A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine

A Phase IV, Randomized, Observer-Blind, Multi-Center, Non Inferiority Comparison of the Immune Response of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Inactivated Split-Virion Influenza Vaccine in Adults Aged Greater Than or Equal to 65 Years

The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US Licensed Comparator Influenza Virus Vaccine.

Inclusion Criteria:

1. Males aged ≥ 65 years or females of non-childbearing potential aged ≥ 65 years ;
2. Written informed consent ;
3. Willingness to provide a blood sample.

Exclusion Criteria:

1. Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccines;
2. Previous vaccination against influenza in 2008 or 2009 with seasonal trivalent inactivated influenza vaccine;
3. Known history of Guillain-Barré Syndrome;
4. Clinical signs of active infection and/or an oral temperature of greater than or equal to 100 degrees F (37.8 degrees C).
5. Have active or recent and clinically significant gastrointestinal/hepatic, renal, neurological, cardiovascular, respiratory, endocrine disorders or other medical disorders;
6. History of seizures;
7. Confirmed or suspected immunosuppressive condition, or a previously diagnosed immunodeficiency disorder;
8. Clinically significant history of malignancy
9. Current treatment, or treatment with radiotherapy or cytotoxic drugs at any time during the six months prior to administration of the Study Vaccine;
10. Current immunosuppressive or immunomodulative therapy;
11. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the Study Vaccine;
12. Participation in a clinical trial or use of an investigational compound within 30 days prior to receiving the Study Vaccine ;
13. Vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to receiving the Study Vaccine.
14. Current treatment with warfarin or other anticoagulants;
15. Major congenital defects;
16. Evidence, or history (within the previous 12 months) of drug or alcohol abuse;
17. Unwillingness or inability to comply with the study protocol including completion of adverse event diary cards;
18. History of psychiatric disorders;
19. Resident of long term care facility.