Epidemiological study of severe febrile reactions in young children in Western Australia caused by a 2010 trivalent inactivated influenza vaccine

Epidemiological study of severe febrile reactions in young children in Western Australia caused by a 2010 trivalent inactivated influenza vaccine
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DOI:
10.1136/bmjopen-2010-000016
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发表时间:
2011-01-01
期刊:
影响因子:
2.9
通讯作者:
Weeramanthri, T. S.
Weeramanthri, T. S.
中科院分区:
医学3区
文献类型:
--
作者:
Armstrong, P. K.;Dowse, G. K.;Weeramanthri, T. S.

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背景资料:2010年西澳大利亚州(WA)针对6个月至4岁儿童的流感疫苗接种计划在接种三价灭活流感疫苗(TIV)后出现严重发热反应(包括热性惊厥)的报告后暂停。方法:为了调查严重发热反应与TIV之间的关系,进行了三项研究:(i)按疫苗配方和批次估计2010年接种TIV后72小时内的热性惊厥发生率;(ii)比较2008年至2010年因热性惊厥到医院急诊科就诊的儿童人数;和(iii)对360名儿童进行回顾性队列研究,以比较可用的TIV制剂的反应原性。2010年,估计最多给予18816剂TIV,记录了63例发热性惊厥,估计发生率为3.3(95% CI 2.6 - 4.2)/1000剂TIV给药。2010年,IV相关热性惊厥的几率大幅升高(p < 0.001),且与一种疫苗制剂-Fluvax和Fluvax Junior(CSL Biotherapies)相关。两种热性惊厥的风险(p
Background: The 2010 influenza vaccination program for children aged 6 months to 4 years in Western Australia (WA) was suspended following reports of severe febrile reactions, including febrile convulsions, following vaccination with trivalent inactivated influenza vaccine (TIV).Methods: To investigate the association between severe febrile reactions and TIV, three studies were conducted: (i) rates of febrile convulsions within 72 h of receiving TIV in 2010 were estimated by vaccine formulation and batch; (ii) numbers of children presenting to hospital emergency departments with febrile convulsions from 2008 to 2010 were compared; and (iii) a retrospective cohort study of 360 children was conducted to compare the reactogenicity of available TIV formulations.Findings: In 2010, an estimated maximum of 18 816 doses of TIV were administered and 63 febrile convulsions were recorded, giving an estimated rate of 3.3 (95% CI 2.6 to 4.2) per 1000 doses of TIV administered. The odds of a TIV-associated febrile convulsion was highly elevated in 2010 (p < 0.001) and was associated with the vaccine formulations of one manufacturer-Fluvax and Fluvax Junior (CSL Biotherapies). The risk of both febrile convulsions (p