Adjuvanted Influenza Vaccination in U.S. Nursing Homes
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Influenza |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 12/2/2018 |
| Start Date: | April 2016 |
| End Date: | May 1, 2019 |
Adjuvanted Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes
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).
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).
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.
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.
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
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