<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/NCT02249221</url>
  </required_header>
  <id_info>
    <org_study_id>GC3106_P1/2a</org_study_id>
    <nct_id>NCT02249221</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability, and Immunogenicity of GC3106 (Quadrivalent Cell-culture Based Influenza Vaccine)</brief_title>
  <official_title>A Randomized (Part B), Open-label (Part A) or Double-blind (Part B), Active-controlled (Part B) Phase I/IIa Study to Investigate the Safety, Tolerability, and Immunogenicity of GC3106 (Quadrivalent Cell-culture Based Influenza Vaccine)</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of&#xD;
      GC3106 after single intramuscular administration in Korean healthy adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is the first in human trial of GC3106 and is designed as an adaptive Phase I/IIa&#xD;
      to ensure participants protection. Part A is an open-label and single arm study in 9 healthy&#xD;
      volunteers. Data and Safety Monitoring Board (DSMB) will review the solicited/unsolicited&#xD;
      adverse events conditionally if any toxicity of Grade 3 or 4 has been reported during 7 days&#xD;
      after vaccination from the first 9 healthy volunteers. Part B is a randomized (2:1),&#xD;
      double-blind, active controlled study and a total of 75 volunteers will participate in this&#xD;
      part. Adverse events assessment will be done according to the 'Toxicity Grading Scale for&#xD;
      Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials'.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Solicited adverse events following vaccination</measure>
    <time_frame>Day 1 up to 7 Days post vaccination</time_frame>
    <description>Solicited injection site reactions: Pain, Tenderness, Erythema, Redness, Induration, and Swelling; Solicited systemic reactions: Fever, Sweating, Chill, Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, arthralgia.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Unsolicited adverse events following vaccination</measure>
    <time_frame>Day 1 up to 22 Days post vaccination</time_frame>
    <description>It can be estimated by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Abnormalities in physical examination, vital signs, and/or clinical laboratory tests</measure>
    <time_frame>Day 22 post vaccination</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Seroprotection rate of HI (Hemagglutination Inhibition) antibody for each strain</measure>
    <time_frame>Day 22 post vaccination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seroconversion rate of HI (Hemagglutination Inhibition) antibody for each strain</measure>
    <time_frame>Day 22 post vaccination</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GMT(geometric mean titers) for each strain</measure>
    <time_frame>Day 22 post vaccination</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">84</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Quadrivalent cell-culture based influenza vaccin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Day 1: GC3106, 0.5ml, intramuscular, a single dosing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trivalent influenza vaccine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Day 1: GC Flu Pre-filled Syringe Inj., 0.5ml, intramuscular, a single dosing</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Quadrivalent cell-culture based influenza vaccin</intervention_name>
    <description>GC3106, 0.5ml, intramuscular, a single dosing at Day 1</description>
    <arm_group_label>Quadrivalent cell-culture based influenza vaccin</arm_group_label>
    <other_name>GC3106</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Trivalent influenza vaccine</intervention_name>
    <description>GC Flu Pre-filled Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1</description>
    <arm_group_label>Trivalent influenza vaccine</arm_group_label>
    <other_name>GC Flu Pre-filled Syringe Inj.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Given written informed consent&#xD;
&#xD;
          -  Healthy Korean adults (age: between over 19 and under 65)&#xD;
&#xD;
          -  Korean adults who agree with 21 days follow up after vaccination and good compliance&#xD;
             to study procedures&#xD;
&#xD;
          -  Those who are able to comply with the requirements for the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability in written/verbal communication&#xD;
&#xD;
          -  Subjects who have participated in other interventional study within 30 days&#xD;
&#xD;
          -  Alcohol or drug abuse within 6 months&#xD;
&#xD;
          -  Heavy drinkers or subjects who do not agree to stop drinking for 3 days before&#xD;
             vaccination and other 3 days after vaccination&#xD;
&#xD;
          -  Who got the treatment of psychotropic drugs and narcotic analgesic drugs within 6&#xD;
             months of enrollment&#xD;
&#xD;
          -  Hypersensitivity with drug or active ingredient&#xD;
&#xD;
          -  Disorders in immune function&#xD;
&#xD;
          -  History of Guillain-Barré syndrome&#xD;
&#xD;
          -  Disease/medications which are likely to cause any severe bleeding&#xD;
&#xD;
          -  Active infection or experience of fever (&gt;38.0 ℃) within 72 hours following&#xD;
             vaccination&#xD;
&#xD;
          -  Oral temperature &gt;38.0 ℃ at the vaccination day&#xD;
&#xD;
          -  Erythema, tattoo, injury at shoulder (vaccination site)&#xD;
&#xD;
          -  Influenza vaccination within 6months&#xD;
&#xD;
          -  Any vaccination within 30 days&#xD;
&#xD;
          -  Concomitant medications/therapy such as immunosuppressants or immune modifying drugs,&#xD;
             systemic corticosteroids, immunoglobulins, blood or blood- derived products, or&#xD;
             anti-cancer chemotherapy or radiation therapy within3 months&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  Clinically significant underlying diseases or medical history at investigator's&#xD;
             discretion&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Woo Joo KIM, M.D., Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Korea University Guro Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chang-Hee LEE, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Green Cross Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Korea University Guro Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>December 4, 2014</last_update_submitted>
  <last_update_submitted_qc>December 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 5, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Influenza vaccine</keyword>
  <keyword>Vaccination</keyword>
  <keyword>cell-culture based influenza vaccine</keyword>
  <keyword>cell culture derived influenza vaccine</keyword>
  <keyword>CCIV</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <!-- 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/NCT02249221
org study id: GC3106_P1/2a
nct id: NCT02249221
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of
      GC3106 after single intramuscular administration in Korean healthy adults.
This study is the first in human trial of GC3106 and is designed as an adaptive Phase I/IIa
      to ensure participants protection. Part A is an open-label and single arm study in 9 healthy
      volunteers. Data and Safety Monitoring Board (DSMB) will review the solicited/unsolicited
      adverse events conditionally if any toxicity of Grade 3 or 4 has been reported during 7 days
      after vaccination from the first 9 healthy volunteers. Part B is a randomized (2:1),
      double-blind, active controlled study and a total of 75 volunteers will participate in this
      part. Adverse events assessment will be done according to the 'Toxicity Grading Scale for
      Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials'.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Solicited adverse events following vaccination
time frame: Day 1 up to 7 Days post vaccination
description: Solicited injection site reactions: Pain, Tenderness, Erythema, Redness, Induration, and Swelling; Solicited systemic reactions: Fever, Sweating, Chill, Nausea, Vomiting, Diarrhea, Headache, Fatigue, Myalgia, arthralgia.
measure: Unsolicited adverse events following vaccination
time frame: Day 1 up to 22 Days post vaccination
description: It can be estimated by Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
measure: Abnormalities in physical examination, vital signs, and/or clinical laboratory tests
time frame: Day 22 post vaccination
measure: Seroprotection rate of HI (Hemagglutination Inhibition) antibody for each strain
time frame: Day 22 post vaccination
measure: Seroconversion rate of HI (Hemagglutination Inhibition) antibody for each strain
time frame: Day 22 post vaccination
measure: GMT(geometric mean titers) for each strain
time frame: Day 22 post vaccination
arm group label: Quadrivalent cell-culture based influenza vaccin
arm group type: Experimental
description: Day 1: GC3106, 0.5ml, intramuscular, a single dosing
arm group label: Trivalent influenza vaccine
arm group type: Active Comparator
description: Day 1: GC Flu Pre-filled Syringe Inj., 0.5ml, intramuscular, a single dosing
intervention type: Biological
intervention name: Quadrivalent cell-culture based influenza vaccin
description: GC3106, 0.5ml, intramuscular, a single dosing at Day 1
arm group label: Quadrivalent cell-culture based influenza vaccin
other name: GC3106
intervention type: Biological
intervention name: Trivalent influenza vaccine
description: GC Flu Pre-filled Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1
arm group label: Trivalent influenza vaccine
other name: GC Flu Pre-filled Syringe Inj.
criteria: 
gender: All
minimum age: 19 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Woo Joo KIM, M.D., Ph.D
role: Principal Investigator
affiliation: Korea University Guro Hospital
last name: Chang-Hee LEE, M.D.
role: Study Director
affiliation: Green Cross Corporation
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Influenza, Human