Recombinant Influenza Vaccination in U.S. Nursing Homes

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03965195
Study type	Interventional
Source	Insight Therapeutics, LLC
Contact
Status	Active, not recruiting
Phase	Phase 4
Start date	July 20, 2019
Completion date	December 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05523089` - The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults	Phase 2
Completed	`NCT05009251` - Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake	N/A
Completed	`NCT03282240` - Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US	Phase 3
Completed	`NCT00968539` - Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults	Phase 3
Completed	`NCT00971425` - Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)	Phase 3
Completed	`NCT00968526` - Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults	Phase 3
Completed	`NCT05525494` - Patient Portal Flu Vaccine Reminders (5)	N/A
Completed	`NCT04074928` - Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects	Phase 3
Completed	`NCT04695717` - This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam	Phase 3
Completed	`NCT05012163` - Lottery Incentive Nudges to Increase Influenza Vaccinations	N/A
Completed	`NCT04109222` - Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively	Phase 4
Completed	`NCT03888989` - Response to Influenza Vaccine During Pregnancy	Phase 1
Completed	`NCT02587221` - Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age	Phase 3
Completed	`NCT03453801` - The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection	Phase 1
Completed	`NCT01440387` - A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older	Phase 3
Terminated	`NCT01195779` - Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children	Phase 2
Completed	`NCT03321968` - Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults	Phase 3
Completed	`NCT00972517` - Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children	Phase 3
Completed	`NCT04570904` - Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
Recruiting	`NCT03331991` - Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel	N/A