Uptake, effectiveness and safety of COVID-19 vaccines in children and young people in Scotland: Protocol for early pandemic evaluation and enhanced surveillance of COVID-19 (EAVE II).

Uptake, effectiveness and safety of COVID-19 vaccines in children and young people in Scotland: Protocol for early pandemic evaluation and enhanced surveillance of COVID-19 (EAVE II).
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DOI:
10.7189/jogh.11.05026
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发表时间:
2021
影响因子:
7.2
通讯作者:
Rudan I
Rudan I
中科院分区:
医学2区
文献类型:
--
作者:
Adeloye D;Katikireddi SV;Woolford L;Simpson CR;Shah SA;Agrawal U;Richie LD;Swann OV;Stock SJ;Robertson C;Sheikh A;Rudan I

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急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 在不同环境中儿童和青少年 (CYP) 中的传播动态和疾病严重程度具有相当大的临床、公共卫生和社会意义。一些 CYP 报告了需要住院治疗和死亡的严重 COVID-19 病例,这表明需要将疫苗接种范围扩大到这些年龄组。作为正在进行的 COVID-19 早期流行病评估和加强监测 (EAVE II) 研究的一部分,我们的目标是调查苏格兰 0 至 17 岁儿童和青少年 (CYP) 中 COVID-19 疫苗的使用情况、有效性和安全性。具体来说,我们将估计:(i) 针对 COVID-19 的疫苗接种情况,(ii) 针对有症状的 SARS-CoV-2 感染、住院、重症监护病房 (ICU) 入院和死亡结果的疫苗有效性 (VE); (iii) 不同年龄组和风险组之间第一/第二次给药时间的VE; (iv) 疫苗的安全性。我们将进行一项开放的前瞻性队列研究,将暴露归类为随时间变化的情况。我们将比较第一剂接种疫苗和第二剂接种 CYP 疫苗与尚未接种疫苗的结果。测试阴性设计 (TND) 病例对照研究将嵌套在该国家队列中,以调查 VE 对症状感染的影响。主要结果将是 (i) 针对 COVID-19 的疫苗接种情况,(ii) 感染 COVID-19、住院、入住 ICU 或死亡的时间,以及 (iii) 与疫苗相关的不良事件。疫苗接种状态(未接种疫苗、一剂和两剂)将被定义为随时间变化的暴露。来自多个来源的数据将使用唯一标识符链接。我们将进行描述性分析,以探索疫苗摄入的趋势,并使用多变量逻辑回归模型确定不同暴露变量与疫苗摄入之间的关联。 VE 将根据时间相关的 Cox 模型或泊松回归模型进行评估,并根据相关混杂因素进行调整,包括年龄、性别、社会经济地位和合并症。我们将采用自我对照研究设计来确定 COVID-19 疫苗接种后发生不良事件的风险。获得了苏格兰东南部国家研究伦理委员会 02 的伦理批准。我们将在国际会议、同行评审期刊上并向政策制定者介绍这项研究的结果。
The dynamics of acute respiratory syndrome coronavirus 2 (SARS-CoV-2) transmission and severity of disease among children and young people (CYP) across different settings are of considerable clinical, public health and societal interest. Severe COVID-19 cases, requiring hospitalisations, and deaths have been reported in some CYP suggesting a need to extend vaccinations to these age groups. As part of the ongoing Early Pandemic Evaluation and Enhanced Surveillance of COVID-19 (EAVE II) study, we aim to investigate the uptake, effectiveness and safety of COVID-19 vaccines in children and young people (CYP) aged 0 to 17 years in Scotland. Specifically, we will estimate: (i) uptake of vaccines against COVID-19, (ii) vaccine effectiveness (VE) against the outcomes of symptomatic SARS-CoV-2 infection, hospitalisation, intensive care unit (ICU) admissions, and death; (iii) VE for first/second dose timing among different age groups and risk groups; and (iv) the safety of vaccines. We will conduct an open prospective cohort study classifying exposure as time-varying. We will compare outcomes amongst first dose vaccinated and second dose vaccinated CYP to those not yet vaccinated. A Test Negative Design (TND) case control study will be nested within this national cohort to investigate VE against symptomatic infection. The primary outcomes will be (i) uptake of vaccines against COVID-19, (ii) time to COVID-19 infection, hospitalisation, ICU admissions or death, and (iii) adverse events related to vaccines. Vaccination status (unvaccinated, one dose and two doses) will be defined as a time-varying exposure. Data from multiple sources will be linked using a unique identifier. We will conduct descriptive analyses to explore trends in vaccine uptake, and association between different exposure variables and vaccine uptake will be determined using multivariable logistic regression models. VE will be assessed from time-dependent Cox models or Poisson regression models, adjusted for relevant confounders, including age, sex, socioeconomic status, and comorbidities. We will employ self-controlled study designs to determine the risk of adverse events following COVID-19 vaccination. Ethics approval was obtained from the National Research Ethics Committee, South East Scotland 02. We will present findings of this study at international conferences, in peer-reviewed journals and to policy-makers.
DOI: 10.1136/bmjopen-2021-050724
发表时间: 2021-09-06
期刊: BMJ open
影响因子: 2.9
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发表时间: 2021-02-24
影响因子: 120.7
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DOI: 10.1016/j.poly.2006.05.026
发表时间: 2006-11-13
期刊: Research article
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COVID-19案件的趋势,急诊室就诊以及0-17岁的儿童和青少年的住院 - 美国,2020年8月至8月2021年。
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期刊: MMWR. Morbidity and mortality weekly report
影响因子: --
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