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

NCT06997627 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-07-10

No results posted yet for this study

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.

Conditions

  • Tetanus-diphtheria-acellular Pertussis (Tdap)

Interventions

BIOLOGICAL

GC3111B

0.5 mL, Intramuscular injection

BIOLOGICAL

Boostrix®

0.5 mL, Intramuscular injection

Sponsors & Collaborators

  • GC Biopharma Corp

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-05
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06997627 on ClinicalTrials.gov