A Rapid Surveillance and Cohort Post-Marketing Safety Study to Evaluate the Safety of Respiratory Syncytial Virus Vaccine (ABRYSVO™) Exposure During Pregnancy in the United States (C3671027)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000115
• EU PAS number:
  EUPAS1000000115
• Study ID:
  1000000115
• Official title and acronym:
  A Rapid Surveillance and Cohort Post-Marketing Safety Study to Evaluate the Safety of Respiratory Syncytial Virus Vaccine (ABRYSVO™) Exposure During Pregnancy in the United States (C3671027)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The study will estimate the risk of adverse pregnancy, maternal, and neonatal/infant outcomes among individuals who are exposed to ABRYSVO (RSVpreF) between 32 0/7 through 36 6/7 weeks gestation during pregnancy.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Pfizer

Harvard Pilgrim Health Care Institute

Study timelines

Date when funding contract was signed

Planned: 15/09/2023

Actual: 15/09/2023

Study start date

Planned: 26/04/2024

Actual: 24/04/2024

Data analysis start date

Planned: 01/09/2028

Date of interim report, if expected

Planned: 31/08/2025

Date of final study report

Planned: 28/02/2029

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Study protocol

Initial protocol

C3671027_RSV VACCINE FINAL PROTOCOL V1.0_15MAR2024.pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

C3671027