Jet Injection for Influenza

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.