Comparison of alpha-spending plans for near real-time monitoring for Guillain-Barre Syndrome after influenza vaccination during the 2010/11 influenza season

摘要

Background: Near real-time surveillance of the influenza vaccine, which is administered to a large proportion of the US population every year, is essential to enscure safety of the vaccine. For efficient near real-time surveillance, it is key to select appropriate parameters such as monitoring start date, number of interim tests and a scheme for spending a pre-defined total alpha across the entire influenza season. Guillain-Barre Syndrome, shown to be associated with the 1976 influenza vaccine, is used to evaluate how choices of these parameters can affect whether or not a signal is detected and the time to signal. FDA has been monitoring for the risk of GBS after influenza vaccination for every influenza season since 2008.