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A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3111 in Healthy Adults

Sponsor
Green Cross Corporation (Industry)
Overall Status
Unknown status
CT.gov ID
NCT04238975
Collaborator
(none)
213
Enrollment
1
Location
2
Arms
18.6
Anticipated Duration (Months)
11.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate safety and efficacy (immunogenicity) of a single dose of GC3111 versus Boostrix® vaccine among healthy adults in 19-64 years of age.

Condition or Disease Intervention/Treatment Phase
  • Biological: GC3111 vaccine
  • Biological: Boostrix® vaccine
 Phase 2

Detailed Description

To evaluate immunogenicity of GC3111 as tetanus, diphtheria and acellular pertussis (Tdap) vaccine in healthy adults.

To evaluate safety of GC3111 in healthy adults.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
213 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
Randomized, Double-blind, Active-controlled Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of GC3111 in Healthy Adults
Actual Study Start Date :
Oct 14, 2019
Anticipated Primary Completion Date :
Feb 1, 2021
Anticipated Study Completion Date :
May 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: GC3111 Vaccine Group

Participants randomized to receive a single dose of GC3111 vaccine (Biological: GC3111 vaccine).

Biological: GC3111 vaccine
0.5mL, Intramuscular
Other Names:
  • GC3111

    		•
    Active Comparator: Boostrix® Vaccine Group

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

    Biological: Boostrix® vaccine
    0.5mL, Intramuscular
    Other Names:
  • Boostrix®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Solicited Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine [Day 0 (pre-vaccination) to Day 14 (post-vaccination)]

    2. Unsolicited Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine [Day 0 (pre-vaccination) to Day 28 (post-vaccination)]

    3. Serious Adverse Events Following Vaccination with Either GC3111 or Boostrix® Vaccine [Day 0 (pre-vaccination) to Day 180 (post-vaccination)]

    4. Vital Signs [Day 0 (pre-vaccination), Day 28 (post-vaccination)]

      Blood Pressure (systolic, diastolic) in mmHg

    5. Vital Signs [Day 0 (pre-vaccination), Day 28 (post-vaccination)]

      Pulse Rate in pulses per minute

    6. Vital Signs [Day 0 (pre-vaccination), Day 28 (post-vaccination)]

      Body Temperature in degrees Celcius

    7. Laboratory Examinations [Screening (pre-vaccination), Day 28 (post-vaccination)]

      Blood Test (WBC with differential count (lymphocyte, monocyte etc.), RBC, hemoglobin, hematocrit, platelet count

    8. Laboratory Examinations [Screening (pre-vaccination), Day 28 (post-vaccination)]

      Blood Chemistry Test (K, Na, Cl, P, ALT, AST etc.)

    9. Laboratory Examinations [Screening (pre-vaccination), Day 28 (post-vaccination)]

      Urine Test (pH, specific gravity, bilirubin etc.)

    Secondary Outcome Measures

    1. Ratio of Participants with Antibody Responses (Seroprotection rate) to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine [Day 0 (pre-vaccination) to Day 28 (post-vaccination)]

    2. Ratio of Participants With Antibody Responses (Boosting Response rate) to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine [Day 0 (pre-vaccination) to Day 28 (post-vaccination)]

    3. Geometric Mean Concentrations (GMC) for Diphtheria, Tetanus and Acellular Pertussis Antigens [Day 28 (post-vaccination)]

    4. Geometric Mean Ratio (GMR) of Post-vaccination versus Pre-vaccination antibody concentrations for Diphtheria, Tetanus and Acellular Pertussis Antigens [Day 0 (pre-vaccination) to Day 28 (post-vaccination)]

    Other Outcome Measures

    1. Functional Antibody Response of Pertussis [Day 0 (pre-vaccination) to Day 28 (post-vaccination)]

    2. Stratified Analysis of Pertussis according to Anti-Pertussis antibody titer (Positive/Negative) [Day 0 (pre-vaccination), Day 28 (post-vaccination)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Healthy adults aged above 19 and under 64 at the time of screening

    2. Subject without history of administrating vaccines including diphtheria, tetanus or whooping cough antigens within 2 years prior to administration of investigational drug

    3. Subject who provided informed consent and assent forms

    Exclusion Criteria:

    1. Subject who received vaccine within 4 weeks prior to receiving study vaccine

    2. Subject who received Tdap vaccine prior to receiving study vaccine

    3. Subject with chronic cough history within 12 weeks before receiving study vaccine

    4. Subject who is pregnant, lactating, or of child bearing potential without using an effective method of contraception or not practicing abstinence

    5. Subject who participated in any other clinical study (investigational drug/equipment) within 6 months before receiving study vaccine

    6. Subject with any condition that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Green Cross Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Green Cross Corporation
    ClinicalTrials.gov Identifier:
    NCT04238975
    Other Study ID Numbers:
    • GC3111_P2
    First Posted:
    Jan 23, 2020
    Last Update Posted:
    Jan 23, 2020
    Last Verified:
    Jan 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diphtheria
    Whooping Cough
    Vaccines

    Study Results

    No Results Posted as of Jan 23, 2020