A Pilot Study to Evaluate the Safety and Immunogenicity of Low Dose Flu Vaccines (NANOVAX)
Primary Purpose
Influenza, Human
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Flu Vaccine (FLUARIX®)
Sponsored by
About this trial
This is an interventional prevention trial for Influenza, Human
Eligibility Criteria
Inclusion Criteria:
- Signed an Informed Consent
- No previous immune-related disease
Important Exclusion Criteria:
- Significant illness within the previous 4 weeks
- Subjects who have received an influenza vaccine within the previous 6 months
- An active viral diseases
- Pregnant or nursing women
- Any known contraindication to the study vaccine or vaccine ingredients
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
Arm Description
Low dose flu vaccine delivered intradermally using microneedles
Medium dose flu vaccine delivered intradermally using microneedles
Standard dose flu vaccine delivered intramuscularly with a regular needle
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00558649
Brief Title
A Pilot Study to Evaluate the Safety and Immunogenicity of Low Dose Flu Vaccines
Acronym
NANOVAX
Official Title
A Pilot, Controlled, Comparative and Single Blinded Study to Evaluate the Safety and Immunogenicity of Low Dose Flu Vaccines Administered Intradermally Using Microneedle Injectors as Compared With Standard Dose Intramuscular Flu Vaccines as Reference.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NanoPass Technologies Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether low dose flu vaccines delivered with microneedles into the skin (intradermally) are effective.
Detailed Description
Influenza vaccination is the primary method for preventing influenza and its severe complications. Previous clinical studies demonstrated that delivery of vaccines intradermally (into the skin) can achieve good efficacy even with lower doses of the vaccine.
Comparison: Low dose flu vaccine delivered intradermally with a microneedle device compared to the standard dose flu vaccine delivered intramuscularly (into the muscle) with a regular needle.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Low dose flu vaccine delivered intradermally using microneedles
Arm Title
2
Arm Type
Experimental
Arm Description
Medium dose flu vaccine delivered intradermally using microneedles
Arm Title
3
Arm Type
Active Comparator
Arm Description
Standard dose flu vaccine delivered intramuscularly with a regular needle
Intervention Type
Biological
Intervention Name(s)
Flu Vaccine (FLUARIX®)
Intervention Description
Influenza Virus Vaccine, FLUARIX®, 2006-2007 Formula
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Signed an Informed Consent
No previous immune-related disease
Important Exclusion Criteria:
Significant illness within the previous 4 weeks
Subjects who have received an influenza vaccine within the previous 6 months
An active viral diseases
Pregnant or nursing women
Any known contraindication to the study vaccine or vaccine ingredients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Van Damme, MD, PhD
Organizational Affiliation
Center for the Evaluation of Vaccination, University of Antwerp
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study to Evaluate the Safety and Immunogenicity of Low Dose Flu Vaccines
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