<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/NCT01691326</url>
  </required_header>
  <id_info>
    <org_study_id>GRC49</org_study_id>
    <secondary_id>U1111-1124-8218</secondary_id>
    <nct_id>NCT01691326</nct_id>
  </id_info>
  <brief_title>Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)</brief_title>
  <official_title>Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2012-2013 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 aim of this clinical study is to demonstrate safety and immunogenicity of Fluzone&#xD;
      vaccine.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
        -  To describe the safety of the 2012-2013 formulation of Fluzone vaccine, administered in&#xD;
           a 1- or 2-dose schedule, in accordance with Advisory Committee on Immunization Practices&#xD;
           (ACIP) recommendations, in children 6 months to &lt; 9 years of age.&#xD;
&#xD;
      Observational Objectives:&#xD;
&#xD;
        -  To describe the immunogenicity of the 2012-2013 formulation of Fluzone 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;
        -  To submit remaining available sera from subjects to the Center for Biologics Evaluation&#xD;
           and Research (CBER) for further analysis by the World Health Organization (WHO), the&#xD;
           Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration&#xD;
           (FDA) to support selection and recommendation of strains for subsequent years' influenza&#xD;
           vaccines.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All participants will receive Fluzone vaccine during Visit 1. For subjects receiving 2 doses&#xD;
      of influenza vaccine, per ACIP guidance, a second dose of Fluzone vaccine will be&#xD;
      administered during Visit 2.&#xD;
&#xD;
      Total duration of participation in the study is approximately 28 days for participants&#xD;
      receiving 1 dose and 56 days for those receiving 2 doses of Fluzone vaccine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)</measure>
    <time_frame>Day 0 up to Day 7 post-vaccination</time_frame>
    <description>Solicited injection site reactions (Age 6 to &lt; 24 Months): Tenderness, Erythema and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability.&#xD;
Grade 3: Tenderness, Cries when injected limb is moved; Erythema and Swelling, ≥ 50 mm; Fever, &gt;103.1°F; Vomiting, ≥6 episodes/24 hours; Abnormal crying, &gt;3 hours; Drowsiness, Sleeping most of the time; Loss of appetite, Refuses ≥3 feeds/meals or most feeds/meals; Irritability, Inconsolable.&#xD;
Solicited injection site reactions (Age 24 Months to &lt; 9 Years): Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.&#xD;
Grade 3: Pain, Incapacitating, unable to perform usual activities; Redness and Swelling, ≥ 50 mm; Fever: ≥102.1°F; Headache, Malaise, and Myalgia, Significant, prevents daily activity.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Geometric Mean Titers of Antibodies to Influenza Antigens Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation).</measure>
    <time_frame>Day 0 (pre-vaccination) and Day 28 after final vaccination</time_frame>
    <description>The influenza virus antibodies were measured using a hemagglutination inhibition (HAI) assay.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Seroprotection Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)</measure>
    <time_frame>Day 0 (pre-vaccination) and Day 28 after final vaccination</time_frame>
    <description>Influenza virus antibodies were measured using a HAI assay. Seroprotection was defined as a titer ≥40 (1/dilution).</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Seroconversion Against Influenza Virus Antigens Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)</measure>
    <time_frame>Day 28 after final vaccination</time_frame>
    <description>Influenza virus antibodies were measured using a HAI assay. Seroconversion was defined as a pre-vaccination titer &lt;10 (1/dilution) and a post-vaccination titer ≥40 (1/dilution), or a pre-vaccination titer ≥10 (1/dilution) and ≥4-fold increase in titer 28 days after final vaccination.</description>
  </other_outcome>
  <other_outcome>
    <measure>Geometric Mean Titer Ratios (GMTRs) of Antibodies to Influenza Virus Antigens Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation).</measure>
    <time_frame>Day 0 (pre-vaccination) and Day 28 after final vaccination</time_frame>
    <description>Influenza virus antibodies were measured using a HAI assay. Geometric mean titer ratio is the geometric mean of the individual post-vaccination / pre-vaccination titer of antibodies to the influenza virus antigens</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>6 months to &lt; 36 months of age group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants at 6 months to &lt; 36 months of age at the time of enrollment will receive Influenza Virus Vaccine, No Preservative; Fluzone® (Pediatric Dose).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3 years to &lt; 9 years of age group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants at 3 years to &lt; 9 years of age at the time of enrollment will receive Influenza Virus Vaccine, No Preservative; Fluzone®.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fluzone®: Influenza Virus Vaccine, No Preservative: Pediatric Dose</intervention_name>
    <description>0.25 mL dose, Intramuscular</description>
    <arm_group_label>6 months to &lt; 36 months of age group</arm_group_label>
    <other_name>Fluzone® (Influenza Virus Vaccine) 2012-2013 Formulation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fluzone®; Influenza Virus Vaccine, No Preservative</intervention_name>
    <description>0.5 mL dose, Intramuscular</description>
    <arm_group_label>3 years to &lt; 9 years of age group</arm_group_label>
    <other_name>Fluzone® (Influenza Virus Vaccine) 2012 2013 Formulation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is 6 months to &lt; 9 years of age on the day of inclusion&#xD;
&#xD;
          -  Parent/guardian is willing and able to attend scheduled visits and to comply with the&#xD;
             study procedures during the entire duration of 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&#xD;
&#xD;
          -  For subjects 6 months to &lt; 24 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, latex, or any of the&#xD;
             vaccine components, or a history of a life-threatening reaction to Fluzone vaccine or&#xD;
             to a vaccine containing any of the same substances (the complete list of vaccine&#xD;
             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 influenza vaccine or&#xD;
             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 2012-2013 influenza vaccine&#xD;
&#xD;
          -  Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion,&#xD;
             which may be a contraindication for intramuscular (IM) vaccination, at the discretion&#xD;
             of the Investigator&#xD;
&#xD;
          -  Thrombocytopenia, which may be a contraindication for IM vaccination, at the&#xD;
             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 (HIV), hepatitis B, or hepatitis&#xD;
             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>40004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.sanofipasteur.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <results_first_submitted>January 24, 2014</results_first_submitted>
  <results_first_submitted_qc>March 12, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 16, 2014</results_first_posted>
  <last_update_submitted>March 12, 2014</last_update_submitted>
  <last_update_submitted_qc>March 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Influenza</keyword>
  <keyword>Fluzone® (Influenza Virus Vaccine) 2012-2013 Formulation</keyword>
  <keyword>Influenza virus vaccine</keyword>
  <keyword>Trivalent Inactivated Influenza Vaccine</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>The study participants were enrolled from 19 September 2012 to 12 December 2012 at 2 clinic centers in the United States.</recruitment_details>
      <pre_assignment_details>A total of 60 participants who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Age 6 to &lt; 36 Months Group</title>
          <description>Participants 6 months to &lt; 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine</description>
        </group>
        <group group_id="P2">
          <title>Age 3 to &lt; 9 Years Group</title>
          <description>Participants 3 years to &lt; 9 years of age that received one or two doses 0.5 mL of Fluzone 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>Age 6 to &lt; 36 Months Group</title>
          <description>Participants 6 months to &lt; 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine</description>
        </group>
        <group group_id="B2">
          <title>Age 3 to &lt; 9 Years Group</title>
          <description>Participants 3 years to &lt; 9 years of age that received one or two doses of 0.5 mL of Fluzone 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>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.8" spread="0.6"/>
                    <measurement group_id="B2" value="5.2" spread="1.6"/>
                    <measurement group_id="B3" value="3.5" spread="1.2"/>
                  </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="14"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="33"/>
                  </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>Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)</title>
        <description>Solicited injection site reactions (Age 6 to &lt; 24 Months): Tenderness, Erythema and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability.&#xD;
Grade 3: Tenderness, Cries when injected limb is moved; Erythema and Swelling, ≥ 50 mm; Fever, &gt;103.1°F; Vomiting, ≥6 episodes/24 hours; Abnormal crying, &gt;3 hours; Drowsiness, Sleeping most of the time; Loss of appetite, Refuses ≥3 feeds/meals or most feeds/meals; Irritability, Inconsolable.&#xD;
Solicited injection site reactions (Age 24 Months to &lt; 9 Years): Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.&#xD;
Grade 3: Pain, Incapacitating, unable to perform usual activities; Redness and Swelling, ≥ 50 mm; Fever: ≥102.1°F; Headache, Malaise, and Myalgia, Significant, prevents daily activity.</description>
        <time_frame>Day 0 up to Day 7 post-vaccination</time_frame>
        <population>Solicited injection site reactions and systemic reactions were assessed using the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.</population>
        <group_list>
          <group group_id="O1">
            <title>Age 6 to &lt; 36 Months Group</title>
            <description>Participants 6 months to &lt; 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine</description>
          </group>
          <group group_id="O2">
            <title>Age 3 to &lt; 9 Years Group</title>
            <description>Participants 3 years to &lt; 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)</title>
          <description>Solicited injection site reactions (Age 6 to &lt; 24 Months): Tenderness, Erythema and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability.&#xD;
Grade 3: Tenderness, Cries when injected limb is moved; Erythema and Swelling, ≥ 50 mm; Fever, &gt;103.1°F; Vomiting, ≥6 episodes/24 hours; Abnormal crying, &gt;3 hours; Drowsiness, Sleeping most of the time; Loss of appetite, Refuses ≥3 feeds/meals or most feeds/meals; Irritability, Inconsolable.&#xD;
Solicited injection site reactions (Age 24 Months to &lt; 9 Years): Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.&#xD;
Grade 3: Pain, Incapacitating, unable to perform usual activities; Redness and Swelling, ≥ 50 mm; Fever: ≥102.1°F; Headache, Malaise, and Myalgia, Significant, prevents daily activity.</description>
          <population>Solicited injection site reactions and systemic reactions were assessed using the Safety Analysis Set, which includes all persons who received at least one dose of study vaccine.</population>
          <units>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 = 15, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="NA" lower_limit="0" upper_limit="0">Injection site Tenderness was not solicited in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Injection site Tenderness (N =15, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="NA" lower_limit="0" upper_limit="0">Injection site Tenderness was not solicited in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Pain (N =15, 30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="13" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Injection site Pain (N = 15, 30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Erythema (N = 30, 30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="9" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Injection site Erythema (N = 30, 30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Swelling (N = 30, 30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="7" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Injection site Swelling (N = 30, 30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever (N = 30, 28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fever (N = 30, 28)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache (N = 15, 30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Headache (N = 15, 30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise (N = 15, 30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Malaise (N = 15, 30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia (N = 15, 30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Myalgia (N = 15, 30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting (N = 15, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="NA" lower_limit="0" upper_limit="0">Vomiting was not solicited in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Vomiting (N = 15, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="NA" lower_limit="0" upper_limit="0">Vomiting was not solicited in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Abnormal crying (N = 15, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="NA" lower_limit="0" upper_limit="0">Abnormal crying was not solicited in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Abnormal crying (N = 15, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="NA" lower_limit="0" upper_limit="0">Abnormal crying was not solicited in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drowsiness (N = 15, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="NA" lower_limit="0" upper_limit="0">Drowsiness was not solicited in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Drowsiness (N = 15, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="NA" lower_limit="0" upper_limit="0">Drowsiness was not solicited in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loss of Appetite (N = 15, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="NA" lower_limit="0" upper_limit="0">Loss of Appetite was not solicited in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Loss of Appetite (N = 15, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="NA" lower_limit="0" upper_limit="0">Loss of Appetite was not solicited in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Irritability (N = 15, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="NA" lower_limit="0" upper_limit="0">Irritability was not solicited in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Irritability (N = 15, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="NA" lower_limit="0" upper_limit="0">Irritability was not solicited in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Geometric Mean Titers of Antibodies to Influenza Antigens Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation).</title>
        <description>The influenza virus antibodies were measured using a hemagglutination inhibition (HAI) assay.</description>
        <time_frame>Day 0 (pre-vaccination) and Day 28 after final vaccination</time_frame>
        <population>Geometric mean titers of antibodies against the influenza virus antigens were assessed in the Per-protocol Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>6 to &lt; 36 Months Age Group</title>
            <description>Participants 6 months to &lt; 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine</description>
          </group>
          <group group_id="O2">
            <title>3 to &lt; 9 Years Age Group</title>
            <description>Participants 3 years to &lt; 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers of Antibodies to Influenza Antigens Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation).</title>
          <description>The influenza virus antibodies were measured using a hemagglutination inhibition (HAI) assay.</description>
          <population>Geometric mean titers of antibodies against the influenza virus antigens were assessed in the Per-protocol Analysis Set.</population>
          <units>Titers</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1 (pre-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.6" lower_limit="9.93" upper_limit="42.6"/>
                    <measurement group_id="O2" value="68.8" lower_limit="30.5" upper_limit="155"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H1N1 (post-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="334" lower_limit="189" upper_limit="589"/>
                    <measurement group_id="O2" value="864" lower_limit="559" upper_limit="1337"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2 (pre-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.3" lower_limit="11.4" upper_limit="47.5"/>
                    <measurement group_id="O2" value="84.8" lower_limit="49.5" upper_limit="145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2 (post-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="506" lower_limit="296" upper_limit="865"/>
                    <measurement group_id="O2" value="895" lower_limit="585" upper_limit="1369"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (pre-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.82" lower_limit="4.76" upper_limit="7.13"/>
                    <measurement group_id="O2" value="9.66" lower_limit="7.42" upper_limit="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (post-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.7" lower_limit="11.2" upper_limit="24.8"/>
                    <measurement group_id="O2" value="69.6" lower_limit="46.4" upper_limit="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Seroprotection Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)</title>
        <description>Influenza virus antibodies were measured using a HAI assay. Seroprotection was defined as a titer ≥40 (1/dilution).</description>
        <time_frame>Day 0 (pre-vaccination) and Day 28 after final vaccination</time_frame>
        <population>Seroprotection against the influenza virus antigens were assessed in the Per-protocol Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Age 6 to &lt; 36 Months Group</title>
            <description>Participants 6 months to &lt; 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine</description>
          </group>
          <group group_id="O2">
            <title>Age 3 to &lt; 9 Years Group</title>
            <description>Participants 3 years to &lt; 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Seroprotection Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)</title>
          <description>Influenza virus antibodies were measured using a HAI assay. Seroprotection was defined as a titer ≥40 (1/dilution).</description>
          <population>Seroprotection against the influenza virus antigens were assessed in the Per-protocol Analysis Set.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1 (pre-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="18" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H1N1 (post-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="30" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2 (pre-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="20" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2 (post-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="30" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (pre-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (post-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="21" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Seroconversion Against Influenza Virus Antigens Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)</title>
        <description>Influenza virus antibodies were measured using a HAI assay. Seroconversion was defined as a pre-vaccination titer &lt;10 (1/dilution) and a post-vaccination titer ≥40 (1/dilution), or a pre-vaccination titer ≥10 (1/dilution) and ≥4-fold increase in titer 28 days after final vaccination.</description>
        <time_frame>Day 28 after final vaccination</time_frame>
        <population>Seroconversion against the influenza virus antigens were assessed in the Per-protocol Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Age 6 to &lt; 36 Months Group</title>
            <description>Participants 6 months to &lt; 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine</description>
          </group>
          <group group_id="O2">
            <title>Age 3 to &lt; 9 Years Group</title>
            <description>Participants 3 years to &lt; 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Seroconversion Against Influenza Virus Antigens Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)</title>
          <description>Influenza virus antibodies were measured using a HAI assay. Seroconversion was defined as a pre-vaccination titer &lt;10 (1/dilution) and a post-vaccination titer ≥40 (1/dilution), or a pre-vaccination titer ≥10 (1/dilution) and ≥4-fold increase in titer 28 days after final vaccination.</description>
          <population>Seroconversion against the influenza virus antigens were assessed in the Per-protocol Analysis Set.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="22" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="25" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="20" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Geometric Mean Titer Ratios (GMTRs) of Antibodies to Influenza Virus Antigens Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation).</title>
        <description>Influenza virus antibodies were measured using a HAI assay. Geometric mean titer ratio is the geometric mean of the individual post-vaccination / pre-vaccination titer of antibodies to the influenza virus antigens</description>
        <time_frame>Day 0 (pre-vaccination) and Day 28 after final vaccination</time_frame>
        <population>Geometric mean titer ratios against the influenza virus antigens were assessed in the Per-protocol Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Age 6 to &lt; 36 Months Group</title>
            <description>Participants 6 months to &lt; 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine</description>
          </group>
          <group group_id="O2">
            <title>Age 3 to &lt; 9 Years Group</title>
            <description>Participants 3 years to &lt; 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titer Ratios (GMTRs) of Antibodies to Influenza Virus Antigens Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation).</title>
          <description>Influenza virus antibodies were measured using a HAI assay. Geometric mean titer ratio is the geometric mean of the individual post-vaccination / pre-vaccination titer of antibodies to the influenza virus antigens</description>
          <population>Geometric mean titer ratios against the influenza virus antigens were assessed in the Per-protocol Analysis Set.</population>
          <units>Ratio</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.6" lower_limit="7.24" upper_limit="18.7"/>
                    <measurement group_id="O2" value="10.7" lower_limit="5.56" upper_limit="20.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.2" lower_limit="9.45" upper_limit="27.9"/>
                    <measurement group_id="O2" value="10.3" lower_limit="5.88" upper_limit="18.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.82" lower_limit="1.29" upper_limit="2.55"/>
                    <measurement group_id="O2" value="5.34" lower_limit="3.75" upper_limit="7.60"/>
                  </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 28 after final vaccination.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>6 to &lt; 36 Months Age Group</title>
          <description>Participants 6 months to &lt; 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine</description>
        </group>
        <group group_id="E2">
          <title>3 to &lt; 9 Years Age Group</title>
          <description>Participants 3 years to &lt; 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" 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 15.0 version</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="9" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </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="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Injection site Tenderness</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Injection site Pain</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="15"/>
                <counts group_id="E2" events="13" subjects_affected="13" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Injection site Erythema</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="30"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Injection site Swelling</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <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="28"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="15"/>
                <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>Upper respiratory tract infection</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Loss of Appetite</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="15"/>
                <counts group_id="E2" events="2" subjects_affected="2" 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="5" subjects_affected="5" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="15"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Abnormal crying</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="15"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </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="2" subjects_affected="2" 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/NCT01691326
org study id: GRC49
secondary id: U1111-1124-8218
nct id: NCT01691326
lead sponsor: 
has dmc: No
The aim of this clinical study is to demonstrate safety and immunogenicity of Fluzone
      vaccine.

      Objective:

        -  To describe the safety of the 2012-2013 formulation of Fluzone vaccine, administered in
           a 1- or 2-dose schedule, in accordance with Advisory Committee on Immunization Practices
           (ACIP) recommendations, in children 6 months to < 9 years of age.

      Observational Objectives:

        -  To describe the immunogenicity of the 2012-2013 formulation of Fluzone 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 remaining available sera from subjects to the Center for Biologics Evaluation
           and Research (CBER) for further analysis by the World Health Organization (WHO), the
           Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration
           (FDA) to support selection and recommendation of strains for subsequent years' influenza
           vaccines.
All participants will receive Fluzone vaccine during Visit 1. For subjects receiving 2 doses
      of influenza vaccine, per ACIP guidance, a second dose of Fluzone vaccine will be
      administered during Visit 2.

      Total duration of participation in the study is approximately 28 days for participants
      receiving 1 dose and 56 days for those receiving 2 doses of Fluzone vaccine.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)
time frame: Day 0 up to Day 7 post-vaccination
description: Solicited injection site reactions (Age 6 to < 24 Months): Tenderness, Erythema and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability.
Grade 3: Tenderness, Cries when injected limb is moved; Erythema and Swelling, ≥ 50 mm; Fever, >103.1°F; Vomiting, ≥6 episodes/24 hours; Abnormal crying, >3 hours; Drowsiness, Sleeping most of the time; Loss of appetite, Refuses ≥3 feeds/meals or most feeds/meals; Irritability, Inconsolable.
Solicited injection site reactions (Age 24 Months to < 9 Years): Pain, Erythema, and Swelling. Systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.
Grade 3: Pain, Incapacitating, unable to perform usual activities; Redness and Swelling, ≥ 50 mm; Fever: ≥102.1°F; Headache, Malaise, and Myalgia, Significant, prevents daily activity.
measure: Geometric Mean Titers of Antibodies to Influenza Antigens Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation).
time frame: Day 0 (pre-vaccination) and Day 28 after final vaccination
description: The influenza virus antibodies were measured using a hemagglutination inhibition (HAI) assay.
measure: Number of Participants With Seroprotection Before and Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)
time frame: Day 0 (pre-vaccination) and Day 28 after final vaccination
description: Influenza virus antibodies were measured using a HAI assay. Seroprotection was defined as a titer ≥40 (1/dilution).
measure: Number of Participants With Seroconversion Against Influenza Virus Antigens Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation)
time frame: Day 28 after final vaccination
description: Influenza virus antibodies were measured using a HAI assay. Seroconversion was defined as a pre-vaccination titer <10 (1/dilution) and a post-vaccination titer ≥40 (1/dilution), or a pre-vaccination titer ≥10 (1/dilution) and ≥4-fold increase in titer 28 days after final vaccination.
measure: Geometric Mean Titer Ratios (GMTRs) of Antibodies to Influenza Virus Antigens Following Vaccination With Fluzone® Influenza Virus Vaccine (2012-2013 Formulation).
time frame: Day 0 (pre-vaccination) and Day 28 after final vaccination
description: Influenza virus antibodies were measured using a HAI assay. Geometric mean titer ratio is the geometric mean of the individual post-vaccination / pre-vaccination titer of antibodies to the influenza virus antigens
arm group label: 6 months to < 36 months of age group
arm group type: Experimental
description: Participants at 6 months to < 36 months of age at the time of enrollment will receive Influenza Virus Vaccine, No Preservative; Fluzone® (Pediatric Dose).
arm group label: 3 years to < 9 years of age group
arm group type: Experimental
description: Participants at 3 years to < 9 years of age at the time of enrollment will receive Influenza Virus Vaccine, No Preservative; Fluzone®.
intervention type: Biological
intervention name: Fluzone®: Influenza Virus Vaccine, No Preservative: Pediatric Dose
description: 0.25 mL dose, Intramuscular
arm group label: 6 months to < 36 months of age group
other name: Fluzone® (Influenza Virus Vaccine) 2012-2013 Formulation
intervention type: Biological
intervention name: Fluzone®; Influenza Virus Vaccine, No Preservative
description: 0.5 mL dose, Intramuscular
arm group label: 3 years to < 9 years of age group
other name: Fluzone® (Influenza Virus Vaccine) 2012 2013 Formulation
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: 