Dengvaxia US Pregnancy Registry

Investigating Outcomes in Pregnant Women and Children Exposed to 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 pregnant women and their babies when the women are vaccinated with an investigational vaccine during pregnancy. The focus is on understanding various aspects such as maternal health, pregnancy progress, and the health of the newborn and infant up to one year of age.

Participants in this study will include pregnant women who have received the investigational vaccine. The study will observe these women until the end of their pregnancy and will continue to monitor their babies until they reach one year old.

  • Who can participate: Pregnant women of any age living in the US and its Territories who have been exposed to the investigational vaccine during pregnancy are eligible. The exposure must be reported to the pregnancy registry with sufficient evidence confirming the exposure and the vaccine name.
  • Study details: Participants will be observed throughout their pregnancy, and their babies will be monitored until they are one year old. The study will collect data on the health and outcomes of both the mothers and their babies.
Updated on 25 Sep 2025. Study ID: NCT04486638

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