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

Primary Purpose

Needle Phobia

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Fluviral influenza vaccine

About this trial

This is an interventional prevention trial for Needle Phobia focused on measuring jet injector, influenza vaccine, immune response

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

McGill University Health Centre Vaccine Study Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Jet injector

IM injection (pre-filled syringe)

IM injection (multi-dose vial)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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.

Full Information

NCT ID

NCT03150537

First Posted

May 4, 2017

Last Updated

August 14, 2018

Sponsor

brian.ward

Collaborators

MEDICAL INTERNATIONAL TECHNOLOGIES (MIT CANADA) INC., MedTeq

1. Study Identification

Unique Protocol Identification Number

NCT03150537

Brief Title

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

Acronym

Med-Jet H4™

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

May 12, 2017 (Actual)

Primary Completion Date

June 14, 2017 (Actual)

Study Completion Date

November 6, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

brian.ward

Collaborators

MEDICAL INTERNATIONAL TECHNOLOGIES (MIT CANADA) INC., MedTeq

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Needle Phobia

Keywords

jet injector, influenza vaccine, immune response

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Model Description

Masking

InvestigatorOutcomes Assessor

Masking Description

Observer-blind study

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Jet injector

Arm Type

Active Comparator

Arm Description

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

Arm Title

IM injection (pre-filled syringe)

Arm Type

Active Comparator

Arm Description

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

Arm Title

IM injection (multi-dose vial)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Fluviral influenza vaccine

Intervention Description

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

Primary Outcome Measure Information:

Title

Local and systemic effects will be measured after vaccination

Description

Time Frame

0 - 21 days

Secondary Outcome Measure Information:

Title

Time to administer vaccine by jet-injector or standard needle will be measured

Description

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

Time Frame

Day 0 (day of immunization)

Title

Immunogenicity of influenza vaccine given by needle or jet injector

Description

Time Frame

Day 0 (day of immunization) and day 21

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian J Ward, MD

Organizational Affiliation

Research Institute of the McGill University Helath Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

McGill University Health Centre Vaccine Study Centre

City

Pierrefonds

State/Province

Quebec

ZIP/Postal Code

H9H 4Y6

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30709725

Citation

Shapiro JR, Hodgins B, Hendin HE, Patel A, Menassa K, Menassa C, Menassa M, Pereira JA, Ward BJ. Needle-free delivery of influenza vaccine using the Med-Jet(R) H4 is efficient and elicits the same humoral and cellular responses as standard IM injection: A randomized trial. Vaccine. 2019 Feb 28;37(10):1332-1339. doi: 10.1016/j.vaccine.2019.01.039. Epub 2019 Jan 29.

Results Reference

derived

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

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