Clinical Trial Assessing the Immunologic Response to a Influenza Vaccine Delivered Using an Jet Injection Device or a Needle Syringe

NCT ID: NCT01644149

Last Updated: 2019-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-02-29

Brief Summary

The primary objective of this study was to evaluate if administration of a seasonal flu vaccine using a jet injector device is comparable to traditional needle and syringe delivery for eliciting an immune response. A secondary objective was to compare the safety of the two delivery methods.

Detailed Description

Needle-free jet injection devices create a fine stream of pressurized liquid that is able to deliver vaccines and other pharmaceutical products beneath the skin. Design aspects such as quality, pressure, orifice size, angle of injection relative to skin and injection stream coherence control the depth to which the product is delivered. This technology provides a safer delivery option for patients and healthcare staff by removing the need for needles for the administration of vaccines.

In addition to improved safety, additional benefits of using jet injectors include more consistent and reliable dose volume delivery, reduced vaccine waste, diminished need to transport large quantities of sharps, reduced risk of needle sticks, syringe reuse, and costs associated with sharps waste. Jet injectors offer a needle-free procedure to those individuals who are adverse to needles.

This study compared the efficacy of a disposable syringe jet injection device (Stratis) with traditional needle and syringe (NS) administration for the delivery of a trivalent inactivated influenza vaccine. Efficacy was evaluated by comparing measures of hemagglutination inhibition (HI); specifically GMTs, seroconversion and seroprotection. Safety of the two administration devices was evaluated by comparison of incidence of solicited local and systemic adverse events.

Conditions

Influenza Prophylaxis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Stratis Jet Injector

Single intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine using the Stratis Jet Injector

Group Type: EXPERIMENTAL

Stratis Jet Injector

Intervention Type: DEVICE

Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine

2011-2012 Fluzone trivalent inactivated influenza vaccine

Intervention Type: BIOLOGICAL

Needle and Syringe

Single intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine using Needle and Syringe

Group Type: ACTIVE_COMPARATOR

Needle and Syringe

Intervention Type: DEVICE

Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine

2011-2012 Fluzone trivalent inactivated influenza vaccine

Intervention Type: BIOLOGICAL

Interventions

Stratis Jet Injector

Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine

Intervention Type: DEVICE

Needle and Syringe

Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine

Intervention Type: DEVICE

2011-2012 Fluzone trivalent inactivated influenza vaccine

Intervention Type: BIOLOGICAL

Other Intervention Names

Jet Injector; Disposable Syringe Jet Injector; DSJI

Eligibility Criteria

Inclusion Criteria

• Female and male subjects ages 18 to 59 years
• Healthy volunteers
• Able to provide informed consent and understand study procedures per ICH/GCP guidelines
• Plans to remain in study area for length of the trial; able to adhere to study visit and follow-up schedule
• Able to complete study diary

Exclusion Criteria

• Unwilling or unable to undergo the two blood draws per protocol
• Have received influenza vaccination in the last twelve months
• Have received any vaccination in the last month
• Currently taking antibiotics, steroids, phenytoin, chemotherapy, or other immunosuppressive drugs
• Received recent blood, blood products, or parenteral preparations of immunoglobulin (within 3 months)
• Suffers from allergic reactions to egg, gelatin, or neomycin or has a history of anaphylactic shock, asthma, urticaria, or other allergic reactions to vaccinations.
• Had any serious adverse event associated with a prior vaccination
• Has immunodeficiency or autoimmune disease (including HIV)
• History of chronic alcohol abuse
• Participating in another study concurrently
• Pregnant or breastfeeding during the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PharmaJet, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Perlman, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Bel-Rea Institute

Locations

Bel-Rea Institute

Denver, Colorado, United States

Countries

United States

Other Identifiers

PJ-500-07

Identifier Type: -

Identifier Source: org_study_id