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Sanofi Pasteur Quadrivalent Intradermal Influenza Vaccine Pregnancy Registry
Sanofi Pasteur Quadrivalent Intradermal Influenza Vaccine Pregnancy Registry

NCT02554409

CompletedN/A

Sponsor: Sanofi Pasteur, a Sanofi Company

Conditions: Pregnancy, Influenza

Interventions: Quadrivalent Intradermal Influenza Vaccine (QIV)

Countries: United States

The Sanofi Pasteur Fluzone Intradermal Quadrivalent vaccine (Fluzone QIV-ID) Pregnancy Registry will be a prospectively recruited pregnancy surveillance program designed to collect to collect and analyze information on vaccine exposures, pregnancy outcomes, and fetal and offspring outcomes on pregnant women exposed to Fluzone QIV-ID vaccine.

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 a product 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
  • Miami, Florida, United States
  • Albany, New York, United States
  • Philadelphia, Pennsylvania, United States
  • Nashville, Tennessee, United States