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

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ClinicalTrials.gov Identifier: NCT00976027
Recruitment Status : Terminated (No safety concerns, study terminated due to lack of primary endpoint cases in 2009-2010 Flu season (coincided with H1N1 Pandemic) Subjects followed per-protocol)
First Posted : September 14, 2009
Results First Posted : July 25, 2012
Last Update Posted : August 1, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Influenza Biological: Trivalent inactivated influenza vaccine High Dose Biological: Trivalent inactivated influenza vaccine Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2009
Actual Primary Completion Date : May 2011
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arms and Interventions
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Arm Intervention/treatment
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®


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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:
  1. 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 ]
    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).

  2. 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 ]
    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).

  3. 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 ]
    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


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00976027


Locations
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Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Medical Director Sanofi Pasteur Inc.
More Information
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Additional Information:

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00976027    
Other Study ID Numbers: FIM07
UTN: U1111-1111-4478 ( Other Identifier: WHO )
First Posted: September 14, 2009    Key Record Dates
Results First Posted: July 25, 2012
Last Update Posted: August 1, 2012
Last Verified: July 2012
Keywords provided by Sanofi:
Influenza
Respiratory Tract Infections
Influenza-like illness
 Elderly
Fluzone®
Efficacy
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs