Flulaval Non Inferior Children

Study Design

FLULAVAL QUADRIVALENT was studied in a randomized, double-blind, active-controlled trial. Subjects aged 3 through 17 years received FLULAVAL QUADRIVALENT or 1 of 2 formulations of a comparator trivalent influenza vaccine (FLUARIX TIV-1 or TIV-2), each containing an influenza type B virus that corresponded to one of the two B viruses in FLULAVAL QUADRIVALENT (a type B virus of the Victoria lineage or a type B virus of the Yamagata lineage). Children aged 3 through 8 years received 1 or 2 doses, depending on vaccination history. Children aged 9 years and older received 1 dose. Immune responses were evaluated in sera obtained 28 days following 1 or 2 doses of FLULAVAL QUADRIVALENT or the comparators.1