Clinical trial NCT03965195: Recombinant Influenza Vaccination in U.S. Nursing Homes
Official title: Comparative Effectiveness of Recombinant Versus Standard Dose Quadrivalent Influenza Vaccine in U.S. Nursing Homes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Influenza
Influenza -Like Illness
Influenza, Human
Keywords: Influenza
Vaccine
Vaccination
Nursing Home
Respiratory-Related Hospitalizations
Cluster Randomized Trial
MACE (Major Adverse Cardiovascular Event)
Cardiorespiratory-Related Hospitalizations
All-Cause Hospitalization
Lead sponsor: Insight Therapeutics, LLC
Sponsor class: OTHER
Collaborators: name: Sanofi Pasteur, a Sanofi Company
name: Brown University
name: Case Western Reserve University
First posted: 2019-05-28
Enrollment: 1989
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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

Primary outcomes:
measure: Differences in all-cause hospitalization rates during the 2019-20 and 2020-21 influenza seasons
timeFrame: Up to 8 months each influenza season
Secondary outcomes:
measure: Differences in each pneumonia and influenza-related hospitalization rates
timeFrame: Up to 8 months each influenza season
measure: Differences in pneumonia-related hospitalization rates
timeFrame: Up to 8 months each influenza season
measure: Differences in major adverse cardiovascular event-related (MACE) hospitalization rates
timeFrame: Up to 8 months each influenza season
measure: Differences in cardiorespiratory-related hospitalization rates
timeFrame: Up to 8 months each influenza season
measure: Differences in ICU stay
timeFrame: Up to 8 months each influenza season
measure: Differences in mortality rates
timeFrame: Up to 8 months each influenza season
measure: Differences in activities of daily living (ADL) function score
timeFrame: Up to 8 months each influenza season
measure: Differences in facility-reported outbreaks
timeFrame: Up to 8 months each influenza season
measure: Differences in all-cause hospitalization rates
timeFrame: Up to 8 months each influenza season
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Insight Therapeutics, LLC
state: Virginia
Study officials:
affiliation: Insight Therapeutics, LLC
name: H. Edward Davidson, PharmD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Insight Therapeutics, LLC
name: Stefan Gravenstein, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: