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ACTIVE NOT RECRUITING
NCT06798831
PHASE3

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

Sponsor: BioNet-Asia Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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