A Study to Learn About the Safety of PENBRAYA During Pregnancy

A PREGNANCY REGISTRY STUDY TO EVALUATE THE SAFETY OF PENBRAYA™ MENINGOCOCCAL VACCINE EXPOSURE DURING PREGNANCY

This study is a pregnancy registry designed to learn more about the safety of the study vaccine PENBRAYA (a vaccine that protects against meningitis causing bacteria) when it is given during pregnancy or within 30 days before the last menstrual period (the first day of your last period). Because this vaccine has not been studied in pregnant individuals, the registry collects information on pregnancy outcomes and infant health during the first year of life.

People may join the registry if they:

• are pregnant now (or recently pregnant),
• are 10 to 25 years old, and
• received at least one dose of study vaccine during pregnancy or within 30 days before their last period.

The registry collects information from participants and their doctors at different times:

• at enrollment,
• around 27 weeks of pregnancy,
• at the end of pregnancy, and
• for infants, at 4 months and 12 months of age.

All the information is collected remotely (phone, online forms, email, fax, or mail) by a coordinating center. No new medical tests or office visits are required beyond routine care.

Inclusion

• Currently or recently pregnant (recently pregnant defined as enrollment within 1 year of pregnancy outcome)
• Received at least one dose of PENBRAYA during pregnancy or within 30 days prior to last menstrual period (LMP)
• Personally signed and dated informed consent document or, upon waiver of written consent by the relevant IRB/independent ethics committee, verbal consent, indicating that the individual (or a legally acceptable representative) has been informed of all pertinent aspects of the study
• Authorization for the enrolled participants' health care provider(s) (HCP[s]) to provide data to the registry
• Contact information (for participant and HCPs)

Exclusion

- None