NCT01945424

Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry

Sanofi Pasteur Quadrivalent Influenza Vaccine Pregnancy Registry Protocol

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 244 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry will be a prospectively recruited pregnancy surveillance program designed to collect and analyze information on vaccine exposures, pregnancy outcomes, and fetal and offspring outcomes.

Detailed description

Pregnant women will be enrolled in the registry prospectively (after exposure to QIV in routine clinical settings but before knowledge of the pregnancy outcome). Women exposed to QIV with or without adverse events will be recorded in the Global Pharmacovigilance Database and medically reviewed. Pregnancy outcomes will be sought via questionnaires sent to the reporter at enrollment, estimated time of delivery, and six months after delivery. Descriptive statistical methods will be the primary approach for summarizing data. No vaccine products will be provided or administered as part of this registry protocol.

Conditions

• Pregnancy
• Influenza

Interventions

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

Timeline

• Start date: 2013-08-16
• Primary completion: 2019-09-15
• Completion: 2019-09-15
• First posted: 2013-09-18
• Last updated: 2020-02-12

Locations

5 sites across 1 country: United States