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首页> 外文期刊>Influenza and other respiratory viruses. >An integrated, multistudy analysis of the safety of Ann Arbor strain live attenuated influenza vaccine in children aged 2-17 years.
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An integrated, multistudy analysis of the safety of Ann Arbor strain live attenuated influenza vaccine in children aged 2-17 years.

机译：对Ann Arbor株2-17岁儿童减毒活流感疫苗安全性的综合，多研究分析。

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BACKGROUND: Trivalent, Ann Arbor strain, live attenuated influenza vaccine (LAIV) is approved in several countries for use in eligible children aged >/=2 years. OBJECTIVE: To describe the safety of Ann Arbor strain LAIV in children aged 2-17 years. METHODS: An integrated analysis of randomized, controlled trials of LAIV. RESULTS: A total of 4245 and 10,693 children received >/=1 dose of LAIV in year 1 of 6 trivalent inactivated influenza vaccine (TIV)-controlled and 14 placebo-controlled studies, respectively; 3212 children were revaccinated in year 2 of 4 placebo-controlled studies. Compared with placebo for days 0-10 post-vaccination, LAIV recipients exhibited increased runny/stuffy nose (+7%), headache (+7%), and tiredness/decreased activity (+2%) after dose 1; and a higher rate of decreased appetite (+4%) after year 2 revaccination. Compared with TIV, only runny/stuffy nose was increased (dose 1, +12%; dose 2, +4%). Compared with initial vaccination, LAIV reactogenicity was lower after dose 2 in year 1 and revaccination in year 2. Unsolicited adverse events (AEs) increased with LAIV in some comparisons were headache, nasal congestion/rhinorrhea, rhinitis, and pyrexia; ear pain and lower respiratory illness were decreased. There was no evidence of an increase in any potential vaccine-related serious AE in LAIV recipients. Among children aged 2-17 years and specifically aged 24-35 months, there was no evidence that lower respiratory illness or wheezing illness occurred at a higher rate in LAIV recipients. CONCLUSION: This analysis supports the safety of Ann Arbor strain LAIV in children aged 2-17 years and provides a consensus assessment of events expected after vaccination.
机译：背景：三价Ann Arbor株减毒活流感疫苗（LAIV）已在多个国家/地区获得批准，可用于≥2岁的合格儿童。目的：描述Ann Arbor菌株LAIV在2-17岁儿童中的安全性。方法：对LAIV的随机对照试验进行了综合分析。结果：分别在6项三价灭活流感疫苗（TIV）对照和14项安慰剂对照研究中，分别有4245名和10693名儿童在第一年接受了> / = 1剂量的LAIV。在4个安慰剂对照研究的2年中，对3212名儿童进行了预防接种。接种疫苗后0-10天与安慰剂相比，LAIV接受者在剂量1后表现出流鼻涕/鼻塞（+ 7％），头痛（+ 7％）和疲劳/活动减少（+ 2％）升高;再接种2年后，食欲下降的机率更高（+ 4％）。与TIV相比，仅流鼻涕/鼻塞增加（剂量1，+ 12％;剂量2，+ 4％）。与最初的疫苗接种相比，LAIV的反应原性在第1年第2剂后和第2年再次接种时较低。在某些比较中，LAIV的自发不良事件（AEs）增加，包括头痛，鼻充血/鼻漏，鼻炎和发热。耳痛和下呼​​吸道疾病有所减轻。没有证据表明LAIV接受者中任何潜在的疫苗相关的严重AE增加。在2-17岁，特别是24-35个月的儿童中，没有证据表明LAIV接受者的下呼吸道疾病或喘息病发生率更高。结论：该分析支持Ann Arbor株LAIV对2-17岁儿童的安全性，并为疫苗接种后的预期事件提供了共识评估。

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