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首页> 外文期刊>Vaccine >A postmarketing evaluation of the safety of Ann Arbor strain live attenuated influenza vaccine in children 5 through 17 years of age
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A postmarketing evaluation of the safety of Ann Arbor strain live attenuated influenza vaccine in children 5 through 17 years of age

机译：Ann Arbor毒株减毒活疫苗在5至17岁儿童中的安全性的上市后评估

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Background: Live attenuated influenza vaccine (LAIV) was licensed in 2003 in the United States for use in individuals aged 5-49 years. Methods: A prospective observational postmarketing study was conducted to evaluate the safety of LAIV. Rates of medically attended events (MAEs) and serious adverse events (SAEs) in eligible children aged 5-17 years receiving LAIV as part of routine care from October 2003 to March 2008 were compared with rates in nonrandomized self, matched unvaccinated, and matched trivalent inactivated influenza vaccine (TIV)-vaccinated controls. All MAEs and SAEs through 42 days postvaccination and all hospitalizations and deaths through 6 months postvaccination were analyzed. Statistical significance was assigned without multiplicity adjustment. Results: 43,702 LAIV recipients were matched with similar numbers of TIV-vaccinated and unvaccinated children. Of approximately 9500 MAE incidence rate comparisons, 204 were statistically significantly higher and 168 were statistically significantly lower in LAIV recipients versus controls. No pattern of MAE rate differences suggested a safety signal with LAIV. Asthma/wheezing MAEs were not statistically increased in LAIV recipients. No anaphylaxis events occurred within 3 days postvaccination. Rates of SAEs were similar between LAIV and control groups. Two SAEs were considered possibly related to LAIV: Bell's palsy and nonspecific paroxysmal spell. Conclusions: Results of this postlicensure evaluation of LAIV safety in US children aged 5-17 years are consistent with preapproval clinical studies and Vaccine Adverse Event Reporting System reports, both of which demonstrated no significant increase in asthma/wheezing events or other adverse outcomes among eligible children who received LAIV. (C) 2012 Elsevier Ltd. All rights reserved.
机译：背景：减毒活疫苗（LAIV）于2003年在美国获得许可，可用于5-49岁的人群。方法：进行一项前瞻性观察性上市后研究，以评估LAIV的安全性。将2003年10月至2008年3月接受LAIV作为常规护理一部分的5-17岁合格儿童的就诊事件（MAE）和严重不良事件（SAE）的发生率与非随机自我，配对未接种疫苗和配对三价患儿的发生率进行比较灭活的流感疫苗（TIV）接种的对照。分析了接种后42天的所有MAE和SAE，以及接种后6个月的所有住院和死亡情况。在不进行多重调整的情况下分配统计显着性。结果：43,702名LAIV接受者与接受TIV疫苗接种和未接种疫苗的儿童数量相近。在大约9500次MAE发生率比较中，与对照组相比，LAIV接受者中204例在统计学上显着较高，而168例在统计学上显着较低。没有MAE率差异的模式提示用LAIV发出安全信号。 LAIV接受者的哮喘/喘息性MAE没有统计学上的增加。疫苗接种后3天内未发生过敏反应事件。 LAIV组和对照组之间的SAE发生率相似。人们认为可能有两种SAE与LAIV有关：贝尔麻痹和非特异性阵发性拼写。结论：对美国5-17岁儿童进行LAIV安全性的后置评估结果与批准前的临床研究和疫苗不良事件报告系统报告一致，这两项研究均表明合格人群中哮喘/喘息事件或其他不良后果均无显着增加接受LAIV的儿童。 （C）2012 Elsevier Ltd.保留所有权利。

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