Safety and Immunogenicity Study of Tetanus, Diphtheria and Acellular Pertussis (Tdap) Vaccine
NCT02813486 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 220
Last updated 2016-11-07
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.
Conditions
- Tetanus
- Diphtheria
- Whooping Cough
Interventions
- BIOLOGICAL
-
Biological: GC3111 vaccine
0.5mL, Intramuscular
- BIOLOGICAL
-
Biological: Boostrix® vaccine
0.5mL, Intramuscular
Sponsors & Collaborators
-
Green Cross Corporation
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-06-30
- Primary Completion
- 2016-11-30
- Completion
- 2016-11-30
Countries
- South Korea
Study Locations
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