Clinical Trial

Safety Monitoring of VacPertagen Vaccine in Thailand

Study acronym: PERTg001
Completed
View on ClinicalTrials.gov →
Summary
In compliance with Thailand's conditional approval requirements, this prospective, observational study is designed to actively monitor the safety of VacPertagen vaccine. Healthcare professionals (HCPs) prescribing or administering the vaccine are recruited from hospitals and clinics across central, eastern, southern and northern Thailand. Adverse events following immunization (AEFIs) are reported through standardized questionnaires and modified WHO AEFI forms, enabling systematic evaluation of the vaccine's safety profile in a broader and more heterogeneous population than that assessed in pre-licensure trials. Primary objective: To describe the post-licensure safety profile of VacPertagen in Thailand. Secondary objective: To identify any unexpected safety signals following vaccination with VacPertagen.
Trial Details
NCT Number NCT07400120
Lead Sponsor BioNet-Asia Co., Ltd.
Conditions Pertussis (Whooping Cough)
Enrollment 5,414 participants
Start Date 2018-07-16
Primary Completion 2023-02-21 (estimated)
Study Completion 2023-02-21 (estimated)
Updated on ClinicalTrials.gov 2026-02-10