Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03150537
Recruitment Status : Completed
First Posted : May 12, 2017
Last Update Posted : August 15, 2018
Sponsor:
Collaborators:
MEDICAL INTERNATIONAL TECHNOLOGIES (MIT CANADA) INC.
CONSORTIUM MEDTEQ
Information provided by (Responsible Party):
brian.ward, McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief 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.

Condition or disease Intervention/treatment Phase
Needle Phobia Biological: Fluviral influenza vaccine Phase 4

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
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)
Masking Description: Observer-blind study
Primary Purpose: Prevention
Official Title: Comparison of Routine IM Influenza Immunization and Administration by Jet-injector (Med-Jet MIT H4™ & Disposable Cartridge) in Healthy Young Adults
Actual Study Start Date : May 12, 2017
Actual Primary Completion Date : June 14, 2017
Actual Study Completion Date : November 6, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Active Comparator: Jet injector
40 participants will receive Fluviral influenza vaccine using the Med-Jet H4
Biological: Fluviral influenza vaccine
Influenza vaccine (Fluviral) given via Med-Jet H4 or IM injection

Active Comparator: IM injection (pre-filled syringe)
20 participants will receive Fluviral influenza vaccine using pre-filled syringes for time-motion comparison to Med-Jet H4
Biological: Fluviral influenza vaccine
Influenza vaccine (Fluviral) given via Med-Jet H4 or IM injection

Active Comparator: 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
Biological: Fluviral influenza vaccine
Influenza vaccine (Fluviral) given via Med-Jet H4 or IM injection




Primary Outcome Measures :
  1. Local and systemic effects will be measured after vaccination [ Time Frame: 0 - 21 days ]
    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.


Secondary Outcome Measures :
  1. Time to administer vaccine by jet-injector or standard needle will be measured [ Time Frame: Day 0 (day of immunization) ]
    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

  2. Immunogenicity of influenza vaccine given by needle or jet injector [ Time Frame: Day 0 (day of immunization) and day 21 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03150537


Locations
Layout table for location information
Canada, Quebec
McGill University Health Centre Vaccine Study Centre
Pierrefonds, Quebec, Canada, H9H 4Y6
Sponsors and Collaborators
brian.ward
MEDICAL INTERNATIONAL TECHNOLOGIES (MIT CANADA) INC.
CONSORTIUM MEDTEQ
Investigators
Layout table for investigator information
Principal Investigator: Brian J Ward, MD Research Institute of the McGill University Helath Centre
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: brian.ward, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT03150537    
Other Study ID Numbers: RI-MUHC: 2017-3307
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by brian.ward, McGill University Health Centre/Research Institute of the McGill University Health Centre:
jet injector
influenza vaccine
immune response
Additional relevant MeSH terms:
Layout table for MeSH terms
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases