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Recombinant Influenza Vaccination in U.S. Nursing Homes

Primary Purpose

Influenza, Influenza -Like Illness, Influenza, Human

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Recombinant Influenza Vaccine
Standard Dose Quadrivalent Influenza Vaccine
Sponsored by
Insight Therapeutics, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, Vaccine, Vaccination, Nursing Home, Respiratory-Related Hospitalizations, Cluster Randomized Trial, MACE (Major Adverse Cardiovascular Event), Cardiorespiratory-Related Hospitalizations, All-Cause Hospitalization

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Insight Therapeutics, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RIV4

IV4

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Differences in each pneumonia and influenza-related hospitalization rates
To determine the differences in each pneumonia and influenza-related hospitalization rates during the 2019-20 and 2020-21 influenza seasons experienced by long-stay nursing home residents in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older.
Differences in pneumonia-related hospitalization rates
To determine the differences in each pneumonia-related hospitalization rates during the 2019-20 and 2020-21 influenza seasons experienced by long-stay nursing home residents in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older.
Differences in major adverse cardiovascular event-related (MACE) hospitalization rates
To determine the differences in each major adverse cardiovascular event-related (MACE) hospitalization rates during the 2019-20 and 2020-21 influenza seasons experienced by long-stay nursing home residents in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older.
Differences in cardiorespiratory-related hospitalization rates
To determine the differences in long-stay residents' cardiorespiratory-related hospitalization rates each season and across two seasons in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older.
Differences in ICU stay
To determine the differences in long-stay residents' ICU stay each season and across two seasons in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older.
Differences in mortality rates
To determine the differences in long-stay residents' mortality rates each influenza season and both seasons in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older.
Differences in activities of daily living (ADL) function score
To determine the differences in long-stay residents' composite Activities of Daily Living (ADL) function score based on the MDS experienced during the influenza season by selected comorbidities and specific to respiratory illness, in facilities randomized to either RIV4 or IV4 combined over two seasons for each, residents 18 years of age and older and those 65 years of age and older.
Differences in facility-reported outbreaks
To determine differences in facility-reported outbreaks each season and across two seasons in facilities randomized to either RIV4 or IV4
Differences in all-cause hospitalization rates
To determine differences in long-stay residents' all-cause hospitalization rates as an interim exploratory analysis based on the Minimum Data Set 3.0 for each, residents 18 years of age and older and those 65 years of age and older.

Full Information

First Posted
May 20, 2019
Last Updated
March 14, 2023
Sponsor
Insight Therapeutics, LLC
Collaborators
Sanofi Pasteur, a Sanofi Company, Brown University, Case Western Reserve University
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1. Study Identification

Unique Protocol Identification Number
NCT03965195
Brief Title
Recombinant Influenza Vaccination in U.S. Nursing Homes
Official Title
Comparative Effectiveness of Recombinant Versus Standard Dose Quadrivalent Influenza Vaccine in U.S. Nursing Homes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 20, 2019 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insight Therapeutics, LLC
Collaborators
Sanofi Pasteur, a Sanofi Company, Brown University, Case Western Reserve University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
A study sample goal of 1000 U.S. NHs, housing approximately 112,000 overall residents and 92,000 over the age of 65 years, of whom 64,500 are long-stay NH residents, will be recruited for each of the 2019-20 and 2020-21 influenza seasons. Participating facilities will be randomly allocated in a 1:1 ratio to RIV4 or IV4 vaccine for their residents. Also, all staff must be offered the same vaccine in both allocation groups, in order to eliminate differences in transmission of influenza through staff to residents related to differences in vaccine-related protection of staff and will reduce heterogeneity between clusters. The Minimum Data Set from the NH resident assessment instrument will be evaluated from all evaluable facilities meeting inclusion criteria and will be cross-referenced to Medicare claims and drug use data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Influenza -Like Illness, Influenza, Human
Keywords
Influenza, Vaccine, Vaccination, Nursing Home, Respiratory-Related Hospitalizations, Cluster Randomized Trial, MACE (Major Adverse Cardiovascular Event), Cardiorespiratory-Related Hospitalizations, All-Cause Hospitalization

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1989 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RIV4
Arm Type
Experimental
Arm Description
Nursing homes randomized to receive quadrivalent recombinant influenza vaccine (Flublok) for the residents and staff
Arm Title
IV4
Arm Type
Active Comparator
Arm Description
Nursing homes randomized to receive standard dose quadrivalent influenza vaccine for the residents and staff
Intervention Type
Biological
Intervention Name(s)
Recombinant Influenza Vaccine
Other Intervention Name(s)
Flublok, RIV4
Intervention Description
Nursing home residents and staff 18 years and older are allocated to receive quadrivalent recombinant influenza vaccine.
Intervention Type
Biological
Intervention Name(s)
Standard Dose Quadrivalent Influenza Vaccine
Other Intervention Name(s)
IV4
Intervention Description
Nursing home residents and staff 18 years and older are allocated to receive standard dose quadrivalent influenza vaccine
Primary Outcome Measure Information:
Title
Differences in all-cause hospitalization rates during the 2019-20 and 2020-21 influenza seasons
Description
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).
Time Frame
Up to 8 months each influenza season
Secondary Outcome Measure Information:
Title
Differences in each pneumonia and influenza-related hospitalization rates
Description
To determine the differences in each pneumonia and influenza-related hospitalization rates during the 2019-20 and 2020-21 influenza seasons experienced by long-stay nursing home residents in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older.
Time Frame
Up to 8 months each influenza season
Title
Differences in pneumonia-related hospitalization rates
Description
To determine the differences in each pneumonia-related hospitalization rates during the 2019-20 and 2020-21 influenza seasons experienced by long-stay nursing home residents in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older.
Time Frame
Up to 8 months each influenza season
Title
Differences in major adverse cardiovascular event-related (MACE) hospitalization rates
Description
To determine the differences in each major adverse cardiovascular event-related (MACE) hospitalization rates during the 2019-20 and 2020-21 influenza seasons experienced by long-stay nursing home residents in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older.
Time Frame
Up to 8 months each influenza season
Title
Differences in cardiorespiratory-related hospitalization rates
Description
To determine the differences in long-stay residents' cardiorespiratory-related hospitalization rates each season and across two seasons in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older.
Time Frame
Up to 8 months each influenza season
Title
Differences in ICU stay
Description
To determine the differences in long-stay residents' ICU stay each season and across two seasons in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older.
Time Frame
Up to 8 months each influenza season
Title
Differences in mortality rates
Description
To determine the differences in long-stay residents' mortality rates each influenza season and both seasons in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older.
Time Frame
Up to 8 months each influenza season
Title
Differences in activities of daily living (ADL) function score
Description
To determine the differences in long-stay residents' composite Activities of Daily Living (ADL) function score based on the MDS experienced during the influenza season by selected comorbidities and specific to respiratory illness, in facilities randomized to either RIV4 or IV4 combined over two seasons for each, residents 18 years of age and older and those 65 years of age and older.
Time Frame
Up to 8 months each influenza season
Title
Differences in facility-reported outbreaks
Description
To determine differences in facility-reported outbreaks each season and across two seasons in facilities randomized to either RIV4 or IV4
Time Frame
Up to 8 months each influenza season
Title
Differences in all-cause hospitalization rates
Description
To determine differences in long-stay residents' all-cause hospitalization rates as an interim exploratory analysis based on the Minimum Data Set 3.0 for each, residents 18 years of age and older and those 65 years of age and older.
Time Frame
Up to 8 months each influenza season

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H. Edward Davidson, PharmD, MPH
Organizational Affiliation
Insight Therapeutics, LLC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stefan Gravenstein, MD, MPH
Organizational Affiliation
Insight Therapeutics, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Insight Therapeutics, LLC
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23510
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Recombinant Influenza Vaccination in U.S. Nursing Homes

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