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

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

sites

Clinical Trial Facility in Warwick Rhode Island

Warwick, Rhode Island 02886

from

Warwick, RI