Safety and Immunogenicity Study of Intramuscular CCS/C-adjuvanted Influenza Vaccine in Elderly

A Phase II Safety and Immunogenicity Study of Intramuscular CCS/C-adjuvanted Influenza Vaccine in Elderly, a Double-blind Randomized, Controlled Single Center Study

To examine the safety and immunogenicity of two formulation of liposomal adjuvant / delivery system (VaxiSomeTM=CCS-Cholesterol [CCS/C]), combined with commercial influenza vaccine in an elderly healthy population when given once intramuscularly (IM).

Inclusion Criteria:

• 65 years of age or older, mentally competent, willing and able to give written informed consent prior to study entry, male or female;
• able to comply with all the study requirements;
• in stable good health as determined by medical history; physical examination; clinical judgment of the investigator.
• Have adequate renal function (renal clearance of at > 30ml/min)
• Have normal liver function (hepatic transaminases [ALT and AST] < 43 U/L)
• Have hemoglobin > 11.5 g/L

Exclusion Criteria:

• Any serious chronic or acute disease (in the judgment of the investigator) including but not limited to: cancer, except for localized skin cancer;
• Advanced congestive heart failure; Acute exacerbation of Chronic obstructive pulmonary disease (COPD); Autoimmune disease, Acute or progressive hepatic disease; Acute or progressive renal disease with a renal clearance of at < 30ml/min ; Severe neurological or psychiatric disorder; History of Guillain Barré syndrome; Severe asthma.
• Clinically significant symptoms of neurological disease; untreated hypertension; increased liver enzymes.
• History of any anaphylactic reaction and/or serious allergic reaction following a vaccination