Methods for Safety Evaluation of Vaccination Schedules

疫苗接种计划安全性评估方法

• 批准号: 9327862
• 负责人: Martin Kulldorff
• 金额: $ 38.42万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-01 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9327862
• 关键词: Adverse event; Age; Area; Asthma; Centers for Disease Control and Prevention (U.S.); Chickenpox Vaccine; Child; Childhood; Chronic; Combined Vaccines; Comparative Study; Complex; Data; Databases; Diphtheria-Tetanus-Pertussis Vaccine; Dose; Electronic Health Record; Ensure; Epidemiologic Methods; Evaluation; Event; Exposure to; Health; Health Care Visit; Health Status; Hepatitis B Vaccines; Immune; Immunologics; Individual; Measles; Measles Vaccine; Methodology; Methods; Modeling; Mumps; Pharmaceutical Preparations; Pharmacologic Substance; Physiological; Pneumococcal conjugate vaccine; Public Health; Reporting; Research; Research Design; Risk; Rubella; Safety; Schedule; Source; System; Time; Vaccinated; Vaccination; Vaccines; comparative; design; early onset; novel strategies; post-market; public health relevance; response; safety study; vaccination schedule; vaccine safety

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.

描述（由申请人提供）：迄今为止，很少有比较研究评估不同疫苗时间表的安全性。现有的一些研究表明，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，这既是一个可行的重要研究领域。作为一个相对较新的研究领域，最大的问题是哪种研究设计最适合评估不同的儿童疫苗时间表。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时间表的安全性，相对于疫苗时间表的各种不同方面和组成部分。这些包括单个疫苗的时间；同一疫苗剂量之间的时机；疫苗与并发健康状况或药物的相互作用；同一天给出的不同疫苗的相互作用；不同疫苗的排序；以及累积摘要指标的影响，例如疫苗总数或某些疫苗成分的总量。该项目还涵盖了CDC推荐时间表的比较评估，流行的替代时间表和完全未接种的儿童的研究设计。将针对早期发作的两种不良事件开发方法，这是最容易学习的方法，并且对于发病迟发的不良事件，包括严重的慢性病。

项目成果

Bias from outcome misclassification in immunization schedule safety research.

• DOI: 10.1002/pds.4374
• 发表时间: 2018-03
• 期刊: Pharmacoepidemiology and drug safety
• 影响因子: 2.6
• 作者: Newcomer SR;Kulldorff M;Xu S;Daley MF;Fireman B;Lewis E;Glanz JM
• 通讯作者: Glanz JM

Reply to Ferdinands et al.

回复费迪南德等人。

• DOI: 10.1093/cid/ciy1085
• 发表时间: 2019
• 期刊: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
• 作者: Ray,GThomas;Lewis,Ned;Fireman,Bruce
• 通讯作者: Fireman,Bruce

Methods for addressing "innocent bystanders" when evaluating safety of concomitant vaccines.

在评估伴随疫苗的安全性时解决“无辜旁观者”的方法。

• DOI: 10.1002/pds.4399
• 发表时间: 2018
• 期刊: Pharmacoepidemiology and drug safety
• 影响因子: 2.6
• 作者: Wang,ShirleyV;Abdurrob,Abdurrahman;Spoendlin,Julia;Lewis,Edwin;Newcomer,SophiaR;Fireman,Bruce;Daley,MatthewF;Glanz,JasonM;Duffy,Jonathan;Weintraub,EricS;Kulldorff,Martin
• 通讯作者: Kulldorff,Martin

If Influenza Vaccines Wane, Can We Delay Vaccination Without Compromising Coverage?

• DOI: 10.1093/cid/ciz459
• 发表时间: 2020-04-15
• 期刊: CLINICAL INFECTIOUS DISEASES
• 影响因子: 11.8
• 作者: Klein, Nicola P.;Fireman, Bruce
• 通讯作者: Fireman, Bruce

Use of three summary measures of pediatric vaccination for studying the safety of the childhood immunization schedule.

• DOI: 10.1016/j.vaccine.2019.01.040
• 发表时间: 2019-02
• 期刊: Vaccine
• 影响因子: 5.5
• 作者: Stanley Xu;Sophia R. Newcomer;M. Kulldorff;M. Daley;B. Fireman;J. Glanz