Inactivated Influenza Via Jet Injection
Condition: Influenza, Human
MeSH terms: Influenza, Human
Intervention: Influenza Vaccine
Intervention description: Influenza Vaccine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 985.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Needle Free, Influenza

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.
    

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