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

NCT06888076 | Active Not Recruiting

• 1 other identifier: PerMIS-01
• Study Type: observational
• Target: 2,700
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pertussis Vaccines; Pertussis (Whooping Cough)

Keywords

Pertussis; whooping cough

Outcome Measures

Primary Outcomes (1)

• 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.

  * 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 profile of Pertagen® in pregnant women at delivery

Secondary Outcomes (1)

• 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

  Safety profile of Pertagen® in infants born to mother who received Pertagen® at birth

Other Outcomes (1)

• 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

  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)

Study Arms (1)

Pregnant women received Pertagen® and have given birth in Jan 2021-Apr 2024 and their infants

The pregnant women (previously vaccinated with Pertagen®) and have given birth in Thailand from Jan 2021 - Apr 2024 and infants born to pregnant women who received Pertagen®.

Eligibility Criteria

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

Study Population

The pregnant women who received Pertagen® and have given birth from January 2021 to April 2024 and infants born to pregnant women who received Pertagen® which obtained from medical records in hospitals/clinics

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• BioNet-Asia Co., Ltd.: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital Mahidol University

Bangkok, Bangkok, 10700, 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

• Soaud Mansouri, PhD.

  Bionet-Asia Co., Ltd (Branch1)

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 21, 2025
• Study Start: December 12, 2024
• Primary Completion: April 11, 2025
• Study Completion: October 31, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)