Status:
COMPLETED
Safety and Immunogenicity Study of Intramuscular CCS/C-adjuvanted Influenza Vaccine in Elderly
Lead Sponsor:
NasVax Ltd
Conditions:
Influenza
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
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 hea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00915187
Start Date
October 1 2009
End Date
February 1 2010
Last Update
October 19 2011
Active Locations (1)
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1
Clinical Pharmacology Unit, Division of Medicine, Hadassah University Hospital
Jerusalem, Israel, 91120