A randomized controlled study to assess the immunogenicity and tolerability of a 2012 trivalent seasonal inactivated influenza vaccine administered via a disposable syringe jet injector device versus a traditional pre-filled syringe and needle

•First report of clinical use of Stratis jet injector device for vaccine administration.•Addresses new FDA guidance mandating clinical validation of new vaccine administration devices.•Influenza vaccine immunogenicity maintained when delivered via Stratis device.•Stratis device associated with reduced systemic adverse reactions.•Stratis device caused increased local adverse reactions but only in mild category.

The Stratis® disposable syringe jet injection (DSJI) system (PharmaJet Inc., Denver, USA) delivers vaccine utilizing a spring powered energy source to create a fine high-velocity jet of liquid that directly penetrates the skin without using a needle. We performed a study to collect data on the effect of the Stratis DSJI device on influenza immunization in 46 predominantly elderly subjects (28M, 18F; mean age 61 years) who were randomized 1:1 to receive Fluvax 2012 trivalent inactivated influenza vaccine via prefilled N–S or Stratis DSJI. H1N1 seroprotection was not significantly different for vaccine delivered by DSJI (86.4%, 95% CI 72.1–100) or N–S (79.2%, 95% CI 63.0–95.4), and likewise for H3N2 and B strains. The DSJI had a ∼2-fold higher mean injection pain score (DSJI: 3.0 versus N–S 1.58, p = 0.045) plus increased rates of swelling and tenderness but this was offset by a lower rate of elicited systemic reactions, particularly the frequency of post-immunization headaches (DSJI: 9% vs N–S: 33.3%). This study suggests that subject to confirmation of non-inferiority in an appropriately powered study, the Stratis DSJI is a viable alternative strategy for the administration of seasonal influenza vaccines with particular appeal for individuals with needle phobia. Australia New Zealand Clinical Trials Register: ACTRN12612000709842.