Status:
ACTIVE_NOT_RECRUITING
Study Evaluating the Safety of a Recombinant Acellular Pertussis Vaccine in Pregnant Women
Lead Sponsor:
BioNet-Asia Co., Ltd.
Conditions:
Pertussis Vaccines
Pertussis (Whooping Cough)
Eligibility:
FEMALE
Brief Summary
This is an observational, retrospective, cohort, safety study in pregnant women (vaccinated with Pertagen®) and have given birth in Thailand from January 2021 to April 2024 and infants born to pregnan...
Detailed Description
A CRF has been developed and will be used to collect safety information on pregnancy outcomes including the health status of infants at birth. The following definitions will be used for data collectio...
Eligibility Criteria
Inclusion
- 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.
- Infant of pregnant women who received Pertagen® during second or third trimester of pregnancy
Exclusion
- 1\. pregnant women previously vaccinated with Pertagen®, but maternal and infant data at delivery/birth cannot be obtained.
Key Trial Info
Start Date :
December 12 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2025
Estimated Enrollment :
2700 Patients enrolled
Trial Details
Trial ID
NCT06888076
Start Date
December 12 2024
End Date
October 31 2025
Last Update
October 3 2025
Active Locations (1)
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1
Faculty of Medicine Siriraj Hospital Mahidol University
Bangkok, Bangkok, Thailand, 10700