Safety and Immunogenicity Study of Tetanus, Diphtheria and Acellular Pertussis (Tdap) Vaccine

November 4, 2016 updated by: Green Cross Corporation
The purpose of this study is to evaluate safety of GC3111 and to describe immunogenicity of a single dose of GC3111 versus Boostrix® vaccine among healthy adults in 19 to <65 years of age.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

To evaluate safety (solicited adverse events) of GC3111 in healthy adults.

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of
        • The Catholic Univ.of Korea Bucheon St.Mary's Hospital
      • Gyeonggi-do, Korea, Republic of
        • The Catholic Univ.of Korea Uijeongbu St.Mary's Hospital
      • Seoul, Korea, Republic of
        • The Catholic Univ.of Korea Yeouido St.Mary's Hospital
    • Bupyeong 6-dong, Bupyeong-gu,
      • Incheon, Bupyeong 6-dong, Bupyeong-gu,, Korea, Republic of, 1544-9004
        • Incheon St. Mary's Hospital Catholic Univ.
    • Jung-Gu
      • Daejeon, Jung-Gu, Korea, Republic of, 301-723
        • The Catholic Univ. of Korea Daejeon St.Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 64 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adults aged between 19 and 64 years at the time of vaccination
  • Informed consent and assent forms have been signed and dated

Exclusion Criteria:

  • Known or suspected receipt of any Tdap vaccine
  • Subject is pregnant, or lactating, or of child bearing potential without using an effective method of contraception or not practicing abstinence
  • Receipt of any vaccine within 30 days before receiving study vaccine
  • Any condition that, in the opinion of the Investigator, might interfere with the ability to comply with trial procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: GC3111 Vaccine Group
Participants randomized to receive a single dose of GC3111 vaccine (Biological: GC3111 vaccine).
Biological: 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: Biological: Boostrix® vaccine
0.5mL, Intramuscular
Other Names:
  • Boostrix®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Participants With Antibody Responses to Tetanus and Diphtheria Components Following Vaccination With Either GC3111 or Boostrix® Vaccine
Time Frame: Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Percentage of Participants Achieving Predefined Antibody Level for Diphtheria, Tetanus, and Acellular Pertussis Antigens
Time Frame: 28 days after Vaccination
28 days after Vaccination
Geometric Mean Concentrations (GMC) for Diphtheria, Tetanus and Acellular Pertussis Antigens
Time Frame: 28 days after Vaccination
28 days after Vaccination
Geometric Mean Ratio (GMR) of post-vaccination versus pre-vaccination antibody concentrations against Diphtheria, Tetanus and Acellular Pertussis
Time Frame: Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Day 0 (pre-vaccination) to Day 28 (post-vaccination)

Secondary Outcome Measures

Outcome Measure
Time Frame
Participants Reporting Immediate Solicited Adverse Events Following Vaccination With Either GC3111 or Boostrix® Vaccine
Time Frame: Up to 30 minutes post-vaccination
Up to 30 minutes post-vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Green Cross Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (ANTICIPATED)

November 1, 2016

Study Completion (ANTICIPATED)

November 1, 2016

Study Registration Dates

First Submitted

June 20, 2016

First Submitted That Met QC Criteria

June 22, 2016

First Posted (ESTIMATE)

June 27, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

November 6, 2016

Last Update Submitted That Met QC Criteria

November 4, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC3111_P1/2a

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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