Long-term clinical trial safety experience with the inactivated split influenza vaccine, Vaxigrip®

Safety data on the inactivated split influenza vaccine, Vaxigrip®, were compiled and analysed from 28 clinical trials (total: 4599 subjects aged 6 months to 99 years) to provide a robust estimate of the reactogenicity profile. The most frequent solicited reactions were non-severe injection site pain and erythema in children, adults, and elderly. Mild or moderate fever was the most frequent reaction in 6–36 months olds; few systemic reactions were reported in older groups. Reactogenicity was comparable in healthy and high-risk children. The long-term experience with the world's most widely used influenza vaccine, Vaxigrip®, confirms its excellent tolerability, and supports its continued use in clinical practice worldwide.