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

NCT03150537 | Completed Phase 4

• 1 other identifier: RI-MUHC: 2017-3307
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Needle Phobia

Keywords

jet injector; influenza vaccine; immune response

Outcome Measures

Primary Outcomes (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.

  0 - 21 days

Secondary Outcomes (2)

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

  Day 0 (day of immunization)

• Immunogenicity of influenza vaccine given by needle or jet injector

  Day 0 (day of immunization) and day 21

Study Arms (3)

Jet injector

ACTIVE COMPARATOR

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

Biological: Fluviral influenza vaccine

IM injection (pre-filled syringe)

ACTIVE COMPARATOR

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

Biological: Fluviral influenza vaccine

IM injection (multi-dose vial)

ACTIVE COMPARATOR

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

Biological: Fluviral influenza vaccine

Interventions

Fluviral influenza vaccine BIOLOGICAL

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

IM injection (multi-dose vial); IM injection (pre-filled syringe); Jet injector

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female adults
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• brian.ward: lead
• MEDICAL INTERNATIONAL TECHNOLOGIES (MIT CANADA) INC.: collaborator
• MedTeq: collaborator

Study Sites (1)

McGill University Health Centre Vaccine Study Centre

Pierrefonds, Quebec, H9H 4Y6, Canada

Location

Related Publications (1)

• 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.

  PMID: 30709725 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Brian J Ward, MD

  Research Institute of the McGill University Helath Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Observer-blind study
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Model Details: 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).

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 12, 2017
• Study Start: May 12, 2017
• Primary Completion: June 14, 2017
• Study Completion: November 6, 2017
• Last Updated: August 15, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)