Dengvaxia US Pregnancy Registry

Dengvaxia US Pregnancy Registry: A Surveillance Study to Assess the Safety of Dengvaxia Among Exposed Pregnant Women and Their Offsprings (DNG00044)

The primary objective of this study is to assess maternal, obstetrical, pregnancy, and neonatal and infant outcomes among women and their offspring(s) vaccinated with Dengvaxia during their pregnancy

Exposed pregnant women will be followed up to the end of their pregnancy, and the offspring(s) will be followed up to 1 year of age.

The eligible population will include pregnant women of any age and their offspring(s) residing in the US and its Territories whose Dengvaxia pregnancy exposure is reported to the pregnancy registry.

Reports of Dengvaxia pregnancy exposure must contain the following information to be included in the registry:

• Sufficient evidence to confirm the case qualifies as "exposed during pregnancy";
• Vaccine name (brand or generic) is provided (i.e., including manufacturer unknown exposures).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.