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drugset / Trial / NCT06798831

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

NCT06798831 ↗

Phase 3 Active not recruiting 2399 enrolled BioNet-Asia Co., Ltd.
RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2025-02-08
Primary completion
2025-04-04
Completion
2025-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Boostrix Vaccine — —
Subject Pertagen Vaccine — —

Indications

No indication recorded.