Clinical Trial Assessing the Immunologic Response to a Influenza Vaccine Delivered Using an Jet Injection Device or a Needle Syringe
|Influenza Prophylaxis||Device: Stratis Jet Injector Device: Needle and Syringe Biological: 2011-2012 Fluzone trivalent inactivated influenza vaccine||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||A Randomized Controlled Clinical Trial Assessing the Immunologic Response to an FDA-approved Influenza Vaccine Delivered Using an FDA-Cleared Jet Injection Vaccine Delivery Device or a Needle and Syringe|
- Hemagglutination Inhibition Geometric Mean Titers [ Time Frame: One month ]GMTs were measured for each of the three influenza types (H1N1, H3N2, and influenza B) on a log scale comparing the jet injector device group and the needle and syringe group.
- HI seroconversion [ Time Frame: One month ]Seroconversion was defined as a 4-fold increase in antibody titers compared to pre-vaccination levels when the baseline titer was found to be greater than 10; or simply > 40 when the baseline titer was ≤ 10.
- HI seroprotection [ Time Frame: One month ]Seroprotection was defined as a HI titer ≥ 40 that was met and maintained throughout the study.
|Study Start Date:||January 2012|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Experimental: Stratis Jet Injector
Single intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine using the Stratis Jet Injector
Device: Stratis Jet Injector
Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine
Other Names:Biological: 2011-2012 Fluzone trivalent inactivated influenza vaccine
Active Comparator: Needle and Syringe
Single intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine using Needle and Syringe
Device: Needle and Syringe
Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccineBiological: 2011-2012 Fluzone trivalent inactivated influenza vaccine
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01644149
|United States, Colorado|
|Denver, Colorado, United States, 80247|
|Principal Investigator:||Daniel Perlman, MD, MBA||Bel-Rea Institute|