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Study Evaluating the Safety of a Recombinant Acellular Pertussis Vaccine in Adults
Sponsor: BioNet-Asia Co., Ltd.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
2399
Start Date
2025-02-08
Completion Date
2025-10-31
Last Updated
2025-10-03
Healthy Volunteers
Yes
Conditions
Interventions
Pertussis containing vaccine
Recombinant acellular pertussis (aP) vaccine (containing 5 µg of geneticallydetoxified pertussis toxin (PTgen),
Locations (3)
Chula Clinical Research Center (Chula CRC)
Bangkok, Bangkok, Thailand
Queen Saovabha Memorial Institute, Thai Red Cross Society
Bangkok, Bangkok, Thailand
Thai Red Cross AIDS and Infectious Diseases Research Centre
Bangkok, Bangkok, Thailand