Trial | NCT00915187  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    130
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).
Study Started
Oct 31
2009
Primary Completion
Dec 31
2009
Study Completion
Feb 28
2010
Last Update
Oct 19
2011
Estimate

Drug CCS/C

Adjuvant to influenza vaccine

Biological Influenza Vaccine

Influenza vaccine

Control Active Comparator

CCS/C (Adjuvant Formulation) Experimental

Criteria 

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
No Results Posted