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

July 24, 2012 updated by: Sanofi

Multi-Year Efficacy Study of Fluzone High-Dose Trivalent Vaccine Compared With Fluzone® Vaccine In Adults ≥ 65 Years of Age

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

9172

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00918
      • Toa Baja, Puerto Rico, 00949
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
    • Arizona
      • Glendale, Arizona, United States, 85308
      • Mesa, Arizona, United States, 85203
      • Phoenix, Arizona, United States, 85050
      • Phoenix, Arizona, United States, 85028
      • Scottsdale, Arizona, United States, 85251
      • Tempe, Arizona, United States, 85283
    • California
      • Fountain Valley, California, United States, 92708
      • Los Angeles, California, United States, 90057
      • Oceanside, California, United States, 92056
      • Sacramento, California, United States, 95831
      • Santa Rosa, California, United States, 95405
    • Colorado
      • Aurora, Colorado, United States, 80045
      • Colorado Springs, Colorado, United States, 80909
      • Colorado Springs, Colorado, United States, 80907
    • Connecticut
      • Milford, Connecticut, United States, 06460
      • Ridgefield, Connecticut, United States, 06877
    • Florida
      • Celebration, Florida, United States, 34747
      • Clearwater, Florida, United States, 33756
      • Clearwater, Florida, United States, 33761
      • Coral Gables, Florida, United States, 33134
      • Crystal River, Florida, United States, 34429
      • Cutler Bay, Florida, United States, 33189
      • Deerfield Beach, Florida, United States, 33442
      • Inverness, Florida, United States, 34452
      • Jacksonville, Florida, United States, 32205
      • Jacksonville, Florida, United States, 32216
      • Melbourne, Florida, United States, 32935
      • Miami, Florida, United States, 33126
      • Pembroke Pines, Florida, United States, 33026
      • Pinellas Park, Florida, United States, 33781
      • Sarasota, Florida, United States, 34239
      • South Miami, Florida, United States, 33143
    • Georgia
      • Stockbridge, Georgia, United States, 30281
    • Illinois
      • Chicago, Illinois, United States, 60637
      • Peoria, Illinois, United States, 61602
    • Indiana
      • South Bend, Indiana, United States, 46601
    • Iowa
      • Dubuque, Iowa, United States, 52002
    • Kansas
      • Arkansas City, Kansas, United States, 67005
      • Lenexa, Kansas, United States, 66219
      • Lexena, Kansas, United States, 66215
      • Newton, Kansas, United States, 67114
      • Overland Park, Kansas, United States, 66212
      • Prairie Village, Kansas, United States, 66206
      • Wichita, Kansas, United States, 67205
    • Louisiana
      • Metairie, Louisiana, United States, 70006
    • Maryland
      • Columbia, Maryland, United States, 21042
      • Elkridge, Maryland, United States, 21075
      • Greenbelt, Maryland, United States, 20770
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
      • Haverhill, Massachusetts, United States, 01830
    • Minnesota
      • Chaska, Minnesota, United States, 55318
      • Edina, Minnesota, United States, 55435
    • Missouri
      • St. Louis, Missouri, United States, 63141
    • Montana
      • Missoula, Montana, United States, 59808
    • Nebraska
      • Omaha, Nebraska, United States, 68134
    • Nevada
      • Las Vegas, Nevada, United States, 89104
    • New York
      • Rochester, New York, United States, 14642
    • North Carolina
      • Cary, North Carolina, United States, 27518
      • Charlotte, North Carolina, United States, 28209
      • Hickory, North Carolina, United States, 28601
      • High Point, North Carolina, United States, 27262
      • Raleigh, North Carolina, United States, 27607
      • Raleigh, North Carolina, United States, 27612
      • Salisbury, North Carolina, United States, 28144
      • Winston Salem, North Carolina, United States, 27103
    • North Dakota
      • Fargo, North Dakota, United States, 58104
    • Ohio
      • Akron, Ohio, United States, 44311
      • Cleveland, Ohio, United States, 44122
      • Columbus, Ohio, United States, 43210
      • Columbus, Ohio, United States, 43213
      • Columbus, Ohio, United States, 43201
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
    • Oregon
      • Corvallis, Oregon, United States, 97330
      • Portland, Oregon, United States, 97203
    • Pennsylvania
      • Downingtown, Pennsylvania, United States, 19335
      • Erie, Pennsylvania, United States, 16506
      • Jefferson Hills, Pennsylvania, United States, 15025
      • Penndel, Pennsylvania, United States, 19047
      • Pittsburgh, Pennsylvania, United States, 15241
      • Upper St Clair, Pennsylvania, United States, 15241
    • South Carolina
      • Anderson, South Carolina, United States, 29621
      • Clinton, South Carolina, United States, 29325
      • Goose Creek, South Carolina, United States, 29445
      • Greer, South Carolina, United States, 29651
    • Tennessee
      • Bristol, Tennessee, United States, 37620
      • Nashville, Tennessee, United States, 37212
    • Texas
      • Fort Worth, Texas, United States, 76107
      • Galveston, Texas, United States, 77555
      • Houston, Texas, United States, 77074
      • San Antonio, Texas, United States, 78229
    • Utah
      • Salt Lake City, Utah, United States, 84124
    • Virginia
      • Fredericksburg, Virginia, United States, 22401
      • Williamsburg, Virginia, United States, 23185
    • Washington
      • Lakewood, Washington, United States, 98499
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluzone® High Dose Group
Biological: Trivalent inactivated influenza vaccine High Dose
0.5 mL, Intramuscular
Other Names:
  • Fluzone® High Dose
Active Comparator: Fluzone® Group
Biological: Trivalent inactivated influenza vaccine
0.5 mL, Intramuscular
Other Names:
  • Fluzone®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 0 (pre-vaccination) up to Year 1 post-vaccination

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Day 0 (pre-vaccination) up to the end of the influenza season
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).
Day 14 (post-vaccination) up to 12 Months post-vaccination
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
Day 0 before vaccination to Day 180 after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

September 11, 2009

First Submitted That Met QC Criteria

September 11, 2009

First Posted (Estimate)

September 14, 2009

Study Record Updates

Last Update Posted (Estimate)

August 1, 2012

Last Update Submitted That Met QC Criteria

July 24, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIM07
  • UTN: U1111-1111-4478 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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