<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/NCT03285997</url>
  </required_header>
  <id_info>
    <org_study_id>GC3110A_IF_P3</org_study_id>
    <nct_id>NCT03285997</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Efficacy and Safety of GC3110A in Healthy Infants From 6 Months to 35 Months of Age</brief_title>
  <official_title>A Study to Evaluate the Efficacy and Safety of GC3110A in Healthy Infants From 6 Months to 35 Months of Age</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Green Cross Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GC Biopharma Corp</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      If study subject's legal guardians who decide voluntarily to participate the clinical trial,&#xD;
      and sign the Informed Consent Formed, study subjects eligible for participating this trial&#xD;
      protocol were assigned to test group or control group with the ratio of 4:1 and receiving the&#xD;
      test or control drug 1 time or 2 times.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Part 1 If study subject's legal guardians who decide voluntarily to participate the&#xD;
           clinical trial, and sign the Informed Consent Form, study subjects eligible for&#xD;
           participating this trial protocol were assigned to test group and receiving the test&#xD;
           drug 1 time or 2 times.&#xD;
&#xD;
        2. Part 2 If study subject's legal guardians who decide voluntarily to participate the&#xD;
           clinical trial, and sign the Informed Consent Formed, study subjects eligible for&#xD;
           participating this trial protocol were assigned to test group or control group with the&#xD;
           ratio of 4:1 and receiving the test or control drug 1 time or 2 times.&#xD;
&#xD;
      The investigator will evaluate the efficacy and safety of the test product while clinical&#xD;
      trial.&#xD;
&#xD;
      Blood samples will be collected at visit 1 and visit 5 for immunogenicity evaluation. The&#xD;
      study subject and their legal guardians will be educated to daily record AEs after&#xD;
      vaccination on the patient diary to evaluate the safety.&#xD;
&#xD;
      At visit1, blood samples will be collected from randomized study subjects and investigational&#xD;
      drug will be intramuscularly injected. However, those who had not been vaccinated with&#xD;
      influenza vaccine, will re-visit and have the 2nd vaccination, 4~5 weeks after the 1st&#xD;
      vaccination.&#xD;
&#xD;
      After 4~5 weeks since last vaccination, study subjects will visit and blood sample will be&#xD;
      collected. And the serious adverse events occurred during 180 days after the final&#xD;
      vaccination will be checked through the telephone visit.&#xD;
&#xD;
      The study subjects with 1 dose of vaccine will have 4 visits including Visit 1~2 and Visit&#xD;
      5~6. The study subjects with 2 dose of vaccine will have 6 visits including Visit 3~4.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 30, 2017</start_date>
  <completion_date type="Anticipated">August 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2018</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Seroconversion rate for HI antibody after final injection</measure>
    <time_frame>Post-vaccination (Day 28 or 56)</time_frame>
    <description>the percentage of study subjects with a pre-vaccination (Day 0) HI titer&lt;1:10 and post-vaccination (Day 28) HI antibody titer≥1:40(Case1), or the percentage of study subjects with a pre-vaccination HI antibody titer≥1:10 and a minimum four-fold rise in post-vaccination HI antibody titer(Case 2)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroprotection rate for HI antibody after final injection</measure>
    <time_frame>Post-vaccination (Day 28 or 56)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>GMT</measure>
    <time_frame>Post-vaccination (Day 28 or 56)</time_frame>
    <description>GMT(Geometric Mean Titer) of HI antibody titer before vaccination(Day 0) and after vaccination (Day 28)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GMR</measure>
    <time_frame>Post-vaccination (Day 28 or 56)</time_frame>
    <description>GMR(Geometric Mean Ratio) of HI antibody titer before vaccination(Day 0) and after vaccination (Day 28)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">260</enrollment>
  <condition>Influenza Vaccine</condition>
  <arm_group>
    <arm_group_label>GC3110A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One injection: Day 0 Two injection: Day 0 and Day 28</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GCFLU Pre-filled syringe inj.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>One injection: Day 0 Two injection: Day 0 and Day 28</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>GC3110A</intervention_name>
    <description>A single 0.5mL dose intramuscular injection</description>
    <arm_group_label>GC3110A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>GCFLU Pre-filled syringe inj.</intervention_name>
    <description>A single 0.25mL dose intramuscular injection</description>
    <arm_group_label>GCFLU Pre-filled syringe inj.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy infants aged 6 month to 3 years.&#xD;
&#xD;
          2. Study subject was born at full term pregnancy(37 week)&#xD;
&#xD;
          3. Study subject who understand the details of this clinical trial, decide voluntarily to&#xD;
             participate the trial, and signed the Informed Consent Form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Those with a history of allergic reaction to eggs or chicken, the vaccine components&#xD;
&#xD;
          2. Those who had been ad ministered the influenza vaccine 6 months prior to the study&#xD;
             drug vaccination&#xD;
&#xD;
          3. Those with immunologic impairment including immune deficiency disorders or family&#xD;
             history about it.&#xD;
&#xD;
          4. Those with a history of Guillain-Barre syndrome&#xD;
&#xD;
          5. Those with a history of Down's syndrome or cytogenetic disorders&#xD;
&#xD;
          6. Those who would be ineligible to participate the study as follows: serious chronic&#xD;
             disease&#xD;
&#xD;
          7. Hemophilia patients at risk of serious bleeding with intramuscular injection or those&#xD;
             receiving anticoagulant therapy&#xD;
&#xD;
          8. Those who have active infection or who have fever higher than 38.0℃ within 72 hours&#xD;
             prior to the dosing of study drug&#xD;
&#xD;
          9. Those who had been vaccinated with another vaccine within 28 days prior to the dosing&#xD;
             of study drug or had a scheduled vaccination during the clinical trial period&#xD;
&#xD;
         10. Those who had received an immunosuppressant, immunity-modifying drug within 3 months&#xD;
             prior to the dosing of study drug&#xD;
&#xD;
         11. Those who had received immunoglobulin or a blood-derived product within 3 months prior&#xD;
             to the dosing of study drug or is scheduled to receive those products during the study&#xD;
             period&#xD;
&#xD;
         12. Those who had taken antipyretic/analgesic/nonsteroidal antiinflammatory drugs within 4&#xD;
             hours prior to the dosing of study drug&#xD;
&#xD;
         13. Study subject who had participated in other clinical trial within 28 days prior to the&#xD;
             study vaccination&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>35 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Han-A Cha</last_name>
    <phone>+82-260-1936</phone>
    <email>hacha@greencross.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Catholic Univ.of Korea Seoul St.Mary's Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <contact>
      <last_name>Jin Han Kang, M.D.PhD</last_name>
    </contact>
    <investigator>
      <last_name>Jin Han Kang, M.D.PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>September 15, 2017</last_update_submitted>
  <last_update_submitted_qc>September 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Quadrivalent Influenza Vaccines</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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03285997
org study id: GC3110A_IF_P3
nct id: NCT03285997
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
If study subject's legal guardians who decide voluntarily to participate the clinical trial,
      and sign the Informed Consent Formed, study subjects eligible for participating this trial
      protocol were assigned to test group or control group with the ratio of 4:1 and receiving the
      test or control drug 1 time or 2 times.
1. Part 1 If study subject's legal guardians who decide voluntarily to participate the
           clinical trial, and sign the Informed Consent Form, study subjects eligible for
           participating this trial protocol were assigned to test group and receiving the test
           drug 1 time or 2 times.

        2. Part 2 If study subject's legal guardians who decide voluntarily to participate the
           clinical trial, and sign the Informed Consent Formed, study subjects eligible for
           participating this trial protocol were assigned to test group or control group with the
           ratio of 4:1 and receiving the test or control drug 1 time or 2 times.

      The investigator will evaluate the efficacy and safety of the test product while clinical
      trial.

      Blood samples will be collected at visit 1 and visit 5 for immunogenicity evaluation. The
      study subject and their legal guardians will be educated to daily record AEs after
      vaccination on the patient diary to evaluate the safety.

      At visit1, blood samples will be collected from randomized study subjects and investigational
      drug will be intramuscularly injected. However, those who had not been vaccinated with
      influenza vaccine, will re-visit and have the 2nd vaccination, 4~5 weeks after the 1st
      vaccination.

      After 4~5 weeks since last vaccination, study subjects will visit and blood sample will be
      collected. And the serious adverse events occurred during 180 days after the final
      vaccination will be checked through the telephone visit.

      The study subjects with 1 dose of vaccine will have 4 visits including Visit 1~2 and Visit
      5~6. The study subjects with 2 dose of vaccine will have 6 visits including Visit 3~4.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Seroconversion rate for HI antibody after final injection
time frame: Post-vaccination (Day 28 or 56)
description: the percentage of study subjects with a pre-vaccination (Day 0) HI titer<1:10 and post-vaccination (Day 28) HI antibody titer≥1:40(Case1), or the percentage of study subjects with a pre-vaccination HI antibody titer≥1:10 and a minimum four-fold rise in post-vaccination HI antibody titer(Case 2)
measure: Seroprotection rate for HI antibody after final injection
time frame: Post-vaccination (Day 28 or 56)
measure: GMT
time frame: Post-vaccination (Day 28 or 56)
description: GMT(Geometric Mean Titer) of HI antibody titer before vaccination(Day 0) and after vaccination (Day 28)
measure: GMR
time frame: Post-vaccination (Day 28 or 56)
description: GMR(Geometric Mean Ratio) of HI antibody titer before vaccination(Day 0) and after vaccination (Day 28)
arm group label: GC3110A
arm group type: Experimental
description: One injection: Day 0 Two injection: Day 0 and Day 28
arm group label: GCFLU Pre-filled syringe inj.
arm group type: Active Comparator
description: One injection: Day 0 Two injection: Day 0 and Day 28
intervention type: Biological
intervention name: GC3110A
description: A single 0.5mL dose intramuscular injection
arm group label: GC3110A
intervention type: Biological
intervention name: GCFLU Pre-filled syringe inj.
description: A single 0.25mL dose intramuscular injection
arm group label: GCFLU Pre-filled syringe inj.
criteria: 
gender: All
minimum age: 6 Months
maximum age: 35 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Han-A Cha
phone: +82-260-1936
email: hacha@greencross.com
facility: 
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Influenza, Human
sharing ipd: No