A Post-Authorization Safety Study of Atrial Fibrillation Following Respiratory Syncytial Virus Vaccine (ABRYSVOTM) Among Older Adults in the Veterans Affairs Health System (C3671037)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000290
• EU PAS number:
  EUPAS1000000290
• Study ID:
  1000000290
• Official title and acronym:
  A Post-Authorization Safety Study of Atrial Fibrillation Following Respiratory Syncytial Virus Vaccine (ABRYSVOTM) Among Older Adults in the Veterans Affairs Health System (C3671037)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study will answer the research question: what are the incidence rates of atrial fibrillation and supraventricular arrhythmia, overall and in sub-cohorts of interest, among individuals vaccinated with ABRYSVO within the US Veterans Health Administration (VHA) system as compared to expected rates of those events?
• Study status:
  Planned

Research institutions and networks

Institutions

Pfizer

Analysis Group

Study timelines

Date when funding contract was signed

Planned: 02/06/2023

Actual: 02/06/2023

Study start date

Planned: 01/09/2024

Data analysis start date

Planned: 01/03/2027

Date of interim report, if expected

Planned: 30/06/2026

Date of final study report

Planned: 29/02/2028

Sources of funding

Pharmaceutical company and other private sector 

Study protocol

Initial protocol

C3671037_RSV VACCINE FINAL UPDATED PROTOCOL VERSION 1.0_29NOV2023.pdf

Updated protocol

C3671037_PROTOCOL- ADULT AFIB_V2.0_04DEC2024.pdf

Regulatory

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