Post-Marketing Surveillance of Adverse Events Following Vaccination with the Live-Attenuated Japanese Encephalitis Chimeric Virus Vaccine (Imojev(R)) in South Korea, 2015-2019
Post-Marketing Surveillance of Adverse Events Following Vaccination with the Live-Attenuated Japanese Encephalitis Chimeric Virus Vaccine (Imojev(R)) in South Korea, 2015-2019
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DOI：
10.1007/s40121-020-00305-6
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发表时间：
2020-05-30
影响因子：
5.4
通讯作者：
Yang, Kuhyun
中科院分区：
文献类型：
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作者：
Kim, Hee Soo;Oh, Yongho;Yang, Kuhyun
简介自2015年以来，流行性乙型脑炎嵌合病毒减毒活疫苗(JE-CV；Imojev(R))已在韩国被批准用于年龄在12个月以下的受试者。作为许可协议的一部分，开展了一项上市后监测研究，以积极监测乙脑-CV在韩国人口中的安全状况。方法从2015年4月3日至2019年4月2日，在韩国的12个中心进行了一项观察性的主动安全监测研究。受试者年龄>；=12个月，在常规保健就诊期间接受单剂乙脑-卡介苗(初级或加强剂)治疗，并在接种疫苗后42天内跟踪观察征求的反应(注射部位和全身反应分别为7天和14天)、非严重的主动不良事件和严重的不良事件。结果总共有810名接种乙脑疫苗的受试者进入我们的分析，大多数人将疫苗作为初级疫苗接种(94.9%；769/810)。111名受试者共报告179起征集反应，大多数征集反应发生在0-3天(80.4%；144/179)，持续时间为1-3天(79.3%；142/179)，强度为1级(70.9%；127/179)。有三种3级不良反应(易怒、发热和不适)；均在几天内消失。12岁至24个月(34.7%[52/150]受试者；107个事件)和2至10岁(17.8%[8/45]受试者；14个事件)的引诱反应发生率最高。所有不请自来的不良事件(严重和非严重)均与接种疫苗无关。没有因不良反应/事件而中止治疗的病例。结论JE-CV在韩国临床应用条件下具有良好的安全性。没有发现新的安全问题。
Introduction The live attenuated Japanese encephalitis chimeric virus vaccine (JE-CV; Imojev(R)) has been approved in South Korea for use in subjects aged >= 12 months since 2015. As part of the license agreement, a post-marketing surveillance study was undertaken to actively monitor the safety profile of JE-CV in the Korean population. Methods An observational, active safety surveillance study was conducted from 3 April 2015 through to 2 April 2019 at 12 centers in South Korea. Subjects aged >= 12 months who received a single dose of JE-CV (primary or booster) during a routine healthcare visit were recruited and followed up for solicited reactions (7 and 14 days for injection site and systemic reactions, respectively), non-serious unsolicited adverse events and serious adverse events within 42 days after vaccination. Results Overall, 810 subjects who received JE-CV were included in our analysis, the majority received the vaccine as a primary vaccination (94.9%; 769/810). There were 179 solicited reactions reported by 111 subjects; the majority of solicited reactions occurred within 0-3 days (80.4%; 144/179), were of 1-3 days' duration (79.3%; 142/179) and of grade 1 intensity (70.9%; 127/179). There were three grade 3 adverse reactions (irritability, pyrexia and malaise); all resolved within a few days. The incidence of solicited reactions were highest in those aged 12 to < 24 months (34.7% [52/150] subjects; 107 events) and 2 to < 10 years (17.8% [8/45] subjects; 14 events). All unsolicited adverse events (serious and non-serious) were unrelated to vaccination. There were no discontinuations due to adverse reactions/events. Conclusion JE-CV has a good safety profile under practice conditions in South Korea. No new safety issues were identified.