Study Evaluating the Safety of a Recombinant Acellular Pertussis Vaccine in Pregnant Women

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 pregnant women who received Pertagen®.

Following approval of the final protocol from the Institutional Review Board (IRB) and/or Ethics Committee (EC) and written approval from hospital directors/medical doctors as per requirements of each institutions. The assigned Ob-gyn specialist/physician at each study site will review the medical record of pregnant women (January 2020 to April 2024) based on study selection criteria. Safety information of pregnant women who received Pertagen® and have given birth from January 2021 to April 2024 and infants born to pregnant women who received Pertagen® will be obtained from medical records in hospitals/clinics and will be reported in case report form (CRF) by assigned Ob-gyn specialist/physician at each study site. The assigned Ob-gyn specialist/physician at each study site who will review the medical records and report the data in case report form (CRF) is not part of the research team.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Pertussis Vaccines Bacterial Infections Bacterial Infections and Mycoses Bordetella Infections Gram-Negative Bacterial Infections Infections Pertussis (Whooping Cough) Respiratory Tract Diseases Respiratory Tract Infections Whooping Cough

Sex eligibility

Female

Study type

Observational

Primary location

Faculty of Medicine Siriraj Hospital Mahidol University

Bangkok, 10700, Thailand

About this study

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 collection

The 2nd trimester of pregnancy is defined as gestational period between 13-26 weeks
The 3rd trimester of pregnancy is defined as gestational period from 27 weeks to delivery.
Full term birth is defined as delivery of a baby at gestational age (GA) ≥37 weeks.
Preterm birth is defined as delivery of a baby at GA<37 weeks.
Complications during delivery may include postpartum hemorrhage, maternal fever or infection, or any maternal and fetal indications that may require emergency caesarean section.
Safety information of pregnancy and delivery outcome refers to health of women during pregnancy and childbirth (WHO 2024). The most common direct causes of maternal injury and death are excessive blood loss, infection, high blood pressure, unsafe abortion, and obstructed labor, as well as indirect causes such as anemia and heart disease (WHO 2024).
A newborn is defined as healthy at birth if discharged from the hospital in the first few days of life.
A newborn is defined as not healthy if with difficulty of breathing, congenital abnormality or other conditions that would require prolonged stay at the hospital.

To ensure the privacy and confidentiality of the collected data, strict adherence to all relevant data protection regulations will be followed.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

pregnant women previously vaccinated with Pertagen®, but maternal and infant data at delivery/birth cannot be obtained.

Treatment and study plan

Primary outcomes

1 Number and percentage of pregnant women vaccinated with Pertagen who had experienced full term and preterm (or premature) delivery 1.2 Number and percentage of pregnant women vaccinated with Pertagen® who had experienced complications during delivery.

Time frame: Safety profile of Pertagen® in pregnant women at delivery
- Full term birth is defined as delivery of a baby at gestational age (GA) ≥37 weeks.
- Preterm birth is defined as delivery of a baby at GA<37 weeks.
- Complications during delivery may include postpartum hemorrhage, maternal fever or infection, or any maternal and fetal indications that may require emergency caesarean section.

Secondary outcomes

1 Number and percentage of healthy infants born to mothers who received Pertagen® during pregnancy. 2.2 Number and percentage of not healthy infants born to mothers who received Pertagen® during pregnancy

Time frame: Safety profile of Pertagen® in infants born to mother who received Pertagen® at birth
- A newborn is defined as healthy at birth if discharged from the hospital in the first few days of life.
- A newborn is defined as not healthy if with difficulty of breathing, congenital abnormality or other conditions that would require prolonged stay at the hospital.

Other outcomes

Number and percentage of pregnant women had experienced preterm (or premature) delivery in pregnant women received Pertagen® and gave birth during January 2021 - April 2024 and in pregnant women received licensed Td vaccine and gave during 2019-2020

Time frame: 1. Data from review medical records of pregnant women who received Pertagen® and have given birth in Jan 2021 - Apr2024 with their infants. 2. - Data of pregnant women received Td vaccine and gave birth in 2019-2020 (source: HDC, MopH Thailand)

Preterm birth is defined as delivery of a baby at GA<37 weeks.

Sponsors and collaborators

Lead sponsor

BioNet-Asia Co., Ltd.

Industry

Registry information

Official study title

An Observational Study to Assess the Safety of Pertagen®, a Recombinant Acellular Pertussis Vaccine in Pregnant Women in Thailand

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Mar 21, 2025
Registry last updated: Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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