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

Phase 1

• Conditions: Whooping Cough; Tetanus; Diphtheria

• Registration Number: NCT02813486
• Lead Sponsor: Green Cross Corporation

Brief Summary

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.

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 Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-20
• Study First Submitted QC: 2016-06-22
• Study First Posted: 2016-06-27
• Status Verified: 2016-11
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Last Update Submitted: 2016-11-04
• Last Update Posted: 2016-11-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 220

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Participants Reporting Immediate Solicited Adverse Events Following Vaccination With Either GC3111 or Boostrix® Vaccine	Up to 30 minutes post-vaccination

Trial Locations

Locations (5)

Incheon St. Mary's Hospital Catholic Univ.; 🇰🇷 Incheon, Bupyeong 6-dong, Bupyeong-gu,, Korea, Republic of

The Catholic Univ. of Korea Daejeon St.Mary's Hospital; 🇰🇷 Daejeon, Jung-Gu, 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; 🇰🇷 Gyeonggi-do, Korea, Republic of

The Catholic Univ.of Korea Yeouido St.Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of