Clinical trial NCT00976027: Multi-Year Study of Fluzone High-Dose Influenza Vaccine Compared With Fluzone® Vaccine in Adults Aged 65 Years and Older
Official title: Multi-Year Efficacy Study of Fluzone High-Dose Trivalent Vaccine Compared With Fluzone® Vaccine In Adults ≥ 65 Years of Age
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza
Respiratory Tract Infections
Influenza-like illness
Elderly
Fluzone®
Efficacy
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-09-14
Enrollment: 9172
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 vaccine and that of Fluzone® vaccine in the elderly.

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: The occurrence of influenza-like illness (ILI) will be determined in elderly participants vaccinated with either Fluzone High Dose or Fluzone® vaccine.

The presence of influenza virus in the respiratory tract of vaccinated individuals with ILI will be confirmed by two methods.

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 in another interventional clinical trial investigating a vaccine, drug, medical device, herbal supplement, or a medical procedure in the 4 weeks preceding the trial vaccination or planned participation in another clinical trial investigating a vaccine, drug, medical device, herbal supplement, or a medical procedure during each year of participation in the study trial.
* 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.

Primary outcomes:
measure: Efficacy of Fluzone High Dose Relative to Fluzone in the Prevention of Laboratory Confirmed Influenza Caused by Viral Types and Subtypes That Are Antigenically Similar to Those Contained in the Respective Annual Vaccine Formulations.
timeFrame: Day 0 (pre-vaccination) up to Year 1 post-vaccination
Secondary outcomes:
Other outcomes:
measure: Number of Participants Reporting Events Associated With All Cases of Protocol Defined Influenza-Like Illness (ILI)
timeFrame: Day 0 (pre-vaccination) up to the end of the influenza season
measure: Number of Participants Reporting Events Associated With All Cases of CDC Defined Influenza-Like Illness (ILI)
timeFrame: Day 14 (post-vaccination) up to 12 Months post-vaccination
measure: Number of Participants Reporting Adverse Events of Special Interest (AESIs) and Serious Adverse Events Post-vaccination With Either Fluzone High-Dose and Fluzone
timeFrame: Day 0 before vaccination to Day 180 after vaccination
Locations:
city: Birmingham
country: United States
state: Alabama
city: Glendale
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: Scottsdale
country: United States
state: Arizona
city: Tempe
country: United States
state: Arizona
city: Fountain Valley
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Sacramento
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: Ridgefield
country: United States
state: Connecticut
city: Celebration
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: Cutler Bay
country: United States
state: Florida
city: Deerfield Beach
country: United States
state: Florida
city: Inverness
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Pinellas Park
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: South Miami
country: United States
state: Florida
city: Stockbridge
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Peoria
country: United States
state: Illinois
city: South Bend
country: United States
state: Indiana
city: Dubuque
country: United States
state: Iowa
city: Arkansas City
country: United States
state: Kansas
city: Lenexa
country: United States
state: Kansas
city: Lexena
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: Metairie
country: United States
state: Louisiana
city: Columbia
country: United States
state: Maryland
city: Elkridge
country: United States
state: Maryland
city: Greenbelt
country: United States
state: Maryland
city: Brockton
country: United States
state: Massachusetts
city: Haverhill
country: United States
state: Massachusetts
city: Chaska
country: United States
state: Minnesota
city: Edina
country: United States
state: Minnesota
city: St. Louis
country: United States
state: Missouri
city: Missoula
country: United States
state: Montana
city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
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: High Point
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: Winston Salem
country: United States
state: North Carolina
city: Fargo
country: United States
state: North Dakota
city: Akron
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Norman
country: United States
state: Oklahoma
city: Corvallis
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Downingtown
country: United States
state: Pennsylvania
city: Erie
country: United States
state: Pennsylvania
city: Jefferson Hills
country: United States
state: Pennsylvania
city: Penndel
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Upper St Clair
country: United States
state: Pennsylvania
city: Anderson
country: United States
state: South Carolina
city: Clinton
country: United States
state: South Carolina
city: Goose Creek
country: United States
state: South Carolina
city: Greer
country: United States
state: South Carolina
city: Bristol
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Fort Worth
country: United States
state: Texas
city: Galveston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Fredericksburg
country: United States
state: Virginia
city: Williamsburg
country: United States
state: Virginia
city: Lakewood
country: United States
state: Washington
city: Marshfield
country: United States
state: Wisconsin
city: San Juan
country: Puerto Rico
city: Toa Baja
country: Puerto Rico
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: