NCT03599739

Brief Summary

The purpose of this study is to determine if different influenza vaccines produce different outcomes in nursing facility residents receiving the required annual influenza vaccination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
598

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

July 13, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2019

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2023

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

July 16, 2018

Last Update Submit

March 15, 2023

Conditions

InfluenzaInfluenza-like IllnessInfluenza, Human

Keywords

InfluenzaVaccineVaccinationNursing HomeRespiratory-Related Hospitalizations

Outcome Measures

Primary Outcomes (1)

  • Hospitalization for all causes

    Time to first occurrence of hospitalization for all-causes.

    up to 1 year

Study Arms (2)

Follow-On Cohort

We will survey 823 nursing facilities who participated in the aTIV Influenza Vaccination and Morbitiy and Mortality in U.S. Nursing Homes study in 2016-2017. We anticipate a 70% response rate from this sample for participation.

Biological: Influenza

Parallel Cohort

We will survey an additional 1000 facilities (i.e., facilities not participating in the original 2016-2017 study, but meeting the same entry criteria, except prior use of high dose vaccine will be allowed) in order to capture a cohort that used a wide range of self-selected vaccine choices. We anticipate a 50% response rate from this sample.

Biological: Influenza

Interventions

InfluenzaBIOLOGICAL

Facilities will be asked to complete a survey to evaluate the impact of the influenza vaccine choice on hospitalization risk for the 2017-2018 influenza season.

Follow-On CohortParallel Cohort

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Long-term care facilities within 75 miles of one of the 121 cities that serve as CDC surveillance sites. These facilities must not have fewer than 50 long-stay residents, facilities that are hospital based, facilities with more than 20% of the population under age 65, and facilities not submitting Minimum Data Set (MDS) data.

You may qualify if:

  • Participated in the Adjuvanted Influenza Vaccination and Morbidity and Mortality in U.S. Nursing Homes study
  • Long-term care facilities within 75 miles of one of the 121 cities that serve as CDC surveillance sites

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Insight Therapeutics, LLC

Norfolk, Virginia, 23510, United States

Location

Related Publications (3)

  • DiazGranados CA, Dunning AJ, Robertson CA, Talbot HK, Landolfi V, Greenberg DP. Effect of Previous-Year Vaccination on the Efficacy, Immunogenicity, and Safety of High-Dose Inactivated Influenza Vaccine in Older Adults. Clin Infect Dis. 2016 May 1;62(9):1092-1099. doi: 10.1093/cid/ciw085. Epub 2016 Feb 21.

    PMID: 26908801BACKGROUND

  • Flannery B, Chung JR, Thaker SN, Monto AS, Martin ET, Belongia EA, McLean HQ, Gaglani M, Murthy K, Zimmerman RK, Nowalk MP, Jackson ML, Jackson LA, Foust A, Sessions W, Berman L, Spencer S, Fry AM. Interim Estimates of 2016-17 Seasonal Influenza Vaccine Effectiveness - United States, February 2017. MMWR Morb Mortal Wkly Rep. 2017 Feb 17;66(6):167-171. doi: 10.15585/mmwr.mm6606a3.

    PMID: 28207689BACKGROUND

  • 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: 28736045BACKGROUND

Related Links

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

Study Officials

  • Stefan Gravenstein, MD, MPH

    Brown University

    PRINCIPAL INVESTIGATOR

  • Vincent Mor, PhD

    Brown University

    PRINCIPAL INVESTIGATOR

  • Pedro Gozalo, Phd

    Brown University

    PRINCIPAL INVESTIGATOR

  • H. Edward Davidson, PharmD, MPH

    Insight Therapeutics, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2018

First Posted

July 26, 2018

Study Start

July 13, 2018

Primary Completion

February 15, 2019

Study Completion

January 25, 2023

Last Updated

March 16, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)