Safety, Tolerability and Immunogenicity of Fluzone® With and Without JVRS-100 in Elderly Subjects

• Be adult volunteers aged ≥65 years
• Live in the community, independently or in an assisted living environment
• Be Class 1-5, as defined by the CSHA-CFS
• If female, will be post-menopausal
• Will be available for the duration of the trial (21-day On Study Period) and Follow-Up (4 and 9 months after vaccination)
• Be 'probably not demented' on the Mini-Cog test
• Provide informed consent
• Agree to defer receipt of vaccination of novel H1N1 (swine) influenza until after completion of the Day 28 study procedures

Exclusion Criteria:

• Known allergy to eggs or other components of the vaccine.
• History of severe reaction of any kind to conventional influenza vaccines
• Be Class 6-7 in the CSHA-CFS or be institutionalized (e.g., in a nursing home)
• Requiring nursing home-level equivalent care at home or within a community assisted living environment
• Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine.
• Significant cardiovascular disease (e.g., NYHA class 3 through 4 congestive heart failure; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty within the past 6 months; uncontrolled ventricular cardiac arrhythmias); resting heart rate >100;
• A history of chronic obstructive pulmonary disease or history of other lung disease requiring chronic steroid treatment in excess of a bioequivalent dose of 10 mg prednisone daily; a combined history of lung disease and anemia.
• Evidence of significant (more than 10 pounds) of unintentional weight loss in the last year.
• Changed residence or become hospitalized in the last 6 months.
• Combined history of depression and anemia.
• Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Use of any investigational product within 60 days preceding the administration of the study vaccine, or planned use during the study period.
• Seropositive to HIV or HCV or positive for HBsAg
• Body temperature >38.1°C (100.6°F) or acute illness within 3 days prior to vaccination (subject may be rescheduled)
• History of excessive alcohol consumption, drug abuse, or significant psychiatric illness.
• Be 'probably demented' on the Min-Cog test
• Need for guardian assistance in completing informed consent
• Has received vaccination for novel H1N1 (swine) influenza