Who is sponsoring NCT02813486?

NCT02813486 is sponsored by Green Cross Corporation.

What condition does NCT02813486 study?

NCT02813486 studies Tetanus, Diphtheria, Whooping Cough.

What drugs are being tested in NCT02813486?

Interventions: Biological: GC3111 vaccine, Biological: Boostrix® vaccine.

What is the status of NCT02813486?

NCT02813486 is currently UNKNOWN.

Last reviewed 2016-11-04 · How we verify

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

NCT02813486 Phase 1/Phase 2 UNKNOWN

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.

Details

Lead sponsor	Green Cross Corporation
Phase	Phase 1/Phase 2
Status	UNKNOWN
Enrolment	220
Start date	2016-06
Completion	2016-11

Conditions

Tetanus
Diphtheria
Whooping Cough

Interventions

Biological: GC3111 vaccine
Biological: Boostrix® vaccine

Primary outcomes

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)
Percentage of Participants Achieving Predefined Antibody Level for Diphtheria, Tetanus, and Acellular Pertussis Antigens — 28 days after Vaccination
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)

Countries

South Korea