Methods for Safety Evaluation of Vaccination Schedules

描述(由申请人提供)：到目前为止，很少有评估不同疫苗方案安全性的比较研究。一些现有的研究表明，在某些情况下，不良事件的风险取决于所使用的疫苗接种时间表。因此，这是一个既可行又重要的研究领域。作为一个相对较新的研究领域，最大的问题是什么类型的研究设计最适合评估不同的儿童疫苗计划。在这个项目中，我们将开发、评估、比较和说明各种新的流行病学方法，以研究儿童疫苗接种计划的安全性，涉及疫苗计划的各种不同方面和组成部分。这些包括个别疫苗的接种时间；同一疫苗剂量之间的时间；疫苗与同时健康状况或药物之间的相互作用；同一天接种不同疫苗的相互作用影响；不同疫苗的订购；以及累积汇总指标的影响，如疫苗总数或某种疫苗成分的总量。该项目还包括对疾控中心推荐的时间表、流行的替代时间表和完全未接种疫苗的儿童进行比较评估的研究设计。将为最容易研究的早发不良事件和晚发不良事件(包括严重的慢性病)开发方法。

DESCRIPTION (provided by applicant): To date, there have been few comparative studies evaluating the safety of different vaccine schedules. A few of the existing studies show that there are cases in which the risk of adverse events depends on the vaccination schedule used. Hence, it is both a feasible and important area of study. As a relatively new field of investigatio, the big question is what types of study designs will be most appropriate for evaluating different childhood vaccine schedules. In this project, we will develop, evaluate, compare and illustrate a wide variety of new epidemiological methods for studying the safety of childhood vaccination schedules, with respect to a wide variety of different aspects and components of the vaccine schedule. These include the timing of individual vaccines; the timing between doses of the same vaccine; the interaction effect between vaccines and concurrent health conditions or pharmaceutical medications; the interaction effects of different vaccines given on the same day; the ordering of different vaccines; and the effect of cumulative summary metrics such as the total number of vaccines or the total amount of some vaccine ingredient. The project also covers study designs for the comparative evaluation of the CDC recommended schedule, popular alternative schedules and completely unvaccinated children. Methods will be developed for both adverse events with an early onset, which are the easiest to study, and for adverse events with a late onset, including serious chronic conditions.