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A Study to Learn About the Safety of PENBRAYA During Pregnancy

StatusRecruiting
PhaseNot specified
SponsorPfizer
Started2024-05-03
View on ClinicalTrials.gov ↗
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.
Trial Details
NCT Number NCT07768163
Lead Sponsor Pfizer
Conditions Meningococcal Disease
Enrollment 50 participants
Start Date 2024-05-03
Primary Completion 2032-04-30 (estimated)
Study Completion 2032-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-08-17