Recombinant Influenza Vaccination in U.S. Nursing Homes

Status unconfirmed · Phase 4

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

In brief

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.

Key facts

Study ID

NCT03965195

Run by

Insight Therapeutics, LLC

People needed

1989

Starts

2019-07-20

Expected to finish

2023-12-01

Last updated by the study team

2023-03-15

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Insight Therapeutics, LLC — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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