Dengvaxia US Pregnancy Registry

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

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.