Patterns of use, comparative effectiveness, and safety of rotavirus vaccines

摘要 轮状病毒疫苗RotaTeq(R)(轮状病毒活疫苗、口服疫苗、五价轮状病毒疫苗)[RV5](默克公司) 和Rotarix(R)(轮状病毒活疫苗、口服疫苗)[RV1](葛兰素史克生物制品)推荐用于常规治疗 由免疫实践咨询委员会(ACIP)在美国婴儿中使用。近期观测 研究表明，轮状病毒疫苗大大减少了住院和急诊科就诊 然而，目前还没有大规模的研究比较 RV5和RV1的有效性和安全性。我们建议比较RV5和RV5的有效性和安全性 在美国70多万名由私人保险或医疗补助覆盖的婴儿中出现RV1 2006-2011年的保险业。我们的大规模研究将使我们能够描述 这两种轮状病毒疫苗在有效性方面可能有所不同，因为RV5需要三种 与RV1的两次管理相比。我们的新型自控设计和数据驱动的疫苗监测 方法将帮助我们进一步表征与轮状病毒疫苗接种肠套叠有关的潜在风险 以及确定其他潜在的令人担忧的情况。除了相对有效和安全之外 分析，我们将研究这两种疫苗的覆盖模式，包括地理差异和 完成轮状病毒疫苗接种系列工作。我们将进一步确定个人、提供者和生态 轮状病毒疫苗接种率的预测指标。我们的研究将在一个专家小组的指导下进行 以及来自北卡罗来纳大学教堂山分校、哈佛公共卫生学院和 美国食品和药物管理局(FDA)生物制品评估和研究中心。我们的结果是 通过确定轮状病毒疫苗的预测因子，研究将有助于为潜在的质量改进计划提供信息 并将为临床医生、付款人、监管机构和政策制定者提供有关相关信息的及时信息 RV5和RV1的好处和坏处。这项研究也将有助于现代统计学的发展 可用于研究与儿童疫苗相关的益处和风险的方法和研究设计。

Abstract The rotavirus vaccines RotaTeq(R) (Rotavirus Vaccine, live, oral, pentavalent) [RV5] (Merck & Co., Inc.) and Rotarix(R) (Rotavirus Vaccine, live, oral) [RV1] (GlaxoSmithKline Biologicals) are recommended for routine use among U.S. infants by the Advisory Committee on Immunization Practices (ACIP). Recent observational studies suggest that rotavirus vaccines dramatically reduce hospitalizations and emergency department visits among young children in the U.S.; however, there are currently no large-scale studies comparing the effectiveness and safety of RV5 and RV1. We propose to compare the effectiveness and safety of RV5 and RV1 in a population of over 700,000 infants in the U.S. who were covered by private insurance or Medicaid insurance from 2006-2011.The large size of our study will allow us to characterize small differences between the two rotavirus vaccines with regards to effectiveness, which may differ as RV5 requires three administrations versus two for RV1. Our novel self-controlled design and data-driven vaccine surveillance methods will help us further characterize the potential risks linked to rotavirus vaccination intussusception as well as identify other potential conditions of concern. In addition to comparative effectiveness and safety analyses, we will study coverage patterns of both vaccines, including geographic disparities and differences in completion of the rotavirus vaccination series. We will further determine individual, provider, and ecological predictors of rotavirus vaccine uptake. Our research will be conducted with guidance from a panel of experts and stakeholders from the University of North Carolina at Chapel Hill, Harvard School of Public Health, and the Center Biologics Evaluation and Research at the U.S. Food and Drug Administration (FDA). The results of our research will help inform potential quality improvement initiatives by identifying predictors of rotavirus vaccine uptake and will provide clinicians, payors, regulators, and policy makers with timely information on the relative benefits and harms of RV5 versus RV1. The study will also contribute to the development of modern statistical methods and study designs that can be used to study of benefits and risks associated with childhood vaccines.