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

NasVax

Status and phase

Completed

Phase 2

Conditions

Influenza

Treatments

Biological: Influenza Vaccine

Drug: CCS/C

Study type

Interventional

Funder types

Industry

Identifiers

NCT00915187

NX09-4

Details and patient eligibility

About

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).

Enrollment

130 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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