NCT03965195

Recombinant Influenza Vaccination in U.S. Nursing Homes

Comparative Effectiveness of Recombinant Versus Standard Dose Quadrivalent Influenza Vaccine in U.S. Nursing Homes

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,989 (actual)
• Sponsor: Insight Therapeutics, LLC · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza
• Influenza -Like Illness
• Influenza, Human

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Influenza Vaccine	Nursing home residents and staff 18 years and older are allocated to receive quadrivalent recombinant influenza vaccine.
BIOLOGICAL	Standard Dose Quadrivalent Influenza Vaccine	Nursing home residents and staff 18 years and older are allocated to receive standard dose quadrivalent influenza vaccine

Timeline

• Start date: 2019-07-20
• Primary completion: 2023-08-01
• Completion: 2023-12-01
• First posted: 2019-05-28
• Last updated: 2023-03-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study