Enhanced Surveillance for New Vaccine Preventable Disease

描述（由申请提供）：本合作协议的目的是通过加强住院和急诊（艾德）监测、应用流行病学研究和药品监督管理机构发起的调查，支持一个研究中心网络，提供关于新疫苗使用、新疫苗和即将上市疫苗的影响以及其他免疫预防、新疫苗政策和正在考虑的政策的监测和数据收集。新的疫苗监测网络（NVSN）将致力于实现《2020年健康人民》的免疫接种和传染病优先领域，特别是减少或消除疫苗可预防的疾病，并评估普遍推荐疫苗的接种覆盖率。NVSN计划的目的是利用一个基于人群的研究中心网络，对急性胃肠炎进行积极监测，并提供一个研究其他重要疫苗相关问题的框架。主要重点将是描述轮状病毒感染的负担和流行病学，导致住院治疗和艾德访问之间的15天和11岁的急性胃肠炎的主动监测。将在2个环境（医院和艾德）中对急性胃肠炎进行主动监测，以确定这些环境中急性胃肠炎和轮状病毒的疾病负担，并检查随时间推移的趋势（许可前后）。将对年龄<11岁、在艾德住院或接受护理且有AGE症状的儿童进行筛选，如果他们符合资格标准并同意参加本研究，则邀请他们参加本研究。将收集所有入组儿童的人口统计学和临床数据。将采集粪便标本并进行轮状病毒检测。将分析数据，以估计基于人群的轮状病毒住院率和艾德就诊率，描述轮状病毒所致急性胃肠炎儿童的临床和流行病学因素，利用本研究获得的轮状病毒病例，对轮状病毒疫苗的有效性和轮状病毒疾病的成本进行应用流行病学评估，并使用充分表征的通过该监测系统获得的数据和样本。 公共卫生相关性：新的疫苗监测网络将处理2020年健康人民免疫和传染病的优先领域，特别是减少或消除疫苗可预防的疾病，并评估普遍推荐疫苗的接种覆盖率。在美国引入轮状病毒疫苗之前，轮状病毒造成了估计270万次急性胃肠炎发作、410，000次医生就诊、205- 272，000次艾德就诊、55- 70，000次住院治疗和20-60例<5岁儿童死亡。随着轮状病毒疫苗接种计划的实施，重要的是要监测轮状病毒疾病的流行病学，以确定基因型分布是否发生变化，年龄分布是否发生变化（向老年组），并检查轮状病毒的有效性和保护期。

DESCRIPTION (provided by application): The purpose of this cooperative agreement is to support a network of sites that provide surveillance and data collection on new vaccine use, the impact of the new vaccines and upcoming vaccines and other immunoprophylaxis, new vaccine policies and policies under consideration, through enhanced inpatient and emergency department (ED) surveillance, applied epidemiologic research, and investigator-initiated investigations. This New Vaccine Surveillance Network (NVSN) will address the Healthy People 2020 priority area for immunization and infectious diseases, specifically, the reduction or elimination of vaccine preventable diseases and evaluating vaccination coverage for universally recommended vaccines. The intent of the NVSN program is to utilize a network of population-based sites to conduct active surveillance for acute gastroenteritis in addition to providing a framework in which to study other important vaccine related questions. The major focus will be to describe the burden and epidemiology of rotavirus infection resulting in hospitalization and ED visits between 15 days and 11 years of age using active surveillance for acute gastroenteritis. Active surveillance for acute gastroenteritis will be conducted in 2 settings (hospital and ED) to determine the disease burden of acute gastroenteritis and rotavirus in each of these settings and to examine trends over time (pre- and post-licensure). Children <11 years of age hospitalized or cared for in the ED with symptoms of AGE will be screened, invited to participate if they meet eligibility criteria and consented for the study. Demographic and clinical data will be collected on all enrolled children. A stool specimen will be collected and tested for rotavirus. Data will be analyzed to estimate population-based rotavirus hospitalization and ED visit rates, to characterize the clinical and epidemiologic factors of children with acute gastroenteritis due to rotavirus, to utilize rotavirus cases obtained through this study to conduct applied epidemiologic evaluations of the effectiveness of rotavirus vaccines and costs of rotavirus disease and to examine the burden of other pathogens such as norovirus using the well characterized data and specimens obtained through this surveillance system. PUBLIC HEALTH RELEVANCE: The New Vaccine Surveillance Network will address the Healthy People 2020 priority area for immunization and infectious diseases, specifically, the reduction or elimination of vaccine preventable diseases and evaluating vaccination coverage for universally recommended vaccines. Prior to the introduction of rotavirus vaccines in the US, rotavirus was responsible for an estimated 2.7 million episodes of acute gastroenteritis, 410,000 physician visits, 205-272,000 ED visits, 55-70,000 hospitalizations and between 20-60 deaths among children <5 years of age. With a rotavirus vaccination program now in place, it is important to monitor the epidemiology of rotavirus disease to determine if there are shifts in the genotype distribution, changes in the age distribution (to an older age group) and to examine the effectiveness and duration of protection of rotavirus.