BEXSERO^® Pregnancy Registry

BEXSERO^® pregnancy registry is established to evaluate the safety of BEXSERO when it is used during pregnancy. The registry will prospectively collect information on pregnant women who have been immunized with BEXSERO within 30 days prior to their last menstrual period or at any time during pregnancy. The objective of the BEXSERO Pregnancy Registry is to evaluate the outcomes of pregnancy, including major congenital malformation, preterm birth, and low birth weight. Other pregnancy outcomes will be also be collected, including spontaneous abortions and stillbirths. This registry will not involve any special intervention or treatment and is strictly observational. Routine care will continue unchanged and the schedule of office visits and all treatment regimens will be determined by the treating health care provider (HCP).

The registry has multiple enrolment channels. An Eligible pregnant woman may self-enroll at any time during their pregnancy or, with their consent, their HCP may enroll them on their behalf. In addition, health maintenance organizations can report de-identified data on pregnancy exposures and outcomes. Information will be collected about the general health status of the pregnant woman and her baby during pregnancy and at delivery.

Eligibility Criteria:

The registry population includes pregnant women within the United States (US) who were immunized with the BEXSERO vaccine within 30 days prior to their last menstrual period (LMP) or at any time during pregnancy.

The minimum criteria required for enrollment into the registry are as follows:

• Sufficient evidence to confirm that BEXSERO exposure occurred within 30 days prior to their last menstrual period (LMP) or at any time during pregnancy
• Sufficient information to determine whether the pregnancy is prospectively or retrospectively registered (i.e., whether the outcome of pregnancy was known at the time of first contact with the registry)
• Date the pregnancy exposure is registered
• Full reporter (i.e., HCP) contact information to allow for follow-up (name, address, etc.)

For more information please contact PPD via the information below:

Enrollment:

Estimated Enrollment: 50
Study Start Date: 31 Jan 2016
Estimated Primary Completion Date: 01 Dec 2019
Estimated Completion Date:31 May 2020

Additional resources:

• Interim reports for Bexsero Pregnancy Registry (if available): Not applicable


• Contacts Form for Bexsero Pregnancy Registry (PDF format)


• Patient Registration Form for Bexsero Pregnancy Registry (PDF format)


• Link to prescribing information for Bexsero Pregnancy Registry


• Brochure for Bexsero Pregnancy Registry (PDF Format)