Randomized Trial of High Dose Influenza Vaccine in Long Term Care Setting
| Tracking Information | |||||||||
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| First Received Date ICMJE | July 27, 2012 | ||||||||
| Last Updated Date | July 31, 2012 | ||||||||
| Start Date ICMJE | November 2011 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Non-inferiority of high-dose inactivated influenza vaccine(HDIV) versus standard dose inactivated influenza vaccine(SDIV) among residents of long term care(LTC) settings [ Time Frame: 30 days ] [ Designated as safety issue: No ] The primary objective of this study is to determine the noninferiority of high- dose inactivated influenza vaccine (HDIV) versus standard dose inactivated influenza vaccine(SDIV)among residents of long term care(LTC)settings.Non-inferiority will be determined by comparing baseline and one month post vaccination HAI and MN titers using non-inferiority analysis. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01654224 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Non-inferiority and immunoprotection persistence at 6 months and the impact of potential immune modulators on titer response [ Time Frame: 6 months ] [ Designated as safety issue: No ] Compare the immunogenicity via HAI and MN titers for HDIV and SDIV at 6 months in frail LTC residents and potential modifiers of immune response |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | |||||||||
| Original Other Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Randomized Trial of High Dose Influenza Vaccine in Long Term Care Setting | ||||||||
| Official Title ICMJE | Randomized Trial of High Dose Influenza Vaccine in Long Term Care Setting | ||||||||
| Brief Summary | The purpose of the study is to compare the performance of two currently available influenza (flu) vaccines. This study will try and determine if the high dose flu vaccine provides protection that is the same or better than that of regular dose flu vaccine. Both the regular dose and the high dose flu vaccines are approved by the FDA for use in older adults. |
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| Detailed Description | Influenza and pneumonia are the fifth leading cause of death in the United States, the leading cause of vaccine preventable death, and the leading cause of infection related deaths among nursing home residents(Nace, Drinka et al.2010). Each year, an estimated 36,000 individuals die from seasonal influenza and over 90% of these deaths occur among older adults, primarily the frail older adults residing in LTC settings(Fiore,Uyeki et al. 2010).Vaccination is the most effective means of preventing influenza (Nichol and Treanor 2006). Despite increasing success in immunizing LTC residents though, outbreaks continue to occur annually with case fatality rates ranging between 5-55% (Nace 2008). Older adults have a reduced response to influenza vaccination, in part due to age related immunosenescence (Keitel, Atmar et al. 1121; Skowronski, Tweed et al. 2008). It is widely recognized that more effective vaccine options are needed for frail older adults. One option is to increase the hemagglutinin (HA) dose in influenza vaccines in an effort to increase antibodies to hemagglutinin. To date, no studies have evaluated the effectiveness of the HDIV among LTC residents. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
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| Condition ICMJE | Influenza | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 320 | ||||||||
| Estimated Completion Date | June 2013 | ||||||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 65 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01654224 | ||||||||
| Other Study ID Numbers ICMJE | PRO10110247 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | David Nace, University of Pittsburgh | ||||||||
| Study Sponsor ICMJE | University of Pittsburgh | ||||||||
| Collaborators ICMJE | Sanofi Pasteur MSD | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Pittsburgh | ||||||||
| Verification Date | July 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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