Safety monitoring of GSK's quadrivalent seasonal influenza vaccine in European countries during the 2023/24 flu season: A multicenter, non-interventional study.

ABSTRACT: Influenza significantly impacts global health, particularly vulnerable populations like the elderly and those with chronic conditions. This study evaluated the safety of GlaxoSmithKline (GSK)'s quadrivalent seasonal influenza vaccine (IIV4) during the 2023/24 influenza season in Belgium, Germany, and Spain, per the European Medicines Agency's enhanced safety surveillance guidelines. This prospective, multicenter, non-interventional study, conducted from October 2, 2023, to January 4, 2024, included adults from Belgium and both children and adults from Germany and Spain. Participants received GSK's IIV4 and completed an adverse drug reaction (ADR) questionnaire via an electronic patient-reported outcome portal. Adverse events (AEs) were categorized by severity and analyzed by age group and

SUBMITTER: Salamanca de la Cueva I 

PROVIDER: S-EPMC12542612 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature