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

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.

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.

Exclusion Criteria:

• 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.