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Search / Trial NCT04486638

Dengvaxia US Pregnancy Registry

Launched by SANOFI PASTEUR, A SANOFI COMPANY · Jul 22, 2020

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

ClinConnect Summary

The Dengvaxia US Pregnancy Registry is a study looking at the health outcomes of pregnant women and their babies who received the Dengvaxia vaccine during pregnancy. The main goal is to understand how the vaccine affects mothers, their pregnancies, and the infants after birth. This research is important to ensure the safety and well-being of both mothers and their children in relation to the vaccine.

To participate in this study, women must be pregnant and living in the United States or its territories. They also need to have received the Dengvaxia vaccine during their pregnancy, and there must be enough information to confirm that they were vaccinated while pregnant. If you join, you will help researchers gather valuable information that can improve future care for pregnant women and their babies. The study is currently recruiting participants, and it welcomes women of any age and their newborns.

Gender

ALL

Eligibility 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.

About Sanofi Pasteur, A Sanofi Company

Sanofi Pasteur, a subsidiary of Sanofi, is a global leader in the development and production of vaccines. With a rich heritage in vaccine innovation, the company is dedicated to advancing public health by providing safe, effective, and accessible immunizations for a wide range of infectious diseases. Sanofi Pasteur invests significantly in research and development to address evolving health challenges and to enhance vaccine coverage worldwide. Committed to collaboration with health organizations and communities, the company strives to protect individuals and populations through its comprehensive portfolio of vaccines, contributing to the prevention of diseases and the promotion of healthier lives globally.

Locations

Puerto Rico, , Puerto Rico

Patients applied

0 patients applied

Trial Officials

Clinical Sciences & Operations

Study Director

Sanofi

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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