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

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 3

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: Influenza Vaccines

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:

Efficacy of Fluzone High Dose Relative to Fluzone in the Prevention of Laboratory Confirmed Influenza Caused by Viral Types and Subtypes That Are Antigenically Similar to Those Contained in the Respective Annual Vaccine Formulations. [ Time Frame: Day 0 (pre-vaccination) up to Year 1 post-vaccination ] [ Designated as safety issue: No ]
The presence (and specific identification) of influenza virus in the respiratory tract of vaccinated individuals with influenza like illness (ILI) was confirmed by tissue culture (for infectious virus) and molecular techniques (polymerase chain reaction based assays), with results reported for cases cause by any viral type or subtype.

Other Outcome Measures:

Number of Participants Reporting Events Associated With All Cases of Protocol Defined Influenza-Like Illness (ILI) [ Time Frame: Day 0 (pre-vaccination) up to the end of the influenza season ] [ Designated as safety issue: No ]
Events associated with Protocol defined influenza-like Illnesses (ILI) were defined as pneumonia, new onset or exacerbation of pre-existing cardio respiratory conditions, health care visits, and medication use (including nonsteroidal anti-inflammatory drugs, NSAIDs).
Number of Participants Reporting Events Associated With All Cases of CDC Defined Influenza-Like Illness (ILI) [ Time Frame: Day 14 (post-vaccination) up to 12 Months post-vaccination ] [ Designated as safety issue: No ]
Events associated with CDC defined influenza-like Illnesses (ILI) were defined as pneumonia, new onset or exacerbation of pre existing cardio respiratory conditions, health care visits, and medication use (including nonsteroidal anti-inflammatory drugs, NSAIDs).
Number of Participants Reporting Adverse Events of Special Interest (AESIs) and Serious Adverse Events Post-vaccination With Either Fluzone High-Dose and Fluzone [ Time Frame: Day 0 before vaccination to Day 180 after vaccination ] [ Designated as safety issue: No ]
Adverse events of special interest: new onset of Guillain Barre Syndrome (GBS), Bell's Palsy, encephalitis or myelitis, optic neuritis, Stevens Johnson Syndrome, and toxic epidermal necrolysis

Enrollment:	9172
Study Start Date:	September 2009
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 Other Name: Fluzone® High Dose
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 98 Study Locations

Sponsors and Collaborators

Sanofi

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:	Sanofi
ClinicalTrials.gov Identifier:	NCT00976027 History of Changes
Other Study ID Numbers:	FIM07, UTN: U1111-1111-4478
Study First Received:	September 11, 2009
Results First Received:	June 19, 2012
Last Updated:	July 24, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi:

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 May 19, 2013