Comparison of Routine IM Influenza Immunization and Administration by Jet-injector (Med-Jet H4™) in Healthy Young Adults

Study Overview
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Brief Summary
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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
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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).

Official Title
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Comparison of Routine IM Influenza Immunization and Administration by Jet-injector (Med-Jet MIT H4™ & Disposable Cartridge) in Healthy Young Adults

Conditions
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Needle Phobia

Intervention / Treatment
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* Biological: Fluviral influenza vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female adults 18 to 49 years of age body mass index (BMI) of ≥ 18 kg/m2 and ≤ 32 kg/m2 Must be accessible by phone on a consistent basis and be available for the D21 blood draw Exclusion Criteria: Any influenza vaccine during the 2016-2017 season significant acute or chronic, uncontrolled medical or neuropsychiatric illness confirmed or suspected immunosuppressive condition or immunodeficiency history of autoimmune disease, cancer, or treatment for cancer within 3 years of study vaccine administration Receipt of any investigational or non-registered product within 30 days prior to study enrolment receipt of systemic glucocorticoids at a dose exceeding 10 mg of prednisone per day, or equivalent, for more than 7 consecutive days or for 10 or more days in total within 1 month of vaccine administration any other cytotoxic or immunosuppressant drug or any globulin preparation within 3 months of vaccination blood transfusion within 90 days of study vaccination Although there is no known danger from influenza vaccination during pregnancy, pregnant women will be excluded since the efficacy of the Med-Jet delivery system is not yet known known drug or alcohol abuse will also be excluded. Temporary Contraindications Following the resolution, in the opinion of the Investigator, of the following temporary conditions that constitute contraindications to administration of study vaccine, subjects may be enrolled in the study: Temperature ≥ 38.0 ºC within 24 hours prior to randomization. Acute cold symptoms such as upper respiratory tract infection symptoms, with or without fever, which typically resolve in 48 to 72 hours prior to randomization.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Jet injector<br>40 participants will receive Fluviral influenza vaccine using the Med-Jet H4 | Biological: Fluviral influenza vaccine<br>* Influenza vaccine (Fluviral) given via Med-Jet H4 or IM injection<br>|
| Active Comparator: IM injection (pre-filled syringe)<br>20 participants will receive Fluviral influenza vaccine using pre-filled syringes for time-motion comparison to Med-Jet H4 | Biological: Fluviral influenza vaccine<br>* Influenza vaccine (Fluviral) given via Med-Jet H4 or IM injection<br>|
| Active Comparator: IM injection (multi-dose vial)<br>20 participants will receive Fluviral influenza vaccine using a multi-dose vial for time-motion comparison to Med-Jet H4 | Biological: Fluviral influenza vaccine<br>* Influenza vaccine (Fluviral) given via Med-Jet H4 or IM injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local and systemic effects will be measured after vaccination | Solicited and unsolicited local and systemic adverse events will be collected between day 0-3 by phone and day 4-21 by diary after influenza vaccine (TIV) delivered by jet-injector or by standard needle. | 0 - 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to administer vaccine by jet-injector or standard needle will be measured | Each component of the vaccination process using either the jet-injector or a standard needle will be measured (time-motion study) to determine which method is faster | Day 0 (day of immunization) | 
| Immunogenicity of influenza vaccine given by needle or jet injector | Standard serologic assays will be performed on serum obtained on day 0 (day of injection) and day 21 to measure hemagglutination inhibition and microneutralization titres in subjects who received the vaccine by either standard needle or jet injector. | Day 0 (day of immunization) and day 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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jet injector, influenza vaccine, immune response