Adjuvanted Influenza Vaccination in U.S. Nursing Homes

Phase 4

Completed

• Conditions: Influenza-like Illness; Influenza
• Interventions: Biological: adjuvanted trivalent influenza vaccine; Biological: trivalent influenza vaccine

• Registration Number: NCT02882100
• Lead Sponsor: Insight Therapeutics, LLC

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-08-24
• Study First Submitted QC: 2016-08-24
• Study First Posted: 2016-08-29
• Primary Completion: 2018-10-04
• Study Completion: 2023-01-25
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 823

Inclusion Criteria

• Long-term care facilities within 75 miles of one of the 121 cities that serve as CDC surveillance sites

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aTIV	adjuvanted trivalent influenza vaccine	NH facilities randomized to receive adjuvanted trivalent influenza vaccine (aTIV, FLUAD) for the residents
TIV	trivalent influenza vaccine	NH facilities randomized to receive standard trivalent influenza vaccine (TIV, Fluvirin) for the residents
aTIV	trivalent influenza vaccine	NH facilities randomized to receive adjuvanted trivalent influenza vaccine (aTIV, FLUAD) for the residents

Primary Outcome Measures

Name	Time	Method
Hospitalization for all causes	up to 1 year	Time to first occurrence of hospitalization for all-causes
Hospitalization for a respiratory-related Illness	up to 1 year	Time to first occurrence of hospitalization for a respiratory-related Illness based upon Medicare inpatient hospital claims

Secondary Outcome Measures

Name	Time	Method
Mortality	up to 1 year	Difference in mortality rate
Activities of daily living (ADL) scores	up to 1 year	Change in activities of daily living (ADL) scores

Trial Locations

Locations (1)

Insight Therapeutics, LLC; 🇺🇸 Norfolk, Virginia, United States