Clinical Trial: Safety and Immunogenicity Study of Tetanus, Diphtheria and Acellular Pertussis (Tdap) Vaccine
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Safety and Immunogenicity Study of Tetanus, Diphtheria and Acellular Pertussis (Tdap) Vaccine
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 Summary:
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.
Sponsor: Green Cross Corporation
Current Primary Outcome:
- 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) ]
- Percentage of Participants Achieving Predefined Antibody Level for Diphtheria, Tetanus, and Acellular Pertussis Antigens [ Time Frame: 28 days after Vaccination ]
- Geometric Mean Concentrations (GMC) for Diphtheria, Tetanus and Acellular Pertussis Antigens [ Time Frame: 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) ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Participants Reporting Immediate Solicited Adverse Events Following Vaccination With Either GC3111 or Boostrix® Vaccine [ Time Frame: Up to 30 minutes post-vaccination ]
Original Secondary Outcome: Same as current
Information By: Green Cross Corporation
Dates:
Date Received: June 20, 2016
Date Started: June 2016
Date Completion: November 2016
Last Updated: November 4, 2016
Last Verified: November 2016
