Influenza Clinical Trial
Official title:
A Phase II Safety and Immunogenicity Study of Intramuscular CCS/C-adjuvanted Influenza Vaccine in Elderly, a Double-blind Randomized, Controlled Single Center Study
Verified date | October 2011 |
Source | NasVax Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ministry of Health |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 130 |
Est. completion date | February 2010 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Israel | Clinical Pharmacology Unit, Division of Medicine, Hadassah University Hospital | Jerusalem |
Lead Sponsor | Collaborator |
---|---|
NasVax Ltd |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Immunogenicity will be evaluated according to the CHMP criteria for evaluation of flu vaccines, i.e., Seroprotection, Geometric Mean Ratios, and Seroconversion rate | Day 28 following vaccination | No | |
Secondary | Immunogenicity will be evaluated according to the CHMP criteria for evaluation of flu vaccines, i.e., Seroprotection, Geometric Mean Ratios, and Seroconversion rate | Day 90 following vaccination | No |
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