Comparison of Delivery Routes of Flu Vaccine in Adults

Exclusion Criteria

• •1. Breast-feeding
• •2. Receipt of an investigational drug, biologic or device in the 4 weeks preceding the trial vaccination
• •3. Planned participation in another clinical trial during the present trial period
• •4. History of Guillain-Barré Syndrome
• •5. Congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy
• •6. Hypersensitivity to any of the vaccine components (including eggs or egg products or thimerosol and gelatin) or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
• •7. Chronic illness that could interfere with trial conduct or completion
• •8. Blood or blood-derived products received in the past 3 months
• •9. Has received any inactivated vaccine within 2 weeks or live vaccine within 4 weeks prior to enrollment into this study
• •10. Vaccination planned within the 4 weeks following the trial vaccination
• •11. Known current HIV, hepatitis B (HBsAg) or hepatitis C infection or seropositivity
• •12. Prior vaccination against influenza within the past 6 months
• •13. Allergy shot in the 7-day period prior to enrollment and must not be scheduled to receive any allergy shots in the 7-day period after enrollment
• •14. On coumadin or heparin therapy or has known thrombocytopenia or bleeding disorder contraindicating vaccination
• •15. Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent
• •16. Febrile illness temperature \>= 37.5°C on Day 0, prior to enrollment and vaccination
• •17. Any condition, that, in the opinion of the investigator, would pose a health risk to the participant
• •18. History of alcohol or drug abuse in the last 5 years
• •19. Planned travel outside the US between vaccination and the second study visit
• •20. Presence of any active skin disease at the injection site that, in the opinion of the Investigator, would impact vaccine delivery or assessment of vaccination site