Safety and Immunogenicity of MF59C.1 Adjuvanted Trivalent Subunit Influenza Vaccine in Elderly Subjects

Exclusion Criteria

• •1. Individuals with behavioral or cognitive impairment or a psychiatric condition or with a history of any illness that,in the opinion of the investigator, would have interfered with the subject's ability to participate in the study.
• •2. Individuals who were not able to comprehend and/or follow all required study procedures for the whole period of the study.
• •3. Known or suspected impairment/alteration of immune function.
• •4. Individuals with a known bleeding diathesis.
• •5. History of Guillain-Barré syndrome.
• •6. Individuals with history of allergy to vaccine components and/or a history of any anaphylaxis, serious vaccine reactions or hypersensitivity to influenza viral proteins, egg proteins (including ovalbumin), polymyxin, neomycin, betapropiolactone, thimerosal/ sodium ethylmercurothiosalicylate/ mercury and nonylphenolethoxylate/ nonoxynol-9 (spermicide).
• •7. Receipt of another investigational agent within 30 days prior to enrollment in the study or before completion of the safety follow-up period in another study.
• •8. Individuals who had received any other vaccines within 2 weeks for inactivated vaccines or 4 weeks for live vaccines prior to enrollment in this study or who had planned to receive any vaccine within 3 weeks from the study vaccine.
• •9. Individuals who had received vaccination against seasonal influenza in the previous 6 months.
• •10. Individuals with oral temperature ≥38.0°C (≥100.4°F) on day of study vaccination.
• •11. Individuals with history of substance or alcohol abuse within the past 2 years.
• •12. Individuals providing consent who did not consent to the retention of their serum samples after study completion.
• •13. Elective surgery or hospitalization planned to occur during the treatment phase or during the follow-up phase that, according to the opinion of the investigator, might have poses additional risk to the subject.
• •14. Subjects from whom blood could not be drawn at visit 1.