MedTrace Logo

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

NCT06798831 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2399

Last updated 2025-10-03

No results posted yet for this study

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.

Conditions

  • Pertussis Vaccine

Interventions

BIOLOGICAL

Pertussis containing vaccine

Recombinant acellular pertussis (aP) vaccine (containing 5 µg of geneticallydetoxified pertussis toxin (PTgen),

Sponsors & Collaborators

  • BioNet-Asia Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Thailand

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06798831 on ClinicalTrials.gov