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

Launched by GC BIOPHARMA CORP · May 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new vaccine called GC3111B, which aims to protect against tetanus, diphtheria, and pertussis (whooping cough). The trial has two parts: the first part focuses on ensuring the vaccine is safe for healthy adults, while the second part will check not only its safety but also how well it generates an immune response to protect against these diseases. The trial is not yet recruiting participants, but they are looking for healthy adults between the ages of 19 and 64 who haven’t received any vaccines containing these antigens in the last two years.

To be eligible for the trial, participants cannot have had any vaccinations in the four weeks before receiving the study vaccine, and those who have been vaccinated with a similar vaccine in the past are also not eligible. Additionally, pregnant or breastfeeding women and those who have participated in other clinical research studies in the previous six months cannot join. If you qualify and decide to participate, you can expect to help researchers learn more about this vaccine’s safety and its ability to generate protection against these serious illnesses.

Gender

ALL

Eligibility criteria

• 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.