A Study to Learn About the Safety of PENBRAYA During Pregnancy

Conditions

• Meningococcal Disease

Eligibility Criteria

Sex

FEMALE

Age

10 Years - 25 Years

Healthy Volunteers

Accepted

Interventions

• PENBRAYA — BIOLOGICAL
  Pregnant participants who are exposed to PENBRAYA at any time during pregnancy or within 30 days prior to last menstrual period

Study Details

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.

Key Dates

First listed

Aug 17, 2026

Start date

May 3, 2024

Status verified

Aug 2026

Primary completion

Apr 30, 2032

Completion

Apr 30, 2032

Study Design

Enrollment

50 participants (estimated)

Arms

• Arm: Pregnant participants exposed to PENBRAYA during pregnancy
  Pregnant participants who are exposed to PENBRAYA at any time during pregnancy or within 30 days prior to last menstrual period

Primary Outcome Measure

Percentage of Major congenital malformations [ Time Frame: Enrollment until 12 months after delivery ]

Central Contacts

• Pfizer CT.gov Call Center
  1-800-718-1021
  [email protected]

Locations (1)

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