Fluarix Solicited Adverse Reaction 5

Study Design

FLUARIX QUADRIVALENT was studied in a randomized, double-blind (2 arms) and open-label (1 arm), active-controlled, immunogenicity and safety trial. Subjects aged 18 years and older received FLUARIX QUADRIVALENT (n=3036) or 1 of 2 formulations of a comparator trivalent influenza vaccine (TIV) (FLUARIX TIV-1, n=1010 or TIV-2, n=610), 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