Adjuvanted Influenza Vaccination in U.S. Nursing Homes

March 14, 2023 updated by: Insight Therapeutics, LLC

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

823

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Norfolk, Virginia, United States, 23510
        • Insight Therapeutics, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: aTIV
NH facilities randomized to receive adjuvanted trivalent influenza vaccine (aTIV, FLUAD) for the residents
Biological: adjuvanted trivalent influenza vaccine
Nursing home residents over 65 years are allocated to receive adjuvanted trivalent vaccine. Residents under 65 years are provided standard trivalent vaccine (TIV-Fluvirin).
Other Names:
  • Fluad
  • aTIV
Biological: trivalent influenza vaccine
Nursing home residents are allocated to receive standard trivalent vaccine (TIV).
Other Names:
  • TIV
  • Fluvirin
Active Comparator: TIV
NH facilities randomized to receive standard trivalent influenza vaccine (TIV, Fluvirin) for the residents
Biological: trivalent influenza vaccine
Nursing home residents are allocated to receive standard trivalent vaccine (TIV).
Other Names:
  • TIV
  • Fluvirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalization for a respiratory-related Illness
Time Frame: up to 1 year
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 Frame: up to 1 year
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
Time Frame: up to 1 year
Change in activities of daily living (ADL) scores
up to 1 year
Mortality
Time Frame: up to 1 year
Difference in mortality rate
up to 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Influenza outbreaks
Time Frame: up to 1 year
Difference in occurrence of documented influenza outbreaks
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Insight Therapeutics, LLC

Collaborators

Brown University
Case Western Reserve University
Seqirus

Investigators

  • Principal Investigator: Vincent Mor, PhD, Brown University
  • Principal Investigator: H. Edward Davidson, PharmD, MPH, Insight Therapeutics, LLC
  • Principal Investigator: Stefan Gravenstein, MD, MPH, Case Western Reserve Univsity

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

October 4, 2018

Study Completion (Actual)

January 25, 2023

Study Registration Dates

First Submitted

August 24, 2016

First Submitted That Met QC Criteria

August 24, 2016

First Posted (Estimate)

August 29, 2016

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INSI-201603

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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