Randomized Trial of High Dose Influenza Vaccine in Long Term Care Setting

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Trial of High Dose Influenza Vaccine in Long Term Care Setting

Conditions
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Influenza

Intervention / Treatment
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* Biological: High Dose Inactivated Influenza Vaccine
* Biological: Standard Dose Inactivated Influenza Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Residents of one of the participating LTC sites 65 years or older at the time of consent require assistance in two or more Instrumental Activities of Daily Living and/or one or more Activities of Daily Living as identified by facility staff Exclusion Criteria: Age less than 65 years Life expectancy less than 6 months History of allergic reaction to influenza vaccine, its components, or eggs History of severe allergic reaction to latex History of Guillian-Barre Syndrome Actively undergoing chemotherapy Actively undergoing radiation therapy Use of prednisone (or other steroid) at prednisone-equivalent dosages of 10mg or higher within the past 14 days Serious current immunosuppression or immunosuppression expected in the next 6 weeks Any condition that, in the opinion of the investigator,might interfere with the evaluation of study objectives

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Dose Inactivated Influenza Vaccine<br>For HDIV,0.5 ml of high dose inactivated influenza vaccine consisting of a total of 180mcg (60 mcg each strain) of influenza virus hemagglutinin | Biological: High Dose Inactivated Influenza Vaccine<br>* 0.5 ml HDIV consisting of 180 mcg (60 mcg each strain) of influenza virus hemagglutinin<br>|
| Active Comparator: Standard Dose Inactivated Influenza Vaccine<br>For SDIV, 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg of each strain) of influenza virus hemagglutinin | Biological: Standard Dose Inactivated Influenza Vaccine<br>* 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg each strain) of influenza virus hemagglutinin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings | 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. | 30 days | 
| Non-inferiority of High-dose Inactivated Influenza Vaccine(HDIV) Versus Standard Dose Inactivated Influenza Vaccine(SDIV) Among Residents of Long Term Care(LTC) Settings | 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. | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-inferiority and Immunoprotection Persistence at 6 Months | Compare the immunogenicity via HAI and MN titers for HDIV and SDIV at 6 months in frail LTC residents | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza in Long Term Care Setting, High dose Inactivated influenza vaccine, Standard dose inactivated influenza vaccine