RecruitingPhase 1/2

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

South Korea120 participantsStarted 2025-06-05

Plain-language 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.

Who can participate

Age range19 Years – 64 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Solicited adverse events occurring by day 14 after administration of the investigational product

Timeframe: 14 days after administration of the IP

Unsolicited adverse events occurring by day 28 after administration of the investigational product

Timeframe: 28 days after administration of the IP

Acute adverse events occurring within 30 minutes after administration of the investigational product

Timeframe: 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

Timeframe: 180 days after administration of the IP

Clinically significant findings in vital signs, laboratory tests, 12-lead electrocardiograms, and physical examinations

Timeframe: 28 days after administration of the IP

Trial details

NCT IDNCT06997627

SponsorGC Biopharma Corp

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05

Contact for this trial

Minji Ko

+82-31-260-9143 minji.ko@gccorp.com

View on ClinicalTrials.gov More Tetanus-diphtheria-acellular Pertussis (Tdap) trials

Who can participate

Age range19 Years – 64 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Solicited adverse events occurring by day 14 after administration of the investigational product

Timeframe: 14 days after administration of the IP

Unsolicited adverse events occurring by day 28 after administration of the investigational product

Timeframe: 28 days after administration of the IP

Acute adverse events occurring within 30 minutes after administration of the investigational product

Timeframe: 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

Timeframe: 180 days after administration of the IP

Clinically significant findings in vital signs, laboratory tests, 12-lead electrocardiograms, and physical examinations

Timeframe: 28 days after administration of the IP