Influenza Prophylaxis Clinical Trial
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
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05255822 -
INNA-051 Influenza Challenge Study
|
Phase 2 | |
| Completed |
NCT01863849 -
Tolerability and Immunogenicity Study of Fluval AB Suspension for Injection
|
Phase 4 |