Recombinant Influenza Vaccination in U.S. Nursing Homes

Insight Therapeutics

Status and phase: Active, not recruiting; Phase 4

Conditions: Influenza, Human; Influenza -Like Illness; Influenza

Treatments: Biological: Recombinant Influenza Vaccine; Biological: Standard Dose Quadrivalent Influenza Vaccine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03965195

INSI-201902

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,989 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,989 participants in 2 patient groups

RIV4

Experimental group

Description:

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

Treatment:

Biological: Recombinant Influenza Vaccine

IV4

Active Comparator group

Description:

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

Treatment:

Biological: Standard Dose Quadrivalent Influenza Vaccine