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CYD-TDV Dengue Vaccine

Observational Study to Evaluate the Safety of CYD Tetravalent Dengue Vaccine (CYD-TDV) in Pregnant Women and Their Offsprings Inadvertently Exposed During Pregnancy

Ensayo de Sanofi en Dengue Virus Infection (del registro, en inglés).

Fase

no aplica

Estado

Completado

Participantes

104

previstos

Centros

1

Fin del objetivo primario

mar 2023

fecha real

Qué significa cada fase y cada estado.

Estudio observacional. Comenzó en mar 2022.

Qué mide

Percentage of pregnant women with maternal adverse events (From cohort entry up to 42 days post-end of pregnancy) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary Objective: To evaluate the safety of CYD-TDV in pregnant women and their offsprings inadvertently exposed during pregnancy or up to 30 days preceding their last menstrual period (LMP) with regards to maternal, pregnancy, birth, neonatal and infant outcomes. Specifically, the frequency/rates of these outcomes will be: (i) described, and (ii) compared with population-level background incidence rates prior to the introduction of CYD-TDV immunization (i.e., external unvaccinated comparator). Secondary Objective: To describe: * the characteristics of women exposed to CYD-TDV during pregnancy or up to 30 days before the LMP * the characteristics of CYD-TDV pregnancy exposure with regards to number of doses, dose intervals, and trimester of exposure.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT04023708), actualizada en ene 2024.