Comparison of Routine IM Influenza Immunization and Administration by Jet-injector (Med-Jet H4™) in Healthy Young Adults
Condition: Needle Phobia
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      80 subjects (healthy adults) will be randomized to receive the seasonal flu vaccine either by
      needle & syringe or by the MIT needle-free injector (Med-Jet MIT H4™ & Disposable Cartridge).
      The study will be conducted after the normal flu season has passed (ie: March-April). Half of
      those randomized to standard vaccination (n=20) will receive vaccine drawn from a multi-dose
      vial while the other half (n=20) will receive vaccine drawn from a single use vial. The same
      vaccine as the multi-dose vial will be delivered to the other half of the subjects (n=40)
      using the MIT injector. How long it takes to prepare and deliver the vaccines will be
      assessed (a time-motion study). Subject acceptance before and after injection will be
      assessed as well as local and systemic side effects. Standard serologic measures of immune
      response to flu vaccination (ie: antibodies) will determine whether the Med-Jet H4 injector
      induces the same kind of immune response as needle & syringe delivery.
    

Detailed description: 
      Eighty healthy adults (18-49 years of age) will be randomized 1:1 to receive:

        -  A single dose of trivalent inactivated influenza vaccine (TIV: Fluviral™: 0.5mL IM)

             -  Half will receive the vaccine using a pre-filled syringe

             -  Half will receive the vaccine using a multi-dose vial

        -  Or,the same vaccine delivered IM using the Medical International Technologies Inc. (MIT)
           compressed air vaccine delivery system (Med-Jet MIT H4 & Disposable Cartridge).

      Primary study outcomes will be i) safety (local and systemic reactions) followed for 21 days
      and ii) immunogenicity at 21 days using the standard serologic assays (eg: hemaggultination
      inhibition (HI) and microneutralization (MN)).

      Secondary outcomes will be time-motion analyses of vaccine preparation and administration to
      assess possible time-saving associated with Med-Jet H4 delivery.

      Although full blinding of the study is not possible give the very different vaccine delivery
      methods, all safety assessments and immunological parameters will be collected by
      nurses/technicians blinded to group assignment (ie: observer blind).
    

Intervention name(s): Fluviral influenza vaccine
Intervention type(s): Biological
Intervention description(s): Influenza vaccine (Fluviral) given via Med-Jet H4 or IM injection
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Eighty healthy adults (18-49 years of age) will be randomized 1:1 to receive:
A single dose of trivalent inactivated influenza vaccine (TIV: Fluviral™: 0.5mL IM)
Half will receive the vaccine using a pre-filled syringe
Half will receive the vaccine using a multi-dose vial
Or,the same vaccine delivered IM using the Medical International Technologies Inc. (MIT) compressed air vaccine delivery system (Med-Jet H4).
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: jet injector; influenza vaccine; immune response