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

NCT03150537 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2018-08-15

No results posted yet for this study

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.

Conditions

  • Needle Phobia

Interventions

BIOLOGICAL

Fluviral influenza vaccine

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

Sponsors & Collaborators

  • MEDICAL INTERNATIONAL TECHNOLOGIES (MIT CANADA) INC.

    collaborator UNKNOWN

  • MedTeq

    collaborator INDUSTRY

  • brian.ward

    lead OTHER

Principal Investigators

  • Brian J Ward, MD · Research Institute of the McGill University Helath Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-12
Primary Completion
2017-06-14
Completion
2017-11-06

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03150537 on ClinicalTrials.gov