A Phase I/II Study to Evaluate the Safety and Immunogenicity of GC3111B in Healthy Adults
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age19-64
SponsorGC Biopharma Corp
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- GC3111B
- Boostrix®
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov