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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NasVax Ltd
ClinicalTrials.gov Identifier:
NCT00915187
First received: June 3, 2009
Last updated: October 18, 2011
Last verified: October 2011

June 3, 2009
October 18, 2011
October 2009
December 2009   (final data collection date for primary outcome measure)
Immunogenicity will be evaluated according to the CHMP criteria for evaluation of flu vaccines, i.e., Seroprotection, Geometric Mean Ratios, and Seroconversion rate [ Time Frame: Day 28 following vaccination ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00915187 on ClinicalTrials.gov Archive Site
Immunogenicity will be evaluated according to the CHMP criteria for evaluation of flu vaccines, i.e., Seroprotection, Geometric Mean Ratios, and Seroconversion rate [ Time Frame: Day 90 following vaccination ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Influenza
  • Drug: CCS/C
    Adjuvant to influenza vaccine
  • Biological: Influenza Vaccine
    Influenza vaccine
  • Active Comparator: Control
    Intervention: Biological: Influenza Vaccine
  • Experimental: CCS/C (Adjuvant Formulation)
    Intervention: Drug: CCS/C
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
February 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00915187
NX09-4
Yes
NasVax Ltd
NasVax Ltd
Not Provided
Principal Investigator: Yoseph Caraco, MD Clinical Pharmacology Unit, Division of Medicine, Hadassah University Hospital Jerusalem, Israel
NasVax Ltd
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP