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A Study to Evaluate Efficacy and Safety of GC3110B in Healthy Adults

Primary Purpose

Influenza, Human

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
GC3110B vaccine
GCFLU Quadrivalent Inj. vaccine
Sponsored by
Green Cross Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza, Human focused on measuring Influenza Vaccines

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy adults aged 18 to 60 years
  • Informed consent form has been signed and dated
  • Able to comply with the requirements of the study

Exclusion Criteria:

  • Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components
  • Personal history of Guillain-Barré syndrome
  • Subjects with severe chronic disease who are considered by investigator to be ineligible for the study
  • Subjects who received a vaccination within 28 days before enrollment or who are scheduled for another vaccination during the study
  • Immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    GC3110B Vaccine Group

    GCFLU Quadrivalent Inj.

    Arm Description

    Participants randomized to receive a single dose of GC3110B vaccine (Biological: GC3110B vaccine).

    Participants randomized to receive a single dose of GCFLU Quadrivalent Inj. vaccine (Biological: GCFLU Quadrivalent Inj. vaccine).

    Outcomes

    Primary Outcome Measures

    Geometric Mean Titer Ratios of Antibodies to the GC3110B or GCFLU Quadrivalent Inj.
    Geometric mean titers of antibodies will be assessed using the hemagglutination inhibition (HI) assay.

    Secondary Outcome Measures

    Percentage of Participants Achieving Pre-Defined Seroconversion Before and Following Vaccination
    Seroconversion is defined as either a pre-vaccination titer <1:10 and a post-vaccination titer ≥ 1: 40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer 21 days after vaccination.
    Percentage of Participants Achieving Pre-Defined Seroprotection Before and Following Vaccination
    Antibodies will be assessed using the hemagglutination inhibition (HI) assay. Seroprotection is defined as a titer ≥1:40 at pre-vaccination and 21 days after vaccination.
    Number and Percentage of Participants Reporting Solicited Adverse Events Following Vaccination
    Number and Percentage of Participants Reporting Unsolicited Adverse Events Following Vaccination

    Full Information

    First Posted
    September 25, 2016
    Last Updated
    September 27, 2016
    Sponsor
    Green Cross Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02915809
    Brief Title
    A Study to Evaluate Efficacy and Safety of GC3110B in Healthy Adults
    Official Title
    A Randomized, Double-Blind, Multicenter Study to Compare the Immunological Efficacy and Safety of GC3110B With GCFLU Quadrivalent Inj. Administered Intramuscularly in Healthy Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2016 (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    May 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Green Cross Corporation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate immunological efficacy and safety of GC3110B versus GCFLU Quadrivalent Inj. among healthy adults in 18 to 60 years of age.
    Detailed Description
    Adults 18 to 60 years of age will be randomly assigned in a 1:1 ratio to receive either GC3110B or GCFLU Quadrivalent Inj.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Influenza, Human
    Keywords
    Influenza Vaccines

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    414 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    GC3110B Vaccine Group
    Arm Type
    Experimental
    Arm Description
    Participants randomized to receive a single dose of GC3110B vaccine (Biological: GC3110B vaccine).
    Arm Title
    GCFLU Quadrivalent Inj.
    Arm Type
    Active Comparator
    Arm Description
    Participants randomized to receive a single dose of GCFLU Quadrivalent Inj. vaccine (Biological: GCFLU Quadrivalent Inj. vaccine).
    Intervention Type
    Biological
    Intervention Name(s)
    GC3110B vaccine
    Other Intervention Name(s)
    GC3110B
    Intervention Description
    0.5mL, Intramuscular
    Intervention Type
    Biological
    Intervention Name(s)
    GCFLU Quadrivalent Inj. vaccine
    Other Intervention Name(s)
    GCFLU Quadrivalent Inj.
    Intervention Description
    0.5mL, Intramuscular
    Primary Outcome Measure Information:
    Title
    Geometric Mean Titer Ratios of Antibodies to the GC3110B or GCFLU Quadrivalent Inj.
    Description
    Geometric mean titers of antibodies will be assessed using the hemagglutination inhibition (HI) assay.
    Time Frame
    Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
    Secondary Outcome Measure Information:
    Title
    Percentage of Participants Achieving Pre-Defined Seroconversion Before and Following Vaccination
    Description
    Seroconversion is defined as either a pre-vaccination titer <1:10 and a post-vaccination titer ≥ 1: 40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer 21 days after vaccination.
    Time Frame
    Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
    Title
    Percentage of Participants Achieving Pre-Defined Seroprotection Before and Following Vaccination
    Description
    Antibodies will be assessed using the hemagglutination inhibition (HI) assay. Seroprotection is defined as a titer ≥1:40 at pre-vaccination and 21 days after vaccination.
    Time Frame
    Day 0 (Pre-Vaccination) and Day 21 (Post-Vaccination)
    Title
    Number and Percentage of Participants Reporting Solicited Adverse Events Following Vaccination
    Time Frame
    Day 0 to Day 6
    Title
    Number and Percentage of Participants Reporting Unsolicited Adverse Events Following Vaccination
    Time Frame
    Day 0 to Day 21

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy adults aged 18 to 60 years Informed consent form has been signed and dated Able to comply with the requirements of the study Exclusion Criteria: Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components Personal history of Guillain-Barré syndrome Subjects with severe chronic disease who are considered by investigator to be ineligible for the study Subjects who received a vaccination within 28 days before enrollment or who are scheduled for another vaccination during the study Immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A Study to Evaluate Efficacy and Safety of GC3110B in Healthy Adults

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