Multi-Year Study of Fluzone High-Dose Influenza Vaccine Compared With Fluzone® Vaccine in Adults Aged 65 Years and Older - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00976027

Purpose

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 prevention of laboratory-confirmed influenza caused by viral types/subtypes that are antigenically similar to those contained in the respective annual vaccine formulations.

Secondary objectives:

To compare the clinical efficacy of Fluzone High Dose vaccine with that of Fluzone® vaccine in elderly adults, with respect to laboratory-confirmed influenza illness caused by any type or subtype of influenza virus.
To compare the clinical efficacy of Fluzone High Dose vaccine with that of Fluzone® vaccine in elderly adults, in preventing culture-confirmed influenza illness caused by viral types/subtypes antigenically similar to those contained in the respective annual vaccine formulations.

Condition	Intervention	Phase
Influenza	Biological: Trivalent inactivated influenza vaccine High Dose Biological: Trivalent inactivated influenza vaccine	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Multi-Year Efficacy Study of Fluzone High-Dose Trivalent Vaccine Compared With Fluzone® Vaccine In Adults ≥ 65 Years of Age

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

To compare the clinical efficacy of Fluzone High Dose vaccine with that of Fluzone® vaccine in elderly adults [ Time Frame: 14 days after vaccination until April 30 of following year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare the clinical efficacy of Fluzone High Dose vaccine with that of Fluzone® vaccine in elderly adults, with respect to laboratory-confirmed influenza illness caused by any type or subtype of influenza virus [ Time Frame: 14 days after vaccination until April 30 of following year ] [ Designated as safety issue: No ]

Enrollment:	9172
Study Start Date:	September 2009
Estimated Study Completion Date:	April 2012
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Fluzone High Dose Group	Biological: Trivalent inactivated influenza vaccine High Dose 0.5 mL, Intramuscular
Active Comparator: Fluzone® Group	Biological: Trivalent inactivated influenza vaccine 0.5 mL, Intramuscular Other Name: Fluzone®

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 respiratory tract of vaccinated individuals with ILI will be confirmed by two methods.

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00976027

Show 95 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Medical Director

Sanofi Pasteur Inc.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Medical Director, Sanofi Pasteur Inc.
ClinicalTrials.gov Identifier:	NCT00976027 History of Changes
Other Study ID Numbers:	FIM07, UTN: U1111-1111-4478
Study First Received:	September 11, 2009
Last Updated:	August 12, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Influenza
Respiratory Tract Infections
Influenza-like illness

Elderly
Fluzone®
Efficacy

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections

Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on February 09, 2012