NCT06798831

Study Evaluating the Safety of a Recombinant Acellular Pertussis Vaccine in Adults

A Randomized, Observer-blind, Active-controlled Study to Describe the Safety of Recombinant Acellular Pertussis (aP) Vaccine When Administered to Healthy Adults Aged of 18-75 Years Old

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,399 (actual)
• Sponsor: BioNet-Asia Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This pivotal safety trial aims to extend the safety database for BioNet recombinant acellular pertussis (aP) vaccine (Pertagen®) in a larger population of adults and evaluate the incidence and characteristics of adverse drug reactions (ADRs), including uncommon events, to provide robust safety data. The study focuses on identifying and describing all ADRs following vaccination with BioNet recombinant acellular pertussis (aP) vaccine, ensuring the vaccine's safety is well-characterized in a large population. This study will also describe the lot-to-lot consistency between three lots of BioNet recombinant acellular pertussis (aP) vaccine across safety outcomes.

Detailed description

This is a pivotal, multi-site, observer-blind, randomized, active-controlled vaccine trial in which 2400 healthy adults aged 18 to 75 years will be recruited at approximately 7:1 ratio from three sites in Bangkok, Thailand. As the aim of this trial is to extend the safety database for recombinant acellular pertussis (aP) vaccine in a larger population of adults, the active-controlled arm is added mainly to reduce selection and measurement bias through randomization and blinding methods.

Conditions

• Pertussis Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Pertussis containing vaccine	Recombinant acellular pertussis (aP) vaccine (containing 5 µg of geneticallydetoxified pertussis toxin (PTgen),

Timeline

• Start date: 2025-02-08
• Primary completion: 2025-04-04
• Completion: 2025-10-31
• First posted: 2025-01-29
• Last updated: 2025-10-03

Locations

3 sites across 1 country: Thailand