Status:
RECRUITING
A Phase I/II Study to Evaluate the Safety and Immunogenicity of GC3111B in Healthy Adults
Lead Sponsor:
GC Biopharma Corp
Conditions:
Tetanus-diphtheria-acellular Pertussis (Tdap)
Eligibility:
All Genders
19-64 years
Phase:
PHASE1
PHASE2
Brief Summary
This clinical trial consists of two parts: Part 1, which explores safety, and Part 2, which examines both safety and efficacy (immunogenicity). Part 1 is a single-center, open-label, single-group stud...
Eligibility Criteria
Inclusion
- Healthy adults aged 19 to 64 years old as of the date of written consent.
- Individuals with no history of vaccination with a vaccine containing diphtheria, tetanus, or pertussis antigens within the past 2 years prior to administration of the investigational product.
Exclusion
- Individuals who have received a vaccine within 4 weeks prior to administration of the investigational product.
- Individuals with a history of Tdap vaccination prior to administration of the investigational product.
- Pregnant and breastfeeding women.
- Individuals who have participated in other clinical trials involving investigational products/devices within 6 months prior to administration of the investigational product.
Key Trial Info
Start Date :
June 5 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06997627
Start Date
June 5 2025
End Date
May 1 2026
Last Update
July 10 2025
Active Locations (1)
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1
The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital
Seoul, South Korea, 1021