Fluarix Solicited Adverse Reaction 3

Study Design

FLUARIX QUADRIVALENT was studied in a randomized, double-blind, active-controlled trial. Subjects aged 3 through 17 years received 1 or 2 doses of FLUARIX QUADRIVALENT (n=915) or 1 of 2 formulations of a comparator trivalent influenza vaccine (TIV) (FLUARIX TIV-1, n=912 or TIV-2, n=911), each containing an influenza type B virus that corresponded to one of the 2 type B viruses in FLUARIX QUADRIVALENT (a type B virus of the Victoria lineage or a type B virus of the Yamagata lineage). Solicited local and systemic adverse events were collected for 7 days (day of vaccination and the next 6 days).1