NCT07400120

Safety Monitoring of VacPertagen Vaccine in Thailand

Enhanced Post-Licensure Safety Surveillance Study of the Recombinant Acellular Pertussis Vaccine (aP), VacPertagen, in Thailand

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5,414 (actual)
• Sponsor: BioNet-Asia Co., Ltd. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Detailed description

HCPs eligible to participate were those who prescribed or administered VacPertagen as a booster immunization in line with national guidelines. Recruitment was carried out in hospitals and clinics located in central, eastern, southern and northern Thailand. HCPs who agreed to participate were interviewed periodically regarding adverse events following immunization (AEFIs) with VacPertagen. Data collection was performed using a standardized questionnaire administered monthly, either in person or by telephone. The questionnaire captured the number and type of AEFIs observed, along with other safety-related information. HCPs used a modified WHO AEFI report form to document adverse events. In addition, a pregnancy safety outcome report form was developed to collect data on pregnancy outcomes among vaccinated pregnant women and their newborn. This structured approach enabled systematic monitoring of VacPertagen's safety profile in real-world conditions and ensured early identification of any unexpected safety signals. Statistical Analysis. No formal prespecified study hypothesis was formulated. Descriptive statistics were used to summarize demographic characteristics of VacPertagen recipients, percentage of AEFIs and outcomes of pregnant women vaccinated with VacPertagen including pregnancy complications and newborn health outcomes. Overall data were analyzed using measures such as mean ± standard deviation for continuous variables and numbers with percentages for categorical variables. 95% confidence intervals were calculated for all indicators. Statistical analyses were performed using SPSS version 18 (SPSS Inc., Chicago IL).

Conditions

• Pertussis (Whooping Cough)

Timeline

• Start date: 2018-07-16
• Primary completion: 2023-02-21
• Completion: 2023-02-21
• First posted: 2026-02-10
• Last updated: 2026-02-10

Locations

1 site across 1 country: Thailand