Clinical and Cost Impact of Complete and Incomplete Rotarix Vaccination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 主要终点
- Incidence of RV-related utilization
研究概览
简要总结
This study aims to estimate the clinical and cost impact of Rotarix vaccinations among children aged less than 5 years using insurance claims data from commercial plans and Medicaid low-income population. The impact of incomplete and complete Rotarix vaccination will also be examined, overall and stratified by calendar time of Rotarix vaccination (e.g., 2008 onward).
详细描述
Insurance claims data from the MarketScan Commercial Claims and Encounters Database {MarketScan Commercial (2000-2010)} and the MarketScan Multi-State Medicaid Database {MarketScan Medicaid (2002-2009)} will be analyzed separately; no merging of the databases will occur.
The claims data extracts are fully de-identified and compliant with the Health Insurance Portability and Accountability Act of 1996 (U.S.) (HIPAA).
The children will be observed from birth to the earliest of end of continuous eligibility (due to disenrollment, data cut-off, or death) or 5 years of age. Observation time will be classified using two different definitions of Rotarix vaccination coverage, and analyses will be conducted for each different scenario.
The two definitions for Rotarix vaccination coverage are:
- Rotarix vaccination according to compliance with the Advisory Committee on Immunization Practices (ACIP)-specified vaccination window of 6 weeks to 8 months old.
- Rotarix vaccination according to compliance with the Rotarix prescribing information (PI) window of 6 weeks to 6 months old.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Continuously enrolled from birth. (Note: Due to the absence of birth dates in insurance claims data, this inclusion criterion will be met if a child's year of first enrollment and year of birth are the same. If so, then the date of first enrollment will be used as proxy for date of birth.)
- •Received both medical and pharmacy benefits.
排除标准
- •Enrolled in capitation-based health plans.
- •For MarketScan Commercial, residence in states with universal vaccination programs that include the RV vaccine or where RV vaccine inclusion cannot be ascertained (i.e., Alaska, Idaho, Massachusetts, Maine, North Dakota, New Hampshire, New Mexico, Oregon, Rhode Island, Vermont, Washington, Wisconsin, and Wyoming).
- •Received any Rotateq vaccination.
- •Lost to follow-up prior to end of vaccination window or had RV prior to end of vaccination window.
结局指标
主要结局
Incidence of RV-related utilization
时间窗: During the study period (from 2000 up to 2010)
Estimation and comparison of the clinical impact of complete and incomplete Rotarix vaccination among children less than 5 years of age
Incidence of diarrhea-related utilization
时间窗: During the study period (from 2000 up to 2010)
Estimation and comparison of the clinical impact of complete and incomplete Rotarix vaccination among children less than 5 years of age
Incidence of first RV episode
时间窗: During the study period (from 2000 up to 2010)
Estimation and comparison of the clinical impact of complete and incomplete Rotarix vaccination among children less than 5 years of age
次要结局
未报告次要终点