Flulaval Adverse Reaction Children

Study Design

FLULAVAL QUADRIVALENT was studied in a randomized, double-blind, active-controlled immunogenicity and safety trial. Subjects aged 3 through 17 years received FLULAVAL QUADRIVALENT (n=932) or 1 of 2 formulations of a comparator trivalent influenza vaccine (FLUARIX TIV-1 (n=929) or TIV-2 (n=932)), 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. Solicited local and systemic adverse reactions were collected for 7 days (day of vaccination and the next 6 days).1