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Sanofi Pasteur Quadrivalent Influenza Vaccine (QIV) Pregnancy Registry

NCT01945424

CompletedN/A

Sponsor: Sanofi Pasteur, a Sanofi Company

Conditions: Pregnancy, Influenza

Interventions: Quadrivalent Influenza Vaccine (QIV)

Countries: United States

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria

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)

San Diego, California, United States
Albany, New York, United States
Columbus, Ohio, United States
Harrisburg, Pennsylvania, United States
Nashville, Tennessee, United States