Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
1597 participants
INTERVENTIONAL
2005-09-30
2006-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Group 3
382 subjects will receive one 3 mcg dose of Fluzone intradermally using the Mantoux technique on Day 0,
Trivalent inactivated influenza vaccine
A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain..Group 3: 382 subjects receive 3 mcg Fluzone ID using Mantoux technique on day 0.
Group 4
382 subjects will receive one 15 mcg dose Fluzone vaccine intramuscularly (IM) on Day 0,
Trivalent inactivated influenza vaccine
A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain.. Group 4: 382 subjects receive Fluzone 15 mcg IM on day 0
Group 1
382 subjects will receive one 6 mcg dose of Trivalent inactivated influenza vaccine (TIV) intradermally (ID) with the BD ID System on Day 0,
Trivalent inactivated influenza vaccine
A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain. Group 1: 382 subjects receive 6 mcg ID with BD system. Group 2: 382 subjects receive 9 mcg ID with BD system, all doses on day 0.
Group 2
382 subjects will receive one 9 mcg dose of TIV intradermally (ID) with the BD ID System on Day 0,
Trivalent inactivated influenza vaccine
A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain. Group 1: 382 subjects receive 6 mcg ID with BD system. Group 2: 382 subjects receive 9 mcg ID with BD system, all doses on day 0.
Interventions
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Trivalent inactivated influenza vaccine
A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain.. Group 4: 382 subjects receive Fluzone 15 mcg IM on day 0
Trivalent inactivated influenza vaccine
A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain. Group 1: 382 subjects receive 6 mcg ID with BD system. Group 2: 382 subjects receive 9 mcg ID with BD system, all doses on day 0.
Trivalent inactivated influenza vaccine
A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain..Group 3: 382 subjects receive 3 mcg Fluzone ID using Mantoux technique on day 0.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
64 Years
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Locations
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Stanford University School of Medicine
Stanford, California, United States
UCLA Center For Vaccine Research
Torrance, California, United States
University of Iowa - Vaccine Research & Education Unit
Iowa City, Iowa, United States
University of Maryland Baltimore
Baltimore, Maryland, United States
Saint Louis University
St Louis, Missouri, United States
University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases
Rochester, New York, United States
Duke Health Center
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Vanderbilt University
Nashville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
Countries
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Other Identifiers
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05-0075
Identifier Type: -
Identifier Source: org_study_id