Study of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone® in Adults
NCT ID: NCT00772109
Last Updated: 2016-04-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
4292 participants
INTERVENTIONAL
2008-10-31
2009-07-31
Brief Summary
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Primary Objective:
* To demonstrate lot consistency of the Fluzone ID manufacturing process.
* To provide information concerning the immune response of Fluzone ID.
Secondary Objectives:
Safety
* To describe the safety profile of subjects who receive of Fluzone ID.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Fluzone Intradermal Vaccine Lot 1
Participants will receive a dose of Influenza intradermal vaccine Lot 1
Influenza Virus Vaccine USP Trivalent Types A and B
0.1 mL, Intradermal
Fluzone Intradermal Vaccine Lot 2
Participants will receive a dose of Influenza intradermal vaccine Lot 2
Influenza Virus Vaccine USP Trivalent Types A and B
0.1 mL, Intradermal
Fluzone Intradermal Vaccine Lot 3
Participants will receive a dose of Influenza intradermal vaccine Lot 3
Influenza Virus Vaccine USP Trivalent Types A and B
0.1 mL, Intradermal
Fluzone Intramuscular Vaccine
Participants will receive a dose of influenza intramuscular vaccine
Influenza Virus Vaccine USP Trivalent Types A and B
0.5 mL, Intramuscular
Interventions
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Influenza Virus Vaccine USP Trivalent Types A and B
0.1 mL, Intradermal
Influenza Virus Vaccine USP Trivalent Types A and B
0.1 mL, Intradermal
Influenza Virus Vaccine USP Trivalent Types A and B
0.1 mL, Intradermal
Influenza Virus Vaccine USP Trivalent Types A and B
0.5 mL, Intramuscular
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed consent form signed and dated.
* Able to attend all scheduled visits and to comply with all trial procedures.
* For women of child bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination.
Exclusion Criteria
* For a woman of child-bearing potential: known pregnancy or positive serum/urine pregnancy test.
* Breast-feeding woman.
* Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the four weeks preceding the trial vaccination.
* Planned participation in another clinical trial during the present trial period.
* Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
* Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator.
* Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures.
* Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune response.
* Receipt of any vaccination in the 4 weeks preceding the trial vaccination.
* Planned receipt of any vaccine in the 4 weeks following the trial vaccination.
* Previous vaccination against influenza in the past 6 months with the trial vaccine or another vaccine.
* Thrombocytopenia or bleeding disorder in the 3 weeks preceding inclusion.
* Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
* Neoplastic disease or any hematologic malignancy, (except localized skin or prostate cancer that is stable at the time of vaccination in the absence of therapy, and subjects who have a history of neoplastic disease and who have been disease free for \>=5 years).
* Personal or family history of Guillain-Barré Syndrome.
18 Years
64 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
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Hoover, Alabama, United States
Huntsville, Alabama, United States
Mobile, Alabama, United States
Chandler, Arizona, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Fountain Valley, California, United States
San Diego, California, United States
Milford, Connecticut, United States
Melbourne, Florida, United States
Pembroke Pines, Florida, United States
Pinellas Park, Florida, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Iowa City, Iowa, United States
Wichita, Kansas, United States
Lexington, Kentucky, United States
Madisonville, Kentucky, United States
Rockville, Maryland, United States
Kansas City, Missouri, United States
Springfield, Missouri, United States
St Louis, Missouri, United States
Albuquerque, New Mexico, United States
Binghamton, New York, United States
Endwell, New York, United States
Rochester, New York, United States
Rochester, New York, United States
Cary, North Carolina, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Allentown, Pennsylvania, United States
Bensalem, Pennsylvania, United States
Warwick, Rhode Island, United States
Mt. Pleasant, South Carolina, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Fort Worth, Texas, United States
Fort Worth, Texas, United States
Galveston, Texas, United States
San Angelo, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
West Jordan, Utah, United States
Seattle, Washington, United States
Marshfield, Wisconsin, United States
Castellana Gardens, Carolina, , Puerto Rico
San Juan, , Puerto Rico
San Juan, , Puerto Rico
Countries
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References
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Gorse GJ, Falsey AR, Fling JA, Poling TL, Strout CB, Tsang PH. Intradermally-administered influenza virus vaccine is safe and immunogenic in healthy adults 18-64 years of age. Vaccine. 2013 May 1;31(19):2358-65. doi: 10.1016/j.vaccine.2013.03.008. Epub 2013 Mar 13.
Related Links
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Related Info
Other Identifiers
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FID31
Identifier Type: -
Identifier Source: org_study_id
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