Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Adult and Elderly Subjects

A Phase III, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Adult and Elderly Subjects

This study is designed to evaluate the immunogenicity, safety and tolerability of 2 doses of FLUAD-H5N1 vaccine compared to 2 doses of trivalent, interpandemic FLUAD, each administered 3 weeks apart.

Inclusion Criteria:

• Healthy Subjects 18 years of age who signed the informed consent

Exclusion Criteria:

• Receipt of another investigational agent within 4 weeks
• Receipt of influenza vaccination for current season 2006/2007.
• any acute disease or infection, history of neurological symptoms or signs, known or suspected impairment of immune function, any serious disease, bleeding diathesis
• fever (defined as axillary temperature ³38.0°C) within 3 days (prior to Visit 1)
• Pregnant or breastfeeding or females of childbearing potential who refuse to use an acceptable method of birth control
• Surgery planned during the study period
• Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine
• Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination
• History of (or current) drug or alcohol abuse
• Any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.