Sanofi Pasteur Pregnancy Registries

Flublok quadrivalent Vaccine

The Flublok quadrivalent Pregnancy Registry utilizes passive surveillance to monitor pregnancy exposures to Flublok quadrivalent. All pregnant women who received the Flublok quadrivalent vaccine during pregnancy or within the 30 days following their last menstrual period are eligible for inclusion. The objective of the Flublok quadrivalent pregnancy registry is to monitor and evaluate all submitted reports of vaccine exposure during pregnancy, as well as maternal, obstetrical, pregnancy, neonatal and infant outcomes. Enrollment in the Flublok quadrivalent pregnancy registry should occur as soon as possible following the vaccination, and ideally prior to any pre-natal testing. After enrollment, the Pregnancy Exposure Data Collection form is used to collect information on the reporter, relevant parent medical history, vaccine exposure as well as information about the pregnancy. A request for follow-up information will be sent to the initial reporter after the estimated date of delivery, as necessary. The decision to participate in the registry or to disclose follow-up information is completely voluntary and can be terminated at any time. All information is kept strictly confidential. As per reporting guidelines, anonymized pregnancy exposures will be reported to the US FDA and other health authorities where the vaccine is licensed. The release of medical records and permission to contact the pregnant women health care professional may be sought but is optional and not a requirement for participation in the registry.

We encourage all pregnancy exposures to be reported to the Flublok quadrivalent Pregnancy Registry. There are multiple ways to enroll:

  • Phone 1-800-VACCINE (1-800-822-2463)
  • Email the Pregnancy Exposure Data Collection Form to USPVmailbox@sanofi.com
  • Forms:

  • Pregnancy Exposure Data Collection Form - Download
  • Sanofi Pasteur does not recommend the use of Flublok quadrivalent vaccine in any manner other than that described in the package insert. Please review the full prescribing information before administering Flublok quadrivalent vaccine.

    Flublok quadrivalent Vaccine Prescribing Information

     
     
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    This page last updated: 03-Mar-2021