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
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 64
Healthy Volunteers: t
View:
• 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.
Locations
Other Locations
Republic of Korea
The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital
RECRUITING
Seoul
Contact Information
Primary
Minji Ko
minji.ko@gccorp.com
+82-31-260-9143
Backup
Sujin Lee
Time Frame
Start Date: 2025-06-05
Estimated Completion Date: 2026-05
Participants
Target number of participants: 120
Treatments
Experimental: GC3111B
Participants randomized to receive a single dose of GC3111B vaccine.
Active_comparator: Boostrix®
Participants randomized to receive a single dose of Boostrix® vaccine.
Related Therapeutic Areas
Sponsors
Leads: GC Biopharma Corp