NCT01720277

Brief Summary

The purpose of this pilot evaluation is to help determine the feasibility and power needed to prospectively evaluate relative effectiveness of high-dose influenza vaccine in preventing influenza mortality and hospitalization in a nursing home population in the U.S., compared to the standard-dose influenza vaccine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,957

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2012

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 15, 2012

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 2, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
2 years until next milestone

Results Posted

Study results publicly available

April 18, 2018

Completed
Last Updated

May 23, 2018

Status Verified

April 1, 2018

Enrollment Period

8 months

First QC Date

October 15, 2012

Results QC Date

June 15, 2017

Last Update Submit

April 25, 2018

Conditions

Influenza

Keywords

Randomized Controlled TrialInfluenzaInfluenza vaccineFlu VaccineFluzoneHD FluzoneNursing HomesHospitalizationMortalityHealth Care worker vaccinationADL declinePilotEffectiveness

Outcome Measures

Primary Outcomes (1)

  • Total All-cause Hospitalizations

    The primary outcome will establish our methodology for measuring all-cause hospitalizations using the Minimum Data Set (MDS).

    1 year

Secondary Outcomes (1)

  • Change in Residents' Functional Status

    1 year

Other Outcomes (1)

  • Recruit, Enroll, and Randomize Nursing Homes Per Calculated Sample Size

    1 year

Study Arms (2)

HD Fluzone Vaccine

EXPERIMENTAL

NH facilities randomized to receive high dose trivalent influenza vaccine (HD Fluzone) for the residents.

Biological: HD Fluzone Vaccine

SD Fluzone Vaccine

ACTIVE COMPARATOR

NH facilities randomized to standard dose trivalent influenza vaccine (SD Fluzone) for the residents.

Biological: SD Fluzone Vaccine

Interventions

HD Fluzone VaccineBIOLOGICAL

Nursing home residents over 65 years are allocated to receive high dose trivalent vaccine. Residents under 65 years are provided standard dose trivalent vaccine (TIV).

Also known as: Fluzone High Dose influenza vaccine
HD Fluzone Vaccine
SD Fluzone VaccineBIOLOGICAL

Nursing home residents are allocated to receive standard trivalent vaccine (TIV).

Also known as: Fluzone influenza vaccine
SD Fluzone Vaccine

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Long-term care facilities in one of the 122 cities that serve as Center for Disease Control and Prevention (CDC) surveillance sites

You may not qualify if:

  • Facilities already systematically administering HD vaccine to their residents
  • Facilities for whom over half the residents are on Medicare (short-stay)
  • Facilities in which over half the residents are on Medicare Part A (SNF)
  • Facilities having fewer than 50 long-stay residents
  • Hospital-based facilities
  • Facilities with more than 20% of the population under age 65
  • Facilities with mandated (employment-dependent) seasonal influenza vaccination
  • Facilities not submitting MDS data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brown Univeristy

Providence, Rhode Island, 02903, United States

Location

Insight Therapeutics

Norfolk, Virginia, 23510, United States

Location

Related Publications (12)

  • Thompson WW, Shay DK, Weintraub E, Brammer L, Cox N, Anderson LJ, Fukuda K. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA. 2003 Jan 8;289(2):179-86. doi: 10.1001/jama.289.2.179.

    PMID: 12517228BACKGROUND

  • Thompson WW, Shay DK, Weintraub E, Brammer L, Bridges CB, Cox NJ, Fukuda K. Influenza-associated hospitalizations in the United States. JAMA. 2004 Sep 15;292(11):1333-40. doi: 10.1001/jama.292.11.1333.

    PMID: 15367555BACKGROUND

  • Hayward AC, Harling R, Wetten S, Johnson AM, Munro S, Smedley J, Murad S, Watson JM. Effectiveness of an influenza vaccine programme for care home staff to prevent death, morbidity, and health service use among residents: cluster randomised controlled trial. BMJ. 2006 Dec 16;333(7581):1241. doi: 10.1136/bmj.39010.581354.55. Epub 2006 Dec 1.

    PMID: 17142257BACKGROUND

  • Deguchi Y, Nishimura K. Efficacy of Influenza Vaccine in Elderly Persons in Welfare Nursing Homes: Reduction in Risks of Mortality and Morbidity During an Influenza A (H3N2) Epidemic. J Gerontol A Biol Sci Med Sci. 2001 Jun;56(6):M391-4. doi: 10.1093/gerona/56.6.m391.

    PMID: 11382801BACKGROUND

  • 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: 22724499BACKGROUND

  • Barker WH, Borisute H, Cox C. A study of the impact of influenza on the functional status of frail older people. Arch Intern Med. 1998 Mar 23;158(6):645-50. doi: 10.1001/archinte.158.6.645.

    PMID: 9521230BACKGROUND

  • Jackson LA, Jackson ML, Nelson JC, Neuzil KM, Weiss NS. Evidence of bias in estimates of influenza vaccine effectiveness in seniors. Int J Epidemiol. 2006 Apr;35(2):337-44. doi: 10.1093/ije/dyi274. Epub 2005 Dec 20.

    PMID: 16368725BACKGROUND

  • Simonsen L, Viboud C, Taylor R. Influenza vaccination in elderly people. Lancet. 2005 Dec 17;366(9503):2086. doi: 10.1016/S0140-6736(05)67884-1. No abstract available.

    PMID: 16360785BACKGROUND

  • 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: 17625497BACKGROUND

  • Kingston BJ, Wright CV Jr. Influenza in the nursing home. Am Fam Physician. 2002 Jan 1;65(1):75-8, 72.

    PMID: 11804444BACKGROUND

  • Menec VH, Black C, MacWilliam L, Aoki FY. The impact of influenza-associated respiratory illnesses on hospitalizations, physician visits, emergency room visits, and mortality. Can J Public Health. 2003 Jan-Feb;94(1):59-63. doi: 10.1007/BF03405054.

    PMID: 12583681BACKGROUND

  • Mor V, Intrator O, Unruh MA, Cai S. Temporal and Geographic variation in the validity and internal consistency of the Nursing Home Resident Assessment Minimum Data Set 2.0. BMC Health Serv Res. 2011 Apr 15;11:78. doi: 10.1186/1472-6963-11-78.

    PMID: 21496257BACKGROUND

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Results Point of Contact

Title
Dr. Stefan Gravenstein
Organization
Brown University and Providence VA Medical Center
Stefan_gravenstein@brown.edu
401-863-3172

Study Officials

  • Stefan Gravenstein, MD, MPH

    Case Western Reserve University

    PRINCIPAL INVESTIGATOR

  • Ed Davidson, PharmD, MPH

    Insight Therapeutics, LLC

    PRINCIPAL INVESTIGATOR

  • Vincent Mor, PhD

    Brown University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 15, 2012

First Posted

November 2, 2012

Study Start

September 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2016

Last Updated

May 23, 2018

Results First Posted

April 18, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)