Clinical Trial Info

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

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This observational study's primary objective is 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).

The secondary objective is 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 the number of doses, dose intervals, and trimester of exposure.