Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry

N/ACompletedNCT01945424

Sanofi Pasteur, a Sanofi Company244 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

244

Conditions

Pregnancy Influenza

Interventions

Quadrivalent Influenza Vaccine (QIV)BIOLOGICAL

No Intervention as part of this protocol

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (5)

Unnamed facility

San Diego, California, United States

Unnamed facility

Albany, New York, United States

Unnamed facility

Columbus, Ohio, United States

Unnamed facility

Harrisburg, Pennsylvania, United States

Unnamed facility

Outcomes

Primary Outcomes

Number of cases and outcomes of pregnancies following exposure to QIV vaccine

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.

Time frame: Up to six years

Data from ClinicalTrials.gov

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