Calendario›SNY›Safety of Tetanus, Diphtheria, Acellular Pertussis With 5 Acellular Pertussis Components (Tdap5) Vaccination During Pregnancy
Safety of Tetanus, Diphtheria, Acellular Pertussis With 5 Acellular Pertussis Components (Tdap5) Vaccination During Pregnancy
Ensayo de Sanofi en Pertussis (Whooping Cough) (del registro, en inglés).
- Fase
- no aplica
- Estado
- En marcha, sin reclutar
- Participantes
- 365.000
- Centros
- 1
- Fin del objetivo primario
- dic 2026
previstos
estimado por el promotor
Qué significa cada fase y cada estado.
Estudio observacional. Comenzó en ene 2024.
Qué mide
Pregnancy outcome: Live birth (From 1st day of the 27th week of gestation up to 42 weeks gestation) (del registro, en inglés)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe 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.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT06258057), actualizada en mar 2026.