Comparison of Delivery Routes of Flu Vaccine in Adults
Comparison of Delivery Routes of Flu Vaccine in Adults
This protocol is to compare the immune response of different influenza vaccines given by two
 different routes of administration in healthy adults ages 18 to 64 years.
This is a multi-center, randomized, partially blinded trial to compare the safety and
 immunogenicity of intramuscularly versus intradermally administered influenza vaccine in
 healthy 18-64 year old adults. Subjects will have blood drawn immediately prior to and
 approximately three to four weeks after vaccination. After the completion of the trial, all
 subjects will be offered influenza vaccine of the 2005-2006 formulation.
Inclusion Criteria:

 1. Subject is healthy, as determined by medical history

 2. Over 18 years of age and not yet 65 years old

 3. Provides written informed consent

 4. Able to attend all scheduled visits and to comply with all trial procedures

 5. Women may be menopausal of 1 year or more or sugically sterile. Women of child-bearing
 potential must agree to be abstinent or to use a licensed form of barrier or hormonal
 contraception for the entire study period, and have a negative pregnancy test within
 24 hours prior to vaccination.

 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