Actively Recruiting
A Phase I/II Study to Evaluate the Safety and Immunogenicity of GC3111B in Healthy Adults
Led by GC Biopharma Corp · Updated on 2025-07-10
120
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 study, while Part 2 is designed as a multicenter, double-blind, randomized, active-controlled trial.
CONDITIONS
Official Title
A Phase I/II Study to Evaluate the Safety and Immunogenicity of GC3111B in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults aged 19 to 64 years old as of the date of written consent
- 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
You will not qualify if you...
- Received any vaccine within 4 weeks prior to administration of the investigational product
- History of Tdap vaccination prior to administration of the investigational product
- Pregnant and breastfeeding women
- Participation in other clinical trials involving investigational products or devices within 6 months prior to administration of the investigational product
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital
Seoul, South Korea, 1021
Actively Recruiting
Research Team
M
Minji Ko
CONTACT
S
Sujin Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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