Efficacy, immunogenicity, and safety of a quadrivalent inactivated influenza vaccine in children aged 6-35 months: A multi-season randomised placebo-controlled trial in the Northern and Southern Hemispheres
Efficacy, immunogenicity, and safety of a quadrivalent inactivated influenza vaccine in children aged 6-35 months: A multi-season randomised placebo-controlled trial in the Northern and Southern Hemispheres
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DOI：
10.1016/j.vaccine.2018.11.074
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发表时间：
2019-03-22
期刊：
影响因子：
5.5
通讯作者：
Woods, Anne
中科院分区：
文献类型：
--
作者：
Pepin, Stephanie;Dupuy, Martin;Woods, Anne
背景：一种四价裂解病毒灭活流感疫苗(VaxigrigTetre(TM)，赛诺菲巴斯德；IIV4)包含两个A毒株(H1N1和H3N2)和两个血统的B毒株(维多利亚和山形)，于2016年在欧洲获得批准，适用于年龄=3岁的个人。本研究测试了IIV4在6-35个月儿童中的有效性和安全性。方法：这是一项在北半球2014/2015和2015/2016以及南半球2014和2015流感季节在拉丁美洲、亚洲、非洲和欧洲进行的III期随机对照试验。6-35个月以前没有接种过流感疫苗的健康儿童被随机分成两组，每隔28天接种两次全量IIV4，安慰剂是获得许可的三价分裂病毒灭活疫苗(IIV3)，IIV3是一种研究IIV3，含有来自替代血统的B毒株。主要目标是证明对任何毒株或疫苗相似毒株引起的流感疾病的有效性。结果：这项研究招募了5806名参与者。根据方案对4980名完成研究的参与者进行了疗效评估，证明了IIV4的有效性。对甲型或乙型流感疫苗的有效率为50.98%(97%CI，37.36~61.86%)，对疫苗样株引起的流感疫苗有效率为68.40%(97%CI，47.07%~81.92%)。IIV4、安慰剂和IIV3的安全性相似，尽管IIV4的注射部位反应比安慰剂略高。结论：IIV4可以安全有效地保护6-35个月的儿童免受疫苗类似或任何流行毒株引起的流感疾病的影响。(C)2018年作者。爱思唯尔有限公司出版。
Background: A quadrivalent split-virion inactivated influenza vaccine (VaxigripTetre (TM), Sanofi Pasteur; IIV4) containing two A strains (H1N1 and H3N2) and B strains from both lineages (Victoria and Yamagata) was approved in Europe in 2016 for individuals aged >= 3 years. This study examined the efficacy and safety of IIV4 in children aged 6-35 months.Methods: This was a phase III randomised controlled trial conducted in Latin America, Asia, Africa, and Europe during the Northern Hemisphere 2014/2015 and 2015/2016 and Southern Hemisphere 2014 and 2015 influenza seasons. Healthy children aged 6-35 months not previously vaccinated against influenza were randomised to receive two full doses 28 days apart of IIV4, placebo, the licensed trivalent splitvirion inactivated vaccine (IIV3), an investigational IIV3 containing a B strain from the alternate lineage. The primary objective was to demonstrate efficacy against influenza illness caused by any strain or vaccine-similar strains.Results: The study enrolled 5806 participants. Efficacy, assessed in 4980 participants completing the study according to protocol, was demonstrated for IIV4. Vaccine efficacy was 50.98% (97% CI, 37.36-61.86%) against influenza caused by any A or B type and 68.40% (97% CI, 47.07-81.92%) against influenza caused by vaccine-like strains. Safety profiles were similar for IIV4, placebo, and the IIV3s, although injection-site reactions were slightly more frequent for IIV4 than placebo.Conclusions: IIV4 was safe and effective for protecting children aged 6-35 months against influenza illness caused by vaccine-similar or any circulating strains. (C) 2018 The Authors. Published by Elsevier Ltd.