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

PharmaJet

Status and phase: Completed; Phase 4

Conditions: Influenza Prophylaxis

Treatments: Device: Needle and Syringe; Device: Stratis Jet Injector; Biological: 2011-2012 Fluzone trivalent inactivated influenza vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01644149

PJ-500-07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 83 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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83 participants in 2 patient groups

Stratis Jet Injector

Experimental group

Description:

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

Treatment:

Biological: 2011-2012 Fluzone trivalent inactivated influenza vaccine

Device: Stratis Jet Injector

Needle and Syringe

Active Comparator group

Description:

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

Treatment:

Device: Needle and Syringe

Biological: 2011-2012 Fluzone trivalent inactivated influenza vaccine