A Phase I/II Study to Evaluate the Safety and Immunogenicity of GC3111B in Healthy Adults
Recruiting
Phase 1
Phase 2
Interventional Study
Tetanus-diphtheria-acellular Pertussis (Tdap)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 19 – 64
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 120 (estimated)
- Sponsor
- GC Biopharma Corp · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusio…