A Study of Fluzone® High-Dose Vaccine Compared With Fluzone® Vaccine In Elderly Adults



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:10/21/2012
Start Date:September 2011
End Date:May 2013
Contact:Public Registry Sanofi Pasteur
Email:RegistryContactUs@sanofipasteur.com

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Efficacy Study of Fluzone® High-Dose Vaccine Compared With Fluzone® Vaccine In Elderly Adults


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 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.


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.

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.
We found this trial at
35
sites
156
mi
from
Tulsa, OK
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523
mi
from
Albuquerque, NM
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858
mi
from
Ashville, NC
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402
mi
from
Aurora, CO
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1148
mi
from
Baltimore, MD
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683
mi
from
Birmingham, AL
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645
mi
from
Bismarck, ND
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1444
mi
from
Boston, MA
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1330
mi
from
Bridgeport, CT
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Charleston, South Carolina 29412
1064
mi
from
Charleston, SC
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719
mi
from
Chattanooga, TN
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895
mi
from
Cleveland, OH
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1176
mi
from
Coeur D Alene, ID
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349
mi
from
Dallas, TX
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1128
mi
from
Daytona Beach, FL
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805
mi
from
Decatur, GA
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249
mi
from
Fort Smith, AR
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946
mi
from
Helena, MT
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954
mi
from
Henderson, NV
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643
mi
from
Indianapolis, IN
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1393
mi
from
Lebanon, NH
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657
mi
from
Louisville, KY
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1290
mi
from
New York, NY
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1278
mi
from
Newark, NJ
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1181
mi
from
Norfolk, VA
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262
mi
from
Omaha, NE
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190
mi
from
Overland Park, KS
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604
mi
from
Park Ridge, IL
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1225
mi
from
Philadelphia, PA
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853
mi
from
Phoenix, AZ
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515
mi
from
Rochester, MN
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779
mi
from
Salt Lake City, UT
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1318
mi
from
Santa Clara, CA
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211
mi
from
St. Joseph, MO
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1421
mi
from
Warwick, RI
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