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RECRUITING
NCT06803524
PHASE4

10-year Follow-up After a Single Dose Acellular Pertussis Vaccination

Sponsor: Mahidol University

View on ClinicalTrials.gov

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

BIOLOGICAL

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.

BIOLOGICAL

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