Back to resultsA Study of Fluzone® High-Dose Vaccine Compared With Fluzone® Vaccine In Elderly Adults
Primary Purpose
Influenza
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
High Dose Trivalent Inactivated Influenza Vaccine
Trivalent Inactivated Influenza Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza, Trivalent Inactivated Influenza Vaccine, High-Dose Trivalent Inactivated Influenza Vaccine, Fluzone® High-Dose, Influenza vaccines
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High Dose Trivalent Inactivated Influenza Vaccine
Trivalent Inactivated Influenza Vaccine
Arm Description
Participants will receive an injection of High Dose Trivalent Inactivated Influenza Vaccine
Participants will receive an injection of the Trivalent Inactivated Influenza vaccine
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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)
Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type-specific (i.e., for Influenza A and Influenza B) antibodies. For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney [MDCK] cells, Classic Flu A and B culture using Rhesus Monkey Kidney [RhMK] cells, and R Mix Flu A and B culture. For antigenic similarity determinations, a standard hemagglutination inhibition test using a panel of ferret antisera (ferret antigenicity testing) was used.
Occurrences of Culture-confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Protocol-defined Influenza-like Illness
For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney [MDCK] cells, Classic Flu A and B culture using Rhesus Monkey Kidney [RhMK] cells, and R Mix Flu A and B culture).
A protocol-defined influenza-like illness (ILI) was determined by the occurrence of at least one 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).
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.
Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type-specific antibodies. For culture confirmation of influenza, 3 different 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). For antigenic similarity determinations, a standard hemagglutination inhibition test using a panel of ferret antisera (ferret antigenicity testing) was used.
The modified Centers for Disease Control and Prevention-defined influenza-like illness is the occurrence of fever (defined as temperature > 99.0°F [> 37.2°C]) with cough or sore throat.
Occurrences of Culture-confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Modified CDC-defined Influenza-like Illness
Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type-specific antibodies. For culture confirmation of influenza, 3 different 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). For antigenic similarity determinations, a standard hemagglutination inhibition test using a panel of ferret antisera (ferret antigenicity testing) was used.
The modified Centers for Disease Control and Prevention-defined influenza-like illness is the occurrence of fever (defined as temperature > 99.0°F [> 37.2°C]) with cough or sore throat.
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
Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type-specific antibodies. For culture confirmation of influenza, 3 different 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). For antigenic similarity determinations, a standard hemagglutination inhibition test using a panel of ferret antisera (ferret antigenicity testing) was used.
Respiratory illness was defined as the occurrence of a new onset (or exacerbation of a pre-existing condition/symptom) of one or more of the following symptoms (that persist for or reoccur after a period of at least 12 hours): sneezing, stuffy or runny nose (nasal congestion), sore throat, cough, sputum production, wheezing, or difficulty breathing.
Occurrences of Culture-confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Respiratory Illness
Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type-specific (i.e., for Influenza A and Influenza B) antibodies. For culture confirmation of influenza, 3 different 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).
Respiratory illness is defined as the occurrence of a new onset (or exacerbation of a pre-existing condition/symptom) of one or more of the following symptoms (that persist for or reoccur after a period of at least 12 hours): sneezing, stuffy or runny nose (nasal congestion), sore throat, cough, sputum production, wheezing, or difficulty breathing.
Full Information
NCT ID
NCT01427309
First Posted
August 30, 2011
Last Updated
March 30, 2015
Sponsor
Sanofi Pasteur, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT01427309
Brief Title
A Study of Fluzone® High-Dose Vaccine Compared With Fluzone® Vaccine In Elderly Adults
Official Title
Efficacy Study of Fluzone® High-Dose Vaccine Compared With Fluzone® Vaccine In Elderly Adults
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi Pasteur, a Sanofi Company
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Trivalent Inactivated Influenza Vaccine, High-Dose Trivalent Inactivated Influenza Vaccine, Fluzone® High-Dose, Influenza vaccines
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31989 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Dose Trivalent Inactivated Influenza Vaccine
Arm Type
Experimental
Arm Description
Participants will receive an injection of High Dose Trivalent Inactivated Influenza Vaccine
Arm Title
Trivalent Inactivated Influenza Vaccine
Arm Type
Active Comparator
Arm Description
Participants will receive an injection of the Trivalent Inactivated Influenza vaccine
Intervention Type
Biological
Intervention Name(s)
High Dose Trivalent Inactivated Influenza Vaccine
Other Intervention Name(s)
Fluzone® High Dose
Intervention Description
0.5 mL Intramuscular
Intervention Type
Biological
Intervention Name(s)
Trivalent Inactivated Influenza Vaccine
Other Intervention Name(s)
Fluzone®
Intervention Description
0.5 mL, Intramuscular
Primary Outcome Measure Information:
Title
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).
Description
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).
Time Frame
≥14 days post-vaccination
Secondary Outcome Measure Information:
Title
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)
Description
Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type-specific (i.e., for Influenza A and Influenza B) antibodies. For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney [MDCK] cells, Classic Flu A and B culture using Rhesus Monkey Kidney [RhMK] cells, and R Mix Flu A and B culture. For antigenic similarity determinations, a standard hemagglutination inhibition test using a panel of ferret antisera (ferret antigenicity testing) was used.
Time Frame
≥14 days post-vaccination
Title
Occurrences of Culture-confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Protocol-defined Influenza-like Illness
Description
For culture confirmation of influenza, 3 different culture methods were utilized for each NP sample (Classic Flu A and B culture using Madin Darby Canine Kidney [MDCK] cells, Classic Flu A and B culture using Rhesus Monkey Kidney [RhMK] cells, and R Mix Flu A and B culture).
A protocol-defined influenza-like illness (ILI) was determined by the occurrence of at least one 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).
Time Frame
≥14 days post-vaccination
Title
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.
Description
Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type-specific antibodies. For culture confirmation of influenza, 3 different 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). For antigenic similarity determinations, a standard hemagglutination inhibition test using a panel of ferret antisera (ferret antigenicity testing) was used.
The modified Centers for Disease Control and Prevention-defined influenza-like illness is the occurrence of fever (defined as temperature > 99.0°F [> 37.2°C]) with cough or sore throat.
Time Frame
≥14 days post-vaccination
Title
Occurrences of Culture-confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Modified CDC-defined Influenza-like Illness
Description
Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type-specific antibodies. For culture confirmation of influenza, 3 different 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). For antigenic similarity determinations, a standard hemagglutination inhibition test using a panel of ferret antisera (ferret antigenicity testing) was used.
The modified Centers for Disease Control and Prevention-defined influenza-like illness is the occurrence of fever (defined as temperature > 99.0°F [> 37.2°C]) with cough or sore throat.
Time Frame
≥14 days post-vaccination
Title
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
Description
Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type-specific antibodies. For culture confirmation of influenza, 3 different 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). For antigenic similarity determinations, a standard hemagglutination inhibition test using a panel of ferret antisera (ferret antigenicity testing) was used.
Respiratory illness was defined as the occurrence of a new onset (or exacerbation of a pre-existing condition/symptom) of one or more of the following symptoms (that persist for or reoccur after a period of at least 12 hours): sneezing, stuffy or runny nose (nasal congestion), sore throat, cough, sputum production, wheezing, or difficulty breathing.
Time Frame
≥14 days post-vaccination
Title
Occurrences of Culture-confirmed Influenza Caused by Any Influenza Viral Types/Subtypes, in Association With a Respiratory Illness
Description
Influenza positive cultures were confirmed by using direct immunofluorescence techniques with influenza type-specific (i.e., for Influenza A and Influenza B) antibodies. For culture confirmation of influenza, 3 different 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).
Respiratory illness is defined as the occurrence of a new onset (or exacerbation of a pre-existing condition/symptom) of one or more of the following symptoms (that persist for or reoccur after a period of at least 12 hours): sneezing, stuffy or runny nose (nasal congestion), sore throat, cough, sputum production, wheezing, or difficulty breathing.
Time Frame
≥14 days post-vaccination
Other Pre-specified Outcome Measures:
Title
Safety Overview After Injection With Either Fluzone High Dose or Fluzone Vaccine Through the End of Surveillance Period
Description
All serious adverse events, including deaths and adverse events (AEs) of special interest (Guillain Barre Syndrome, Bell's Palsy, encephalitis/myelitis, optic neuritis, Stevens Johnson Syndrome, and toxic epidermal necrolysis) were collected.
Time Frame
Day 0 up to Day 240 post-vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Sanofi Pasteur Inc.
Official's Role
Study Director
Facility Information:
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85203
Country
United States
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85213
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85028
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
City
Harrisburg
State/Province
Arkansas
ZIP/Postal Code
72432
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
City
Redding
State/Province
California
ZIP/Postal Code
96001
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80922
Country
United States
City
Milford
State/Province
Connecticut
ZIP/Postal Code
01757
Country
United States
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34601
Country
United States
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
City
Crystal River
State/Province
Florida
ZIP/Postal Code
34429
Country
United States
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32935
Country
United States
City
Pembroke Pine
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33781
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34231
Country
United States
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
City
Boise
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
City
Mishawaka
State/Province
Indiana
ZIP/Postal Code
46545
Country
United States
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
City
Haverhill
State/Province
Massachusetts
ZIP/Postal Code
01830
Country
United States
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68005
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
City
Las Vega
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
City
Newington
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08817
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87018
Country
United States
City
Binghamton
State/Province
New York
ZIP/Postal Code
13901
Country
United States
City
Endwell
State/Province
New York
ZIP/Postal Code
13760
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
City
Idaho Falls
State/Province
North Dakota
ZIP/Postal Code
83404
Country
United States
City
Akron
State/Province
Ohio
ZIP/Postal Code
44311
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45259
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16506
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18510
Country
United States
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
City
Clinton
State/Province
South Carolina
ZIP/Postal Code
29325
Country
United States
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
City
Mt. Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
City
Williamsburg
State/Province
Virginia
ZIP/Postal Code
23185
Country
United States
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
City
Coquitlam
State/Province
British Columbia
ZIP/Postal Code
V3K3P4
Country
Canada
City
Mount Pearl
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1N1W7
Country
Canada
City
Truro
State/Province
Nova Scotia
ZIP/Postal Code
B2N1L2
Country
Canada
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E1H5
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9W4L6
Country
Canada
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H4J6
Country
Canada
City
Bayamon
ZIP/Postal Code
00961
Country
Puerto Rico
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
12. IPD Sharing Statement
Citations:
PubMed Identifier
25119609
Citation
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.
Results Reference
result
PubMed Identifier
27669017
Citation
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.
Results Reference
derived
PubMed Identifier
26762363
Citation
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.
Results Reference
derived
Links:
URL
http://www.sanofipasteur.com
Description
Related Info
Learn more about this trial
A Study of Fluzone® High-Dose Vaccine Compared With Fluzone® Vaccine In Elderly Adults
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