Safety and Immunogenicity of a Surface Antigen, Inactivated, Adjuvanted With MF59C.1, Seasonal Influenza Vaccine, Formulation 2009-2010

A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of FLUAD® Surface Antigen, Inactivated, Adjuvanted With MF59C.1 Influenza Vaccine, Formulation 2009-2010, When Administered to Elderly Subjects

This is a trial for annual registration of the updated seasonal influenza vaccine formulation.

Key Inclusion Criteria:

• Subjects of 65 years of age or older
• Mentally competent
• Willing and able to give written informed consent prior to study entry
• Able to comply with all the study requirements
• In general good health

Key Exclusion Criteria:

• Any serious chronic or acute disease disease
• History of any anaphylactic reaction and/or serious allergic reaction following a vaccination
• A proven hypersensitivity to any component of the study vaccine
• Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age)
• Bleeding diathesis or conditions associated with prolonged bleeding time that in the investigator's opinion would interfere with the safety of the subject
• Within the past 12 months, participants had received more than one injection of influenza vaccine
• Within the past 6 months, participants had laboratory confirmed influenza disease or received influenza vaccine