Jet Injection for Influenza
Condition: Influenza, Human
MeSH terms: Influenza, Human
Intervention: AFLURIA vaccine (2012-2013 formulation); Needle-Syringe; Stratis needle-free injection device
Intervention description: Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
Intervention MeSH terms: Vaccines
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 1250.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Injections, Jet; Influenza Vaccines

Summary:

      The purpose of this study is to determine if the administration of a seasonal flu vaccine
      using a PharmaJet's needle-free injection device (STRATIS) is equivalent to needle and
      syringe administration, as measured by laboratory tests of immune response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults aged ≥18 and ≤64 years of age at the time of enrollment

          -  Willing and able to give informed consent after reading the consent form and 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 TIV influenza vaccine, based on University of Colorado Health
             (UCH) employee health flu screening guidelines.

          -  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 immunosuppressive condition including: history of 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, gentamicin 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.