Passive enhanced safety surveillance of GSK’s quadrivalent seasonal influenza vaccine in Belgium Germany and Spain an observational study: protocol for the 2018/2019 influenza season

摘要

IntroductionThe European Medicines Agency requires Marketing Authorisation Holders providing seasonal influenza vaccines in Europe to conduct enhanced safety surveillance accounting for the different age groups based on the vaccine indication, in order to detect any potential increase of local and systemic adverse reactions early in an influenza season. To comply with this requirement, a multicountry European passive enhanced safety surveillance study has been set up to capture and assess adverse events occurring within 7 days following seasonal influenza vaccination. Here we share our surveillance protocol for the 2018/2019 influenza season.