A Phase I/II Study to Evaluate the Safety and Immunogenicity of GC3111B in Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-05

Study Completion Date

2026-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Tetanus-diphtheria-acellular Pertussis (Tdap)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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GC3111B

Participants randomized to receive a single dose of GC3111B vaccine.

Group Type EXPERIMENTAL

GC3111B

Intervention Type BIOLOGICAL

0.5 mL, Intramuscular injection

Boostrix®

Participants randomized to receive a single dose of Boostrix® vaccine.

Group Type ACTIVE_COMPARATOR

Boostrix®

Intervention Type BIOLOGICAL

0.5 mL, Intramuscular injection

Interventions

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GC3111B

0.5 mL, Intramuscular injection

Intervention Type BIOLOGICAL

Boostrix®

0.5 mL, Intramuscular injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes