A Study of Fluzone® High-Dose Vaccine Compared With Fluzone® Vaccine In Elderly Adults

NCT01427309 | Completed Phase 4 Results DMC

• 2 other identifiers: FIM12U1111-1120-1300
• Study Type: interventional
• Target: 31,989
• Locations: 3 countries
• Sites: 113

Brief Summary

The aim of this study is to determine the efficacy of Fluzone High-Dose compared to standard dose Fluzone for laboratory-confirmed or culture-confirmed influenza caused by influenza types/subtypes that are similar (for laboratory-confirmed) or antigenically similar (for culture-confirmed) to those contained in the respective annual vaccine formulations. Primary Objective:

• To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to laboratory-confirmed influenza caused by any influenza viral types/subtypes, associated with the occurrence of a protocol-defined influenza-like-illnesses (ILI). Secondary Objectives:
• To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to laboratory-confirmed influenza, caused by any influenza viral types/subtypes, associated with the occurrence of a protocol-defined ILI.
• To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to culture-confirmed influenza, caused by any influenza viral types/subtypes, associated with the occurrence of a protocol-defined ILI.
• To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to culture-confirmed influenza caused by viral types/subtypes antigenically similar to those contained in the respective annual vaccine formulations, associated with the occurrence of a modified Centers for Disease Control and Prevention (CDC)-defined ILI.
• To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to culture-confirmed influenza caused by any influenza viral types/subtypes, associated with the occurrence of a modified CDC-defined ILI.
• To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to culture-confirmed influenza caused by viral types/subtypes antigenically similar to those contained in the respective annual vaccine formulations, associated with the occurrence of a respiratory illness.
• To compare the clinical efficacy of Fluzone High-Dose to that of Fluzone in elderly adults, with respect to culture-confirmed influenza caused by any influenza viral types/subtypes, associated with the occurrence of a respiratory illness.

Conditions

Influenza

Keywords

Influenza; Trivalent Inactivated Influenza Vaccine; High-Dose Trivalent Inactivated Influenza Vaccine; Fluzone® High-Dose; Influenza vaccines

Outcome Measures

Primary Outcomes (1)

• Occurrences of Culture- or Polymerase Chain Reaction (PCR)-Confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Protocol-defined Influenza-like Illness (ILI).

  Influenza positive cultures were confirmed using direct immunofluorescence techniques with influenza type-specific antibodies. 3 culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney cells, Classic Flu A and B culture using Rhesus Monkey Kidney cells, and R Mix Flu A and B culture). The initial molecular test (PCR) was the validated ProFlu+™ assay by Prodesse, Inc., Waukesha, WI, which had been approved by the Food and Drug Administration through a 510K evaluation for specific detection of Influenza A, B or Respiratory Syncytial Virus. A protocol-defined influenza-like illness was determined by the occurrence of at least 1 of the following respiratory symptoms: sore throat, cough, sputum production, wheezing, or difficulty breathing; concurrently with at least one of the following systemic symptoms: fever (defined as temperature \> 99.0°F \[\> 37.2°C\]), chills (shivering), tiredness (fatigue), headache, or myalgia (muscle aches).

  ≥14 days post-vaccination

Secondary Outcomes (6)

• Occurrences of Culture-confirmed Influenza Caused by Influenza Viral Types/Subtypes That Are Antigenically Similar to Those Contained in the Vaccine Formulations, in Association With a Protocol-defined Influenza-like Illness (ILI)

  ≥14 days post-vaccination

• Occurrences of Culture-confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Protocol-defined Influenza-like Illness

  ≥14 days post-vaccination

• Occurrences of Culture-confirmed Influenza Caused by Influenza Viral Types/Subtypes That Are Antigenically Similar to Those Contained in the Vaccine Formulations, in Association With a Modified CDC-defined Influenza-like Illness.

  ≥14 days post-vaccination

• Occurrences of Culture-confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Modified CDC-defined Influenza-like Illness

  ≥14 days post-vaccination

• Occurrences of Culture-confirmed Influenza Caused by Influenza Viral Types/Subtypes That Are Antigenically Similar to Those Contained in the Vaccine Formulations, in Association With a Respiratory Illness

  ≥14 days post-vaccination

Other Outcomes (1)

• Safety Overview After Injection With Either Fluzone High Dose or Fluzone Vaccine Through the End of Surveillance Period

  Day 0 up to Day 240 post-vaccination

Study Arms (2)

High Dose Trivalent Inactivated Influenza Vaccine

EXPERIMENTAL

Participants will receive an injection of High Dose Trivalent Inactivated Influenza Vaccine

Biological: High Dose Trivalent Inactivated Influenza Vaccine

Trivalent Inactivated Influenza Vaccine

ACTIVE COMPARATOR

Participants will receive an injection of the Trivalent Inactivated Influenza vaccine

Biological: Trivalent Inactivated Influenza Vaccine

Interventions

High Dose Trivalent Inactivated Influenza Vaccine BIOLOGICAL

0.5 mL Intramuscular

Also known as: Fluzone® High Dose

High Dose Trivalent Inactivated Influenza Vaccine

Trivalent Inactivated Influenza Vaccine BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Fluzone®

Trivalent Inactivated Influenza Vaccine

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 at the time of study enrollment (or in the 4 weeks preceding the trial vaccination), or planned participation during each year of the trial period, in another clinical trial investigating a vaccine, drug, medical device, or medical procedure (Note: Concomitant participation in an observational trial is acceptable)
• 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 High-Dose or 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 contraindicating intramuscular (IM) vaccination, as judged by the investigator
• Current alcohol abuse or drug addiction
• Subject deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
• Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study
• Moderate or severe acute illness with or without fever (oral temperature \> 99.0ºF \[\> 37.2ºC\]). If this contraindication exists, vaccination will be deferred until the individual has been medically stable and/or afebrile (temperature ≤ 99.0 ºF \[≤ 37.2ºC\]) for at least 24 hours
• Signs and symptoms of an acute infectious respiratory illness. If this exists, vaccination will be deferred until the symptoms resolve.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (113)

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Mobile, Alabama, 36608, United States

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Chandler, Arizona, 85224, United States

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Glendale, Arizona, 85306, United States

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Glendale, Arizona, 85308, United States

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Mesa, Arizona, 85203, United States

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Mesa, Arizona, 85213, United States

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Phoenix, Arizona, 85020, 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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Harrisburg, Arkansas, 72432, United States

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Anaheim, California, 92801, United States

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La Mesa, California, 91942, United States

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Oceanside, California, 92056, United States

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Redding, California, 96001, United States

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San Diego, California, 92103, 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, 80922, United States

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Milford, Connecticut, 01757, United States

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Milford, Connecticut, 06460, United States

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Brooksville, Florida, 34601, 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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DeLand, Florida, 32720, United States

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Jacksonville, Florida, 32216, United States

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Melbourne, Florida, 32935, United States

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Pembroke Pine, Florida, 33026, United States

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Pinellas Park, Florida, 33781, United States

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Sarasota, Florida, 34231, United States

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Stockbridge, Georgia, 30281, United States

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Boise, Idaho, 83642, United States

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Chicago, Illinois, 60654, United States

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Peoria, Illinois, 61602, United States

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Mishawaka, Indiana, 46545, United States

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Lenexa, Kansas, 66219, 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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Wichita, Kansas, 67207, United States

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Bardstown, Kentucky, 40004, United States

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Lexington, Kentucky, 40504, United States

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Columbia, Maryland, 21045, United States

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Elkridge, Maryland, 21075, United States

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Rockville, Maryland, 20850, United States

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Brockton, Massachusetts, 02301, United States

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Haverhill, Massachusetts, 01830, United States

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Edina, Minnesota, 55435, United States

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Kansas City, Missouri, 64114, 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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Bellevue, Nebraska, 68005, United States

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Omaha, Nebraska, 68114, United States

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Las Vega, Nevada, 89104, United States

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Newington, New Hampshire, 03801, United States

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Edison, New Jersey, 08817, United States

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Albuquerque, New Mexico, 87018, United States

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Binghamton, New York, 13901, United States

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Endwell, New York, 13760, United States

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Rochester, New York, 14609, 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, 28602, United States

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Raleigh, North Carolina, 27609, 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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Wilmington, North Carolina, 28401, 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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Idaho Falls, North Dakota, 83404, United States

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Akron, Ohio, 44311, United States

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Cincinnati, Ohio, 45227, United States

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Cincinnati, Ohio, 45259, United States

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Cleveland, Ohio, 44122, United States

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Columbus, Ohio, 43213, United States

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Norman, Oklahoma, 73069, United States

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Erie, Pennsylvania, 16506, United States

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Pittsburgh, Pennsylvania, 15241, United States

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Scranton, Pennsylvania, 18510, United States

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Warwick, Rhode Island, 02886, 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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Greer, South Carolina, 29650, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Spartanburg, South Carolina, 29303, United States

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Bristol, Tennessee, 37620, United States

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Nashville, Tennessee, 37203, 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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San Antonio, Texas, 78229, United States

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Tomball, Texas, 77375, United States

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Salt Lake City, Utah, 84109, United States

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Salt Lake City, Utah, 84121, United States

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Salt Lake City, Utah, 84124, United States

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South Jordan, Utah, 84095, United States

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West Jordan, Utah, 84088, United States

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Norfolk, Virginia, 23507, United States

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Williamsburg, Virginia, 23185, United States

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Winchester, Virginia, 22601, United States

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Coquitlam, British Columbia, V3K3P4, Canada

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Mount Pearl, Newfoundland and Labrador, A1N1W7, Canada

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Truro, Nova Scotia, B2N1L2, Canada

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Greater Sudbury, Ontario, P3E1H5, Canada

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Toronto, Ontario, M9W4L6, Canada

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Sherbrooke, Quebec, J1H4J6, Canada

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Bayamón, 00961, Puerto Rico

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San Juan, 00909, Puerto Rico

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Related Publications (3)

• DiazGranados CA, Dunning AJ, Kimmel M, Kirby D, Treanor J, Collins A, Pollak R, Christoff J, Earl J, Landolfi V, Martin E, Gurunathan S, Nathan R, Greenberg DP, Tornieporth NG, Decker MD, Talbot HK. Efficacy of high-dose versus standard-dose influenza vaccine in older adults. N Engl J Med. 2014 Aug 14;371(7):635-45. doi: 10.1056/NEJMoa1315727.

  PMID: 25119609 RESULT

• Becker DL, Chit A, DiazGranados CA, Maschio M, Yau E, Drummond M. High-dose inactivated influenza vaccine is associated with cost savings and better outcomes compared to standard-dose inactivated influenza vaccine in Canadian seniors. Hum Vaccin Immunother. 2016 Dec;12(12):3036-3042. doi: 10.1080/21645515.2016.1215395. Epub 2016 Sep 26.

  PMID: 27669017 DERIVED

• Dunning AJ, DiazGranados CA, Voloshen T, Hu B, Landolfi VA, Talbot HK. Correlates of Protection against Influenza in the Elderly: Results from an Influenza Vaccine Efficacy Trial. Clin Vaccine Immunol. 2016 Jan 13;23(3):228-35. doi: 10.1128/CVI.00604-15.

  PMID: 26762363 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

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
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• 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: August 30, 2011
• First Posted: September 1, 2011
• Study Start: September 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: November 1, 2013
• Last Updated: April 20, 2015
• Results First Posted: August 6, 2014

Record last verified: 2015-03

Locations

PR (2); US (105); CA (6)