- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00915187
Safety and Immunogenicity Study of Intramuscular CCS/C-adjuvanted Influenza Vaccine in Elderly
October 18, 2011 updated by: NasVax Ltd
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
130
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Jerusalem, Israel, 91120
- Clinical Pharmacology Unit, Division of Medicine, Hadassah University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
|
Influenza vaccine
|
Experimental: CCS/C (Adjuvant Formulation)
|
Adjuvant to influenza vaccine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Day 28 following vaccination
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Day 90 following vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yoseph Caraco, MD, Clinical Pharmacology Unit, Division of Medicine, Hadassah University Hospital Jerusalem, Israel
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
June 3, 2009
First Submitted That Met QC Criteria
June 3, 2009
First Posted (Estimate)
June 5, 2009
Study Record Updates
Last Update Posted (Estimate)
October 19, 2011
Last Update Submitted That Met QC Criteria
October 18, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NX09-4
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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