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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-12

Study Completion Date

2017-11-06

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.

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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).

Conditions

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Needle Phobia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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).

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Observer-blind study

Study Groups

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Jet injector

40 participants will receive Fluviral influenza vaccine using the Med-Jet H4

Group Type ACTIVE_COMPARATOR

Fluviral influenza vaccine

Intervention Type BIOLOGICAL

Influenza vaccine (Fluviral) given via Med-Jet H4 or IM injection

IM injection (pre-filled syringe)

20 participants will receive Fluviral influenza vaccine using pre-filled syringes for time-motion comparison to Med-Jet H4

Group Type ACTIVE_COMPARATOR

Fluviral influenza vaccine

Intervention Type BIOLOGICAL

Influenza vaccine (Fluviral) given via Med-Jet H4 or IM injection

IM injection (multi-dose vial)

20 participants will receive Fluviral influenza vaccine using a multi-dose vial for time-motion comparison to Med-Jet H4

Group Type ACTIVE_COMPARATOR

Fluviral influenza vaccine

Intervention Type BIOLOGICAL

Influenza vaccine (Fluviral) given via Med-Jet H4 or IM injection

Interventions

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Fluviral influenza vaccine

Influenza vaccine (Fluviral) given via Med-Jet H4 or IM injection

Intervention Type BIOLOGICAL

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes