Protocol

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

March 6, 2025
Authors:

Harvard Pilgrim Health Care Institute, CVS Health, Carelon Research, Humana HealthCare, HealthPartners Institute, GlaxoSmithKline

Capability:
Validation Studies & Algorithm Development
Multi-Site Methods & Coordination
Expertise:
Regulatory Research & Support
RWE Research & Consulting
View the public protocol

GlaxoSmithKline Biologicals SA, Harvard Pilgrim Health Care Institute,CVS Health, Carelon Research, HealthPartners, Humana, Point32Health. 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 (220149) (EUPAS1000000486). Amsterdam: European Medicines Agency (EMA); 2025 Mar 6. Available from: https://catalogues.ema.europa.eu/node/4387/administrative-details