Health Technology/clinical-trials

Large-Scale Cohort Study Examines Tdap5 Vaccination Safety in Pregnancy — 365,000 Participants Across Electronic Medical Records

247 Health News Editorial

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8 Apr 2026

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3 min read

·clinical-trials

A landmark 365,000-participant cohort study examines the safety of Adacel (Tdap5) vaccination during pregnancy, comparing pregnancy and birth outcomes between vaccinated and unvaccinated women. Results expected by 2026 will inform global vaccination guidelines.

Originally reported by ClinicalTrials.gov

References

  1. 1.Australian Technical Advisory Group on Immunisation. (2023). Australian Immunisation Handbook: Pertussis (whooping cough). Australian Government Department of Health. https://immunisationhandbook.health.gov.au/vaccine-preventable-diseases/pertussis-whooping-cough
  2. 2.Kharbanda, E. O., Vazquez-Benitez, G., Lipkind, H. S., Klein, N. P., Cheetham, T. C., Naleway, A. L., Lee, G. M., Jackson, M., Omer, S. B., Sukumaran, L., & Nordin, J. D. (2014). Evaluation of the association of maternal pertussis vaccination with obstetric events and birth outcomes. JAMA, 312(18), 1897-1904. https://doi.org/10.1001/jama.2014.14825
  3. 3.Liang, J. L., Tiwari, T., Moro, P., Messonnier, N. E., Reingold, A., Sawyer, M., & Clark, T. A. (2018). Prevention of pertussis, tetanus, and diphtheria with vaccines in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recommendations and Reports, 67(2), 1-44. https://doi.org/10.15585/mmwr.rr6702a1
  4. 4.Sanofi. (2024). Safety of Tetanus, Diphtheria, Acellular Pertussis With 5 Acellular Pertussis Components (Tdap5) Vaccination During Pregnancy: A Cohort Study Using US Electronic Medical Record Data. ClinicalTrials.gov. NCT06258057. https://clinicaltrials.gov/study/NCT06258057
  5. 5.Therapeutic Goods Administration. (2023). Australian Register of Therapeutic Goods: Adacel. Australian Government Department of Health. https://www.tga.gov.au/resources/artg
  6. 6.Winter, K., Glaser, C., Watt, J., Harriman, K., & Centers for Disease Control and Prevention. (2012). Pertussis epidemic—California, 2014. MMWR Morbidity and Mortality Weekly Report, 63(48), 1129-1132. https://doi.org/10.15585/mmwr.mm6348a2
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247 Health News Editorial

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