Dengvaxia US Pregnancy Registry

Investigating Outcomes of Receiving a Vaccine Shot During Pregnancy

Recruiting
All
Phase N/A
500 participants needed
2 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

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.

Updated on 15 Jun 2025. Study ID: NCT04486638

This study investigates the effects of vaccination during pregnancy on mothers and their babies. It looks at the health outcomes for both the mothers and their newborns when the mothers receive a vaccine called an investigational vaccine during pregnancy. The study aims to understand how this vaccine affects both maternal and infant health.

Participants in the study will include pregnant women who have received the investigational vaccine. These women will be monitored until the end of their pregnancy, and their babies will be followed up until they reach one year of age. The study will collect information on various health outcomes to assess any potential impacts of the vaccine.

  • 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, confirming exposure during pregnancy and including the vaccine's name.
  • Study details: Participants will be involved in data collection to understand the effects of the investigational vaccine on health outcomes.

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