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

NCT00976027 | Terminated Phase 3 Results DMC

• 2 other identifiers: FIM07UTN: U1111-1111-4478
• Study Type: interventional
• Target: 9,172
• Locations: 2 countries
• Sites: 98

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.

Conditions

Influenza

Keywords

Influenza; Respiratory Tract Infections; Influenza-like illness; Elderly; Fluzone®; Efficacy

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (3)

• Number of Participants Reporting Events Associated With All Cases of Protocol Defined Influenza-Like Illness (ILI)

  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)

  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

  Day 0 before vaccination to Day 180 after vaccination

Study Arms (2)

Fluzone® High Dose Group

EXPERIMENTAL

Biological: Trivalent inactivated influenza vaccine High Dose

Fluzone® Group

ACTIVE COMPARATOR

Biological: Trivalent inactivated influenza vaccine

Interventions

Trivalent inactivated influenza vaccine High Dose BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Fluzone® High Dose

Fluzone® High Dose Group

Trivalent inactivated influenza vaccine BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Fluzone®

Fluzone® Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (98)

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Birmingham, Alabama, 35209, United States

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Glendale, Arizona, 85308, United States

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Mesa, Arizona, 85203, United States

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Phoenix, Arizona, 85028, United States

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Phoenix, Arizona, 85050, United States

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Scottsdale, Arizona, 85251, United States

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Tempe, Arizona, 85283, United States

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Fountain Valley, California, 92708, United States

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Los Angeles, California, 90057, United States

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Oceanside, California, 92056, United States

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Sacramento, California, 95831, United States

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Santa Rosa, California, 95405, United States

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Aurora, Colorado, 80045, United States

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Colorado Springs, Colorado, 80907, United States

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Colorado Springs, Colorado, 80909, United States

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Milford, Connecticut, 06460, United States

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Ridgefield, Connecticut, 06877, United States

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Celebration, Florida, 34747, United States

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Clearwater, Florida, 33756, United States

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Clearwater, Florida, 33761, United States

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Coral Gables, Florida, 33134, United States

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Crystal River, Florida, 34429, United States

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Cutler Bay, Florida, 33189, United States

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Deerfield Beach, Florida, 33442, United States

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Inverness, Florida, 34452, United States

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Jacksonville, Florida, 32205, United States

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Jacksonville, Florida, 32216, United States

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Melbourne, Florida, 32935, United States

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Miami, Florida, 33126, United States

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Pembroke Pines, Florida, 33026, United States

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Pinellas Park, Florida, 33781, United States

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Sarasota, Florida, 34239, United States

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South Miami, Florida, 33143, United States

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Stockbridge, Georgia, 30281, United States

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Chicago, Illinois, 60637, United States

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Peoria, Illinois, 61602, United States

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South Bend, Indiana, 46601, United States

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Dubuque, Iowa, 52002, United States

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Arkansas City, Kansas, 67005, United States

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Lenexa, Kansas, 66219, United States

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Lexena, Kansas, 66215, United States

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Newton, Kansas, 67114, United States

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Overland Park, Kansas, 66212, United States

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Prairie Village, Kansas, 66206, United States

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Wichita, Kansas, 67205, United States

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Metairie, Louisiana, 70006, United States

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Columbia, Maryland, 21042, United States

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Elkridge, Maryland, 21075, United States

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Greenbelt, Maryland, 20770, United States

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Brockton, Massachusetts, 02301, United States

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Haverhill, Massachusetts, 01830, United States

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Chaska, Minnesota, 55318, United States

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Edina, Minnesota, 55435, United States

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St Louis, Missouri, 63141, United States

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Missoula, Montana, 59808, United States

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Omaha, Nebraska, 68134, United States

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Las Vegas, Nevada, 89104, United States

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Rochester, New York, 14642, United States

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Cary, North Carolina, 27518, United States

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Charlotte, North Carolina, 28209, United States

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Hickory, North Carolina, 28601, United States

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High Point, North Carolina, 27262, United States

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Raleigh, North Carolina, 27607, United States

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Raleigh, North Carolina, 27612, United States

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Salisbury, North Carolina, 28144, United States

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Winston-Salem, North Carolina, 27103, United States

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Fargo, North Dakota, 58104, United States

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Akron, Ohio, 44311, United States

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Cleveland, Ohio, 44122, United States

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Columbus, Ohio, 43201, United States

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Columbus, Ohio, 43210, United States

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Columbus, Ohio, 43213, United States

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Norman, Oklahoma, 73069, United States

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Corvallis, Oregon, 97330, United States

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Portland, Oregon, 97203, United States

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Downingtown, Pennsylvania, 19335, United States

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Erie, Pennsylvania, 16506, United States

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Jefferson Hills, Pennsylvania, 15025, United States

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Penndel, Pennsylvania, 19047, United States

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Pittsburgh, Pennsylvania, 15241, United States

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Upper Saint Clair, Pennsylvania, 15241, United States

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Anderson, South Carolina, 29621, United States

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Clinton, South Carolina, 29325, United States

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Goose Creek, South Carolina, 29445, United States

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Greer, South Carolina, 29651, United States

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Bristol, Tennessee, 37620, United States

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Nashville, Tennessee, 37212, United States

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Fort Worth, Texas, 76107, United States

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Galveston, Texas, 77555, United States

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Houston, Texas, 77074, United States

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San Antonio, Texas, 78229, United States

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Salt Lake City, Utah, 84124, United States

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Fredericksburg, Virginia, 22401, United States

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Williamsburg, Virginia, 23185, United States

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Lakewood, Washington, 98499, United States

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Marshfield, Wisconsin, 54449, United States

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San Juan, 00918, Puerto Rico

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Toa Baja, 00949, Puerto Rico

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Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human; Respiratory Tract Infections

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Limitations and Caveats

The study was terminated due to lack of primary endpoint cases in 2009-2010 influenza season (coincided with the H1N1 Pandemic). There were no safety concerns; enrolled subjects were followed per-protocol.

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2009
• First Posted: September 14, 2009
• Study Start: September 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: April 1, 2012
• Last Updated: August 1, 2012
• Results First Posted: July 25, 2012

Record last verified: 2012-07

Locations

PR (2); US (96)