Comparison of Delivery Routes of Flu Vaccine in Adults
Immunogenicity and Safety of a Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route Compared to an Intramuscular Vaccination With Fluzone(R) in Healthy Adults
1 other identifier
interventional
1,597
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2005
Shorter than P25 for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedDecember 5, 2014
July 1, 2006
4 months
September 9, 2005
December 4, 2014
Conditions
Keywords
Study Arms (4)
Group 3
EXPERIMENTAL382 subjects will receive one 3 mcg dose of Fluzone intradermally using the Mantoux technique on Day 0,
Group 4
EXPERIMENTAL382 subjects will receive one 15 mcg dose Fluzone vaccine intramuscularly (IM) on Day 0,
Group 1
EXPERIMENTAL382 subjects will receive one 6 mcg dose of Trivalent inactivated influenza vaccine (TIV) intradermally (ID) with the BD ID System on Day 0,
Group 2
EXPERIMENTAL382 subjects will receive one 9 mcg dose of TIV intradermally (ID) with the BD ID System on Day 0,
Interventions
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
Eligibility Criteria
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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Stanford University School of Medicine
Stanford, California, 94305-2200, United States
UCLA Center For Vaccine Research
Torrance, California, 90509, United States
University of Iowa - Vaccine Research & Education Unit
Iowa City, Iowa, 52242-2600, United States
University of Maryland Baltimore
Baltimore, Maryland, 21201, United States
Saint Louis University
St Louis, Missouri, 63110, United States
University of Rochester Medical Center - Strong Memorial Hospital - Infectious Diseases
Rochester, New York, 14642-0001, United States
Duke Health Center
Durham, North Carolina, 27704, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 15, 2005
Study Start
September 1, 2005
Primary Completion
January 1, 2006
Study Completion
February 1, 2006
Last Updated
December 5, 2014
Record last verified: 2006-07