GC3111B versus Boostrix® as a Tdap booster in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial has two parts: Part 1 is a single-center, open-label, single-group safety evaluation, and Part 2 is a multicenter, double-blind, randomized, active-controlled comparison of GC3111B to Boostrix®. Healthy adults aged 19–64 who have not received a diphtheria-, tetanus-, or pertussis-containing vaccine in the previous 2 years are eligible, while recent vaccination, pregnancy, breastfeeding, or recent participation in other investigational trials are excluded. Participants will receive either GC3111B or Boostrix® and be followed for safety and antibody responses (immunogenicity) over predefined visits. The primary outcomes focus on safety/tolerability and laboratory measures of immune response to the vaccine antigens.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Catholic Univ. of Korea Eunpyeong St. Mary's Hospital
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Minji Ko
• Email: minji.ko@gccorp.com
• Phone: +82-31-260-9143

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.