccination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.2"/>
                    <measurement group_id="O2" value="89.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Yamagata); Post-vaccination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0"/>
                    <measurement group_id="O2" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Victoria); Pre-vaccination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.2"/>
                    <measurement group_id="O2" value="82.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Victoria); Post-vaccination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0"/>
                    <measurement group_id="O2" value="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine</title>
        <description>Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroconversion is defined as either a pre-vaccination HAI titer &lt; 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer.</description>
        <time_frame>Day 28 post-final vaccination</time_frame>
        <population>Seroconversion was assessed in the Per-Protocol Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>6 to &lt; 36 Months of Age</title>
            <description>Participants 6 to &lt; 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.</description>
          </group>
          <group group_id="O2">
            <title>3 to &lt; 9 Years of Age</title>
            <description>Participants 3 to &lt; 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine</title>
          <description>Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroconversion is defined as either a pre-vaccination HAI titer &lt; 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer.</description>
          <population>Seroconversion was assessed in the Per-Protocol Analysis Set.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.2"/>
                    <measurement group_id="O2" value="34.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.7"/>
                    <measurement group_id="O2" value="58.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Yamagata)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.2"/>
                    <measurement group_id="O2" value="58.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Victoria)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.7"/>
                    <measurement group_id="O2" value="69.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine</title>
        <description>Geometric titer ratios of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.</description>
        <time_frame>Day 28 post-final vaccination</time_frame>
        <population>Geometric mean titer ratios were assessed in the Per-Protocol Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>6 to &lt; 36 Months of Age</title>
            <description>Participants 6 to &lt; 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.</description>
          </group>
          <group group_id="O2">
            <title>3 to &lt; 9 Years of Age</title>
            <description>Participants 3 to &lt; 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine</title>
          <description>Geometric titer ratios of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.</description>
          <population>Geometric mean titer ratios were assessed in the Per-Protocol Analysis Set.</population>
          <units>Titer ratio</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.9" lower_limit="6.61" upper_limit="18.0"/>
                    <measurement group_id="O2" value="3.30" lower_limit="2.14" upper_limit="5.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.4" lower_limit="6.59" upper_limit="16.4"/>
                    <measurement group_id="O2" value="4.51" lower_limit="3.09" upper_limit="6.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Yamagata)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.0" lower_limit="6.35" upper_limit="15.9"/>
                    <measurement group_id="O2" value="5.02" lower_limit="3.43" upper_limit="7.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Victoria)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.9" lower_limit="11.6" upper_limit="30.8"/>
                    <measurement group_id="O2" value="7.10" lower_limit="4.71" upper_limit="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected from Day 0 (post-vaccination) up to Day 7 post-any vaccination.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>6 to &lt; 36 Months of Age</title>
          <description>Participants 6 to &lt; 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.</description>
        </group>
        <group group_id="E2">
          <title>3 to &lt; 9 Years of Age</title>
          <description>Participants 3 to &lt; 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA version 16.0</default_vocab>
        <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="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abscess neck</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5.00</frequency_threshold>
        <default_vocab>MedDRA version 16.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Injection site Tenderness</sub_title>
                <counts group_id="E1" events="21" subjects_affected="21" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Injection site Erythema</sub_title>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="30"/>
                <counts group_id="E2" events="20" subjects_affected="20" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Injection site Swelling</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="30"/>
                <counts group_id="E2" events="13" subjects_affected="13" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="29"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Injection site Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="22" subjects_affected="22" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Appetite lost</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Drowsiness</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Crying abnormal</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" events="16" subjects_affected="16" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </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>Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Director</name_or_title>
      <organization>Sanofi Pasteur Inc.</organization>
      <email>RegistryContactUs@sanofipasteur.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02222870
org study id: GRC56
secondary id: U1111-1143-8966
nct id: NCT02222870
lead sponsor: 
has dmc: No
The study will evaluate the safety and immunogenicity of the 2014-2015 formulation of Fluzone
      Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with the
      Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6 months to
      < 9 years of age.

      Objective:

        -  To describe the safety of the 2014-2015 formulation of Fluzone Quadrivalent vaccine,
           administered in a 1- or 2-dose schedule, in accordance with ACIP recommendations, in
           children 6 months to < 9 years of age.

      Observational objectives:

        -  To describe the immunogenicity of the 2014-2015 formulation of Fluzone Quadrivalent
           vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP
           recommendations, in children 6 months to < 9 years of age.

        -  To submit available sera from each subject to Center for Biologics Evaluation and
           Research (CBER) for further analysis by the WHO, the Centers for Disease Control and
           Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation
           recommendations for subsequent influenza vaccines.
Participants will be assigned to the appropriate age group based on the age at the time of
      enrollment. Participants will receive a dose of Fluzone Quadrivalent vaccine, those for whom
      2 doses of influenza vaccine are recommended per ACIP guidance, will receive a second dose
      during Visit 2 (28 days after Visit 1).

      Solicited adverse event (AE) information will be collected for 7 days after each vaccination,
      unsolicited AE information will be collected from Visit 1 to Visit 2, or to Visit 3 for those
      subjects receiving 2 doses. Serious adverse event (SAE) information will be collected the
      study. Immunogenicity will be evaluated in all participants prior to vaccination and at Day
      28 after the final vaccination.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine
time frame: Day 0 up to Day 7 post-any injection
description: Solicited Injection-site: 6 to < 36 months - Tenderness, Erythema, and Swelling; 3 to < 9 years - Pain, Erythema, and Swelling. Solicited systemic reactions: 6 to < 36 months - Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability; 3 to < 9 years - Fever, Headache, Malaise, and Myalgia.
Grade 3: Fever, > 39.5˚C (6 to < 36 months), ≥ 39.0˚C (3 to < 9 years); Vomiting, ≥ 6 episodes/24 hours or requires parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, Sleeping often/difficult to wake; Appetite lost, Refuses ≥ 3 or most meals; Irritability, Inconsolable; Headache, Malaise, and Myalgia, Significant, prevents daily activity.
measure: Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine
time frame: Day 0 (pre-vaccination) and Day 28 post-final vaccination
description: Geometric titers of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.
measure: Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine
time frame: Day 0 (pre-vaccination) and Day 28 post-final vaccination
description: Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (l/dil) at pre-vaccination and at 28 days after the final vaccination.
measure: Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine
time frame: Day 28 post-final vaccination
description: Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay. Seroconversion is defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer.
measure: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine
time frame: Day 28 post-final vaccination
description: Geometric titer ratios of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.
arm group label: Fluzone Study Group 1
arm group type: Experimental
description: Participants at 6 months to < 36 months age at enrollment
arm group label: Fluzone Study Group 2
arm group type: Experimental
description: Participants at 3 years to < 9 years of age at enrollment
intervention type: Biological
intervention name: Fluzone® Quadrivalent Influenza Vaccine, No Preservative
description: 0.25 mL, Intramuscular (Pediatric Dose, 2014-2015 formulation)
arm group label: Fluzone Study Group 1
other name: Fluzone® Quadrivalent, No Preservative
intervention type: Biological
intervention name: Fluzone® Quadrivalent Influenza Vaccine, No Preservative
description: 0.5 mL, Intramuscular (2014-2015 formulation)
arm group label: Fluzone Study Group 2
other name: Fluzone® Quadrivalent, No Preservative
criteria: 
gender: All
minimum age: 6 Months
maximum age: 8 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Sanofi Pasteur Inc.
facility: 
facility: 
country: United States
url: http://www.sanofipasteur.com
description: Related Info
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Vaccines
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 