Overview
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 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.