Safety Study of Seasonal Influenza Vaccine by Jet Injection

2014-08-27 03:18:58 | BioPortfolio


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


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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Healthy Adults


LectraJet, TIV by jet injection


University of Maryland College Park Health Center
College Park
United States


Active, not recruiting


University of Maryland

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:18:58-0400

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Medical and Biotech [MESH] Definitions

Healthy People Programs are a set of health objectives to be used by governments, communities, professional organizations, and others to help develop programs to improve health. It builds on initiatives pursued over the past two decades beginning with the 1979 Surgeon General's Report, Healthy People, Healthy People 2000: National Health Promotion and Disease Prevention Objectives, and Healthy People 2010. These established national health objectives and served as the basis for the development of state and community plans. These are administered by the Office of Disease Prevention and Health Promotion (ODPHP). Similar programs are conducted by other national governments.

Adverse reactions that occur initially at the site of injection or infusion. Milder type is confined to a local allergic flare reaction. A more severe reaction is caused by extravasation of VESICANTS from the blood vessel at the site of injection and can cause damage to the surrounding tissue. In tumor flare reaction symptoms involve well beyond the injection site such as an increase in the tumor size and tumor markers levels, bone pain, and HYPERCALCEMIA.

Governmental guidelines and objectives pertaining to public food supply and nutrition including recommendations for healthy diet and changes in food habits to ensure healthy diet.

Total or subtotal destruction of the pituitary gland by chemical injection. It is usually achieved by injection of ethyl alcohol via trans-sphenoidal cannulation under stereotaxic control. It is usually performed for the treatment of intractable pain.

Surgical reinnervation of a denervated peripheral target using a healthy donor nerve and/or its proximal stump. The direct connection is usually made to a healthy postlesional distal portion of a non-functioning nerve or implanted directly into denervated muscle or insensitive skin. Nerve sprouts will grow from the transferred nerve into the denervated elements and establish contact between them and the neurons that formerly controlled another area.

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