Comparison of Delivery Routes of Flu Vaccine in Adults

Completed · Phase 2

Conditions studied: Influenza

In brief

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.

Key facts

Study ID: NCT00170547
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 1597
Starts: 2005-09-01
Expected to finish: 2006-02-01
Last updated by the study team: 2014-12-05

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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