A Pregnancy Registry Study to Evaluate the Safety of PENBRAYA™ Meningococcal Vaccine Exposure During Pregnancy

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000078
• EU PAS number:
  EUPAS1000000078
• Study ID:
  1000000078
• Official title and acronym:
  A Pregnancy Registry Study to Evaluate the Safety of PENBRAYA™ Meningococcal Vaccine Exposure During Pregnancy
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  PENBRAYA (Neisseria meningitidis Groups A, B, C, W, and Y Vaccine; MenABCWY) is a pentavalent meningococcal vaccine composed of 2 licensed meningococcal vaccines: Trumenba® (N meningitidis serogroup B bivalent recombinant lipoprotein 2086 vaccine [bivalent rLP2086, also referred to as MenB-fHbp]) and Nimenrix® (meningococcal polysaccharide groups A, C, W, and Y tetanus toxoid conjugate vaccine [MenACWY-TT]).; ; On 20 October 2023, the United States (US) Food and Drug Administration (FDA) approved PENBRAYA for the prevention of meningococcal disease caused by meningococcal groups A, B, C, W, and Y in adolescents and young adults 10 through 25 years of age. As part of the PENBRAYA pharmacovigilance plan and in fulfillment of a post-marketing commitment (PMC) requested by the Center for Biologics Evaluation and Research (CBER), this noninterventional study (NIS) is being conducted to evaluate the safety of PENBRAYA exposure during pregnancy in a real-world setting. ; ; The research question is: What is the risk of maternal, neonatal, or infant safety outcomes; among individuals exposed to PENBRAYA during pregnancy?; ; The specific objective is: To estimate the proportion of major congenital malformation (MCM), spontaneous abortion (SAB), elective termination, stillbirth, preterm birth, and small for gestational age (SGA) among individuals exposed to PENBRAYA during pregnancy or within 30 days prior to last menstrual period (LMP).
• Study status:
  Planned

Research institution and networks

Institutions

Pfizer

Pharmaceutical Product Development (PPD)

Study timelines

Date when funding contract was signed

Planned: 28/12/2023

Actual: 28/12/2023

Study start date

Planned: 30/04/2024

Date of interim report, if expected

Planned: 30/04/2025

Date of final study report

Planned: 30/04/2033

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer 100%

Study protocol

Initial protocol

C3511007_PROTOCOL_v1_24JAN2024.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

C3511007