A Phase 4 interventional study of Recombinant Influenza Vaccine and Standard Dose Quadrivalent Influenza Vaccine in Influenza, Influenza -Like Illness and Influenza, Human, sponsored by Insight Therapeutics, LLC. Status unknown at 1 site in United States. Open to participants aged 18 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-15.
Sponsored by Insight Therapeutics, LLC · Phase 4, Interventional, and Prevention
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.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 1,989 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Insight Therapeutics, LLC is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Nursing homes randomized to receive quadrivalent recombinant influenza vaccine (Flublok) for the residents and staff
Biological: Recombinant Influenza Vaccine
Nursing homes randomized to receive standard dose quadrivalent influenza vaccine for the residents and staff
Biological: Standard Dose Quadrivalent Influenza Vaccine
Nursing home residents and staff 18 years and older are allocated to receive quadrivalent recombinant influenza vaccine.
Also known as: Flublok, RIV4
Nursing home residents and staff 18 years and older are allocated to receive standard dose quadrivalent influenza vaccine
Also known as: IV4
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).
Time frame: Up to 8 months each influenza season
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.
Time frame: Up to 8 months each influenza season
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Up to 8 months each influenza season
Plan to share: No
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This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Insight Therapeutics, LLC