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

Study acronym: PertaSafe
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: estimated 2400 to confirmed 2399
    • Site details revised at 3 of 3 sites
    v4
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Apr 30, 2025 to Apr 4, 2025
    • Study completion date: Apr 30, 2025 to Oct 31, 2025
    • Site details revised at 3 of 3 sites
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 3 of 3 sites
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06798831
Lead Sponsor BioNet-Asia Co., Ltd.
Conditions
(from sponsor)		 Pertussis Vaccine
Enrollment 2,399 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov