Clinical Trial

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

Study acronym: PertaSafe
Active, Not Recruiting Phase 3
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-01-23; most recent amendment 2025-10-02.
Status change: Recruiting → Active, Not Recruiting 2025-09-30
Status change: Not Yet Recruiting → Recruiting 2025-02-17
Trial Details
NCT Number NCT06798831
Lead Sponsor BioNet-Asia Co., Ltd.
Conditions Pertussis Vaccine
Enrollment 2,399 participants
Start Date 2025-02-08
Primary Completion 2025-04-04 (estimated)
Study Completion 2025-10-31 (estimated)
Updated on ClinicalTrials.gov 2025-10-03