Multi-Year Study of Fluzone High-Dose Influenza Vaccine Compared With Fluzone® Vaccine in Adults Aged 65 Years and Older

Stopped early · Phase 3

Conditions studied: Influenza

In brief

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.

Key facts

Study ID

NCT00976027

Run by

Sanofi

People needed

9172

Starts

2009-09-01

Expected to finish

2012-04-01

Last updated by the study team

2012-08-01

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Glendale, Arizona, United States
• Study site — Mesa, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Phoenix, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Tempe, Arizona, United States
• Study site — Fountain Valley, California, United States
• Study site — Los Angeles, California, United States
• Study site — Oceanside, California, United States
• Study site — Sacramento, California, United States
• Study site — Santa Rosa, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Milford, Connecticut, United States
• Study site — Ridgefield, Connecticut, United States
• Study site — Celebration, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — Coral Gables, Florida, United States
• Study site — Crystal River, Florida, United States
• Study site — Cutler Bay, Florida, United States
• Study site — Deerfield Beach, Florida, United States
• Study site — Inverness, Florida, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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