Fluarix Solicited Adverse Reaction 1

Study Design

FLUARIX QUADRIVALENT was studied in a randomized, observer-blind, non-influenza vaccine-controlled efficacy, immunogenicity, and safety trial. The trial included subjects aged 6 through 35 months who received 1 or 2 doses of FLUARIX QUADRIVALENT 0.5 mL (n=6006) or a non-influenza control vaccine (n=6012). Solicited local adverse reactions and systemic adverse events were collected for 7 days (day of vaccination and the next 6 days).1