Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry

Completed

• Conditions: Pregnancy; Influenza
• Interventions: Biological: Quadrivalent Influenza Vaccine (QIV)

• Registration Number: NCT01945424
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief 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.

Study Timeline

• Study Start: 2013-08-16
• Study First Submitted: 2013-09-13
• Study First Submitted QC: 2013-09-13
• Study First Posted: 2013-09-18
• Primary Completion: 2019-09-15
• Study Completion: 2019-09-15
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 244

Inclusion Criteria

• Pregnant women will be enrolled in the registry prospectively (after exposure to Quadrivalent Influenza Vaccine (QIV) but before the conduct of any prenatal tests that could provide knowledge of the outcome of pregnancy). If the condition of the fetus has already been assessed through prenatal testing (e.g., targeted ultrasound, amniocentesis, etc.), such reports will be considered retrospective reports. Retrospective reports are also eligible for the registry but they will be analyzed separately from prospective reports.

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnancy Cases	Quadrivalent Influenza Vaccine (QIV)	Pregnant women exposed to Sanofi Pasteur's Quadrivalent Influenza Vaccine (QIV)

Primary Outcome Measures

Name	Time	Method
Number of cases and outcomes of pregnancies following exposure to QIV vaccine	Up to six years	Data will be summarized using descriptive statistical methods and stratified by pregnancy outcome (spontaneous abortion, elective termination, fetal death/stillbirth, live birth) and timing of vaccine exposure. Infant outcomes include birth defects and physical and social development.