Clinical trial NCT02882100: Adjuvanted Influenza Vaccination in U.S. Nursing Homes
Official title: Adjuvanted Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Influenza-like Illness
Keywords: influenza
vaccine
vaccination
nursing home
cluster randomized trial
respiratory-related hospitalization
Lead sponsor: Insight Therapeutics, LLC
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
name: Brown University
name: Seqirus
First posted: 2016-08-29
Enrollment: 823
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hospitalization for a respiratory-related Illness
timeFrame: up to 1 year
measure: Hospitalization for all causes
timeFrame: up to 1 year
Secondary outcomes:
measure: Activities of daily living (ADL) scores
timeFrame: up to 1 year
measure: Mortality
timeFrame: up to 1 year
Other outcomes:
measure: Influenza outbreaks
timeFrame: up to 1 year
Locations:
city: Norfolk
country: United States
facility: Insight Therapeutics, LLC
state: Virginia
Study officials:
affiliation: Case Western Reserve Univsity
name: Stefan Gravenstein, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University
name: Vincent Mor, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Insight Therapeutics, LLC
name: H. Edward Davidson, PharmD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thompson WW, Shay DK, Weintraub E, Brammer L, Cox N, Anderson LJ, Fukuda K. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA. 2003 Jan 8;289(2):179-86. doi: 10.1001/jama.289.2.179.
citation: Thompson WW, Shay DK, Weintraub E, Brammer L, Bridges CB, Cox NJ, Fukuda K. Influenza-associated hospitalizations in the United States. JAMA. 2004 Sep 15;292(11):1333-40. doi: 10.1001/jama.292.11.1333.
citation: Hayward AC, Harling R, Wetten S, Johnson AM, Munro S, Smedley J, Murad S, Watson JM. Effectiveness of an influenza vaccine programme for care home staff to prevent death, morbidity, and health service use among residents: cluster randomised controlled trial. BMJ. 2006 Dec 16;333(7581):1241. doi: 10.1136/bmj.39010.581354.55. Epub 2006 Dec 1.
citation: Gravenstein S, McConeghy KW, Saade E, Davidson HE, Canaday DH, Han L, Rudolph J, Joyce N, Dahabreh IJ, Mor V. Adjuvanted Influenza Vaccine and Influenza Outbreaks in US Nursing Homes: Results From a Pragmatic Cluster-Randomized Clinical Trial. Clin Infect Dis. 2021 Dec 6;73(11):e4229-e4236. doi: 10.1093/cid/ciaa1916.
citation: McConeghy KW, Davidson HE, Canaday DH, Han L, Saade E, Mor V, Gravenstein S. Cluster-randomized Trial of Adjuvanted Versus Nonadjuvanted Trivalent Influenza Vaccine in 823 US Nursing Homes. Clin Infect Dis. 2021 Dec 6;73(11):e4237-e4243. doi: 10.1093/cid/ciaa1233.