UnknownPhase 4

Recombinant Influenza Vaccination in U.S. Nursing Homes

United States1,989 participantsStarted 2019-07-20

Plain-language 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.

Who can participate

Age range18 Years – 120 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Differences in all-cause hospitalization rates during the 2019-20 and 2020-21 influenza seasons

Timeframe: Up to 8 months each influenza season

Trial details

NCT IDNCT03965195

SponsorInsight Therapeutics, LLC

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08

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