drugset / Trial / NCT06803524
10-year Follow-up After a Single Dose Acellular Pertussis Vaccination
Non-randomizedParallel-groupOpen-labelPrevention
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).
Timeline
- Start
- 2025-05-13
- Primary completion
- 2026-03
- Completion
- 2026-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Adacel | Vaccine | 0.5 ml | Intramuscular |
| Subject | Pertagen | Vaccine | 0.5 ml | Intramuscular |