High-Dose Influenza Vaccine in Nursing Homes

NCT01815268 | Unknown Phase 4

• 1 other identifier: GRC75-EXT
• Study Type: interventional
• Target: 823
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Influenza

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Hospitalization rate

  up to 1 year

Secondary Outcomes (5)

• Change in activities of daily living (ADL) scores

  up to 1 year

• Facility-level mortality rate

  up to 1 year

• Hospitalization rate based on vaccine type and influenza strain

  Up to 3 years

• Cost difference between vaccine types

  up to 3 years

• Effect of facility policies on staff vaccination rates

  up to 3 years

Other Outcomes (1)

• Difference in hospitalization claims based on staff vaccination status

  up to 1 year

Study Arms (4)

HD Vaccine (Residents) + Free Vaccine (Staff)

EXPERIMENTAL

NH facilities randomized to receive high-dose trivalent influenza vaccine (Fluzone High-Dose) for the residents and provided free SD vaccine (Fluzone) for the staff.

Biological: HD Vaccine; Biological: Free Vaccine

HD Vaccine (Residents) + Usual Care (Staff)

EXPERIMENTAL

NH facilities randomized to receive high-dose trivalent influenza vaccine (Fluzone High-Dose) for the residents and not provided free vaccine for the staff.

Biological: HD Vaccine; Biological: Usual Care

SD Vaccine (Residents) + Free Vaccine (Staff)

ACTIVE COMPARATOR

NH facilities randomized to receive standard dose influenza vaccine (Fluzone) for the residents and provided free standard dose vaccine (Fluzone) for the staff.

Biological: SD Vaccine; Biological: Free Vaccine

SD Vaccine (Residents) + Usual Care (Staff)

ACTIVE COMPARATOR

NH facilities randomized to receive standard dose influenza vaccine (Fluzone) for the residents and not provided free vaccine for the staff.

Biological: SD Vaccine; Biological: Usual Care

Interventions

HD Vaccine BIOLOGICAL

Nursing home residents over 65 years are allocated to receive high-dose vaccine. Residents under 65 years are provided standard-dose vaccine.

Also known as: Fluzone High-Dose

HD Vaccine (Residents) + Free Vaccine (Staff); HD Vaccine (Residents) + Usual Care (Staff)

SD Vaccine BIOLOGICAL

Nursing home residents are allocated to receive standard-dose vaccine.

Also known as: Fluzone

SD Vaccine (Residents) + Free Vaccine (Staff); SD Vaccine (Residents) + Usual Care (Staff)

Free Vaccine BIOLOGICAL

Nursing home facilities are provided free standard-dose vaccine for their staff.

Also known as: Fluzone

HD Vaccine (Residents) + Free Vaccine (Staff); SD Vaccine (Residents) + Free Vaccine (Staff)

Usual Care BIOLOGICAL

Nursing home staff will have access to influenza vaccine, per standard of care. No free vaccine provided as part of study.

HD Vaccine (Residents) + Usual Care (Staff); SD Vaccine (Residents) + Usual Care (Staff)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insight Therapeutics, LLC: lead
• Brown University: collaborator
• Case Western Reserve University: collaborator

Study Sites (3)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

Brown University

Providence, Rhode Island, 02912, United States

Location

Insight Therapeutics, LLC

Norfolk, Virginia, 23510, United States

Location

Related Publications (7)

• Gozalo PL, Pop-Vicas A, Feng Z, Gravenstein S, Mor V. Effect of influenza on functional decline. J Am Geriatr Soc. 2012 Jul;60(7):1260-7. doi: 10.1111/j.1532-5415.2012.04048.x. Epub 2012 Jun 21.

  PMID: 22724499 BACKGROUND

• Fiore AE, Shay DK, Haber P, Iskander JK, Uyeki TM, Mootrey G, Bresee JS, Cox NJ; Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention (CDC). Prevention and control of influenza. Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2007. MMWR Recomm Rep. 2007 Jul 13;56(RR-6):1-54.

  PMID: 17625497 BACKGROUND

• DiazGranados CA, Dunning AJ, Kimmel M, Kirby D, Treanor J, Collins A, Pollak R, Christoff J, Earl J, Landolfi V, Martin E, Gurunathan S, Nathan R, Greenberg DP, Tornieporth NG, Decker MD, Talbot HK. Efficacy of high-dose versus standard-dose influenza vaccine in older adults. N Engl J Med. 2014 Aug 14;371(7):635-45. doi: 10.1056/NEJMoa1315727.

  PMID: 25119609 BACKGROUND

• Keitel WA, Atmar RL, Cate TR, Petersen NJ, Greenberg SB, Ruben F, Couch RB. Safety of high doses of influenza vaccine and effect on antibody responses in elderly persons. Arch Intern Med. 2006 May 22;166(10):1121-7. doi: 10.1001/archinte.166.10.1121.

  PMID: 16717175 BACKGROUND

• Falsey AR, Treanor JJ, Tornieporth N, Capellan J, Gorse GJ. Randomized, double-blind controlled phase 3 trial comparing the immunogenicity of high-dose and standard-dose influenza vaccine in adults 65 years of age and older. J Infect Dis. 2009 Jul 15;200(2):172-80. doi: 10.1086/599790.

  PMID: 19508159 BACKGROUND

• Gravenstein S, Davidson HE, Taljaard M, Ogarek J, Gozalo P, Han L, Mor V. Comparative effectiveness of high-dose versus standard-dose influenza vaccination on numbers of US nursing home residents admitted to hospital: a cluster-randomised trial. Lancet Respir Med. 2017 Sep;5(9):738-746. doi: 10.1016/S2213-2600(17)30235-7. Epub 2017 Jul 20.

  PMID: 28736045 DERIVED

• Gravenstein S, Dahal R, Gozalo PL, Davidson HE, Han LF, Taljaard M, Mor V. A cluster randomized controlled trial comparing relative effectiveness of two licensed influenza vaccines in US nursing homes: Design and rationale. Clin Trials. 2016 Jun;13(3):264-74. doi: 10.1177/1740774515625976. Epub 2016 Feb 11.

  PMID: 26908539 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Fluzone High-Dose; Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Stefan Gravenstein, MD, MPH

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

• Vincent Mor, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

• Ed Davidson, PharmD, MPH

  Insight Therapeutics, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2013
• First Posted: March 21, 2013
• Study Start: February 1, 2013
• Primary Completion: May 15, 2017
• Study Completion: September 1, 2018
• Last Updated: July 16, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)