Dengvaxia US Pregnancy Registry

Study on Pregnancy Outcomes with Investigational Medication Exposure

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 effects of an investigational vaccine on pregnancy outcomes. The study focuses on exposure to the vaccine during pregnancy.

The study evaluates various outcomes related to maternal health, obstetrical events, and infant development. It focuses on understanding the effects of the investigational vaccine on both mothers and their infants.

  • Who can participate: Pregnant women of any age residing in the US and its Territories who have been exposed to the investigational vaccine during pregnancy are eligible. Key eligibility factors include confirmed exposure during pregnancy and documentation of the vaccine name.
  • Study details: Participants will be monitored throughout their pregnancy, and their infants will be followed up to one year of age. This study involves tracking health outcomes to evaluate the effects of the investigational vaccine.
Updated on 23 May 2026. Study ID: NCT04486638

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