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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：Ann Arbor株减毒流感活疫苗在2-17岁儿童中的安全性的综合多研究分析

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Please cite this paper as: Ambrose et al. (2011) An integrated, multistudy analysis of the safety of Ann Arbor strain live attenuated influenza vaccine in children aged 2–17 years. Influenza and Other Respiratory Viruses 5(6), 389–397. >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：请将此论文引用为：Ambrose等。 （2011）对2-17岁儿童使用Ann Arbor毒株减毒活疫苗的安全性的综合，多研究分析。流感和其他呼吸道病毒5（6），389-397。 >背景在许多国家/地区，三价的Ann Arbor减毒活流感疫苗（LAIV）获准用于≥2岁的合格儿童。 >目的描述Ann Arbor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。 >结果在6项三价灭活流感疫苗（TIV）对照和14项安慰剂对照研究的第1年中，总共有4245名儿童和10 693名儿童接受了≥1剂量的LAIV；在4个安慰剂对照研究的第2年中，对3212名儿童进行了预防接种。与接种疫苗后0-10天的安慰剂相比，LAIV接受者在剂量1后表现出流鼻涕/鼻塞增加（+ 7％），头痛（+ 7％）和疲劳/活动减少（+ 2％）。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剂和第2年再接种时较低，在某些情况下，LAIV的自发不良事件（AEs）增加，包括头痛，鼻充血/鼻溢液，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接受者的任何潜在的疫苗相关严重AE增加。在2-17岁的儿童中，尤其是在24-35个月的儿童中，没有证据表明接受LAIV的患者发生下呼吸道疾病或喘息病的比例更高。 >结论该分析支持Ann Arbor株LAIV在2-17岁儿童中的安全性，并为疫苗接种后的预期事件提供了共识评估。

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