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Sanofi Pasteur Quadrivalent Intradermal Influenza Vaccine Pregnancy Registry

Pregnancy Clinical Trial

Official title:
Sanofi Pasteur Quadrivalent Intradermal Influenza Vaccine Pregnancy Registry Protocol

Clinical Trial Summary

The Sanofi Pasteur Fluzone Intradermal Quadrivalent vaccine (Fluzone QIV-ID) Pregnancy Registry will be a prospectively recruited pregnancy surveillance program designed to collect to collect and analyze information on vaccine exposures, pregnancy outcomes, and fetal and offspring outcomes on pregnant women exposed to Fluzone QIV-ID vaccine.

Clinical Trial Description

Sanofi Pasteur will encourage registration of pregnant women exposed to Fluzone QIV-ID in the Sanofi Pasteur Pregnancy Registry by providing the registry's toll-free number, 1-800-VACCINE (1-800-822-2463), in the USPI. The toll-free number will also be available through the Sanofi Pasteur-sponsored Website for the Pregnancy Registry. Both the United States product insert (USPI) and Website will advise health care providers to register women who are pregnant or became aware they were pregnant at the time of Fluzone QIV-ID immunization.

Descriptive statistical methods will be the primary approach for summarizing data from the Fluzone QIV-ID Pregnancy Registry. No vaccine products will be provided or administered as part of this registry protocol. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02554409
Study type Observational
Source Sanofi
Contact
Status Completed
Phase
Start date October 13, 2015
Completion date April 30, 2019
View Details
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