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Safety of Tetanus, Diphtheria, Acellular Pertussis With 5 Acellular Pertussis Components (Tdap5) Vaccination During Pregnancy
Sponsor: Sanofi
Summary
The purpose of this study is to evaluate the safety of Adacel vaccine among pregnant individuals exposed to Adacel at any point between the 1st day of the 27th week of gestation up to the end of pregnancy and their offspring (ie, Adacel-exposed cohort), in comparison with pregnant individuals not vaccinated with any Tdap vaccines during pregnancy and their offspring (ie, Tdap-unvaccinated comparator cohort). The primary objectives are to estimate incidence rates and relative risks for each prespecified pregnancy outcome in Adacel-exposed and Tdap-unvaccinated comparator cohorts and for each prespecified adverse birth outcome in the offspring of both cohorts. The secondary objectives are to estimate incidence rates and relative risks for each prespecified adverse fetal and neonatal outcome in the offspring of Adacel-exposed and Tdap unvaccinated comparator cohorts and for each prespecified adverse outcome for pregnant individuals in both cohorts.
Official title: Safety of Tetanus, Diphtheria, Acellular Pertussis With 5 Acellular Pertussis Components (Tdap5) Vaccination During Pregnancy: A Cohort Study Using US Electronic Medical Record Data
Key Details
Gender
FEMALE
Age Range
15 Years - 49 Years
Study Type
OBSERVATIONAL
Enrollment
365000
Start Date
2024-01-02
Completion Date
2026-12-31
Last Updated
2026-04-06
Healthy Volunteers
Yes
Conditions
Interventions
Not applicable / database analysis
Not applicable / database analysis
Locations (1)
Investigational Site
Chilly-Mazarin, France