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10-year Follow-up After a Single Dose Acellular Pertussis Vaccination
Sponsor: Mahidol University
Summary
This is a phase IV, open-label, non-randomized study to demonstrate superior immunogenicity and safety of a second booster dose of Pertagen® as compared to Adacel® at 10 years after the first booster vaccination and to evaluate the long-term persistence of specific antibodies induced by BioNet's recombinant aP (Pertagen®) and TdaP (Boostagen®) vaccines and a chemically-detoxified Tdap vaccine (Adacel®) at 10 years after the first booster in participants who were vaccinated in the phase II/III trial (Protocol No. TDA202).
Official title: Antibody Persistence and Safety and Immunogenicity of a Second Booster Dose 10 Years After a First Booster Vaccination With a Single Dose Vaccination of aP Vaccine in Adults: A Phase IV, Open-label, Non-randomized, Follow-up Study
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
126
Start Date
2025-05-13
Completion Date
2026-03
Last Updated
2025-06-11
Healthy Volunteers
Yes
Conditions
Interventions
Pertagen® vaccine
Pertagen® vaccine, manufactured by BioNet-Asia Co., Ltd., Bangkok, Thailand. The vaccine is presented in pre-filled syringe, each containing one human dose (0.5 mL) of aP vaccine.
Adacel® vaccine
Adacel® vaccine, manufactured by Sanofi Pasteur, Ltd, Toronto, Ontario, Canada. The vaccine is presented in a single-dose vial, each containing one human dose (0.5 mL) of Tdap vaccine.
Locations (2)
Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok Metropolis, Thailand
Vaccine Trial Centre
Ratchathewi, Bangkok Metropolis, Thailand