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

Use our guide to learn which trials are right for you!

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
1748
mi
from 43215
Coeur D Alene, ID
Click here to add this to my saved trials
1333
mi
from 43215
Albuquerque, NM
Click here to add this to my saved trials
302
mi
from 43215
Ashville, NC
Click here to add this to my saved trials
1154
mi
from 43215
Aurora, CO
Click here to add this to my saved trials
344
mi
from 43215
Baltimore, MD
Click here to add this to my saved trials
492
mi
from 43215
Birmingham, AL
Click here to add this to my saved trials
1006
mi
from 43215
Bismarck, ND
Click here to add this to my saved trials
643
mi
from 43215
Boston, MA
Click here to add this to my saved trials
522
mi
from 43215
Bridgeport, CT
Click here to add this to my saved trials
Charleston, South Carolina 29412
527
mi
from 43215
Charleston, SC
Click here to add this to my saved trials
362
mi
from 43215
Chattanooga, TN
Click here to add this to my saved trials
127
mi
from 43215
Cleveland, OH
Click here to add this to my saved trials
910
mi
from 43215
Dallas, TX
Click here to add this to my saved trials
749
mi
from 43215
Daytona Beach, FL
Click here to add this to my saved trials
430
mi
from 43215
Decatur, GA
Click here to add this to my saved trials
698
mi
from 43215
Fort Smith, AR
Click here to add this to my saved trials
1518
mi
from 43215
Helena, MT
Click here to add this to my saved trials
1751
mi
from 43215
Henderson, NV
Click here to add this to my saved trials
166
mi
from 43215
Indianapolis, IN
Click here to add this to my saved trials
609
mi
from 43215
Lebanon, NH
Click here to add this to my saved trials
188
mi
from 43215
Louisville, KY
Click here to add this to my saved trials
481
mi
from 43215
New York, NY
Click here to add this to my saved trials
468
mi
from 43215
Newark, NJ
Click here to add this to my saved trials
422
mi
from 43215
Norfolk, VA
Click here to add this to my saved trials
682
mi
from 43215
Omaha, NE
Click here to add this to my saved trials
624
mi
from 43215
Overland Park, KS
Click here to add this to my saved trials
288
mi
from 43215
Park Ridge, IL
Click here to add this to my saved trials
416
mi
from 43215
Philadelphia, PA
Click here to add this to my saved trials
1662
mi
from 43215
Phoenix, AZ
Click here to add this to my saved trials
559
mi
from 43215
Rochester, MN
Click here to add this to my saved trials
1513
mi
from 43215
Salt Lake City, UT
Click here to add this to my saved trials
2091
mi
from 43215
Santa Clara, CA
Click here to add this to my saved trials
627
mi
from 43215
St. Joseph, MO
Click here to add this to my saved trials
752
mi
from 43215
Tulsa, OK
Click here to add this to my saved trials
615
mi
from 43215
Warwick, RI
Click here to add this to my saved trials