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Recruiting NCT06997627

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

Phase I / Phase II Interventional Tetanus-diphtheria-acellular Pertussis (Tdap)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GC3111B, Boostrix®.
Who it may be relevant to
Registry conditions: Tetanus-diphtheria-acellular Pertussis (Tdap). Basic parameters: 19 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An 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

Overview

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.

Interventions

  • Biological GC3111B
    0.5 mL, Intramuscular injection
  • Biological Boostrix®
    0.5 mL, Intramuscular injection

Primary outcome measures

  • Solicited adverse events occurring by day 14 after administration of the investigational product [Time frame: 14 days after administration of the IP]
  • Unsolicited adverse events occurring by day 28 after administration of the investigational product [Time frame: 28 days after administration of the IP]
  • Acute adverse events occurring within 30 minutes after administration of the investigational product [Time frame: 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 [Time frame: 180 days after administration of the IP]
  • Clinically significant findings in vital signs, laboratory tests, 12-lead electrocardiograms, and physical examinations [Time frame: 28 days after administration of the IP]
Secondary outcome measures (3)
  • Antibody rates for diphtheria and tetanus on day 28 after administration of the investigational product [Time frame: 28 days after administration of the IP]
  • Boosting response rates for diphtheria, tetanus, and pertussis on day 28 after administration of the investigational product [Time frame: 28 days after administration of the IP]
  • Geometric mean concentrations (GMC) of antibodies against diphtheria, tetanus, and pertussis antitoxins (anti-PT, anti-FHA, anti-PRN) on day 28 after administration of the investigational product [Time frame: 28 days after administration of the IP]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

South Korea · 1 center
  • The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital — Seoul

Identifiers

NCT: NCT06997627 · GC3111B_Tdap_P1201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗