Evaluating the safety of a pertussis vaccine in pregnant women
An Observational Study to Assess the Safety of Pertagen®, a Recombinant Acellular Pertussis Vaccine in Pregnant Women in Thailand
This study is testing the safety of the Pertagen® vaccine given to pregnant women in Thailand to see if it affects their pregnancies and the health of their babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2700 (estimated) |
| Sex | Female |
| Sponsor | BioNet-Asia Co., Ltd. Industry-sponsored |
| Locations | 1 site (Thailand, Bangkok) |
| Trial ID | NCT06888076 on ClinicalTrials.gov |
What this trial studies
This observational study assesses the safety of the Pertagen® vaccine administered to pregnant women in Thailand from January 2021 to April 2024. It involves reviewing medical records of these women and their infants to gather data on pregnancy outcomes and health status at birth. The study aims to identify any complications during pregnancy and delivery, as well as the health of newborns. Data will be collected through case report forms by assigned Ob-gyn specialists at participating hospitals.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women who received the Pertagen® vaccine during their second or third trimester and gave birth in Thailand between January 2021 and April 2024.
Not a fit: Patients who may not benefit from this study include those who were vaccinated with Pertagen® but for whom maternal and infant data at delivery cannot be obtained.
Why it matters
Potential benefit: If successful, this study could provide valuable safety data on the use of the Pertagen® vaccine in pregnant women, potentially leading to improved maternal and infant health outcomes.
How similar studies have performed: Other studies evaluating the safety of vaccines in pregnant populations have shown success, suggesting that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Data of pregnant women previously vaccinated with Pertagen® during second or third trimester of pregnancy and have given birth in Thailand from January 2021 to April 2024 and infants born to pregnant women who received Pertagen® during pregnancy. 2. Infant of pregnant women who received Pertagen® during second or third trimester of pregnancy Exclusion Criteria: 1. pregnant women previously vaccinated with Pertagen®, but maternal and infant data at delivery/birth cannot be obtained.
Where this trial is running
Thailand, Bangkok
- Faculty of Medicine Siriraj Hospital Mahidol University — Thailand, Bangkok, Thailand (Recruiting)
Study contacts
- Study coordinator: Vilasinee Yuwaree, MSc.
- Email: vilasinee.y@bionet-asia.com
- Phone: 023618110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.