Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Sanofi Pasteur, a Sanofi Company | INDUSTRY |
| Brown University | OTHER |
| Case Western Reserve University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RIV4 | Experimental | Nursing homes randomized to receive quadrivalent recombinant influenza vaccine (Flublok) for the residents and staff |
|
| IV4 | Active Comparator | Nursing homes randomized to receive standard dose quadrivalent influenza vaccine for the residents and staff |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Influenza Vaccine | Biological | Nursing home residents and staff 18 years and older are allocated to receive quadrivalent recombinant influenza vaccine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Differences in all-cause hospitalization rates during the 2019-20 and 2020-21 influenza seasons | To determine the differences in all-cause hospitalization rates during the 2019-20 and 2020-21 influenza seasons experienced by all long-stay nursing home residents 18 years of age and older in facilities randomized to offer either quadrivalent recombinant influenza vaccine (RIV4) or standard dose quadrivalent influenza vaccine (IV4). | Up to 8 months each influenza season |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in each pneumonia and influenza-related hospitalization rates | To determine the differences in each pneumonia and influenza-related hospitalization rates during the 2019-20 and 2020-21 influenza seasons experienced by long-stay nursing home residents in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older. | Up to 8 months each influenza season |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| H. Edward Davidson, PharmD, MPH | Insight Therapeutics, LLC | Principal Investigator |
| Stefan Gravenstein, MD, MPH | Insight Therapeutics, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Insight Therapeutics, LLC | Norfolk | Virginia | 23510 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39745702 | Derived | McConeghy KW, Davidson HE, Canaday DH, Han L, Hayes K, Baier RR, Abul Y, Saade E, Mor V, Gravenstein S. Recombinant vs Egg-Based Quadrivalent Influenza Vaccination for Nursing Home Residents: A Cluster Randomized Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2452677. doi: 10.1001/jamanetworkopen.2024.52677. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C528512 | FluBlok |
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Standard Dose Quadrivalent Influenza Vaccine | Biological | Nursing home residents and staff 18 years and older are allocated to receive standard dose quadrivalent influenza vaccine |
|
|
| Differences in pneumonia-related hospitalization rates | To determine the differences in each pneumonia-related hospitalization rates during the 2019-20 and 2020-21 influenza seasons experienced by long-stay nursing home residents in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older. | Up to 8 months each influenza season |
| Differences in major adverse cardiovascular event-related (MACE) hospitalization rates | To determine the differences in each major adverse cardiovascular event-related (MACE) hospitalization rates during the 2019-20 and 2020-21 influenza seasons experienced by long-stay nursing home residents in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older. | Up to 8 months each influenza season |
| Differences in cardiorespiratory-related hospitalization rates | To determine the differences in long-stay residents' cardiorespiratory-related hospitalization rates each season and across two seasons in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older. | Up to 8 months each influenza season |
| Differences in ICU stay | To determine the differences in long-stay residents' ICU stay each season and across two seasons in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older. | Up to 8 months each influenza season |
| Differences in mortality rates | To determine the differences in long-stay residents' mortality rates each influenza season and both seasons in facilities randomized to either RIV4 or IV4 for each, residents 18 years of age and older and those 65 years of age and older. | Up to 8 months each influenza season |
| Differences in activities of daily living (ADL) function score | To determine the differences in long-stay residents' composite Activities of Daily Living (ADL) function score based on the MDS experienced during the influenza season by selected comorbidities and specific to respiratory illness, in facilities randomized to either RIV4 or IV4 combined over two seasons for each, residents 18 years of age and older and those 65 years of age and older. | Up to 8 months each influenza season |
| Differences in facility-reported outbreaks | To determine differences in facility-reported outbreaks each season and across two seasons in facilities randomized to either RIV4 or IV4 | Up to 8 months each influenza season |
| Differences in all-cause hospitalization rates | To determine differences in long-stay residents' all-cause hospitalization rates as an interim exploratory analysis based on the Minimum Data Set 3.0 for each, residents 18 years of age and older and those 65 years of age and older. | Up to 8 months each influenza season |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |