Status:
COMPLETED
Comparison of Delivery Routes of Flu Vaccine in Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Influenza
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
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 ad...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
1597 Patients enrolled
Trial Details
Trial ID
NCT00170547
Start Date
September 1 2005
End Date
February 1 2006
Last Update
December 5 2014
Active Locations (10)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305-2200
2
UCLA Center For Vaccine Research
Torrance, California, United States, 90509
3
University of Iowa - Vaccine Research & Education Unit
Iowa City, Iowa, United States, 52242-2600
4
University of Maryland Baltimore
Baltimore, Maryland, United States, 21201