A Phase 1/2 interventional study of Biological: GC3111 vaccine and Biological: Boostrix® vaccine in Tetanus, Diphtheria and Whooping Cough, sponsored by Green Cross Corporation. Status unknown at 5 sites in Korea, Republic of. Open to participants aged 19 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-06.
Sponsored by Green Cross Corporation · Phase 1/2, Interventional, and Prevention
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.
238 studies on the registry are indexed under Whooping Cough; 15 are open to participants now.
This study's planned enrollment of 220 is below the median of 375 across 180 interventional studies indexed under Whooping Cough.
Browse Whooping Cough studies →Green Cross Corporation is the lead sponsor of 61 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants randomized to receive a single dose of GC3111 vaccine (Biological: GC3111 vaccine).
Biological: Biological: GC3111 vaccine
Participants randomized to receive a single dose of Boostrix® vaccine (Biological: Boostrix® vaccine).
Biological: Biological: Boostrix® vaccine
0.5mL, Intramuscular
Also known as: GC3111
0.5mL, Intramuscular
Also known as: Boostrix®
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
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Green Cross Corporation