<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/NCT02263131</url>
  </required_header>
  <id_info>
    <org_study_id>IY_IFEZ_CH_301</org_study_id>
    <nct_id>NCT02263131</nct_id>
  </id_info>
  <brief_title>Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactivated Split Influenza Vaccine in Healthy Korea Children</brief_title>
  <official_title>Randomized, Double Blind, Active-controlled, Phase Ⅲ Study to Evaluate the Immunogenicity and Safety of 'Ilyang Flu Vaccine Pre-filled Syringe Inj.(Influenza Split Vaccine)' in Healthy Children Aged From 6 Months to &lt; 18 Years.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Il-Yang Pharm. Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Il-Yang Pharm. Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG Inactivated&#xD;
      Split Influenza Vaccine (IL-YANG FLU Vaccine Prefilled Syringe INJ.) administered as a single&#xD;
      intramuscular injection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a multi-center, randomized, double-blind, active-controlled study.&#xD;
&#xD;
      Before initiation of any protocol-specific activities, written informed consent was obtained&#xD;
      from each patient and their legally acceptable representatives (consent of the legally&#xD;
      acceptable representative was required for children younger than 10 years of age, and for the&#xD;
      some sites, for children younger than 7 years of age). Subjects who met all of the&#xD;
      eligibility criteria after screening assessments as specified in the protocol, were&#xD;
      randomized into the test group or the comparator group in a ratio of 5 to 1 according to the&#xD;
      pre-generated site-specific randomization table, and received a single dose or two doses of&#xD;
      the study vaccine. The investigator performed the efficacy (immunogenicity) and safety&#xD;
      assessments throughout the study. Efficacy data were collected at Visit 1 (prior to&#xD;
      vaccination) and at the end-of-study visit for efficacy (immunogenicity) assessments, and for&#xD;
      safety assessment, subjects and their legally acceptable representatives were instructed to&#xD;
      record any treatment-emergent adverse event in Patient Diary cards.&#xD;
&#xD;
      For all randomized subjects, blood sample was obtained prior to vaccination, and the study&#xD;
      vaccine 0.5mL or 0.25mL was administered to the deltoid muscle or anterolateral thigh muscle.&#xD;
      For children aged from 6 months to &lt;9 years of age who had not been previously exposed to&#xD;
      influenza virus or had not previously received influenza vaccine, another dose of the study&#xD;
      vaccine was administered 4 to 5 weeks after the first dose. Blood samples were collected 4 to&#xD;
      5 weeks after the last dose of the study drug for the assessment of antibody titer. All&#xD;
      subjects were followed for 6 months after the last dose of the study drug for the safety&#xD;
      assessments, and Month 6 follow-up visit was the end-of-study visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Healthy Children Aged From 6 Months to &lt;18 Years With Seroconversion</measure>
    <time_frame>up to Day28(+7)</time_frame>
    <description>Seroconversion is defined as follows. (Case 1) A pre-vaccination (Day 0) HI antibody titer &lt; 1:10 and a post-vaccination (Day 28) HI antibody titer ≥ 1: 40. or (Case 2) a pre-vaccination (Day 0) HI antibody titer ≥ 1:10 and a minimum four-fold rise in post-vaccination (Day 28) HI antibody titer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Subjects Achieving Seroconversion for HI Antibody After Administration of the Study Vaccine Depending of the Number of Vaccination</measure>
    <time_frame>up to Day28(+7)</time_frame>
    <description>Seroconversion: a pre-vaccination (Day 0) hemagglutination-inhibition (HI) antibody titer &lt; 1:10 and a post-vaccination (last vaccination + Day 28) HI antibody titer ≥ 1: 40 (Case 1), or a pre-vaccination (Day 0) HI antibody titer ≥ 1:10 and a minimum four-fold rise in post-vaccination (last vaccination + Day 28) HI antibody titer (Case 2),</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroprotection Rate for HI Antibody</measure>
    <time_frame>up to Day28(+7)</time_frame>
    <description>Percentage of Participants With Healthy Children Aged From 6 Months to &lt;18 Years With Seroprotection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroprotection Rate of HI Antibody</measure>
    <time_frame>up to Day28(+7)</time_frame>
    <description>Percentage of subjects achieving seroprotection for HI antibody after administration of the study vaccine depending of the number of vaccination</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titer* (GMT) of HI Antibody</measure>
    <time_frame>Day28(+7)</time_frame>
    <description>Geometric Mean Titer (GMT), as measured by pre-vaccination (Day 0) HI antibody titer and post-vaccination (vaccination + 28 days) HI antibody titer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GMR of HI Antibody Titer Before Vaccination and After Vaccination</measure>
    <time_frame>Day28(+7)</time_frame>
    <description>Geometric Mean Ratio (GMR), as measured by pre-vaccination (Day 0) HI antibody titer and post-vaccination (vaccination + 28 days) HI antibody titer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With a Pre-vaccination (Day 0) HI Antibody Titer &lt; 1:40, Minimum Four-fold Rise in Post-vaccination (Day 28) HI Antibody Titer</measure>
    <time_frame>Day28(+7)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">416</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>IL-YANG PFS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IL-YANG FLU Vaccine Prefilled Syringe INJ.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TIV PFS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>VAXIGRIP Prefilled Syringe INJ.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>IL-YANG FLU Vaccine Prefilled Syringe INJ.</intervention_name>
    <description>IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL</description>
    <arm_group_label>IL-YANG PFS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>VAXIGRIP Prefilled Syringe INJ.</intervention_name>
    <description>VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL</description>
    <arm_group_label>TIV PFS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy men or women aged from 6 months to &lt; 18 years&#xD;
&#xD;
          -  Subjects were born after full term pregnancy (37 weeks)&#xD;
&#xD;
          -  Voluntary written informed consent was obtained from the subject and the subject's&#xD;
             legally acceptable representative (consent of legally acceptable representative was&#xD;
             required for subjects younger than 10 years of age (and for subjects younger than 7&#xD;
             years of age for the some institutions)).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject with a known allergy to eggs, chicken, neomycin, gentamicin or any components&#xD;
             of the study vaccine&#xD;
&#xD;
          -  Subject who had received an influenza vaccine within the last 6 months&#xD;
&#xD;
          -  Subject who has, or has a family history of, an immune system disorder including&#xD;
             immune deficiency disease&#xD;
&#xD;
          -  Subject with a history of Guillain-Barre syndrome&#xD;
&#xD;
          -  Subject with Down's syndrome or cytogenetic disorders.&#xD;
&#xD;
          -  Subject with severe chronic disease which in the investigator's opinion would not make&#xD;
             the subject a good candidate for the clinical trial&#xD;
&#xD;
          -  Subject with hemophilia or being treated with an anticoagulant, who are at increased&#xD;
             risk of serious bleeding during intramuscular injection&#xD;
&#xD;
          -  Subject who had an acute fever with body temperature &gt; 38.0 Cº within 72 hours prior&#xD;
             to administration of the study vaccine&#xD;
&#xD;
          -  Subject who had previously received another vaccine within 28 days before&#xD;
             administration of the study drug, or is scheduled to receive another vaccine during&#xD;
             the study period.&#xD;
&#xD;
          -  Subject who had received immunosuppressant or immune modifying drug within the last 3&#xD;
             months prior to administration of the study vaccine&#xD;
&#xD;
          -  Subject who had previously received immunoglobulin or blood-derived products within&#xD;
             the last 3 months prior to administration of the study vaccine, or is expecting to be&#xD;
             treated with immunoglobulin or blood-derived products during the study.&#xD;
&#xD;
          -  Subject who had participated in another experimental study within 30 days prior to&#xD;
             administration of the study vaccine&#xD;
&#xD;
          -  Subject with other clinically significant medical or psychological condition who in&#xD;
             the investigator's opinion would not be suitable for the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jin-Han Kang, MD.PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul St. Mary's Hospital, The Catholic University of Korea</affiliation>
  </overall_official>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <results_first_submitted>March 26, 2015</results_first_submitted>
  <results_first_submitted_qc>March 26, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 6, 2015</results_first_posted>
  <last_update_submitted>June 25, 2020</last_update_submitted>
  <last_update_submitted_qc>June 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Influenza</keyword>
  <keyword>Influenza vaccine</keyword>
  <keyword>Split influenza vaccine</keyword>
  <keyword>Seasonal influenza vaccine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>IL-YANG PFS</title>
          <description>IL-YANG FLU Vaccine Prefilled Syringe INJ.&#xD;
IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL</description>
        </group>
        <group group_id="P2">
          <title>TIV PFS</title>
          <description>VAXIGRIP Prefilled Syringe INJ.&#xD;
VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="347"/>
                <participants group_id="P2" count="69"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="337"/>
                <participants group_id="P2" count="68"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>IL-YANG PFS</title>
          <description>IL-YANG FLU Vaccine Prefilled Syringe INJ.&#xD;
IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL</description>
        </group>
        <group group_id="B2">
          <title>TIV PFS</title>
          <description>VAXIGRIP Prefilled Syringe INJ.&#xD;
VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL</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="347"/>
            <count group_id="B2" value="69"/>
            <count group_id="B3" value="416"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="7.83" spread="4.87"/>
                    <measurement group_id="B2" value="7.45" spread="5.01"/>
                    <measurement group_id="B3" value="7.77" spread="4.89"/>
                  </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="191"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="225"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="156"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="191"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Healthy Children Aged From 6 Months to &lt;18 Years With Seroconversion</title>
        <description>Seroconversion is defined as follows. (Case 1) A pre-vaccination (Day 0) HI antibody titer &lt; 1:10 and a post-vaccination (Day 28) HI antibody titer ≥ 1: 40. or (Case 2) a pre-vaccination (Day 0) HI antibody titer ≥ 1:10 and a minimum four-fold rise in post-vaccination (Day 28) HI antibody titer.</description>
        <time_frame>up to Day28(+7)</time_frame>
        <population>Whole participant</population>
        <group_list>
          <group group_id="O1">
            <title>IL-YANG PFS</title>
            <description>IL-YANG FLU Vaccine Prefilled Syringe INJ.&#xD;
IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL</description>
          </group>
          <group group_id="O2">
            <title>TIV PFS</title>
            <description>VAXIGRIP Prefilled Syringe INJ.&#xD;
VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Healthy Children Aged From 6 Months to &lt;18 Years With Seroconversion</title>
          <description>Seroconversion is defined as follows. (Case 1) A pre-vaccination (Day 0) HI antibody titer &lt; 1:10 and a post-vaccination (Day 28) HI antibody titer ≥ 1: 40. or (Case 2) a pre-vaccination (Day 0) HI antibody titer ≥ 1:10 and a minimum four-fold rise in post-vaccination (Day 28) HI antibody titer.</description>
          <population>Whole participant</population>
          <units>percentage of paticipants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="337"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Strain H1N1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.02"/>
                    <measurement group_id="O2" value="76.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strain H3N2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.41"/>
                    <measurement group_id="O2" value="57.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strain B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.90"/>
                    <measurement group_id="O2" value="66.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Subjects Achieving Seroconversion for HI Antibody After Administration of the Study Vaccine Depending of the Number of Vaccination</title>
        <description>Seroconversion: a pre-vaccination (Day 0) hemagglutination-inhibition (HI) antibody titer &lt; 1:10 and a post-vaccination (last vaccination + Day 28) HI antibody titer ≥ 1: 40 (Case 1), or a pre-vaccination (Day 0) HI antibody titer ≥ 1:10 and a minimum four-fold rise in post-vaccination (last vaccination + Day 28) HI antibody titer (Case 2),</description>
        <time_frame>up to Day28(+7)</time_frame>
        <population>This is because the results showed that the seroconversion rate of HI antibody varies depending on the number of vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>IL-YANG PFS</title>
            <description>IL-YANG FLU Vaccine Prefilled Syringe INJ.&#xD;
IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL</description>
          </group>
          <group group_id="O2">
            <title>TIV PFS</title>
            <description>VAXIGRIP Prefilled Syringe INJ.&#xD;
VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects Achieving Seroconversion for HI Antibody After Administration of the Study Vaccine Depending of the Number of Vaccination</title>
          <description>Seroconversion: a pre-vaccination (Day 0) hemagglutination-inhibition (HI) antibody titer &lt; 1:10 and a post-vaccination (last vaccination + Day 28) HI antibody titer ≥ 1: 40 (Case 1), or a pre-vaccination (Day 0) HI antibody titer ≥ 1:10 and a minimum four-fold rise in post-vaccination (last vaccination + Day 28) HI antibody titer (Case 2),</description>
          <population>This is because the results showed that the seroconversion rate of HI antibody varies depending on the number of vaccination.</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="337"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Strain H1N1(1st)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="308"/>
                    <count group_id="O2" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.06"/>
                    <measurement group_id="O2" value="54.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strain H1N1(2nd)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.76"/>
                    <measurement group_id="O2" value="66.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strain H3N2(1st)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="308"/>
                    <count group_id="O2" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.41"/>
                    <measurement group_id="O2" value="56.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strain H3N2(2nd)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.86"/>
                    <measurement group_id="O2" value="66.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strain B(1st)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="308"/>
                    <count group_id="O2" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.22"/>
                    <measurement group_id="O2" value="66.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strain B(2nd)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.07"/>
                    <measurement group_id="O2" value="66.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Seroprotection Rate for HI Antibody</title>
        <description>Percentage of Participants With Healthy Children Aged From 6 Months to &lt;18 Years With Seroprotection</description>
        <time_frame>up to Day28(+7)</time_frame>
        <population>Whole participant</population>
        <group_list>
          <group group_id="O1">
            <title>IL-YANG PFS</title>
            <description>IL-YANG FLU Vaccine Prefilled Syringe INJ.&#xD;
IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL</description>
          </group>
          <group group_id="O2">
            <title>TIV PFS</title>
            <description>VAXIGRIP Prefilled Syringe INJ.&#xD;
VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL</description>
          </group>
        </group_list>
        <measure>
          <title>Seroprotection Rate for HI Antibody</title>
          <description>Percentage of Participants With Healthy Children Aged From 6 Months to &lt;18 Years With Seroprotection</description>
          <population>Whole participant</population>
          <units>percentage of paticipants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="337"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Strain H1N1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.96"/>
                    <measurement group_id="O2" value="89.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strain H3N2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.77"/>
                    <measurement group_id="O2" value="91.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strain B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.25"/>
                    <measurement group_id="O2" value="95.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Seroprotection Rate of HI Antibody</title>
        <description>Percentage of subjects achieving seroprotection for HI antibody after administration of the study vaccine depending of the number of vaccination</description>
        <time_frame>up to Day28(+7)</time_frame>
        <population>This is because the results showed that the seroconversion rate of HI antibody varies depending on the number of vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>IL-YANG PFS</title>
            <description>IL-YANG FLU Vaccine Prefilled Syringe INJ.&#xD;
IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL</description>
          </group>
          <group group_id="O2">
            <title>TIV PFS</title>
            <description>VAXIGRIP Prefilled Syringe INJ.&#xD;
VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL</description>
          </group>
        </group_list>
        <measure>
          <title>Seroprotection Rate of HI Antibody</title>
          <description>Percentage of subjects achieving seroprotection for HI antibody after administration of the study vaccine depending of the number of vaccination</description>
          <population>This is because the results showed that the seroconversion rate of HI antibody varies depending on the number of vaccination.</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="337"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Strain H1N1(1st)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="308"/>
                    <count group_id="O2" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.10"/>
                    <measurement group_id="O2" value="91.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strain H1N1(2nd)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.76"/>
                    <measurement group_id="O2" value="66.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strain H3N2(1st)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="308"/>
                    <count group_id="O2" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.45"/>
                    <measurement group_id="O2" value="93.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strain H3N2(2nd)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.86"/>
                    <measurement group_id="O2" value="66.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strain B(1st)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="308"/>
                    <count group_id="O2" value="62"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.75"/>
                    <measurement group_id="O2" value="96.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strain B(2nd)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="29"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.31"/>
                    <measurement group_id="O2" value="83.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titer* (GMT) of HI Antibody</title>
        <description>Geometric Mean Titer (GMT), as measured by pre-vaccination (Day 0) HI antibody titer and post-vaccination (vaccination + 28 days) HI antibody titer.</description>
        <time_frame>Day28(+7)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IL-YANG PFS</title>
            <description>IL-YANG FLU Vaccine Prefilled Syringe INJ.&#xD;
IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL</description>
          </group>
          <group group_id="O2">
            <title>TIV PFS</title>
            <description>VAXIGRIP Prefilled Syringe INJ.&#xD;
VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titer* (GMT) of HI Antibody</title>
          <description>Geometric Mean Titer (GMT), as measured by pre-vaccination (Day 0) HI antibody titer and post-vaccination (vaccination + 28 days) HI antibody titer.</description>
          <units>Titer</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="337"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Strain H1N1(pre)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.40" lower_limit="21.99" upper_limit="27.07"/>
                    <measurement group_id="O2" value="24.80" lower_limit="19.76" upper_limit="31.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strain H1N1(post)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="111.40" lower_limit="101.52" upper_limit="122.25"/>
                    <measurement group_id="O2" value="88.45" lower_limit="70.33" upper_limit="111.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strain H3N2(pre)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.85" lower_limit="28.47" upper_limit="35.63"/>
                    <measurement group_id="O2" value="30.00" lower_limit="22.59" upper_limit="39.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strain H3N2(post)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110.60" lower_limit="100.93" upper_limit="121.19"/>
                    <measurement group_id="O2" value="104.92" lower_limit="82.25" upper_limit="133.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strain B(pre)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.22" lower_limit="32.63" upper_limit="40.21"/>
                    <measurement group_id="O2" value="39.44" lower_limit="31.96" upper_limit="48.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strain B(post)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="130.53" lower_limit="117.98" upper_limit="144.41"/>
                    <measurement group_id="O2" value="151.70" lower_limit="119.0" upper_limit="192.90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>GMR of HI Antibody Titer Before Vaccination and After Vaccination</title>
        <description>Geometric Mean Ratio (GMR), as measured by pre-vaccination (Day 0) HI antibody titer and post-vaccination (vaccination + 28 days) HI antibody titer.</description>
        <time_frame>Day28(+7)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>IL-YANG PFS</title>
            <description>IL-YANG FLU Vaccine Prefilled Syringe INJ.&#xD;
IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL</description>
          </group>
          <group group_id="O2">
            <title>TIV PFS</title>
            <description>VAXIGRIP Prefilled Syringe INJ.&#xD;
VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL</description>
          </group>
        </group_list>
        <measure>
          <title>GMR of HI Antibody Titer Before Vaccination and After Vaccination</title>
          <description>Geometric Mean Ratio (GMR), as measured by pre-vaccination (Day 0) HI antibody titer and post-vaccination (vaccination + 28 days) HI antibody titer.</description>
          <units>Ratio of GMT titer</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="337"/>
                <count group_id="O2" value="68"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Strain H1N1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.57" lower_limit="4.11" upper_limit="5.08"/>
                    <measurement group_id="O2" value="3.57" lower_limit="2.79" upper_limit="4.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strain H3N2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.47" lower_limit="3.16" upper_limit="3.82"/>
                    <measurement group_id="O2" value="3.50" lower_limit="2.77" upper_limit="4.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strain B</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.60" lower_limit="3.26" upper_limit="3.98"/>
                    <measurement group_id="O2" value="3.85" lower_limit="3.01" upper_limit="4.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With a Pre-vaccination (Day 0) HI Antibody Titer &lt; 1:40, Minimum Four-fold Rise in Post-vaccination (Day 28) HI Antibody Titer</title>
        <time_frame>Day28(+7)</time_frame>
        <population>Number of subjects whose HI antibody titer increased minimum four-fold on day 28 after vaccination</population>
        <group_list>
          <group group_id="O1">
            <title>IL-YANG PFS</title>
            <description>IL-YANG FLU Vaccine Prefilled Syringe INJ.&#xD;
IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL</description>
          </group>
          <group group_id="O2">
            <title>TIV PFS</title>
            <description>VAXIGRIP Prefilled Syringe INJ.&#xD;
VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With a Pre-vaccination (Day 0) HI Antibody Titer &lt; 1:40, Minimum Four-fold Rise in Post-vaccination (Day 28) HI Antibody Titer</title>
          <population>Number of subjects whose HI antibody titer increased minimum four-fold on day 28 after vaccination</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="54"/>
                <count group_id="O2" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Strain H1N1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.29"/>
                    <measurement group_id="O2" value="28.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strain H3N2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.90"/>
                    <measurement group_id="O2" value="50.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Strain B</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="3"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.75"/>
                    <measurement group_id="O2" value="0.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>IL-YANG PFS</title>
          <description>IL-YANG FLU Vaccine Prefilled Syringe INJ.&#xD;
IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL</description>
        </group>
        <group group_id="E2">
          <title>TIV PFS</title>
          <description>VAXIGRIP Prefilled Syringe INJ.&#xD;
VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>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="8" subjects_at_risk="347"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchopneumonia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="347"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="347"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Otitis media acute</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="347"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="347"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="347"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Febrile convulsion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="347"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="347"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Kawasaki's disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="347"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <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="185" subjects_at_risk="347"/>
                <counts group_id="E2" subjects_affected="41" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="120" subjects_at_risk="347"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Tenderness</sub_title>
                <counts group_id="E1" subjects_affected="168" subjects_at_risk="347"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Redness</sub_title>
                <counts group_id="E1" subjects_affected="48" subjects_at_risk="347"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="69"/>
              </event>
              <event>
                <sub_title>Swelling</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="347"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="69"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Kang Jin Han</name_or_title>
      <organization>The Catholic University of Korea, Seoul St. Mary's Hospital</organization>
      <phone>+82-10-4251-8375</phone>
      <email>kjhan@catholic.ac.kr</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/NCT02263131
org study id: IY_IFEZ_CH_301
nct id: NCT02263131
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the safety and immunogenicity of IL-YANG Inactivated
      Split Influenza Vaccine (IL-YANG FLU Vaccine Prefilled Syringe INJ.) administered as a single
      intramuscular injection.
This was a multi-center, randomized, double-blind, active-controlled study.

      Before initiation of any protocol-specific activities, written informed consent was obtained
      from each patient and their legally acceptable representatives (consent of the legally
      acceptable representative was required for children younger than 10 years of age, and for the
      some sites, for children younger than 7 years of age). Subjects who met all of the
      eligibility criteria after screening assessments as specified in the protocol, were
      randomized into the test group or the comparator group in a ratio of 5 to 1 according to the
      pre-generated site-specific randomization table, and received a single dose or two doses of
      the study vaccine. The investigator performed the efficacy (immunogenicity) and safety
      assessments throughout the study. Efficacy data were collected at Visit 1 (prior to
      vaccination) and at the end-of-study visit for efficacy (immunogenicity) assessments, and for
      safety assessment, subjects and their legally acceptable representatives were instructed to
      record any treatment-emergent adverse event in Patient Diary cards.

      For all randomized subjects, blood sample was obtained prior to vaccination, and the study
      vaccine 0.5mL or 0.25mL was administered to the deltoid muscle or anterolateral thigh muscle.
      For children aged from 6 months to <9 years of age who had not been previously exposed to
      influenza virus or had not previously received influenza vaccine, another dose of the study
      vaccine was administered 4 to 5 weeks after the first dose. Blood samples were collected 4 to
      5 weeks after the last dose of the study drug for the assessment of antibody titer. All
      subjects were followed for 6 months after the last dose of the study drug for the safety
      assessments, and Month 6 follow-up visit was the end-of-study visit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Percentage of Participants With Healthy Children Aged From 6 Months to <18 Years With Seroconversion
time frame: up to Day28(+7)
description: Seroconversion is defined as follows. (Case 1) A pre-vaccination (Day 0) HI antibody titer < 1:10 and a post-vaccination (Day 28) HI antibody titer ≥ 1: 40. or (Case 2) a pre-vaccination (Day 0) HI antibody titer ≥ 1:10 and a minimum four-fold rise in post-vaccination (Day 28) HI antibody titer.
measure: Percentage of Subjects Achieving Seroconversion for HI Antibody After Administration of the Study Vaccine Depending of the Number of Vaccination
time frame: up to Day28(+7)
description: Seroconversion: a pre-vaccination (Day 0) hemagglutination-inhibition (HI) antibody titer < 1:10 and a post-vaccination (last vaccination + Day 28) HI antibody titer ≥ 1: 40 (Case 1), or a pre-vaccination (Day 0) HI antibody titer ≥ 1:10 and a minimum four-fold rise in post-vaccination (last vaccination + Day 28) HI antibody titer (Case 2),
measure: Seroprotection Rate for HI Antibody
time frame: up to Day28(+7)
description: Percentage of Participants With Healthy Children Aged From 6 Months to <18 Years With Seroprotection
measure: Seroprotection Rate of HI Antibody
time frame: up to Day28(+7)
description: Percentage of subjects achieving seroprotection for HI antibody after administration of the study vaccine depending of the number of vaccination
measure: Geometric Mean Titer* (GMT) of HI Antibody
time frame: Day28(+7)
description: Geometric Mean Titer (GMT), as measured by pre-vaccination (Day 0) HI antibody titer and post-vaccination (vaccination + 28 days) HI antibody titer.
measure: GMR of HI Antibody Titer Before Vaccination and After Vaccination
time frame: Day28(+7)
description: Geometric Mean Ratio (GMR), as measured by pre-vaccination (Day 0) HI antibody titer and post-vaccination (vaccination + 28 days) HI antibody titer.
measure: Number of Subjects With a Pre-vaccination (Day 0) HI Antibody Titer < 1:40, Minimum Four-fold Rise in Post-vaccination (Day 28) HI Antibody Titer
time frame: Day28(+7)
arm group label: IL-YANG PFS
arm group type: Experimental
description: IL-YANG FLU Vaccine Prefilled Syringe INJ.
arm group label: TIV PFS
arm group type: Active Comparator
description: VAXIGRIP Prefilled Syringe INJ.
intervention type: Biological
intervention name: IL-YANG FLU Vaccine Prefilled Syringe INJ.
description: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL
arm group label: IL-YANG PFS
intervention type: Biological
intervention name: VAXIGRIP Prefilled Syringe INJ.
description: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL
arm group label: TIV PFS
criteria: 
gender: All
minimum age: 6 Months
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jin-Han Kang, MD.PhD
role: Principal Investigator
affiliation: Seoul St. Mary's Hospital, The Catholic University of Korea
responsible party type: Sponsor
mesh term: Influenza, Human
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 