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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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5 November 2012 |
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Main ID: |
NCT01427309 |
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Date of registration:
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30/08/2011 |
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Primary sponsor: |
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Public title:
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A Study of Fluzone® High-Dose Vaccine Compared With Fluzone® Vaccine In Elderly Adults
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Scientific title:
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Efficacy Study of Fluzone® High-Dose Vaccine Compared With Fluzone® Vaccine In Elderly Adults |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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26000 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01427309 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Countries of recruitment
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Canada
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Puerto Rico
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United States
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Contacts
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Name:
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Medical Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi Pasteur Inc. |
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Key inclusion & exclusion criteria
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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.
Age minimum:
65 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Influenza
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Intervention(s)
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Biological: High Dose Trivalent Inactivated Influenza Vaccine
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Biological: Trivalent Inactivated Influenza Vaccine
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Primary Outcome(s)
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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).
[Time Frame: = 14 days post-vaccination]
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Secondary Outcome(s)
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Occurrences of culture-confirmed influenza caused by any influenza viral types/subtypes, in association with a modified CDC-defined ILI.
[Time Frame: = 14 days post-vaccination]
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Occurrences of culture-confirmed influenza caused by any influenza viral types/subtypes, in association with a protocol-defined ILI.
[Time Frame: = 14 days post-vaccination]
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Occurrences of culture-confirmed influenza caused by any influenza viral types/subtypes, in association with a respiratory illness.
[Time Frame: = 14 days post-vaccination]
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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 ILI.
[Time Frame: = 14 days post-vaccination]
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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 ILI.
[Time Frame: = 14 days post-vaccination]
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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.
[Time Frame: = 14 days post-vaccination]
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Secondary ID(s)
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FIM12
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U1111-1120-1300
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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