Recruiting
NCT04486638
Dengue Virus Infection
Dengvaxia US Pregnancy Registry
All gender
This study targets all gender participants
N/A
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500 participants
Study involves a large group of participants
4 locations
Available in numerous locations
Study Overview
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
Study Details
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.
Eligibility Criteria
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.