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

Last updated: July 8, 2025
Sponsor: GC Biopharma Corp
Overall Status: Active - Recruiting

Phase

1/2

Condition

Throat And Tonsil Infections

Treatment

Boostrix®

GC3111B

Clinical Study ID

NCT06997627
GC3111B_Tdap_P1201
  • Ages 19-64
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

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 ofthe investigational product.

Exclusion

Exclusion Criteria:

  • Individuals who have received a vaccine within 4 weeks prior to administration ofthe investigational product.

  • Individuals with a history of Tdap vaccination prior to administration of theinvestigational product.

  • Pregnant and breastfeeding women.

  • Individuals who have participated in other clinical trials involving investigationalproducts/devices within 6 months prior to administration of the investigationalproduct.

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Boostrix®
Phase: 1/2
Study Start date:
June 05, 2025
Estimated Completion Date:
May 31, 2026

Connect with a study center

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

    Seoul, 1021
    Korea, Republic of

    Active - Recruiting

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