Safety Study of Seasonal Influenza Vaccine by Jet Injection
Condition: Healthy Adults
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This research study involves testing of a device that can give injections (shots) without the
      use of a needle.
    

Detailed description: 
      The device is called LectraJet M3 and has recently been approved by the Food and Drug
      Administration (or FDA), the government agency that oversees the approval of new medical
      devices. The approval is called a 510(k) and allows for the marketing and use of the device
      in the United States (US). Devices under a 510(k) do not need to have clinical trials
      performed. The researchers are performing this study in order to collect clinical data in a
      controlled environment. Non significant risk (NSR) devices such as the LectraJet may be
      studied in clinical trials with or without a 510(k). Currently there are several other
      disposable-syringe jet injectors that are also FDA approved for sale and use in the United
      States, including: 1) Biojector® 2000 , 2) Medi-Jector Vision, and 3) Injex™. These devices
      have been used to deliver millions of injections in a variety of healthcare settings. The
      LectraJet® is jet injector that is most suited for mass immunization campaigns due to the
      ability to power the device with a foot pedal as well as electricity and the speed with which
      immunizations can be delivered. It is designed so that vaccine delivery characteristics are
      the same as that of the licensed disposable-syringe jet injectors.

      Giving vaccines without needles (needle-free vaccine delivery) may be better than giving them
      using a needle for many reasons. One method for giving shots without needles is a technique
      called jet injection. This is what the researchers are testing in this study. A jet injector
      pushes the vaccine fluid out of a small hole at a high enough speed to allow the vaccine to
      go under the subject's skin without needing a needle. Years ago, people got shots using jet
      injectors, but these older devices reused the same "nozzle" or hole through which the fluid
      was forced. Newer jet injectors, including the one the researchers are testing in this study,
      use disposable cartridges to hold the vaccine. So, the only thing that touches the subject's
      skin is their own cartridge, which gets thrown away after injection.

      In this study, the volunteers are getting the licensed seasonal flu vaccine to see if the jet
      injector works as well as giving the vaccine by needle and syringe. The seasonal flu vaccine
      that the researchers are using is called trivalent influenza vaccine (TIV). It is licensed in
      the US to protect people 6 months of age and older against influenza. Influenza is a virus
      that is also commonly known as the "flu". The flu is a serious illness that kills over 35,000
      people per year in the US alone. The flu virus constantly changes and that is why people who
      are at risk for developing complications from the flu, such as children, the elderly, and
      people with underlying health conditions need to be vaccinated every year. Volunteers will
      receive the 2009-2010 annual seasonal flu vaccine called TIV either by needle and syringe or
      by jet injection. The researchers will compare the side effects and see how well the vaccine
      generates an immune response when given by the two methods.
    

Intervention name(s): LectraJet; TIV by jet injection; Seasonal Trivalent Influenza Vaccine
Intervention type(s): Device; Device; Biological
Intervention description(s): LectraJet is a new jet injector studied for the first time in humans. It is in the category known as disposable-syringe jet injectors that have the advantage of eliminating the risk of disease transmission between subjects. A new syringe and nozzle is used for each patient so that no splash back of blood can occur onto the jet apparatus itself.; Administration of seasonal trivalent influenza vaccine (TIV) by jet injection; Licensed trivalent influenza vaccine provided by either jet injection or traditional needle and syringe.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Device Feasibility
Keywords: Jet Injector; Vaccine; Influenza