Clinical trial NCT01427309: A Study of Fluzone® High-Dose Vaccine Compared With Fluzone® Vaccine In Elderly Adults
Official title: Efficacy Study of Fluzone® High-Dose Vaccine Compared With Fluzone® Vaccine In Elderly Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: Influenza
Trivalent Inactivated Influenza Vaccine
High-Dose Trivalent Inactivated Influenza Vaccine
Fluzone® High-Dose
Influenza vaccines
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-09-01
Enrollment: 31989
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to determine the efficacy of Fluzone High-Dose compared to standard dose Fluzone for laboratory-confirmed or culture-confirmed influenza caused by influenza types/subtypes that are similar (for laboratory-confirmed) or antigenically similar (for culture-confirmed) to those contained in the respective annual vaccine formulations.

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.

Detailed description: The trial will span 2 influenza seasons. Each study year, participants will be randomized to receive one dose of either Fluzone® High-Dose or Fluzone® vaccine prior to the start of the influenza season and will be followed until the end of each season.

The duration of each participant's participation in the respective study year will be 6 to 8 months, depending on the time of enrollment.

Eligibility criteria: Inclusion Criteria:

* Aged ≥ 65 years on the day of vaccination
* Informed consent form signed and dated
* Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

* Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination), or planned participation during each year of the trial period, in another clinical trial investigating a vaccine, drug, medical device, or medical procedure (Note: Concomitant participation in an observational trial is acceptable)
* 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.

Primary outcomes:
measure: Occurrences of Culture- or Polymerase Chain Reaction (PCR)-Confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Protocol-defined Influenza-like Illness (ILI).
timeFrame: ≥14 days post-vaccination
Secondary outcomes:
measure: Occurrences of Culture-confirmed Influenza Caused by Influenza Viral Types/Subtypes That Are Antigenically Similar to Those Contained in the Vaccine Formulations, in Association With a Protocol-defined Influenza-like Illness (ILI)
timeFrame: ≥14 days post-vaccination
measure: Occurrences of Culture-confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Protocol-defined Influenza-like Illness
timeFrame: ≥14 days post-vaccination
measure: Occurrences of Culture-confirmed Influenza Caused by Influenza Viral Types/Subtypes That Are Antigenically Similar to Those Contained in the Vaccine Formulations, in Association With a Modified CDC-defined Influenza-like Illness.
timeFrame: ≥14 days post-vaccination
measure: Occurrences of Culture-confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Modified CDC-defined Influenza-like Illness
timeFrame: ≥14 days post-vaccination
measure: Occurrences of Culture-confirmed Influenza Caused by Influenza Viral Types/Subtypes That Are Antigenically Similar to Those Contained in the Vaccine Formulations, in Association With a Respiratory Illness
timeFrame: ≥14 days post-vaccination
measure: Occurrences of Culture-confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Respiratory Illness
timeFrame: ≥14 days post-vaccination
Other outcomes:
measure: Safety Overview After Injection With Either Fluzone High Dose or Fluzone Vaccine Through the End of Surveillance Period
timeFrame: Day 0 up to Day 240 post-vaccination
Locations:
city: Mobile
country: United States
state: Alabama
city: Chandler
country: United States
state: Arizona
city: Glendale
country: United States
state: Arizona
city: Glendale
country: United States
state: Arizona
city: Mesa
country: United States
state: Arizona
city: Mesa
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Tempe
country: United States
state: Arizona
city: Harrisburg
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: La Mesa
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Redding
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Colorado Springs
country: United States
state: Colorado
city: Colorado Springs
country: United States
state: Colorado
city: Milford
country: United States
state: Connecticut
city: Milford
country: United States
state: Connecticut
city: Brooksville
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Coral Gables
country: United States
state: Florida
city: Crystal River
country: United States
state: Florida
city: DeLand
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: Pembroke Pine
country: United States
state: Florida
city: Pinellas Park
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Stockbridge
country: United States
state: Georgia
city: Boise
country: United States
state: Idaho
city: Chicago
country: United States
state: Illinois
city: Peoria
country: United States
state: Illinois
city: Mishawaka
country: United States
state: Indiana
city: Lenexa
country: United States
state: Kansas
city: Newton
country: United States
state: Kansas
city: Overland Park
country: United States
state: Kansas
city: Prairie Village
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Bardstown
country: United States
state: Kentucky
city: Lexington
country: United States
state: Kentucky
city: Columbia
country: United States
state: Maryland
city: Elkridge
country: United States
state: Maryland
city: Rockville
country: United States
state: Maryland
city: Brockton
country: United States
state: Massachusetts
city: Haverhill
country: United States
state: Massachusetts
city: Edina
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Missoula
country: United States
state: Montana
city: Bellevue
country: United States
state: Nebraska
city: Omaha
country: United States
state: Nebraska
city: Las Vega
country: United States
state: Nevada
city: Newington
country: United States
state: New Hampshire
city: Edison
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Binghamton
country: United States
state: New York
city: Endwell
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Cary
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Salisbury
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Winston Salem
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Idaho Falls
country: United States
state: North Dakota
city: Akron
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Norman
country: United States
state: Oklahoma
city: Erie
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Scranton
country: United States
state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Anderson
country: United States
state: South Carolina
city: Clinton
country: United States
state: South Carolina
city: Greer
country: United States
state: South Carolina
city: Mt. Pleasant
country: United States
state: South Carolina
city: Spartanburg
country: United States
state: South Carolina
city: Bristol
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Fort Worth
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Tomball
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: South Jordan
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Williamsburg
country: United States
state: Virginia
city: Winchester
country: United States
state: Virginia
city: Coquitlam
country: Canada
state: British Columbia
city: Mount Pearl
country: Canada
state: Newfoundland and Labrador
city: Truro
country: Canada
state: Nova Scotia
city: Sudbury
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Sherbrooke
country: Canada
state: Quebec
city: Bayamon
country: Puerto Rico
city: San Juan
country: Puerto Rico
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.