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InfluenzaPhase 4NCT01815268

High-Dose Influenza Vaccine in Nursing Homes

A Phase 4 study testing HD Vaccine, SD Vaccine and Free Vaccine in people with Influenza, run by Insight Therapeutics, LLC at 3 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
HD Vaccine, SD Vaccine and Free Vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
823 participants
Where
3 sitesUnited States
Study dates
Feb 2013to Sep 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Insight Therapeutics, LLC

    Norfolk, Virginia, 23510

  • Brown University

    Providence, Rhode Island, 02912

Other trials in United States

About this study

Official title: High Dose Influenza Vaccination and Morbidity & Mortality in U.S. Nursing Homes

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.

Read the detailed description

SUMMARY: This nationally representative study samples from estimated 6782 Medicare-certified nursing homes 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 (High-Dose Fluzone [HD vaccine]), or 2) the standard dose (SD) trivalent influenza vaccine (Fluzone [SD vaccine]) for their residents. Additionally, half the facilities will receive free SD vaccine for their staff and the remaining facilities will practice usual care (no free vaccine) for staff.

BACKGROUND: Influenza and pneumonia (P\&I) are leading infectious causes of hospitalization and mortality in community-dwelling older adults and residents of long-term custodial care facilities or nursing homes (NH), and produce substantial annual health care costs. The elderly incur over 90% of this disease burden and NH residents are especially vulnerable given immune senescence, multimorbidity, and close living quarters. While hospitalization rates for NH residents vary considerably between facilities, most occur during the sixteen weeks of peak influenza activity annually. Influenza vaccination, a mainstay in prevention, is recommended in the U.S. for all individuals six months of age and older. Vaccination associates with reduced rates of stroke, heart attack, hospitalization, and death in non-institutional older adult populations. However, the benefit of influenza vaccine for the elderly in general has been questioned, a salient concern for frail elderly, such as NH residents. Influenza vaccination rates vary substantially between nursing homes. Influenza vaccine response declines with advancing age, indicating the need for a better vaccine.

OBJECTIVES: The primary objective is to estimate the differences in all-cause hospitalization rates during influenza season experienced by long-stay nursing home residents, between facilities using HD vaccine vs. SD 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.

Conditions
Influenza
Being tested
HD Vaccine, SD Vaccine, Free Vaccine, Usual Care
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
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HD VaccineBiological

    Also called Fluzone High-Dose

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

  • SD VaccineBiological

    Also called Fluzone

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

  • Free VaccineBiological

    Also called Fluzone

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

  • Usual CareBiological

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

Study groups in NCT01815268
Study groupRoleWhat they receive
HD Vaccine (Residents) + Free Vaccine (Staff)ExperimentalNH facilities randomized to receive high-dose trivalent influenza vaccine (Fluzone High-Dose) for the residents and provided free SD vaccine (Fluzone) for the staff.
Receives: Biological: HD Vaccine; Biological: Free Vaccine
HD Vaccine (Residents) + Usual Care (Staff)ExperimentalNH facilities randomized to receive high-dose trivalent influenza vaccine (Fluzone High-Dose) for the residents and not provided free vaccine for the staff.
Receives: Biological: HD Vaccine; Biological: Usual Care
SD Vaccine (Residents) + Free Vaccine (Staff)Active comparatorNH facilities randomized to receive standard dose influenza vaccine (Fluzone) for the residents and provided free standard dose vaccine (Fluzone) for the staff.
Receives: Biological: SD Vaccine; Biological: Free Vaccine
SD Vaccine (Residents) + Usual Care (Staff)Active comparatorNH facilities randomized to receive standard dose influenza vaccine (Fluzone) for the residents and not provided free vaccine for the staff.
Receives: Biological: SD Vaccine; Biological: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hospitalization rate

    Measured: up to 1 year

Secondary outcomes (5)

  1. Change in activities of daily living (ADL) scores

    Measured: up to 1 year

  2. Facility-level mortality rate

    Measured: up to 1 year

  3. Hospitalization rate based on vaccine type and influenza strain

    Measured: Up to 3 years

  4. Cost difference between vaccine types

    Measured: up to 3 years

  5. Effect of facility policies on staff vaccination rates

    Measured: up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completion15 May 2017
  4. Study completionSep 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
823 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01815268
Sponsor's protocol ID
GRC75-EXT
Status last verified
Jul 2018
First submitted
11 Mar 2013
Last updated
16 Jul 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22724499

  • 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.

    PubMed 17625497

  • 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.

    PubMed 25119609

  • 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.

    PubMed 16717175

  • 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.

    PubMed 19508159

  • 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.

    PubMed 28736045

  • 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.

    PubMed 26908539

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing HD Vaccine, SD Vaccine and Free Vaccine in people with Influenza, run by Insight Therapeutics, LLC at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospitalization rate (time frame: up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01815268, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2018.

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