What is required to be eligible to participate?

• The patient must be at least 18 years of age.
• The patient must currently be pregnant, or have already delivered, and the infant has been diagnosed with a birth defect.
• The patient must have received a dose of the hepatitis B vaccine HEPLISAV-B within 28 days prior to conception or during their pregnancy. Patients will not be vaccinated as part of the study.
• The patient must agree to provide personal and healthcare provider contact information and consent for release of medical information for them and their infant. Once enrolled we will collect all necessary information from you and the infant’s respective healthcare providers.

How can I help my patients join the HEPLISAV-B Pregnancy Registry?

Doctors or healthcare providers should encourage their patients to enroll in the pregnancy registry. To assist your patients in joining, simply provide them with the following:

• The registry website address: heplisavbpregnancyregistry.com
• The registry toll-free telephone number: 1-844-443-7734 or toll-free fax: 1-877-202-3940
• The registry email address: heplisavbpregnancyregistry@ppdi.com
• Advise your patients to submit the Participant Consent to Contact Card
• In addition, you may contact the Registry to enroll a patient as a de-identified/anonymous report

Once a patient is consented….

• We will request that you provide information that is routinely collected in the course of usual care.
• Maternal healthcare providers will be contacted at registration, at the end of the 2nd trimester and at pregnancy outcome.
• Pediatric healthcare providers will be contacted when the infant is 12 months of age.

How can I learn about HEPLISAV-B and the Registry data collected to date?

• The Registry will produce annual summary reports which can be accessed by contacting the Registry Coordinating Center at heplisavbpregnancyregistry@ppdi.com
• Prescribing information can be found at www.HEPLISAV-B.com