Text Size

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
History of Changes
  Purpose

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).


Condition Intervention Phase
Influenza
 Drug: CCS/C
Biological: Influenza Vaccine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by NasVax Ltd:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 130
Study Start Date: October 2009
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control Biological: Influenza Vaccine
Influenza vaccine
Experimental: CCS/C (Adjuvant Formulation) Drug: CCS/C
Adjuvant to influenza vaccine

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00915187

Locations
Israel
Clinical Pharmacology Unit, Division of Medicine, Hadassah University Hospital
Jerusalem, Israel, 91120
Sponsors and Collaborators
NasVax Ltd
Investigators
Principal Investigator: Yoseph Caraco, MD Clinical Pharmacology Unit, Division of Medicine, Hadassah University Hospital Jerusalem, Israel
  More Information

No publications provided

Responsible Party: NasVax Ltd
ClinicalTrials.gov Identifier: NCT00915187     History of Changes
Other Study ID Numbers: NX09-4
Study First Received: June 3, 2009
Last Updated: October 18, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by NasVax Ltd:
Vaccination, influenza prevention

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 22, 2013