Dengvaxia US Pregnancy Registry

Study on Health Outcomes Related to Vaccine Exposure in Pregnancy

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 of pregnancy and infant health when women receive an investigational vaccine during pregnancy. The purpose is to assess how the vaccine affects maternal health, pregnancy, and the health of newborns and infants up to one year of age.

Participants in this study will be monitored throughout their pregnancy, and their infants will be observed for one year after birth. This involves collecting data on health outcomes without altering any treatments.

  • Who can participate: Pregnant women of any age living in the US and its Territories, who have been exposed to the Dengvaxia vaccine during pregnancy, can participate. Eligibility requires confirmed evidence of exposure during pregnancy, documentation of the vaccine used, and reporting to the pregnancy registry.
  • Study details: Participants will be observed for health outcomes during and after pregnancy as part of a registry study. Data will be collected on both maternal and infant health without any changes to their routine care.
Updated on 22 Jan 2026. Study ID: NCT04486638

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