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
1 other identifier
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2025
CompletedFirst Posted
Study publicly available on registry
May 30, 2025
CompletedStudy Start
First participant enrolled
June 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedJuly 10, 2025
July 1, 2025
11 months
May 15, 2025
July 8, 2025
Conditions
Outcome Measures
Primary Outcomes (5)
Solicited adverse events occurring by day 14 after administration of the investigational product
14 days after administration of the IP
Unsolicited adverse events occurring by day 28 after administration of the investigational product
28 days after administration of the IP
Acute adverse events occurring within 30 minutes after administration of the investigational product
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
180 days after administration of the IP
Clinically significant findings in vital signs, laboratory tests, 12-lead electrocardiograms, and physical examinations
28 days after administration of the IP
Secondary Outcomes (3)
Antibody rates for diphtheria and tetanus on day 28 after administration of the investigational product
28 days after administration of the IP
Boosting response rates for diphtheria, tetanus, and pertussis on day 28 after administration of the investigational product
28 days after administration of the IP
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
28 days after administration of the IP
Study Arms (2)
GC3111B
EXPERIMENTALParticipants randomized to receive a single dose of GC3111B vaccine.
Boostrix®
ACTIVE COMPARATORParticipants randomized to receive a single dose of Boostrix® vaccine.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital
Seoul, 1021, South Korea
MeSH Terms
Interventions
Central Study Contacts
Sujin Lee
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2025
First Posted
May 30, 2025
Study Start
June 5, 2025
Primary Completion
May 1, 2026
Study Completion
May 1, 2026
Last Updated
July 10, 2025
Record last verified: 2025-07