GSK Seasonal Influenza Vaccine Pregnancy Registry

FLUARIX (influenza virus vaccine)

FLUARIX QUADRIVALENT (influenza virus vaccine)

FLULAVAL Quadrivalent (influenza virus vaccine)

FLUARIX (influenza virus vaccine,not currently marketed in US)

FLULAVAL (influenza virus vaccine,not currently marketed in US) suspension

This is a registry for all four GSK seasonal influenza vaccines, as listed above, approved in the United States. To participate in this registry: Registration should take place as early in the pregnancy as possible and prior to any knowledge of the pregnancy outcome.However, Healthcare providers(HCPs) are encouraged to notify the registry staff of ongoing pregnancies where exposure to the vaccine has already occurred.

HCPs can enroll their patients by completing and sending the Enrollment Form available below

Among the forms on this website, we also include a Patient Informed Consent Form.HCPs are encouraged to review this form with their patient and have it signed at the time of enrollment so GSK can follow up on the health of the infant for up to a year after delivery.

The healthcare provider supervising the pregnancy can also report on the pregnancy course and delivery outcome by completing and sending the Pregnancy Outcome form included below.

All forms can be sent by mail or fax through the contact details listed below.

This information can also be provided by calling GlaxoSmithKline directly at 1-888-452-9622 (toll-free).

GlaxoSmithKline's Seasonal Influenza Vaccine Pregnancy Registry is managed at:

Seasonal Influenza Vaccine Pregnancy Registry
GlaxoSmithKline
Global Clinical Safety and Pharmacovigilance Mailstop 5.3461
PO Box 13398
Research Triangle Park, NC 27709-9627
Phone: 888-825-5249
Fax: 1-919-287-2902

Information collected at the time of registration includes date(s) of vaccine exposure, estimated date of delivery, and sufficient contact information to allow for follow-up of the subsequent pregnancy outcome. Measures are in place to protect patient confidentiality. If registration is initiated from a consumer, permission is requested to obtain confirmation and follow-up from their health care provider. Around the patientís estimated date of delivery and if not already provided, a follow-up form is sent to the healthcare provider supervising the pregnancy to report on the pregnancy course and outcome.

Forms:

Additional resources: