Recombinant Influenza Vaccination in U.S. Nursing Homes

Phase 4

Active, not recruiting

• Conditions: Influenza, Human; Influenza -Like Illness; Influenza
• Interventions: Biological: Recombinant Influenza Vaccine; Biological: Standard Dose Quadrivalent Influenza Vaccine

• Registration Number: NCT03965195
• Lead Sponsor: Insight Therapeutics, LLC

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.

Study Timeline

• Study First Submitted: 2019-05-20
• Study First Submitted QC: 2019-05-24
• Study First Posted: 2019-05-28
• Study Start: 2019-07-20
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-14
• Last Update Posted: 2023-03-15
• Primary Completion: 2023-08
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1989

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RIV4	Recombinant Influenza Vaccine	Nursing homes randomized to receive quadrivalent recombinant influenza vaccine (Flublok) for the residents and staff
IV4	Standard Dose Quadrivalent Influenza Vaccine	Nursing homes randomized to receive standard dose quadrivalent influenza vaccine for the residents and staff

Primary Outcome Measures

Name	Time	Method
Differences in all-cause hospitalization rates during the 2019-20 and 2020-21 influenza seasons	Up to 8 months each influenza season	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

Name	Time	Method
Differences in all-cause hospitalization rates	Up to 8 months each influenza season	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.
Differences in pneumonia-related hospitalization rates	Up to 8 months each influenza season	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 activities of daily living (ADL) function score	Up to 8 months each influenza season	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 each pneumonia and influenza-related hospitalization rates	Up to 8 months each influenza season	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 major adverse cardiovascular event-related (MACE) hospitalization rates	Up to 8 months each influenza season	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 ICU stay	Up to 8 months each influenza season	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	Up to 8 months each influenza season	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 facility-reported outbreaks	Up to 8 months each influenza season	To determine differences in facility-reported outbreaks each season and across two seasons in facilities randomized to either RIV4 or IV4
Differences in cardiorespiratory-related hospitalization rates	Up to 8 months each influenza season	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.

Trial Locations

Locations (1)

Insight Therapeutics, LLC; 🇺🇸 Norfolk, Virginia, United States