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

Condition(s) targeted: Influenza

Intervention: High Dose Trivalent Inactivated Influenza Vaccine (Biological); Trivalent Inactivated Influenza Vaccine (Biological)

Phase: Phase 4

Status: Completed

Sponsored by: Sanofi Pasteur, a Sanofi Company

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Sanofi Pasteur Inc.

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.

Official title: Efficacy Study of Fluzone® High-Dose Vaccine Compared With Fluzone® Vaccine In Elderly Adults

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: 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).

Secondary outcome:

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)

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

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.

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

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

Occurrences of Culture-confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Respiratory Illness

Detailed description: The trial will span 2 influenza seasons. Each study year, participants will be randomized to receive one dose of either Fluzone® High-Dose or Fluzone® vaccine prior to the start of the influenza season and will be followed until the end of each season. The duration of each participant's participation in the respective study year will be 6 to 8 months, depending on the time of enrollment.

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

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 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

- Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion,

contraindicating intramuscular 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.

Bayamon 00961, Puerto Rico

San Juan 00909, Puerto Rico

Mobile, Alabama 36608, United States

Chandler, Arizona 85224, United States

Glendale, Arizona 85306, United States

Glendale, Arizona 85308, United States

Mesa, Arizona 85203, United States

Mesa, Arizona 85213, United States

Phoenix, Arizona 85050, United States

Phoenix, Arizona 85028, United States

Phoenix, Arizona 85020, United States

Scottsdale, Arizona 85251, United States

Tempe, Arizona 85283, United States

Harrisburg, Arkansas 72432, United States

Coquitlam, British Columbia V3K3P4, Canada

Anaheim, California 92801, United States

La Mesa, California 91942, United States

Oceanside, California 92056, United States

Redding, California 96001, United States

San Diego, California 92103, United States

Santa Rosa, California 95405, United States

Aurora, Colorado 80045, United States

Colorado Springs, Colorado 80907, United States

Colorado Springs, Colorado 80922, United States

Milford, Connecticut 01757, United States

Milford, Connecticut 06460, United States

Brooksville, Florida 34601, United States

Clearwater, Florida 33756, United States

Clearwater, Florida 33761, United States

Coral Gables, Florida 33134, United States

Crystal River, Florida 34429, United States

DeLand, Florida 32720, United States

Jacksonville, Florida 32216, United States

Melbourne, Florida 32935, United States

Pembroke Pine, Florida 33026, United States

Pinellas Park, Florida 33781, United States

Sarasota, Florida 34231, United States

Stockbridge, Georgia 30281, United States

Boise, Idaho 83642, United States

Chicago, Illinois 60654, United States

Peoria, Illinois 61602, United States

Mishawaka, Indiana 46545, United States

Lenexa, Kansas 66219, United States

Newton, Kansas 67114, United States

Overland Park, Kansas 66212, United States

Prairie Village, Kansas 66206, United States

Wichita, Kansas 67205, United States

Wichita, Kansas 67207, United States

Bardstown, Kentucky 40004, United States

Lexington, Kentucky 40504, United States

Columbia, Maryland 21045, United States

Elkridge, Maryland 21075, United States

Rockville, Maryland 20850, United States

Brockton, Massachusetts 02301, United States

Haverhill, Massachusetts 01830, United States

Edina, Minnesota 55435, United States

Kansas City, Missouri 64114, United States

St. Louis, Missouri 63141, United States

Missoula, Montana 59808, United States

Bellevue, Nebraska 68005, United States

Omaha, Nebraska 68114, United States

Las Vega, Nevada 89104, United States

Newington, New Hampshire 03801, United States

Edison, New Jersey 08817, United States

Albuquerque, New Mexico 87018, United States

Binghamton, New York 13901, United States

Endwell, New York 13760, United States

Rochester, New York 14642, United States

Rochester, New York 14609, United States

Mount Pearl, Newfoundland and Labrador A1N1W7, Canada

Cary, North Carolina 27518, United States

Charlotte, North Carolina 28209, United States

Hickory, North Carolina 28602, United States

Raleigh, North Carolina 27612, United States

Raleigh, North Carolina 27609, United States

Salisbury, North Carolina 28144, United States

Wilmington, North Carolina 28401, United States

Winston Salem, North Carolina 27103, United States

Fargo, North Dakota 58104, United States

Idaho Falls, North Dakota 83404, United States

Truro, Nova Scotia B2N1L2, Canada

Akron, Ohio 44311, United States

Cincinnati, Ohio 45227, United States

Cincinnati, Ohio 45259, United States

Cleveland, Ohio 44122, United States

Columbus, Ohio 43213, United States

Norman, Oklahoma 73069, United States

Sudbury, Ontario P3E1H5, Canada

Toronto, Ontario M9W4L6, Canada

Erie, Pennsylvania 16506, United States

Pittsburgh, Pennsylvania 15241, United States

Scranton, Pennsylvania 18510, United States

Sherbrooke, Quebec J1H4J6, Canada

Warwick, Rhode Island 02886, United States

Anderson, South Carolina 29621, United States

Clinton, South Carolina 29325, United States

Greer, South Carolina 29650, United States

Mt. Pleasant, South Carolina 29464, United States

Spartanburg, South Carolina 29303, United States

Bristol, Tennessee 37620, United States

Nashville, Tennessee 37203, United States

Nashville, Tennessee 37212, United States

Fort Worth, Texas 76107, United States

San Antonio, Texas 78229, United States

Tomball, Texas 77375, United States

Salt Lake City, Utah 84124, United States

Salt Lake City, Utah 84121, United States

Salt Lake City, Utah 84109, United States

South Jordan, Utah 84095, United States

West Jordan, Utah 84088, United States

Norfolk, Virginia 23507, United States

Williamsburg, Virginia 23185, United States

Winchester, Virginia 22601, United States

Starting date: September 2011
Last updated: March 30, 2015