Multi-Year Study of Fluzone High-Dose Influenza Vaccine Compared With Fluzone® Vaccine in Adults Aged 65 Years and Older
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|ClinicalTrials.gov Identifier: NCT00976027|
Recruitment Status : Terminated (No safety concerns, study terminated due to lack of primary endpoint cases in 2009-2010 Flu season (coincided with H1N1 Pandemic) Subjects followed per-protocol)
First Posted : September 14, 2009
Results First Posted : July 25, 2012
Last Update Posted : August 1, 2012
The aim of this study is to determine the efficacy of Fluzone High Dose vaccine and that of Fluzone® vaccine in the elderly.
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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: Trivalent inactivated influenza vaccine High Dose Biological: Trivalent inactivated influenza vaccine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9172 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Multi-Year Efficacy Study of Fluzone High-Dose Trivalent Vaccine Compared With Fluzone® Vaccine In Adults ≥ 65 Years of Age|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||April 2012|
|Experimental: Fluzone® High Dose Group||
Biological: Trivalent inactivated influenza vaccine High Dose
0.5 mL, Intramuscular
Other Name: Fluzone® High Dose
|Active Comparator: Fluzone® Group||
Biological: Trivalent inactivated influenza vaccine
0.5 mL, Intramuscular
Other Name: Fluzone®
- 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.
- 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).
- 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).
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00976027
|Study Director:||Medical Director||Sanofi Pasteur Inc.|