Inactivated Influenza Via Jet Injection

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.

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