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

Inclusion Criteria: * 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