inactivated influenza via jet injection

Conditions: Influenza, Human

Summary: the purpose of this study is to determine if the administration of flu vaccine using needle-free is equivalent to needle and syringe administration as measured by laboratory tests of immune response.

primary: to evaluate the non-inferiority of flu vaccine administered by needle-free intramuscular (im) injection versus needle and syringe im injection as determined with serum hemagglutination inhibition (hai) reciprocal titers in healthy adults between 18-64 years. secondary: to compare tolerability and safety of the vaccine in the same population based on specifically solicited local and systemic reactions occurring through 7 days post-immunization and adverse events spontaneously reported through approximately 28 days post immunization.

Eligibility criteria:
inclusion criteria: * adults aged ≥ 18 and ≤ 64 years of age at time of enrollment * willing and able to give informed consent after reading the consent form and given adequate opportunity to discuss the study with the investigator or qualified designee * willing and able to adhere to all protocol required study procedures and to attend scheduled visits * able to receive the trivalent influenza vaccine (tiv) or quadrivalent influenza vaccine (qiv) based on pi judgment * stable health status with no exclusionary medical or neuropsychiatric conditions as determined during the screening evaluation and based on the clinical judgment of the investigator or qualified designee * access to a consistent means of telephone contact exclusion criteria: * presence of any febrile illness (oral temperature \>38 °c) on the day of immunization. such subjects will be reevaluated for enrollment after resolution of illness * presence of significant acute or chronic uncontrolled medical or neuropsychiatric illness and /or presence of any significant condition that may prohibit inclusion as determined by the investigator or his qualified designee. uncontrolled is defined as: requiring institution of a new treatment within 1 month prior to study enrollment or change in medication dosage in the month prior to study enrollment * any known immunosuppressive condition including: history of human immunodeficiency virus (hiv) infection, cancer or cancer treatment within 3 years of study enrollment, systemic glucocorticoids (in a dose ≥10 mg prednisone daily or equivalent for more than 7 consecutive days or for 10 or more days in total) within 1 month of study enrollment, or any other cytotoxic or immunosuppressive drug within 3 months of study enrollment. any significant disorder of coagulation that would increase the risk of intramuscular injections or treatment with coumadin derivatives or heparin * known or suspected to be allergic to eggs, chicken protein, neomycin, polymyxin or influenza vaccine * history of severe or previous serious adverse reaction after an influenza vaccination * receipt of any immunoglobulin and/or blood products within 3 months of immunization or planned administration of any of these products during the study period * prior history of any demyelinating disease including guillain-barre syndrome. * presence of an active neurological disorder * history of significant alcohol or drug abuse within one year prior to study enrollment * influenza vaccination or laboratory confirmed influenza infection within the previous six months before study vaccination or planned influenza vaccination during the study period * planned administration of any non-influenza vaccines 30 days prior to the study or during the study period * pregnant or plans to become pregnant during the study period * currently enrolled in another vaccine or drug study

Keywords: needle free, influenza