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

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ClinicalTrials.gov Identifier: NCT00915187
Recruitment Status : Completed
First Posted : June 5, 2009
Last Update Posted : October 19, 2011
Sponsor:
Information provided by (Responsible Party):
NasVax Ltd

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 healthy population when given once intramuscularly (IM).

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Active Comparator: Control Biological: Influenza Vaccine
Influenza vaccine

Experimental: CCS/C (Adjuvant Formulation) Drug: CCS/C
Adjuvant to influenza vaccine




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: NasVax Ltd
ClinicalTrials.gov Identifier: NCT00915187     History of Changes
Other Study ID Numbers: NX09-4
First Posted: June 5, 2009    Key Record Dates
Last Update Posted: October 19, 2011
Last Verified: October 2011

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
Vaccines
Immunologic Factors
Physiological Effects of Drugs