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

NCT06888076 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2700

Last updated 2025-10-03

No results posted yet for this study

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)

Sponsors & Collaborators

  • BioNet-Asia Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Soaud Mansouri, PhD. · Bionet-Asia Co., Ltd (Branch1)

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-12
Primary Completion
2025-04-11
Completion
2025-10-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06888076 on ClinicalTrials.gov