Comparison of Routine IM Influenza Immunization and Administration by Jet-injector (Med-Jet H4™) in Healthy Young Adults

Summary

80 subjects (healthy adults) will be randomized to receive the seasonal flu vaccine either by needle \& syringe or by the MIT needle-free injector (Med-Jet MIT H4™ \& Disposable Cartridge). The study will be conducted after the normal flu season has passed (ie: March-April). Half of those randomized to standard vaccination (n=20) will receive vaccine drawn from a multi-dose vial while the other half (n=20) will receive vaccine drawn from a single use vial. The same vaccine as the multi-dose vial will be delivered to the other half of the subjects (n=40) using the MIT injector. How long it takes to prepare and deliver the vaccines will be assessed (a time-motion study). Subject acceptance before and after injection will be assessed as well as local and systemic side effects. Standard serologic measures of immune response to flu vaccination (ie: antibodies) will determine whether the Med-Jet H4 injector induces the same kind of immune response as needle \& syringe delivery.

Timeline

Start

2017-05-12

Primary completion

2017-06-14

Completion

2017-11-06

Publications

• Shapiro JR, Hodgins B, Hendin HE, Patel A, Menassa K, Menassa C, Menassa M, Pereira JA, Ward BJ. Needle-free delivery of influenza vaccine using the Med-Jet(R) H4 is efficient and elicits the same humoral and cellular responses as standard IM injection: A randomized trial. Vaccine. 2019 Feb 28;37(10):1332-1339. doi: 10.1016/j.vaccine.2019.01.039. Epub 2019 Jan 29.

Drugs

Indications

No indication recorded.