Safety Monitoring of VacPertagen Vaccine in Thailand

NCT07400120 | Completed

• 1 other identifier: PERTg001
• Study Type: observational
• Target: 5,414
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pertussis (Whooping Cough)

Keywords

Pertussis

Outcome Measures

Primary Outcomes (3)

• Incidence and percentage of AEFIs following vaccination with VacPertagen.

  Measure the frequency, categorize the types, assess the severity, and determine the causal relationship to vaccination for all AEFIs.

  From the date of vaccination up to 30 days post-vaccination.

• Incidence and percentage of pregnant women vaccinated with VacPertagen who had experienced complications during pregnancy

  Incidence rate is defined as the number of maternal complications in 1000 vaccinees. Pregnancy complications include but are not limited to the following: pregnancy loss or stillbirth, preterm delivery (\< 37 weeks of gestation), premature rupture of membranes, pregnancy-induced hypertension, pre-eclampsia/eclampsia, intrauterine growth restriction (IUGR), obstetric hemorrhage, and gestational diabetes.

  From administration of VacPertagen during pregnancy until delivery

• Incidence and percentage of healthy and not healthy infants born to mothers who received VacPertagen during pregnancy.

  Incidence rate is defined as the number of healthy and not healthy infants in 1000 infants born to mothers who received VacPertagen during pregnancy. This outcome assesses the health status of infants born to mothers who received VacPertagen during pregnancy. Infants will be classified at birth as healthy or not healthy based on clinical assessment and review of delivery and neonatal records. A healthy infant is defined as a live-born infant without any congenital anomalies, neonatal complications, or conditions requiring significant medical intervention at birth. A not healthy infant is defined as a live-born infant with at least one reported adverse neonatal outcome, including but not limited to congenital anomalies, preterm birth, low birth weight, neonatal intensive care unit (NICU) admission, or other clinically significant medical conditions identified at or shortly after birth.

  From maternal vaccination during pregnancy until birth of the infant.

Secondary Outcomes (3)

• Incidence and percentage of unexpected serious adverse events (SAEs) following VacPertagen vaccination

  From the date of vaccination up to 30 days post-vaccination for adults and up to delivery for pregnant women.

• Incidence and percentage of rare adverse events following VacPertagen vaccination

  From the date of vaccination up to 30 days post-vaccination for adults and up to delivery for pregnant women.

• Incidence and percentage of new patterns of known adverse events

  From the date of vaccination up to 30 days post-vaccination for adults and up to delivery for pregnant women.

Study Arms (1)

VacPertagen recipients

Vaccinees consist of adults including the elderly and pregnant women in private and government hospitals and clinics located in the central, eastern, northern, and southern regions of Thailand.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of a cohort of HCPs working in private and government hospitals and clinics in central, eastern, northern and southern Thailand where VacPertagen vaccine is marketed. An HCP is defined as medically qualified person, such as physician, nurse or pharmacist.

You may qualify if:

• Has prescribed and/or administered VacPertagen to adults and adolescents in accordance with current national immunization guidelines.
• Employed full-or part-time (\> 8 hours/week) in a government or private hospital or medical clinic.
• Available for follow-up by telephone call, email or site visit if there are missing information in the study questionnaire, to confirm the occurrence or clarify the nature of an adverse event following immunization with VacPertagen.
• Willing and able to comply with the study procedures.

You may not qualify if:

• Unwilling to take part in the study.

Sponsors & Collaborators

• BioNet-Asia Co., Ltd.: lead

Study Sites (1)

BioNet-Asia Co.,Ltd.

Bangkok, Bangkok, 10260, Thailand

Location

MeSH Terms

Conditions

Whooping Cough

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Study Director, PhD.

  BioNet-Asia Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: February 10, 2026
• Study Start: July 16, 2018
• Primary Completion: February 21, 2023
• Study Completion: February 21, 2023
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

TH (1)