Brand-Specific Enhanced Safety Surveillance of GSK's Quadrivalent Seasonal Influenza Vaccine in Belgium, Germany and Spain for the 2018/2019 Season.

ABSTRACT: INTRODUCTION:Seasonal influenza causes numerous deaths worldwide each year. Annual vaccination for disease prevention is crucial. Seasonal vaccines are updated each year to closely match circulating strains. OBJECTIVE:To comply with European Medicines Agency (EMA) guidance, an enhanced safety study was conducted to rapidly collect and assess adverse events (AEs) within 7 days following vaccination with GSK's inactivated quadrivalent seasonal influenza vaccine (IIV4) in 2018/2019. METHODS:A customised AE reporting card (AERC) and standardised electronic data reporting application were used in Belgium, Germany and Spain in adult and paediatric subjects in this study. RESULTS:In 2018, 1060 subjects vaccinated with one dose of GSK's IIV4 were enrolled (all subjects in Belgium and Germany were

SUBMITTER: Dos Santos G 

PROVIDER: S-EPMC7048703 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature