Multi-Year Study of Fluzone High-Dose Influenza Vaccine Compared With Fluzone® Vaccine in Adults Aged 65 Years and Older
NCT ID: NCT00976027
Last Updated: 2012-08-01
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
9172 participants
INTERVENTIONAL
2009-09-30
2012-04-30
Brief Summary
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Primary objective:
To measure the efficacy of the vaccine, defined as the prevention of laboratory-confirmed influenza caused by viral types/subtypes that are antigenically similar to those contained in the respective annual vaccine formulations.
Secondary objectives:
* To compare the clinical efficacy of Fluzone High Dose vaccine with that of Fluzone® vaccine in elderly adults, with respect to laboratory-confirmed influenza illness caused by any type or subtype of influenza virus.
* To compare the clinical efficacy of Fluzone High Dose vaccine with that of Fluzone® vaccine in elderly adults, in preventing culture-confirmed influenza illness caused by viral types/subtypes antigenically similar to those contained in the respective annual vaccine formulations.
Detailed Description
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The presence of influenza virus in the respiratory tract of vaccinated individuals with ILI will be confirmed by two methods.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Fluzone® High Dose Group
Trivalent inactivated influenza vaccine High Dose
0.5 mL, Intramuscular
Fluzone® Group
Trivalent inactivated influenza vaccine
0.5 mL, Intramuscular
Interventions
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Trivalent inactivated influenza vaccine High Dose
0.5 mL, Intramuscular
Trivalent inactivated influenza vaccine
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.
Exclusion Criteria
* Vaccination against influenza in the 6 months preceding the trial vaccination.
* Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone vaccine or to a vaccine containing any of the same substances.
* Personal history of Guillain-Barré syndrome.
* Dementia or any other cognitive condition at a stage that could interfere with following the trial procedures.
* Thrombocytopenia, bleeding disorder, or anticoagulation therapy contraindicating intramuscular (IM) vaccination.
* Known or suspected human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C seropositivity.
* Alcohol abuse or drug addiction that could interfere with the subject's ability to comply with trial procedures.
* Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
* Bedridden subjects.
65 Years
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
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Birmingham, Alabama, United States
Glendale, Arizona, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tempe, Arizona, United States
Fountain Valley, California, United States
Los Angeles, California, United States
Oceanside, California, United States
Sacramento, California, United States
Santa Rosa, California, United States
Aurora, Colorado, United States
Colorado Springs, Colorado, United States
Colorado Springs, Colorado, United States
Milford, Connecticut, United States
Ridgefield, Connecticut, United States
Celebration, Florida, United States
Clearwater, Florida, United States
Clearwater, Florida, United States
Coral Gables, Florida, United States
Crystal River, Florida, United States
Cutler Bay, Florida, United States
Deerfield Beach, Florida, United States
Inverness, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Melbourne, Florida, United States
Miami, Florida, United States
Pembroke Pines, Florida, United States
Pinellas Park, Florida, United States
Sarasota, Florida, United States
South Miami, Florida, United States
Stockbridge, Georgia, United States
Chicago, Illinois, United States
Peoria, Illinois, United States
South Bend, Indiana, United States
Dubuque, Iowa, United States
Arkansas City, Kansas, United States
Lenexa, Kansas, United States
Lexena, Kansas, United States
Newton, Kansas, United States
Overland Park, Kansas, United States
Prairie Village, Kansas, United States
Wichita, Kansas, United States
Metairie, Louisiana, United States
Columbia, Maryland, United States
Elkridge, Maryland, United States
Greenbelt, Maryland, United States
Brockton, Massachusetts, United States
Haverhill, Massachusetts, United States
Chaska, Minnesota, United States
Edina, Minnesota, United States
St Louis, Missouri, United States
Missoula, Montana, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Rochester, New York, United States
Cary, North Carolina, United States
Charlotte, North Carolina, United States
Hickory, North Carolina, United States
High Point, North Carolina, United States
Raleigh, North Carolina, United States
Raleigh, North Carolina, United States
Salisbury, North Carolina, United States
Winston-Salem, North Carolina, United States
Fargo, North Dakota, United States
Akron, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Columbus, Ohio, United States
Columbus, Ohio, United States
Norman, Oklahoma, United States
Corvallis, Oregon, United States
Portland, Oregon, United States
Downingtown, Pennsylvania, United States
Erie, Pennsylvania, United States
Jefferson Hills, Pennsylvania, United States
Penndel, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Upper Saint Clair, Pennsylvania, United States
Anderson, South Carolina, United States
Clinton, South Carolina, United States
Goose Creek, South Carolina, United States
Greer, South Carolina, United States
Bristol, Tennessee, United States
Nashville, Tennessee, United States
Fort Worth, Texas, United States
Galveston, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Fredericksburg, Virginia, United States
Williamsburg, Virginia, United States
Lakewood, Washington, United States
Marshfield, Wisconsin, United States
San Juan, , Puerto Rico
Toa Baja, , Puerto Rico
Countries
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Related Links
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Related Info
Other Identifiers
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UTN: U1111-1111-4478
Identifier Type: OTHER
Identifier Source: secondary_id
FIM07
Identifier Type: -
Identifier Source: org_study_id