Status:
TERMINATED
Multi-Year Study of Fluzone High-Dose Influenza Vaccine Compared With Fluzone® Vaccine in Adults Aged 65 Years and Older
Lead Sponsor:
Sanofi
Conditions:
Influenza
Eligibility:
All Genders
65+ years
Phase:
PHASE3
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...
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 respirat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
9172 Patients enrolled
Trial Details
Trial ID
NCT00976027
Start Date
September 1 2009
End Date
April 1 2012
Last Update
August 1 2012
Active Locations (98)
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1
Birmingham, Alabama, United States, 35209
2
Glendale, Arizona, United States, 85308
3
Mesa, Arizona, United States, 85203
4
Phoenix, Arizona, United States, 85028