Dengvaxia US Pregnancy Registry

Study on Pregnancy Outcomes Following Investigational Vaccine

Recruiting
All
Phase N/A
500 participants needed
1 Location

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

You may be eligible for this study if you meet the following criteria:

  • Conditions: Dengue Virus Infection
  • Gender: All

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.

This study investigates the outcomes for mothers and their babies when the mothers receive the investigational vaccine during pregnancy. The focus is on understanding how the vaccine affects maternal health, pregnancy progress, and the newborn's health. Outcomes will be closely monitored to gather important data on these aspects.

Participants in the study will include pregnant women who have received the investigational vaccine. These women and their babies will be observed throughout the pregnancy and until the child reaches one year of age. This follow-up will help researchers collect comprehensive information about the vaccine's effects.

  • Who can participate: Pregnant women of any age residing in the US and its Territories are eligible if they have been exposed to the investigational vaccine during pregnancy and reported to the pregnancy registry with sufficient evidence and vaccine name details.
  • Study details: Participants will be part of a registry tracking health outcomes of mothers and their babies following exposure to the investigational vaccine to understand its impact on maternal and neonatal health.
Updated on 29 Jan 2026. Study ID: NCT04486638

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