Comparison of Delivery Routes of Flu Vaccine in Adults
Influenza
About this trial
This is an interventional prevention trial for Influenza focused on measuring inactivated, trivalent, influenza, vaccine, Fluzone
Eligibility Criteria
Inclusion Criteria: Subject is healthy, as determined by medical history Over 18 years of age and not yet 65 years old Provides written informed consent Able to attend all scheduled visits and to comply with all trial procedures 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: Breast-feeding Receipt of an investigational drug, biologic or device in the 4 weeks preceding the trial vaccination Planned participation in another clinical trial during the present trial period History of Guillain-Barré Syndrome 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 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 Chronic illness that could interfere with trial conduct or completion Blood or blood-derived products received in the past 3 months Has received any inactivated vaccine within 2 weeks or live vaccine within 4 weeks prior to enrollment into this study Vaccination planned within the 4 weeks following the trial vaccination Known current HIV, hepatitis B (HBsAg) or hepatitis C infection or seropositivity Prior vaccination against influenza within the past 6 months 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 On coumadin or heparin therapy or has known thrombocytopenia or bleeding disorder contraindicating vaccination Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent Febrile illness temperature >= 37.5°C on Day 0, prior to enrollment and vaccination Any condition, that, in the opinion of the investigator, would pose a health risk to the participant History of alcohol or drug abuse in the last 5 years Planned travel outside the US between vaccination and the second study visit 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
Sites / Locations
- Stanford University School of Medicine
- UCLA Center For Vaccine Research
- University of Iowa - Vaccine Research & Education Unit
- University of Maryland Baltimore
- Saint Louis University
- University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases
- Duke Health Center
- Cincinnati Children's Hospital Medical Center
- Vanderbilt University
- Baylor College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Group 3
Group 4
Group 1
Group 2
382 subjects will receive one 3 mcg dose of Fluzone intradermally using the Mantoux technique on Day 0,
382 subjects will receive one 15 mcg dose Fluzone vaccine intramuscularly (IM) on Day 0,
382 subjects will receive one 6 mcg dose of Trivalent inactivated influenza vaccine (TIV) intradermally (ID) with the BD ID System on Day 0,
382 subjects will receive one 9 mcg dose of TIV intradermally (ID) with the BD ID System on Day 0,