A Phase I/II Study to Evaluate the Safety and Immunogenicity of GC3111B in Healthy Adults
An Open(Part 1), Single-arm(Part 1), Randomized(Part 2), Double-blind(Part 2), Active-controlled(Part 2) Phase I/II Clinical Trial to Evaluate the Safety and Efficacy (Immunogenicity) of GC3111B in Healthy Adults
GC Biopharma Corp
120 participants
Jun 5, 2025
INTERVENTIONAL
Conditions
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 study, while Part 2 is designed as a multicenter, double-blind, randomized, active-controlled trial.
Eligibility
Inclusion Criteria2
- 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 Criteria4
- 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.
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Interventions
0.5 mL, Intramuscular injection
0.5 mL, Intramuscular injection
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06997627