Dengvaxia US Pregnancy Registry

Dengvaxia US Pregnancy Registry: A Surveillance Study to Assess the Safety of Dengvaxia Among Exposed Pregnant Women and Their Offsprings (DNG00044)

NCT04486638•Sanofi Pasteur, a Sanofi Company

View on ClinicalTrials.gov

Summary

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

Detailed Description

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

Age

All ages

Sex

ALL

Healthy Volunteers

Yes

Inclusion 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.

Locations (1)

Investigational Site

San Juan, Puerto Rico

Key Dates

Start Date

January 1, 2023

Primary Completion Date

June 30, 2029

Completion Date

June 30, 2029

Last Updated

January 21, 2026

Enrollment

500

ESTIMATED participants

Conditions

Dengue Virus Infection

Interventions

Dengue Tetravalent Vaccine, Live

BIOLOGICAL

Contacts

Dengvaxia US Pregnancy Registry HelpLine

CONTACT

1-800-822-2463

Trial Transparency email recommended (Toll free number for US & Canada)

CONTACT

800-633-1610 contact-us@sanofi.com

Observational Study to Evaluate the Safety of CYD Tetravalent Dengue Vaccine (CYD-TDV) in Pregnant Women and Their Offsprings Inadvertently Exposed During Pregnancy

NCT04023708

Dengue Virus Infection

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 21, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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