Adjuvanted Influenza Vaccination in U.S. Nursing Homes

Insight Therapeutics

Status and phase: Completed; Phase 4

Conditions: Influenza-like Illness; Influenza

Treatments: Biological: trivalent influenza vaccine; Biological: adjuvanted trivalent influenza vaccine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02882100

INSI-201603

Details and patient eligibility

About

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).

Full 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.

Enrollment: 823 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

823 participants in 2 patient groups

aTIV

Experimental group

Description:

NH facilities randomized to receive adjuvanted trivalent influenza vaccine (aTIV, FLUAD) for the residents

Treatment:

Biological: adjuvanted trivalent influenza vaccine

Biological: trivalent influenza vaccine

TIV

Active Comparator group

Description:

NH facilities randomized to receive standard trivalent influenza vaccine (TIV, Fluvirin) for the residents

Treatment:

Biological: trivalent influenza vaccine