Adjuvanted Influenza Vaccination in U.S. Nursing Homes

Study Overview
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Brief Summary
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This study is powered to prospectively evaluate the relative effectiveness of adjuvanted trivalent influenza vaccine (aTIV; FLUAD) in preventing influenza mortality, hospitalization, and functional decline in a nursing home population in the U.S., compared to the commercially available, standard dose trivalent seasonal influenza vaccine (TIV; Fluvirin).

Detailed Description
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SUMMARY: A random study sample of up to 1000 NHs within 75 miles of the local area of the 121 cities where the CDC performs weekly influenza surveillance (estimated N= 11,239) may be offered the opportunity for participation; the first 1000 eligible to participate and accepting the offer will be enrolled. Participating facilities will be offered vaccine education for residents and staff, but will be randomly allocated to receive aTIV (FLUAD) vaccine or usual care (TIV) vaccination for their residents. BACKGROUND: Lower respiratory tract infection (LRI), including pneumonia, bronchitis, and tracheobronchitis, is the leading cause of infectious mortality and hospitalization in older adults , and nursing home (NH) residents. Pneumonia and infection often produce attenuated signs and symptoms in older adults, leading to delayed or even misdiagnosis for this population. Diagnosis is further compromised due to few and sporadic clinician visits with nursing home residents, and reduced access to radiology. LRI may or may not directly lead to hospitalization, but LRIs are associated with considerable other morbidity than can result in hospitalization, including exacerbation of underlying cardiopulmonary diseases. Hospitalization rates for NH residents vary considerably between facilities, but the majority of hospitalizations occur during the 12 weeks during which influenza peaks each year. OBJECTIVES: The primary objective is to estimate the differences in hospitalization rates during influenza season experienced by long-stay nursing home residents, between facilities using adjuvanted trivalent vaccine vs. standard trivalent vaccine. The secondary objective is to estimate the differences in the likelihood of Activities of Daily Living (ADL) functional decline and mortality rates in the study nursing homes, and influenza outbreaks.

Official Title
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Adjuvanted Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes

Conditions
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Influenza, Influenza-like Illness

Intervention / Treatment
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* Biological: adjuvanted trivalent influenza vaccine
* Biological: trivalent influenza vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Long-term care facilities within 75 miles of one of the 121 cities that serve as CDC surveillance sites Exclusion Criteria: Facilities that used high dose influenza vaccine in residents over age 65 in previous influenza season (2015-16) Facilities having fewer than 50 long-stay residents Hospital-based facilities Facilities with more than 20% of the population under age 65 Facilities not submitting Minimum Data Set (MDS) data

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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No

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 |
| --- | --- |
| Experimental: aTIV<br>NH facilities randomized to receive adjuvanted trivalent influenza vaccine (aTIV, FLUAD) for the residents | Biological: adjuvanted trivalent influenza vaccine<br>* Nursing home residents over 65 years are allocated to receive adjuvanted trivalent vaccine. Residents under 65 years are provided standard trivalent vaccine (TIV-Fluvirin).<br>* Other names: aTIV;Biological: trivalent influenza vaccine<br>* Nursing home residents are allocated to receive standard trivalent vaccine (TIV).<br>* Other names: TIV;|
| Active Comparator: TIV<br>NH facilities randomized to receive standard trivalent influenza vaccine (TIV, Fluvirin) for the residents | Biological: trivalent influenza vaccine<br>* Nursing home residents are allocated to receive standard trivalent vaccine (TIV).<br>* Other names: TIV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalization for a respiratory-related Illness | Time to first occurrence of hospitalization for a respiratory-related Illness based upon Medicare inpatient hospital claims | up to 1 year | 
| Hospitalization for all causes | Time to first occurrence of hospitalization for all-causes | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activities of daily living (ADL) scores | Change in activities of daily living (ADL) scores | up to 1 year | 
| Mortality | Difference in mortality rate | up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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influenza, vaccine, vaccination, nursing home, cluster randomized trial, respiratory-related hospitalization