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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PharmaJet, Inc.
ClinicalTrials.gov Identifier:
NCT01644149
First received: July 16, 2012
Last updated: March 14, 2013
Last verified: March 2013

July 16, 2012
March 14, 2013
January 2012
February 2012   (final data collection date for primary outcome measure)
Hemagglutination Inhibition Geometric Mean Titers [ Time Frame: One month ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01644149 on ClinicalTrials.gov Archive Site
  • HI seroconversion [ Time Frame: One month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Seroprotection was defined as a HI titer ≥ 40 that was met and maintained throughout the study.
Same as current
Not Provided
Not Provided
 
Clinical Trial Assessing the Immunologic Response to a Influenza Vaccine Delivered Using an Jet Injection Device or a Needle Syringe
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Influenza Prophylaxis
  • Device: Stratis Jet Injector
    Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine
    Other Names:
    • Jet Injector
    • Disposable Syringe Jet Injector
    • DSJI
  • Device: Needle and Syringe
    Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine
  • Biological: 2011-2012 Fluzone trivalent inactivated influenza vaccine
  • Experimental: Stratis Jet Injector
    Single intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine using the Stratis Jet Injector
    Interventions:
    • Device: Stratis Jet Injector
    • 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
    Interventions:
    • Device: Needle and Syringe
    • Biological: 2011-2012 Fluzone trivalent inactivated influenza vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 59 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01644149
PJ-500-07
No
PharmaJet, Inc.
PharmaJet, Inc.
Not Provided
Principal Investigator: Daniel Perlman, MD, MBA Bel-Rea Institute
PharmaJet, Inc.
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP