Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry

Sanofi

Status: Completed

Conditions: Influenza; Pregnancy

Treatments: Biological: Quadrivalent Influenza Vaccine (QIV)

Study type: Observational

Funder types: Industry

Identifiers

NCT01945424

QIV08

U1111-1143-8433 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 244 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

244 participants in 1 patient group

Pregnancy Cases

Description:

Pregnant women exposed to Sanofi Pasteur's Quadrivalent Influenza Vaccine (QIV)

Treatment:

Biological: Quadrivalent Influenza Vaccine (QIV)