High Dose Influenza Vaccine in Nursing Homes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Brown University
Healthcentric Advisors
Case Western Reserve University
Information provided by (Responsible Party):
Insight Therapeutics, LLC
ClinicalTrials.gov Identifier:
NCT01815268
First received: March 11, 2013
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to prospectively evaluate relative effectiveness of high dose influenza vaccine in preventing influenza mortality, hospitalization, and functional decline in a nursing home population in the U.S., compared to the standard dose trivalent seasonal influenza vaccine.


Condition Intervention Phase
Influenza
Biological: HD Vaccine
Biological: SD Vaccine
Biological: Free Staff Vaccine
Biological: No Free Staff Vaccine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: High Dose Influenza Vaccination and Morbidity & Mortality in U.S. Nursing Homes

Resource links provided by NLM:


Further study details as provided by Insight Therapeutics, LLC:

Primary Outcome Measures:
  • Total influenza mortality per nursing home based on vaccination status [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]

    LINKED AT THE FACILITY LEVEL. The primary outcome measure will determine influenza mortality.

    [Vaccine uptake information will be collected for flu season November 2013 to March 2014. There is a data lag of 18 months for this cohort, therefore data analysis will be completed by December 2016.]



Secondary Outcome Measures:
  • Change in activities of daily living (ADL) scores per NH resident by vaccination status [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]

    LINKED AT THE RESIDENT LEVEL. The secondary outcome measure evaluates comparative vaccine effectiveness for functional status of HD vaccine compared to no or SD vaccine. Changes in ADL scores from baseline (Oct 2013 or prior and closest to Oct 2013) to any post-baseline MDS assessment (2014).

    [Vaccine uptake information will be collected for flu season November 2013 to March 2014. There is a data lag of 18 months for this cohort, therefore data analysis will be completed by December 2016.]



Other Outcome Measures:
  • Difference in hospitalization claims based on staff vaccination status [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]

    LINKED AT THE FACILITY LEVEL. The exploratory outcome measure evaluates comparative cost effectiveness high dose vaccine compared to no or standard dose vaccine, and effect on clinical outcomes based on staff vaccine uptake. The facilities will be compared to test the main effect of staff vaccination on NH resident hospitalization rate.

    [Staff vaccine uptake information will be collected for flu season November 2013 to March 2014. There is a data lag of 18 months for the NH cohort, therefore data analysis will be completed by December 2016.]



Estimated Enrollment: 800
Study Start Date: February 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HD Vaccine with Free Staff Vaccine
NH facilities randomized to receive high dose trivalent influenza vaccine (HD Fluzone) for the residents and provided free SD vaccine (Fluzone) for the staff.
Biological: HD Vaccine Biological: Free Staff Vaccine
Experimental: HD Vaccine with No Free Staff Vaccine
NH facilities randomized to receive high dose trivalent influenza vaccine (HD Fluzone) for the residents and not provided free SD vaccine (Fluzone) for the staff.
Biological: HD Vaccine Biological: No Free Staff Vaccine
[Note: For the group 'No free staff vaccine', Insight will not be providing free SD vaccine, however, staff vaccine will be available as per standard of care.]
Active Comparator: SD Vaccine and Free Staff Vaccine
NH facilities randomized to receive SD influenza vaccine (Fluzone) for the residents and provided free SD vaccine (Fluzone) for the staff.
Biological: SD Vaccine Biological: Free Staff Vaccine
Active Comparator: SD Vaccine with No Free Staff Vaccine
NH facilities randomized to receive SD influenza vaccine (Fluzone) for the residents and not provided free SD vaccine (Fluzone) for the staff.
Biological: SD Vaccine Biological: No Free Staff Vaccine
[Note: For the group 'No free staff vaccine', Insight will not be providing free SD vaccine, however, staff vaccine will be available as per standard of care.]

Detailed Description:

SUMMARY: This study includes estimated 6782 Medicare-certified nursing homes (NHs) co-located within 50 miles of the 122 cities reporting to Center for Disease Control and Prevention (CDC) weekly influenza surveillance. In total, 1000 facilities will be enrolled for random assignment to either 1) the licensed high dose (HD) trivalent influenza vaccine (Fluzone HD [HD vaccine]),or 2) the standard dose (SD) trivalent influenza vaccine (Fluzone [SD vaccine]) for their residents and free SD vaccine vs. usual care (no free vaccine) for staff.

BACKGROUND: Lower respiratory tract infection (LRI), which includes pneumonia, bronchitis, and tracheobronchitis, is the leading cause of mortality and hospitalization in older adults, and NH residents. Often, the signs and symptoms of pneumonia, in particular, are not apparent in elderly patients, making diagnosis more complicated. In addition, clinician visits to these residents are few and sporadic and radiological facilities are not readily available. LRI may or may not directly lead to hospitalization, but LRIs are associated with considerable other morbidity than can result in hospitalization. Hospitalization rates for NH residents vary considerably between facilities, but the majority of hospitalizations occur during the 12 weeks in which influenza peaks each year.

Influenza is the most common viral infection of older adults. Influenza and pneumonia account for the majority of infectious morbidity and mortality in late life, and possibly for at least some of temporally associated—and vaccine preventable—vascular mortality such as heart attacks and strokes. Influenza can cause more than just viral pneumonia because it results in a systemic inflammatory response that is thrombogenic. Some experts believe that influenza vaccine can prevent thrombotic outcomes, such as strokes and heart attacks, mechanistically by reducing the overall inflammatory response through targeted priming of the immune system.

Influenza vaccination has been associated with reduced hospitalization, strokes, heart attacks and death in non-institutional older adult populations, but the benefit of influenza vaccine for the oldest population has been questioned. Also, influenza vaccination rates vary substantially between NHs.

OBJECTIVES: The primary objective is to estimate the differences in all-cause hospitalization rates during flu season experienced by long stay nursing home residents in facilities using the HD vaccine vs. usual care vaccination nursing homes. The secondary objective is to estimate the differences in the likelihood of Activities of Daily Living (ADL) functional decline experienced during the influenza season by long stay nursing home residents of facilities using the HD vaccine vs. the level of functional decline experienced by residents of usual care nursing homes.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Long-term care facilities within 50 miles of one of the 122 cities that serve as CDC surveillance sites

Exclusion Criteria:

  • Facilities already systematically administering HD vaccine to their residents
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01815268

Locations
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
United States, Rhode Island
Brown University
Providence, Rhode Island, United States, 02912
United States, Virginia
Insight Therapeutics, LLC
Norfolk, Virginia, United States, 23510
Sponsors and Collaborators
Insight Therapeutics, LLC
Brown University
Healthcentric Advisors
Case Western Reserve University
Investigators
Principal Investigator: Stefan Gravenstein, MD, MPH Case Western Reserve University
Principal Investigator: Vincent Mor, PhD Brown University
Principal Investigator: Ed Davidson, PharmD, MPH Insight Therapeutics, LLC
  More Information

Additional Information:
Publications:

Responsible Party: Insight Therapeutics, LLC
ClinicalTrials.gov Identifier: NCT01815268     History of Changes
Other Study ID Numbers: GRC75-EXT
Study First Received: March 11, 2013
Last Updated: October 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Insight Therapeutics, LLC:
Randomized Controlled Trial
Influenza
Influenza vaccine
Flu Vaccine
Fluzone
HD Fluzone
Nursing Home
Hospitalization
Mortality
Health Care worker vaccination
ADL decline
Effectiveness
Elderly
Morbidity
Nursing Home resident
Frail
Institutionalized
Epidemiology
CDC
US
city

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 21, 2014