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Needle PhobiaPhase 4Med-Jet H4™NCT03150537

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

A Phase 4 study testing Fluviral influenza vaccine in people with Needle Phobia, run by brian.ward at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Needle Phobia
What is being tested?
Fluviral influenza vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteCanada
Study dates
12 May 2017to 6 Nov 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • McGill University Health Centre Vaccine Study Centre

    Pierrefonds, Quebec, H9H 4Y6

Other trials in Canada

About this study

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

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.

Read the 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).

Conditions
Needle Phobia
Being tested
Fluviral influenza vaccine
Keywords
jet injector, influenza vaccine, immune response
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fluviral influenza vaccineBiological

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

Study groups in NCT03150537
Study groupRoleWhat they receive
Jet injectorActive comparator40 participants will receive Fluviral influenza vaccine using the Med-Jet H4
Receives: Biological: Fluviral influenza vaccine
IM injection (pre-filled syringe)Active comparator20 participants will receive Fluviral influenza vaccine using pre-filled syringes for time-motion comparison to Med-Jet H4
Receives: Biological: Fluviral influenza vaccine
IM injection (multi-dose vial)Active comparator20 participants will receive Fluviral influenza vaccine using a multi-dose vial for time-motion comparison to Med-Jet H4
Receives: Biological: Fluviral influenza vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 0 - 21 days

Secondary outcomes (2)

  1. 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

    Measured: Day 0 (day of immunization)

  2. 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.

    Measured: Day 0 (day of immunization) and day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2017
  2. Study start12 May 2017
  3. Primary completion14 Jun 2017
  4. Study completion6 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
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 blind
Who is masked
Investigator, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03150537
Sponsor's protocol ID
RI-MUHC: 2017-3307
Acronym
Med-Jet H4™
Status last verified
Aug 2018
First submitted
4 May 2017
Last updated
15 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30709725

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Fluviral influenza vaccine in people with Needle Phobia, run by brian.ward at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local and systemic effects will be measured after vaccination (time frame: 0 - 21 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03150537, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2018.

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