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
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: CSL Limited Influenza Virus Vaccine (Afluria®); US Licensed Influenza Virus Vaccine (Fluzone®)
Intervention description: A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.; A single 0.5 mL, intramuscular injection in the deltoid region of the arm on day 0.
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 1268.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility criteria:

        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.