NCT03965195

Brief Summary

Based on recent evidence on the mutation of the A/H3N2 strain in egg-grown vaccine, the investigators will study the quadrivalent recombinant influenza vaccine (RIV4, Flublok) compared to the standard dose quadrivalent vaccine (IV4) in a cohort of long-stay NH residents with a primary endpoint of all-cause hospitalization.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,989

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2019

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 20, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 28, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

July 20, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

4 years

First QC Date

May 20, 2019

Last Update Submit

March 14, 2023

Conditions

InfluenzaInfluenza -Like IllnessInfluenza, Human

Keywords

InfluenzaVaccineVaccinationNursing HomeRespiratory-Related HospitalizationsCluster Randomized TrialMACE (Major Adverse Cardiovascular Event)Cardiorespiratory-Related HospitalizationsAll-Cause Hospitalization

Outcome Measures

Primary Outcomes (1)

  • Differences in all-cause hospitalization rates during the 2019-20 and 2020-21 influenza seasons

    To determine the differences in all-cause hospitalization rates during the 2019-20 and 2020-21 influenza seasons experienced by all long-stay nursing home residents 18 years of age and older in facilities randomized to offer either quadrivalent recombinant influenza vaccine (RIV4) or standard dose quadrivalent influenza vaccine (IV4).

    Up to 8 months each influenza season

Secondary Outcomes (9)

  • Differences in each pneumonia and influenza-related hospitalization rates

    Up to 8 months each influenza season

  • Differences in pneumonia-related hospitalization rates

    Up to 8 months each influenza season

  • Differences in major adverse cardiovascular event-related (MACE) hospitalization rates

    Up to 8 months each influenza season

  • Differences in cardiorespiratory-related hospitalization rates

    Up to 8 months each influenza season

  • Differences in ICU stay

    Up to 8 months each influenza season

  • +4 more secondary outcomes

Study Arms (2)

RIV4

EXPERIMENTAL

Nursing homes randomized to receive quadrivalent recombinant influenza vaccine (Flublok) for the residents and staff

Biological: Recombinant Influenza Vaccine

IV4

ACTIVE COMPARATOR

Nursing homes randomized to receive standard dose quadrivalent influenza vaccine for the residents and staff

Biological: Standard Dose Quadrivalent Influenza Vaccine

Interventions

Recombinant Influenza VaccineBIOLOGICAL

Nursing home residents and staff 18 years and older are allocated to receive quadrivalent recombinant influenza vaccine.

Also known as: Flublok, RIV4
RIV4
Standard Dose Quadrivalent Influenza VaccineBIOLOGICAL

Nursing home residents and staff 18 years and older are allocated to receive standard dose quadrivalent influenza vaccine

Also known as: IV4
IV4

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medicare-certified NHs with at least 50 long-stay residents ≥ 18 years of age
  • Facilities with at least 80% of their long-stay population ≥ 65 years of age or at least 70 long stay residents ≥ 65 years of age that make up ≥ 45% of their total number of beds

You may not qualify if:

  • Hospital-based facilities
  • Facilities where Fluzone High-Dose or Fluad was used in the previous influenza season (2018-19 or 2019-20), or who's leadership plans to use one of these vaccines in the 2019- 2020 or 2020-21 season
  • Facilities not submitting MDS data
  • Facilities not in one of the 50 U.S. states

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Insight Therapeutics, LLC

Norfolk, Virginia, 23510, United States

Location

Related Publications (1)

  • McConeghy KW, Davidson HE, Canaday DH, Han L, Hayes K, Baier RR, Abul Y, Saade E, Mor V, Gravenstein S. Recombinant vs Egg-Based Quadrivalent Influenza Vaccination for Nursing Home Residents: A Cluster Randomized Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2452677. doi: 10.1001/jamanetworkopen.2024.52677.

    PMID: 39745702DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

FluBlokInfluenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • H. Edward Davidson, PharmD, MPH

    Insight Therapeutics, LLC

    PRINCIPAL INVESTIGATOR

  • Stefan Gravenstein, MD, MPH

    Insight Therapeutics, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2019

First Posted

May 28, 2019

Study Start

July 20, 2019

Primary Completion

August 1, 2023

Study Completion

December 1, 2023

Last Updated

March 15, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)