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Recombinant Influenza Vaccination in U.S. Nursing Homes

UnknownPhase 4

Sponsor: Insight Therapeutics, LLC

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

Interventions: Recombinant Influenza Vaccine, Standard Dose Quadrivalent Influenza Vaccine

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 120 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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

Locations (1)

Norfolk, Virginia, United States