The NIH-supported clinical trial that led to U.S. licensure enrolled 1,357 volunteers at nine clinical sites in the U.S. in a pivotal, Phase III, randomized, double-blind, placebo-controlled study. The study evaluated the safety, tolerability and immunogenicity of thimerosal-free and thimerosal-containing formulations of influenza vaccine in healthy adults aged 18 to < 65 years.

Important Safety Information

Afluria is indicated for active immunization of persons age 18 years and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. The indication is based on the immune response elicited by Afluria; no controlled clinical studies have demonstrated a decrease in influenza disease after vaccination with Afluria.

Afluria should not be administered to individuals with hypersensitivity to eggs or chicken protein or other components of Afluria, and in anyone who has had a life-threatening reaction to previous influenza vaccination. The most common injection-site adverse reactions were tenderness, pain, redness and swelling. The most common systemic adverse reactions were headache, malaise and muscle aches. Vaccination with Afluria may not protect all individuals. Immunocompromised persons may have a diminished immune response. If Guillain-Barr?— syndrome has occurred within six weeks of receipt of prior influenza vaccine, the decision to give Afluria should be based on careful consideration of the potential benefits and risks. Full prescribing information on Afluria can be found at www.Afluria.

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