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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
NanoPass Technologies Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza, Human

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    May 27, 2007
    Last Updated
    May 8, 2013
    Sponsor
    NanoPass Technologies Ltd
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    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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