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Safety reporting in developing country vaccine clinical trials-A systematic review

机译：发展中国家疫苗临床试验中的安全性报告-系统评价

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With more vaccines becoming available worldwide, vaccine research is on the rise in developing countries. To gain a better understanding of safety reporting from vaccine clinical research in developing countries, we conducted a systematic review in Medline and Embase (1989-2011) of published randomized clinical trials (RCTs) reporting safety outcomes with >= 50% developing country participation (PROSPERO systematic review registration number: CRD42012002025). Developing country vaccine RCTs were analyzed with respect to the number of participants, age groups studied, inclusion of safety information, number of reported adverse events following immunization (AEFI), type and duration of safety follow-up, use of standardized AEFI case definitions, grading of AEFI severity, and the reporting of levels of diagnostic certainty for AEFI. The systematic search yielded a total number of 50 randomized vaccine clinical trials investigating 12 different vaccines, most commonly rotavirus and malaria vaccines. In these trials, 94,459 AEFI were reported from 446,908 participants receiving 735,920 vaccine doses. All 50 RCTs mentioned safety outcomes with 70% using definitions for at least one AEFI. The most commonly defined AEFI was fever (27), followed by local (16) and systemic reactions (14). Logistic regression analysis revealed a positive correlation between the implementation of a fever case definition and the reporting rate for fever as an AEFI (p = 0.027). Overall, 16 different definitions for fever and 7 different definitions for erythema were applied. Predefined AEFI case definitions by the Brighton Collaboration were used in only two out of 50 RCTs. The search was limited to RCTs published in English or German and may be missing studies published locally. The reported systematic review suggests room for improvement with respect to the harmonization of safety reporting from developing country vaccine clinical trials and the implementation of standardized case definitions. (c) 2012 Elsevier Ltd
机译：随着全球越来越多的疫苗问世，发展中国家的疫苗研究正在增加。为了从发展中国家的疫苗临床研究中更好地了解安全性报告，我们在Medline和Embase（1989-2011）中对发表的随机临床试验（RCT）进行了系统评价，报告了≥50％发展中国家参与的安全性结果（ PROSPERO系统审查注册编号：CRD42012002025。分析了发展中国家疫苗的RCT，涉及参与者的数量，研究的年龄组，纳入安全信息，报告的免疫接种后不良事件数量（AEFI），安全跟进的类型和持续时间，标准化AEFI病例定义的使用， AEFI严重性等级，以及AEFI诊断确定性水平的报告。通过系统搜索，总共进行了50项随机疫苗临床试验，研究了12种不同的疫苗，最常见的是轮状病毒和疟疾疫苗。在这些试验中，从446,908名参与者中报告了94,459 AEFI，接受了735,920剂疫苗。所有50个RCT都使用至少一种AEFI的定义提及了安全性结果，其中70％。最常见的AEFI是发烧（27），其次是局部（16）和全身反应（14）。 Logistic回归分析显示，发烧病例定义的实施与发烧的AEFI报告率之间呈正相关（p = 0.027）。总体而言，应用了16种不同的发烧定义和7种不同的红斑定义。 Brighton Collaboration预先定义的AEFI案例定义仅在50个RCT中有两个使用。该搜索仅限于以英语或德语发布的RCT，并且可能缺少本地发布的研究。所报告的系统评价提出了在协调发展中国家疫苗临床试验的安全性报告和实施标准化病例定义方面仍有改进的余地。 （c）2012爱思唯尔有限公司

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