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.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
220
0.5mL, Intramuscular
0.5mL, Intramuscular
Incheon St. Mary's Hospital Catholic Univ.
Incheon, Bupyeong 6-dong, Bupyeong-gu,, South Korea
The Catholic Univ. of Korea Daejeon St.Mary's Hospital
Daejeon, Jung-Gu, South Korea
The Catholic Univ.of Korea Bucheon St.Mary's Hospital
Gyeonggi-do, South Korea
The Catholic Univ.of Korea Uijeongbu St.Mary's Hospital
Gyeonggi-do, South Korea
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)
Participants Reporting Immediate Solicited Adverse Events Following Vaccination With Either GC3111 or Boostrix® Vaccine
Time frame: Up to 30 minutes post-vaccination
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The Catholic Univ.of Korea Yeouido St.Mary's Hospital
Seoul, South Korea