Clinical Trial

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

Recruiting Phase 4
View on ClinicalTrials.gov →
Record status
This record was last updated June 11, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.
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).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-01-27.
Status change: Not Yet Recruiting → Recruiting 2025-06-09
Trial Details
NCT Number NCT06803524
Lead Sponsor Mahidol University
Collaborators: BioNet-Asia Co., Ltd.
Conditions Pertussis
Enrollment 126 participants
Start Date 2025-05-13
Primary Completion 2026-03 (estimated)
Study Completion 2026-03 (estimated)
Updated on ClinicalTrials.gov 2025-06-11