The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital
Seoul, 1021, South Korea
Location status: Recruiting
Location contact
Junghyun Choi, MD, PhD.
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT06997627
A Phase I/II Study to Evaluate the Safety and 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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
19 year–64 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1 / Phase 2
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
GC3111B
Biological0.5 mL, Intramuscular injection
Boostrix®
Biological0.5 mL, Intramuscular injection
Primary outcomes
-
Solicited adverse events occurring by day 14 after administration of the investigational product
Time frame: 14 days after administration of the IP
-
Unsolicited adverse events occurring by day 28 after administration of the investigational product
Time frame: 28 days after administration of the IP
-
Acute adverse events occurring within 30 minutes after administration of the investigational product
Time frame: 30 minutes after administration of the IP
-
Serious adverse events (SAE) and adverse events of special interest (AESI) occurring up to 180 days after administration of the investigational product
Time frame: 180 days after administration of the IP
-
Clinically significant findings in vital signs, laboratory tests, 12-lead electrocardiograms, and physical examinations
Time frame: 28 days after administration of the IP
Secondary outcomes
-
Antibody rates for diphtheria and tetanus on day 28 after administration of the investigational product
Time frame: 28 days after administration of the IP
-
Boosting response rates for diphtheria, tetanus, and pertussis on day 28 after administration of the investigational product
Time frame: 28 days after administration of the IP
Boosting response rate: 1) If less than 0.1 IU/ml before vaccination, it should be 0.4 IU/ml or higher after the vaccination, or 2) if not less than 0.1 IU/ml before vaccination, it should be 4 times or higher after the vaccination.
-
Geometric mean concentrations (GMC) of antibodies against diphtheria, tetanus, and pertussis antitoxins (anti-PT, anti-FHA, anti-PRN) on day 28 after administration of the investigational product
Time frame: 28 days after administration of the IP
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
GC Biopharma Corp
Industry
Registry information
Official study title
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
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- May 30, 2025
- Registry last updated
- Jul 10, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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