Registry for pregnant women vaccinated with Dengvaxia
Official title: Dengvaxia US Pregnancy Registry: A Surveillance Study to Assess the Safety of Dengvaxia Among Exposed Pregnant Women and Their Offsprings (DNG00044)
Run by Sanofi · NCT04486638 · Data updated 2026-11-12
This study is tracking the health of pregnant women and their babies who received the Dengvaxia vaccine to see how it affects their pregnancies and infant development.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Sanofi Industry-sponsored |
| Locations | 1 site (San Juan) |
| Status | Recruiting |
| Started | January 1, 2023 |
| Main results expected | June 30, 2029 |
| Study ends | June 30, 2029 |
| Registry record updated | January 21, 2026 |
| Trial ID | NCT04486638 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant women of any age who have received the Dengvaxia vaccine and reside in the US or its territories.
✕Probably not a fit
Patients who have not been vaccinated with Dengvaxia during pregnancy or those who do not reside in the US or its territories may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the outcomes of pregnancies and infants among women who received the Dengvaxia vaccine during pregnancy. Pregnant women will be monitored throughout their pregnancy, and their infants will be followed for up to one year after birth. The study will collect data on maternal health, obstetrical outcomes, and neonatal development to assess any potential impacts of the vaccine. The registry will include cases reported from the US and its territories.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effects of the Dengvaxia vaccine during pregnancy, informing future vaccination guidelines.
How similar studies have gone: While there may be limited data on similar registries, the approach of monitoring vaccine exposure during pregnancy is increasingly recognized as important for maternal and infant health.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Investigational Site
San Juan, Puerto Rico Recruiting
Study contacts
- Study coordinator: Dengvaxia US Pregnancy Registry HelpLine
- Phone: 1-800-822-2463
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Why dengue is more severe in people with sickle cell disease
This project will test whether immune cells and tiny blood particles from young people with SC or SS sickle cell disease respond differently to dengue virus compared with healthy controls, which could explain more severe infections.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.