Comparative Effectiveness of Recombinant Versus Standard Dose Quadrivalent Influenza Vaccine in U.S. Nursing Homes
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,989
- 试验地点
- 2
- 主要终点
- Differences in all-cause hospitalization rates during the 2019-20 and 2020-21 influenza seasons
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Differences in all-cause hospitalization rates during the 2019-20 and 2020-21 influenza seasons
时间窗: Up to 8 months each influenza season
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).
次要结局
- Differences in all-cause hospitalization rates(Up to 8 months each influenza season)
- Differences in pneumonia-related hospitalization rates(Up to 8 months each influenza season)
- Differences in activities of daily living (ADL) function score(Up to 8 months each influenza season)
- Differences in each pneumonia and influenza-related hospitalization rates(Up to 8 months each influenza season)
- Differences in major adverse cardiovascular event-related (MACE) hospitalization rates(Up to 8 months each influenza season)
- Differences in ICU stay(Up to 8 months each influenza season)
- Differences in mortality rates(Up to 8 months each influenza season)
- Differences in facility-reported outbreaks(Up to 8 months each influenza season)
- Differences in cardiorespiratory-related hospitalization rates(Up to 8 months each influenza season)