Dengvaxia US Pregnancy Registry

Study of Pregnancy and Infant Outcomes After Dengue Vaccination

Gender
All
Phase
N/A
Participants needed
500
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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.

The purpose of this research study is to learn about pregnancy, newborn, and infant outcomes in pregnant women in the US and its Territories who received a dengue vaccine during pregnancy, and in their child(ren).

Participants will not receive a study treatment. This study follows pregnant women whose dengue vaccine exposure during pregnancy is reported to a pregnancy registry and follows their child(ren) after birth.

Who can participate:
Pregnant women in the US and its Territories may be able to participate if they:

  • Have had a dengue vaccine exposure during pregnancy that is reported to the pregnancy registry
  • Have enough information reported to confirm they were exposed during pregnancy
  • Have the vaccine name reported (brand or generic), including cases where the manufacturer is unknown

Study timeline and visits:
Pregnant women will be followed until the end of pregnancy. Their child(ren) will be followed until 1 year of age.

Updated on 23 May 2026. Study ID: NCT04486638

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