A Study of Fluzone® High-Dose Vaccine Compared With Fluzone® Vaccine In Elderly Adults
NCT ID: NCT01427309
Last Updated: 2015-04-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
31989 participants
INTERVENTIONAL
2011-09-30
2013-11-30
Brief Summary
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Primary Objective:
* To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to laboratory-confirmed influenza caused by any influenza viral types/subtypes, associated with the occurrence of a protocol-defined influenza-like-illnesses (ILI).
Secondary Objectives:
* To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to laboratory-confirmed influenza, caused by any influenza viral types/subtypes, associated with the occurrence of a protocol-defined ILI.
* To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to culture-confirmed influenza, caused by any influenza viral types/subtypes, associated with the occurrence of a protocol-defined ILI.
* To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to culture-confirmed influenza caused by viral types/subtypes antigenically similar to those contained in the respective annual vaccine formulations, associated with the occurrence of a modified Centers for Disease Control and Prevention (CDC)-defined ILI.
* To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to culture-confirmed influenza caused by any influenza viral types/subtypes, associated with the occurrence of a modified CDC-defined ILI.
* To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to culture-confirmed influenza caused by viral types/subtypes antigenically similar to those contained in the respective annual vaccine formulations, associated with the occurrence of a respiratory illness.
* To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to culture-confirmed influenza caused by any influenza viral types/subtypes, associated with the occurrence of a respiratory illness.
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Detailed Description
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The duration of each participant's participation in the respective study year will be 6 to 8 months, depending on the time of enrollment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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High Dose Trivalent Inactivated Influenza Vaccine
Participants will receive an injection of High Dose Trivalent Inactivated Influenza Vaccine
High Dose Trivalent Inactivated Influenza Vaccine
0.5 mL Intramuscular
Trivalent Inactivated Influenza Vaccine
Participants will receive an injection of the Trivalent Inactivated Influenza vaccine
Trivalent Inactivated Influenza Vaccine
0.5 mL, Intramuscular
Interventions
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High Dose Trivalent Inactivated Influenza Vaccine
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 High-Dose or 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 contraindicating intramuscular (IM) vaccination, as judged by the investigator
* Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination, as judged by the investigator
* Current alcohol abuse or drug addiction
* Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
* Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
* Moderate or severe acute illness with or without fever (oral temperature \> 99.0ºF \[\> 37.2ºC\]). If this contraindication exists, vaccination will be deferred until the individual has been medically stable and/or afebrile (temperature ≤ 99.0 ºF \[≤ 37.2ºC\]) for at least 24 hours
* Signs and symptoms of an acute infectious respiratory illness. If this exists, vaccination will be deferred until the symptoms resolve.
65 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 Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
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Mobile, Alabama, United States
Chandler, Arizona, United States
Glendale, Arizona, United States
Glendale, Arizona, United States
Mesa, Arizona, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tempe, Arizona, United States
Harrisburg, Arkansas, United States
Anaheim, California, United States
La Mesa, California, United States
Oceanside, California, United States
Redding, California, United States
San Diego, 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
Milford, Connecticut, United States
Brooksville, Florida, United States
Clearwater, Florida, United States
Clearwater, Florida, United States
Coral Gables, Florida, United States
Crystal River, Florida, United States
DeLand, Florida, United States
Jacksonville, Florida, United States
Melbourne, Florida, United States
Pembroke Pine, Florida, United States
Pinellas Park, Florida, United States
Sarasota, Florida, United States
Stockbridge, Georgia, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Peoria, Illinois, United States
Mishawaka, Indiana, United States
Lenexa, Kansas, United States
Newton, Kansas, United States
Overland Park, Kansas, United States
Prairie Village, Kansas, United States
Wichita, Kansas, United States
Wichita, Kansas, United States
Bardstown, Kentucky, United States
Lexington, Kentucky, United States
Columbia, Maryland, United States
Elkridge, Maryland, United States
Rockville, Maryland, United States
Brockton, Massachusetts, United States
Haverhill, Massachusetts, United States
Edina, Minnesota, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Missoula, Montana, United States
Bellevue, Nebraska, United States
Omaha, Nebraska, United States
Las Vega, Nevada, United States
Newington, New Hampshire, United States
Edison, New Jersey, 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
Charlotte, North Carolina, United States
Hickory, North Carolina, United States
Raleigh, North Carolina, United States
Raleigh, North Carolina, United States
Salisbury, North Carolina, United States
Wilmington, North Carolina, United States
Winston-Salem, North Carolina, United States
Fargo, North Dakota, United States
Idaho Falls, North Dakota, United States
Akron, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Norman, Oklahoma, United States
Erie, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Scranton, Pennsylvania, United States
Warwick, Rhode Island, United States
Anderson, South Carolina, United States
Clinton, South Carolina, United States
Greer, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Spartanburg, South Carolina, United States
Bristol, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Fort Worth, Texas, United States
San Antonio, Texas, United States
Tomball, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
South Jordan, Utah, United States
West Jordan, Utah, United States
Norfolk, Virginia, United States
Williamsburg, Virginia, United States
Winchester, Virginia, United States
Coquitlam, British Columbia, Canada
Mount Pearl, Newfoundland and Labrador, Canada
Truro, Nova Scotia, Canada
Greater Sudbury, Ontario, Canada
Toronto, Ontario, Canada
Sherbrooke, Quebec, Canada
Bayamón, , Puerto Rico
San Juan, , Puerto Rico
Countries
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References
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DiazGranados CA, Dunning AJ, Kimmel M, Kirby D, Treanor J, Collins A, Pollak R, Christoff J, Earl J, Landolfi V, Martin E, Gurunathan S, Nathan R, Greenberg DP, Tornieporth NG, Decker MD, Talbot HK. Efficacy of high-dose versus standard-dose influenza vaccine in older adults. N Engl J Med. 2014 Aug 14;371(7):635-45. doi: 10.1056/NEJMoa1315727.
Becker DL, Chit A, DiazGranados CA, Maschio M, Yau E, Drummond M. High-dose inactivated influenza vaccine is associated with cost savings and better outcomes compared to standard-dose inactivated influenza vaccine in Canadian seniors. Hum Vaccin Immunother. 2016 Dec;12(12):3036-3042. doi: 10.1080/21645515.2016.1215395. Epub 2016 Sep 26.
Dunning AJ, DiazGranados CA, Voloshen T, Hu B, Landolfi VA, Talbot HK. Correlates of Protection against Influenza in the Elderly: Results from an Influenza Vaccine Efficacy Trial. Clin Vaccine Immunol. 2016 Jan 13;23(3):228-35. doi: 10.1128/CVI.00604-15.
Related Links
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Related Info
Other Identifiers
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U1111-1120-1300
Identifier Type: OTHER
Identifier Source: secondary_id
FIM12
Identifier Type: -
Identifier Source: org_study_id
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