Recruiting

GC3111B Safety and Immunogenicity in Healthy Adults

What is being tested

GC3111B

+ Boostrix®

Biological

Who is being recruted

From 19 to 64 Years

+6 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Phase 1 & 2

Interventional

Study Start: June 2025

See protocol details

Summary

Principal SponsorGC Biopharma Corp

Study ContactMinji KoMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 5, 2025

Actual date on which the first participant was enrolled.

This clinical trial is designed to test a new medical intervention called GC3111B, focusing on its safety and effectiveness in healthy adults. The study aims to evaluate how this intervention can help prevent certain health conditions. It is important because it could lead to new preventative treatments that improve health outcomes for many people. By understanding the safety and immune response triggered by GC3111B, researchers hope to develop better ways to protect against diseases. The trial is divided into two parts. In Part 1, volunteers at a single location will participate in an open-label study, meaning both the researchers and participants know what treatment is being given. This part focuses solely on checking the safety of the intervention. In Part 2, the study will involve multiple locations and will be conducted in a double-blind manner, where neither the participants nor the researchers know who is receiving the treatment or a control, to fairly assess its effectiveness and safety. Researchers will monitor participants closely to measure how well the treatment works and ensure there are no adverse effects.

Official TitleAn 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

NCT06997627

Principal SponsorGC Biopharma Corp

Study ContactMinji KoMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 19 to 64 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate

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.

4 exclusion criteria prevent from participating

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants randomized to receive a single dose of GC3111B vaccine.

Group II

Active Comparator

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital

Seoul, South KoreaOpen The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital in Google Maps

Recruiting

One Study Center