A post-marketing active surveillance study to evaluate the risk of Guillain-Barré syndrome, acute disseminated encephalomyelitis, and atrial fibrillation in adults 50 years and older vaccinated with GSK’s Arexvy vaccine in the United States

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000486
• EU PAS number:
  EUPAS1000000486
• Study ID:
  1000000486
• Official title and acronym:
  A post-marketing active surveillance study to evaluate the risk of Guillain-Barré syndrome, acute disseminated encephalomyelitis, and atrial fibrillation in adults 50 years and older vaccinated with GSK’s Arexvy vaccine in the United States
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study status:
  Planned

Research institutions and networks

Institutions

GlaxoSmithKline Biologicals SA

Harvard Pilgrim Health Care Institute

Networks

CVS Health, Carelon Research, HealthPartners, Humana, Point32Health

Study timelines

Date when funding contract was signed

Planned: 22/05/2023

Actual: 22/05/2023

Study start date

Planned: 15/03/2025

Date of final study report

Planned: 31/10/2031

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

GlaxoSmithKline Biologicals SA

Study protocol

Initial protocol

Protocol Amendment 2 Anonymised 24 Jan 2025.pdf

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only