<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/NCT02228980</url>
  </required_header>
  <id_info>
    <org_study_id>FST01</org_study_id>
    <secondary_id>U1111-1143-8684</secondary_id>
    <secondary_id>CTR20140452</secondary_id>
    <nct_id>NCT02228980</nct_id>
  </id_info>
  <brief_title>Study of a Single Dose or Two Doses of a Trivalent Inactivated Influenza Vaccine Produced at Shenzhen, China</brief_title>
  <official_title>Immunogenicity and Safety of a Single Dose (Subjects From 3 Years of Age) or Two Doses Given 28 Days Apart (Children From 6 to 35 Months of Age) of a Trivalent Inactivated Influenza Vaccine Produced at Shenzhen, China</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 main purpose of this trial is to describe the product profile in terms of immunogenicity&#xD;
      and safety following administration of trivalent influenza vaccine (split-virion,&#xD;
      inactivated) produced at Shenzhen (SP Shz TIV).&#xD;
&#xD;
      Primary objective:&#xD;
&#xD;
        -  To describe in each group the immune response induced by a single dose (subjects aged ≥&#xD;
           3 years) or by two doses (subjects aged 6 to 35 months) of SP Shz-TIV.&#xD;
&#xD;
      Secondary objective:&#xD;
&#xD;
        -  To describe in each group the safety profile of the vaccine after a single dose&#xD;
           (subjects aged ≥ 3 years) or after each and any dose administered (subjects aged 6-35&#xD;
           months).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Healthy subjects will be included to receive one or two doses of SP Shz TIV The study will&#xD;
      assess the immunogenicity and safety of a single dose (in subjects from 3 years) or two doses&#xD;
      of SP Shz TIV vaccine given 28 days apart (pediatric population from 6 to 35 months).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">October 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>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>Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine</measure>
    <time_frame>Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination</time_frame>
    <description>Anti-hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine</measure>
    <time_frame>Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination</time_frame>
    <description>Anti-hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 and Day 28 or Day 56.</description>
  </other_outcome>
  <other_outcome>
    <measure>Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Trivalent Inactivated Influenza Vaccine</measure>
    <time_frame>Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination</time_frame>
    <description>Anti hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique. Seroconversion was defined as titers &lt; 10 (1/dil) on Day 0 and post vaccination titer ≥ 40 (1/dil) on Day 28 or Day 56 or significant increase was titers ≥ 10 (1/dil) on Day 0 and ≥ 4-fold increase of post-vaccination titer on Day 28 or Day 56.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine</measure>
    <time_frame>Day 0 up to Day 7 post any vaccination</time_frame>
    <description>Solicited injection site: Tenderness/Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic: Fever, (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability (≤ 23 months); Fever, Headache, Malaise, Myalgia, and Shivering (≥2 years).&#xD;
Grade 3: Tenderness - Cries if injected limb is moved; Pain - Incapacitating; Erythema, Swelling, Induration, Ecchymosis, ≥ 50 mm or 100 mm age ≥ 12 years: Fever &gt;39.5˚C; Crying abnormal - &gt;3 hours; Drowsiness - Difficulty waking; Appetite lost - Refuses ≥3 meals; Irritability - Inconsolable; Vomiting - ≥6 incidents per 24 hours: Fever ≥39.0˚C; Headache, Malaise, Myalgia, and Shivering - Prevents activity (≥ 2 years)</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">602</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Subjects aged 6 to 35 months (Group 1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants aged 6 months to 35 months will receive two 0.25 mL doses of SP Shz TIV given 28 days apart.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjects aged 3 to 17 years (Group 2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants aged 3 years to 17 years will receive a single 0.5 mL dose of SP Shz TIV</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjects aged 18 to 60 years (Group 3)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants aged 18 years to 60 years will receive a single 0.5 mL dose of SP Shz TIV</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subjects aged 61 years or older (Group 4)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants aged 61 years or older will receive a single 0.5 mL dose of SP Shz TIV</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation</intervention_name>
    <description>0.25 mL Intramuscular (2 doses given 28 days apart)</description>
    <arm_group_label>Subjects aged 6 to 35 months (Group 1)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation</intervention_name>
    <description>0.5 mL Intramuscular</description>
    <arm_group_label>Subjects aged 3 to 17 years (Group 2)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation</intervention_name>
    <description>0.5 mL Intramuscular</description>
    <arm_group_label>Subjects aged 18 to 60 years (Group 3)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation</intervention_name>
    <description>0.5 mL Intramuscular</description>
    <arm_group_label>Subjects aged 61 years or older (Group 4)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged ≥ 6 months on the day of inclusion&#xD;
&#xD;
          -  Informed Consent Form has been signed and dated:&#xD;
&#xD;
               -  by the parent(s) or legally acceptable representative, if applicable, for&#xD;
                  subjects &lt;18 years of age. Additionally, an assent form has been signed by the&#xD;
                  subject if aged 10 to 17 years (based on local regulations).&#xD;
&#xD;
               -  by the subject himself/herself for subjects ≥18 years of age.&#xD;
&#xD;
          -  Subject and parent(s)/legally acceptable representative (if applicable) are able to&#xD;
             attend all scheduled visits and to comply with all trial procedures&#xD;
&#xD;
          -  For subjects aged 6-35 months only: Born at full term of pregnancy (≥37 weeks) and&#xD;
             with a birth weight ≥2.5 kg&#xD;
&#xD;
          -  For subjects aged 3-8 years only: Subject has previously received at least one dose of&#xD;
             influenza vaccine in the past years or has a history of prior exposure to influenza&#xD;
             virus through natural infection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is pregnant (positive urine pregnancy test), or lactating, or of childbearing&#xD;
             potential (to be considered of non-childbearing potential, a female must be&#xD;
             pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an&#xD;
             effective method of contraception or abstinence from at least 4 weeks prior to&#xD;
             vaccination and until at least 4 weeks after vaccination)&#xD;
&#xD;
          -  Participation at the time of study enrollment (or in the 4 weeks preceding the first&#xD;
             trial vaccination) or planned participation during the present trial period in another&#xD;
             clinical trial investigating a vaccine, drug, medical device, or medical procedure&#xD;
&#xD;
          -  Receipt of any vaccine or planned receipt of any vaccine within the period from 2&#xD;
             weeks before to 2 weeks after trial vaccination (subjects aged ≥3 years) or within the&#xD;
             period from 2 weeks before the first trial vaccination to 2 weeks after the second&#xD;
             trial vaccination (subjects aged 6-35 months)&#xD;
&#xD;
          -  For subjects aged 6-35 months only: Previous vaccination against influenza (i.e. 2&#xD;
             consecutive doses of influenza vaccine [same seasonal strain composition]) any time&#xD;
             prior to study enrollment or history of prior exposure to influenza virus through&#xD;
             natural infection&#xD;
&#xD;
          -  Vaccination against influenza given in the past 6 months with any influenza vaccine or&#xD;
             planned receipt of influenza vaccination during the present study&#xD;
&#xD;
          -  Receipt of immune globulins, blood or blood-derived products in the past 3 months,&#xD;
             which might interfere with assessment of the immune response&#xD;
&#xD;
          -  Known or suspected congenital or acquired immunodeficiency; or receipt of&#xD;
             immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,&#xD;
             within the preceding 6 months; or long-term systemic corticosteroid therapy&#xD;
             (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)&#xD;
&#xD;
          -  Reported history of seropositivity for Human Immunodeficiency Virus (HIV), after&#xD;
             questioning the subject or the subject's parents or another legally acceptable&#xD;
             representative&#xD;
&#xD;
          -  Known systemic hypersensitivity to eggs, chicken proteins, neomycin, formaldehyde and&#xD;
             octoxynol-9, or to any of the vaccine components, or history of a life-threatening&#xD;
             reaction to the vaccine used in the study or to a vaccine containing any of the same&#xD;
             substance&#xD;
&#xD;
          -  Self-reported thrombocytopenia, as reported by the subject, parent or legally&#xD;
             acceptable representative contraindicating intramuscular vaccination&#xD;
&#xD;
          -  Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,&#xD;
             contraindicating intramuscular vaccination upon investigator's judgment&#xD;
&#xD;
          -  Deprived of freedom by an administrative or court order, or in an emergency setting,&#xD;
             or hospitalized involuntarily&#xD;
&#xD;
          -  Current alcohol abuse or drug addiction that might interfere with the ability to&#xD;
             comply with trial procedures&#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;
          -  Moderate or severe acute illness/infection (according to investigator judgment) on the&#xD;
             day of vaccination or febrile illness (axillary temperature ≥37.1°C). A prospective&#xD;
             subject should not be included in the study until the condition has resolved or the&#xD;
             febrile event has subsided&#xD;
&#xD;
          -  Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first&#xD;
             blood draw&#xD;
&#xD;
          -  Identified as an Investigator or employee of the Investigator or study center with&#xD;
             direct involvement in the proposed study, or identified as an immediate family member&#xD;
             (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with&#xD;
             direct involvement in the proposed study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>N/A</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 SA</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Nanning</city>
        <state>Guangxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://www.sanofipasteur.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <results_first_submitted>November 18, 2015</results_first_submitted>
  <results_first_submitted_qc>December 22, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 29, 2016</results_first_posted>
  <last_update_submitted>December 22, 2015</last_update_submitted>
  <last_update_submitted_qc>December 22, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Influenza</keyword>
  <keyword>Trivalent influenza vaccine</keyword>
  <keyword>Sanofi Pasteur Shenzhen trivalent 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 05 September 2014 to 09 October 2014 at 1 clinical center at the Province of Guangxi China.</recruitment_details>
      <pre_assignment_details>A total of 602 participants who met all of the inclusion and none of the exclusion criteria were vaccinated in this study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Age 6 to 35 Months Group</title>
          <description>Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.</description>
        </group>
        <group group_id="P2">
          <title>Age 3 to 17 Years Group</title>
          <description>Participants 3 to 17 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).</description>
        </group>
        <group group_id="P3">
          <title>Age 18 to 60 Years Group</title>
          <description>Participants 18 to 60 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).</description>
        </group>
        <group group_id="P4">
          <title>Age ≥61 Years Group</title>
          <description>Participants ≥61 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="150"/>
                <participants group_id="P2" count="150"/>
                <participants group_id="P3" count="151"/>
                <participants group_id="P4" count="151"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="126"/>
                <participants group_id="P2" count="147"/>
                <participants group_id="P3" count="149"/>
                <participants group_id="P4" count="148"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Age 6 to 35 Months Group</title>
          <description>Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.</description>
        </group>
        <group group_id="B2">
          <title>Age 3 to 17 Years Group</title>
          <description>Participants 3 to 17 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).</description>
        </group>
        <group group_id="B3">
          <title>Age 18 to 60 Years Group</title>
          <description>Participants 18 to 60 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).</description>
        </group>
        <group group_id="B4">
          <title>Age ≥61 Years Group</title>
          <description>Participants ≥61 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).</description>
        </group>
        <group group_id="B5">
          <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="150"/>
            <count group_id="B2" value="150"/>
            <count group_id="B3" value="151"/>
            <count group_id="B4" value="151"/>
            <count group_id="B5" value="602"/>
          </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="150"/>
                    <measurement group_id="B2" value="150"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="300"/>
                  </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="151"/>
                    <measurement group_id="B4" value="41"/>
                    <measurement group_id="B5" value="192"/>
                  </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 group_id="B4" value="110"/>
                    <measurement group_id="B5" value="110"/>
                  </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="1.45" spread="0.597"/>
                    <measurement group_id="B2" value="8.55" spread="3.09"/>
                    <measurement group_id="B3" value="46.5" spread="11.2"/>
                    <measurement group_id="B4" value="69.8" spread="6.37"/>
                    <measurement group_id="B5" value="31.5" spread="5.31425"/>
                  </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="68"/>
                    <measurement group_id="B2" value="70"/>
                    <measurement group_id="B3" value="114"/>
                    <measurement group_id="B4" value="79"/>
                    <measurement group_id="B5" value="331"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                    <measurement group_id="B2" value="80"/>
                    <measurement group_id="B3" value="37"/>
                    <measurement group_id="B4" value="72"/>
                    <measurement group_id="B5" value="271"/>
                  </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>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="150"/>
                    <measurement group_id="B2" value="150"/>
                    <measurement group_id="B3" value="151"/>
                    <measurement group_id="B4" value="151"/>
                    <measurement group_id="B5" value="602"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine</title>
        <description>Anti-hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique.</description>
        <time_frame>Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination</time_frame>
        <population>Geometric mean titers against the trivalent inactivated influenza vaccine antigens were assessed in the Immunogenicity Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Age 6 to 35 Months Group</title>
            <description>Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Age 3 to 17 Years Group</title>
            <description>Participants 3 to 17 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).</description>
          </group>
          <group group_id="O3">
            <title>Age 8 to 60 Years Group</title>
            <description>Participants 18 to 60 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).</description>
          </group>
          <group group_id="O4">
            <title>Age ≥61 Years Group</title>
            <description>Participants ≥61 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine</title>
          <description>Anti-hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique.</description>
          <population>Geometric mean titers against the trivalent inactivated influenza vaccine antigens were assessed in the Immunogenicity Analysis Set.</population>
          <units>Titers (1/dilution)</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="150"/>
                <count group_id="O2" value="150"/>
                <count group_id="O3" value="151"/>
                <count group_id="O4" value="151"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1 (Pre-dose; N=150,150,151,151)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.8" lower_limit="10.5" upper_limit="15.6"/>
                    <measurement group_id="O2" value="24.3" lower_limit="20.1" upper_limit="29.4"/>
                    <measurement group_id="O3" value="11.2" lower_limit="9.49" upper_limit="13.1"/>
                    <measurement group_id="O4" value="9" lower_limit="7.68" upper_limit="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H1N1 (Post-dose; N=125,145,149,145)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="152.2" lower_limit="120" upper_limit="193"/>
                    <measurement group_id="O2" value="300.7" lower_limit="243" upper_limit="372"/>
                    <measurement group_id="O3" value="188.3" lower_limit="158" upper_limit="224"/>
                    <measurement group_id="O4" value="144" lower_limit="116" upper_limit="180"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2 (Pre-dose; n=150,150,151,151)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.3" lower_limit="11.3" upper_limit="18.1"/>
                    <measurement group_id="O2" value="62" lower_limit="51.5" upper_limit="74.8"/>
                    <measurement group_id="O3" value="12.2" lower_limit="10.4" upper_limit="14.4"/>
                    <measurement group_id="O4" value="21.1" lower_limit="16.9" upper_limit="26.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2 (Post-dose; N=125,146,149,147)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="235.9" lower_limit="191" upper_limit="291"/>
                    <measurement group_id="O2" value="236.2" lower_limit="207" upper_limit="270"/>
                    <measurement group_id="O3" value="166.1" lower_limit="140" upper_limit="197"/>
                    <measurement group_id="O4" value="237.8" lower_limit="198" upper_limit="285"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Pre-dose; N=150,150,151,151)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9" lower_limit="5.49" upper_limit="6.30"/>
                    <measurement group_id="O2" value="17.7" lower_limit="15.0" upper_limit="20.9"/>
                    <measurement group_id="O3" value="16.3" lower_limit="13.7" upper_limit="19.5"/>
                    <measurement group_id="O4" value="15.3" lower_limit="12.8" upper_limit="18.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Post-dose; N=123,146,149,148)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="108.5" lower_limit="90.9" upper_limit="129"/>
                    <measurement group_id="O2" value="216.8" lower_limit="180" upper_limit="261"/>
                    <measurement group_id="O3" value="202.8" lower_limit="168" upper_limit="245"/>
                    <measurement group_id="O4" value="170" lower_limit="140" upper_limit="207"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine</title>
        <description>Anti-hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 and Day 28 or Day 56.</description>
        <time_frame>Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination</time_frame>
        <population>Seroprotection against the trivalent inactivated influenza vaccine were assessed in the Immunogenicity Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Age 6 to 35 Months Group</title>
            <description>Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Age 3 to 17 Years Group</title>
            <description>Participants 3 to 17 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).</description>
          </group>
          <group group_id="O3">
            <title>Age 8 to 60 Years Group</title>
            <description>Participants 18 to 60 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).</description>
          </group>
          <group group_id="O4">
            <title>Age ≥61 Years Group</title>
            <description>Participants ≥61 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine</title>
          <description>Anti-hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 and Day 28 or Day 56.</description>
          <population>Seroprotection against the trivalent inactivated influenza vaccine were assessed in the Immunogenicity 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="150"/>
                <count group_id="O2" value="150"/>
                <count group_id="O3" value="151"/>
                <count group_id="O4" value="151"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1 (Pre-dose; N=150,150,151,151)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.3"/>
                    <measurement group_id="O2" value="45.3"/>
                    <measurement group_id="O3" value="17.2"/>
                    <measurement group_id="O4" value="14.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H1N1 (Post-dose; N=125,145,149,145)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.8"/>
                    <measurement group_id="O2" value="94.5"/>
                    <measurement group_id="O3" value="96.6"/>
                    <measurement group_id="O4" value="89.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2 (Pre-dose; N=150,150,151,151)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.0"/>
                    <measurement group_id="O2" value="78.0"/>
                    <measurement group_id="O3" value="21.9"/>
                    <measurement group_id="O4" value="39.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2 (Post-dose; N=125,146,149,147)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.4"/>
                    <measurement group_id="O2" value="99.3"/>
                    <measurement group_id="O3" value="95.3"/>
                    <measurement group_id="O4" value="95.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Pre-dose; N=150,150,151,151)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3"/>
                    <measurement group_id="O2" value="30.0"/>
                    <measurement group_id="O3" value="29.8"/>
                    <measurement group_id="O4" value="23.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (Post-dose; N=123,146,149,148)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.5"/>
                    <measurement group_id="O2" value="95.2"/>
                    <measurement group_id="O3" value="98.7"/>
                    <measurement group_id="O4" value="93.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Trivalent Inactivated Influenza Vaccine</title>
        <description>Anti hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique. Seroconversion was defined as titers &lt; 10 (1/dil) on Day 0 and post vaccination titer ≥ 40 (1/dil) on Day 28 or Day 56 or significant increase was titers ≥ 10 (1/dil) on Day 0 and ≥ 4-fold increase of post-vaccination titer on Day 28 or Day 56.</description>
        <time_frame>Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination</time_frame>
        <population>Seroconversion or significant increase against the trivalent inactivated influenza vaccine were assessed in the Immunogenicity Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>Age 6 to 35 Months Group</title>
            <description>Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Age 3 to 17 Years Group</title>
            <description>Participants 3 to 17 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).</description>
          </group>
          <group group_id="O3">
            <title>Age 18 to 60 Years Group</title>
            <description>Participants 18 to 60 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).</description>
          </group>
          <group group_id="O4">
            <title>Age ≥61 Years Group</title>
            <description>Participants ≥61 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Trivalent Inactivated Influenza Vaccine</title>
          <description>Anti hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique. Seroconversion was defined as titers &lt; 10 (1/dil) on Day 0 and post vaccination titer ≥ 40 (1/dil) on Day 28 or Day 56 or significant increase was titers ≥ 10 (1/dil) on Day 0 and ≥ 4-fold increase of post-vaccination titer on Day 28 or Day 56.</description>
          <population>Seroconversion or significant increase against the trivalent inactivated influenza vaccine were assessed in the Immunogenicity 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="125"/>
                <count group_id="O2" value="146"/>
                <count group_id="O3" value="149"/>
                <count group_id="O4" value="148"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1 (N=125,145,149,145)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.4"/>
                    <measurement group_id="O2" value="79.3"/>
                    <measurement group_id="O3" value="91.3"/>
                    <measurement group_id="O4" value="84.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2 (N=125,146,149,147)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.4"/>
                    <measurement group_id="O2" value="56.2"/>
                    <measurement group_id="O3" value="83.2"/>
                    <measurement group_id="O4" value="78.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B (N=123,146,149,148)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.5"/>
                    <measurement group_id="O2" value="82.2"/>
                    <measurement group_id="O3" value="85.9"/>
                    <measurement group_id="O4" value="80.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine</title>
        <description>Solicited injection site: Tenderness/Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic: Fever, (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability (≤ 23 months); Fever, Headache, Malaise, Myalgia, and Shivering (≥2 years).&#xD;
Grade 3: Tenderness - Cries if injected limb is moved; Pain - Incapacitating; Erythema, Swelling, Induration, Ecchymosis, ≥ 50 mm or 100 mm age ≥ 12 years: Fever &gt;39.5˚C; Crying abnormal - &gt;3 hours; Drowsiness - Difficulty waking; Appetite lost - Refuses ≥3 meals; Irritability - Inconsolable; Vomiting - ≥6 incidents per 24 hours: Fever ≥39.0˚C; Headache, Malaise, Myalgia, and Shivering - Prevents activity (≥ 2 years)</description>
        <time_frame>Day 0 up to Day 7 post any vaccination</time_frame>
        <population>Solicited injection site and systemic reactions were assessed in the Safety Population.</population>
        <group_list>
          <group group_id="O1">
            <title>Age 6 to 35 Months Group</title>
            <description>Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.</description>
          </group>
          <group group_id="O2">
            <title>Age 3 to 17 Years Group</title>
            <description>Participants 3 to 17 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).</description>
          </group>
          <group group_id="O3">
            <title>Age 18 to 60 Years Group</title>
            <description>Participants 18 to 60 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).</description>
          </group>
          <group group_id="O4">
            <title>Age ≥61 Years Group</title>
            <description>Participants ≥61 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine</title>
          <description>Solicited injection site: Tenderness/Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic: Fever, (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability (≤ 23 months); Fever, Headache, Malaise, Myalgia, and Shivering (≥2 years).&#xD;
Grade 3: Tenderness - Cries if injected limb is moved; Pain - Incapacitating; Erythema, Swelling, Induration, Ecchymosis, ≥ 50 mm or 100 mm age ≥ 12 years: Fever &gt;39.5˚C; Crying abnormal - &gt;3 hours; Drowsiness - Difficulty waking; Appetite lost - Refuses ≥3 meals; Irritability - Inconsolable; Vomiting - ≥6 incidents per 24 hours: Fever ≥39.0˚C; Headache, Malaise, Myalgia, and Shivering - Prevents activity (≥ 2 years)</description>
          <population>Solicited injection site and systemic reactions were assessed in the Safety Population.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="150"/>
                <count group_id="O2" value="150"/>
                <count group_id="O3" value="151"/>
                <count group_id="O4" value="151"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Injection site Tenderness/Pain (N=140,148,150,151)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="52"/>
                    <measurement group_id="O3" value="25"/>
                    <measurement group_id="O4" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Tenderness/Pain (N=140,148,150,151)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Erythema (N=140,148,150,151)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Inj. site Erythema (N=140,148,150,151)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection-site Swelling (n=140,148,150,151)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Inj. site Swelling (n=140,148,150,151)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Induration (N=140,148,150,151)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Inj. site Induration (N=140,148,150,151)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Ecchymosis (N=140,148,150,151)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Inj. site Ecchymosis (N=140,148,150,151)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever (N=138,148,149,150)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fever (N=138,148,149,150)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache (N=70,148,150,151)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Headache (N=70,148,150,151)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise (N=70,148,150,151)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Malaise (N=70,148,150,151)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia (N=70,148,150,151)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Myalgia (N=70,148,150,151)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Shivering (N=70,148,150,151)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Shivering (N=70,148,150,151)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Crying abnormal (N=69,0,0,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="NA">Event was not solicited in this group</measurement>
                    <measurement group_id="O3" value="NA">Event was not solicited in this group</measurement>
                    <measurement group_id="O4" value="NA">Event was not solicited in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Crying abnormal (N=69,0,0,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="NA">Event was not solicited in this group</measurement>
                    <measurement group_id="O3" value="NA">Event was not solicited in this group</measurement>
                    <measurement group_id="O4" value="NA">Event was not solicited in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Drowsiness (N=69,0,0,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="NA">Event was not solicited in this group</measurement>
                    <measurement group_id="O3" value="NA">Event was not solicited in this group</measurement>
                    <measurement group_id="O4" value="NA">Event was not solicited in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Drowsiness (N=69,0,0,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="NA">Event was not solicited in this group</measurement>
                    <measurement group_id="O3" value="NA">Event was not solicited in this group</measurement>
                    <measurement group_id="O4" value="NA">Event was not solicited in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Appetite lost (N=69,0,0,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="NA">Event was not solicited in this group</measurement>
                    <measurement group_id="O3" value="NA">Event was not solicited in this group</measurement>
                    <measurement group_id="O4" value="NA">Event was not solicited in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Appetite lost (N=69,0,0,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="NA">Event was not solicited in this group</measurement>
                    <measurement group_id="O3" value="NA">Event was not solicited in this group</measurement>
                    <measurement group_id="O4" value="NA">Event was not solicited in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Irritability (N=69,0,0,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="NA">Event was not solicited in this group</measurement>
                    <measurement group_id="O3" value="NA">Event was not solicited in this group</measurement>
                    <measurement group_id="O4" value="NA">Event was not solicited in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Irritability (N=69,0,0,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="NA">Event was not solicited in this group</measurement>
                    <measurement group_id="O3" value="NA">Event was not solicited in this group</measurement>
                    <measurement group_id="O4" value="NA">Event was not solicited in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting (N=69,0,0,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="NA">Event was not solicited in this group</measurement>
                    <measurement group_id="O3" value="NA">Event was not solicited in this group</measurement>
                    <measurement group_id="O4" value="NA">Event was not solicited in this group</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Vomiting (N =69,0,0,0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="NA">Event was not solicited in this group</measurement>
                    <measurement group_id="O3" value="NA">Event was not solicited in this group</measurement>
                    <measurement group_id="O4" value="NA">Event was not solicited in this group</measurement>
                  </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 56 post-vaccination.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Group 1</title>
          <description>Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.</description>
        </group>
        <group group_id="E2">
          <title>Group 2</title>
          <description>Participants 3 to 17 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).</description>
        </group>
        <group group_id="E3">
          <title>Group 3</title>
          <description>Participants 18 to 60 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).</description>
        </group>
        <group group_id="E4">
          <title>Group 4</title>
          <description>Participants ≥61 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 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="150"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="150"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="150"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="150"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Hand foot and mouth disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="150"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="150"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="150"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="150"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="150"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="150"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5.00</frequency_threshold>
        <default_vocab>MedDRA 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="38" subjects_at_risk="150"/>
                <counts group_id="E2" subjects_affected="52" subjects_at_risk="150"/>
                <counts group_id="E3" subjects_affected="25" subjects_at_risk="151"/>
                <counts group_id="E4" subjects_affected="12" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site Pain/Tenderness</sub_title>
                <counts group_id="E1" events="38" subjects_affected="38" subjects_at_risk="140"/>
                <counts group_id="E2" events="52" subjects_affected="52" subjects_at_risk="148"/>
                <counts group_id="E3" events="25" subjects_affected="25" subjects_at_risk="150"/>
                <counts group_id="E4" events="12" subjects_affected="12" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="38" subjects_affected="38" subjects_at_risk="138"/>
                <counts group_id="E2" events="22" subjects_affected="22" subjects_at_risk="148"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="149"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="150"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="70"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="148"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="150"/>
                <counts group_id="E4" events="5" subjects_affected="5" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="150"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="150"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="151"/>
              </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="21" subjects_affected="21" subjects_at_risk="150"/>
                <counts group_id="E2" events="5" subjects_affected="3" subjects_at_risk="150"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="150"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="150"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="151"/>
              </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="20" subjects_affected="20" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" 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="4" subjects_affected="4" subjects_at_risk="70"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="148"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="150"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="151"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="70"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="148"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="150"/>
                <counts group_id="E4" events="4" subjects_affected="4" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Drowsiness</sub_title>
                <counts group_id="E1" events="12" subjects_affected="12" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Crying abnormal</sub_title>
                <counts group_id="E1" events="20" subjects_affected="20" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Irritability</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="69"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E4" 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="13" subjects_affected="13" subjects_at_risk="150"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="150"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="151"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="151"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="150"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="150"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="151"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="151"/>
              </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/NCT02228980
org study id: FST01
secondary id: U1111-1143-8684
secondary id: CTR20140452
nct id: NCT02228980
lead sponsor: 
has dmc: No
The main purpose of this trial is to describe the product profile in terms of immunogenicity
      and safety following administration of trivalent influenza vaccine (split-virion,
      inactivated) produced at Shenzhen (SP Shz TIV).

      Primary objective:

        -  To describe in each group the immune response induced by a single dose (subjects aged ≥
           3 years) or by two doses (subjects aged 6 to 35 months) of SP Shz-TIV.

      Secondary objective:

        -  To describe in each group the safety profile of the vaccine after a single dose
           (subjects aged ≥ 3 years) or after each and any dose administered (subjects aged 6-35
           months).
Healthy subjects will be included to receive one or two doses of SP Shz TIV The study will
      assess the immunogenicity and safety of a single dose (in subjects from 3 years) or two doses
      of SP Shz TIV vaccine given 28 days apart (pediatric population from 6 to 35 months).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Geometric Mean Titers of Influenza Antibodies Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine
time frame: Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination
description: Anti-hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique.
measure: Percentage of Participants With Seroprotection Before and Following Vaccination With a Trivalent Inactivated Influenza Vaccine
time frame: Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination
description: Anti-hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique. Seroprotection was defined as titers ≥ 40 (1/dil) on Day 0 and Day 28 or Day 56.
measure: Percentage of Participants With Seroconversion or Significant Increase in Influenza Antibody Titers Following Vaccination With a Trivalent Inactivated Influenza Vaccine
time frame: Day 0 (pre-vaccination) up to Day 28 or Day 56 (Age 6 to 35 Months Group) post-vaccination
description: Anti hemagglutinin (HA) antibody titers were measured using the Hemagglutination Inhibition (HAI) technique. Seroconversion was defined as titers < 10 (1/dil) on Day 0 and post vaccination titer ≥ 40 (1/dil) on Day 28 or Day 56 or significant increase was titers ≥ 10 (1/dil) on Day 0 and ≥ 4-fold increase of post-vaccination titer on Day 28 or Day 56.
measure: Number of Participants Reporting Solicited Injection Site or Systemic Reactions Following Vaccination With a Trivalent Inactivated Influenza Vaccine
time frame: Day 0 up to Day 7 post any vaccination
description: Solicited injection site: Tenderness/Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic: Fever, (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability (≤ 23 months); Fever, Headache, Malaise, Myalgia, and Shivering (≥2 years).
Grade 3: Tenderness - Cries if injected limb is moved; Pain - Incapacitating; Erythema, Swelling, Induration, Ecchymosis, ≥ 50 mm or 100 mm age ≥ 12 years: Fever >39.5˚C; Crying abnormal - >3 hours; Drowsiness - Difficulty waking; Appetite lost - Refuses ≥3 meals; Irritability - Inconsolable; Vomiting - ≥6 incidents per 24 hours: Fever ≥39.0˚C; Headache, Malaise, Myalgia, and Shivering - Prevents activity (≥ 2 years)
arm group label: Subjects aged 6 to 35 months (Group 1)
arm group type: Experimental
description: Participants aged 6 months to 35 months will receive two 0.25 mL doses of SP Shz TIV given 28 days apart.
arm group label: Subjects aged 3 to 17 years (Group 2)
arm group type: Experimental
description: Participants aged 3 years to 17 years will receive a single 0.5 mL dose of SP Shz TIV
arm group label: Subjects aged 18 to 60 years (Group 3)
arm group type: Experimental
description: Participants aged 18 years to 60 years will receive a single 0.5 mL dose of SP Shz TIV
arm group label: Subjects aged 61 years or older (Group 4)
arm group type: Experimental
description: Participants aged 61 years or older will receive a single 0.5 mL dose of SP Shz TIV
intervention type: Biological
intervention name: Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation
description: 0.25 mL Intramuscular (2 doses given 28 days apart)
arm group label: Subjects aged 6 to 35 months (Group 1)
intervention type: Biological
intervention name: Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation
description: 0.5 mL Intramuscular
arm group label: Subjects aged 3 to 17 years (Group 2)
intervention type: Biological
intervention name: Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation
description: 0.5 mL Intramuscular
arm group label: Subjects aged 18 to 60 years (Group 3)
intervention type: Biological
intervention name: Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation
description: 0.5 mL Intramuscular
arm group label: Subjects aged 61 years or older (Group 4)
criteria: 
gender: All
minimum age: 6 Months
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Sanofi Pasteur SA
facility: 
country: China
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: 