NCT02554409

Sanofi Pasteur Quadrivalent Intradermal Influenza Vaccine Pregnancy Registry

Sanofi Pasteur Quadrivalent Intradermal Influenza Vaccine Pregnancy Registry Protocol

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 87 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Pregnancy
• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent Intradermal Influenza Vaccine (QIV)	No Intervention as part of this protocol

Timeline

• Start date: 2015-10-13
• Primary completion: 2019-04-30
• Completion: 2019-04-30
• First posted: 2015-09-18
• Last updated: 2020-02-12

Locations

5 sites across 1 country: United States