Influenza A (H1N1) 2009 two-dose immunization of US children: An observer-blinded, randomized, placebo-controlled trial
Influenza A (H1N1) 2009 two-dose immunization of US children: An observer-blinded, randomized, placebo-controlled trial
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DOI：
10.1016/j.vaccine.2010.12.116
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发表时间：
2011-02-11
期刊：
影响因子：
5.5
通讯作者：
Denis, Martine
中科院分区：
文献类型：
--
作者：
Plennevaux, Eric;Blatter, Mark;Denis, Martine
这项儿科临床试验的目的是评估两种不同剂量的 2009 年 H1N1 流感单价灭活疫苗对美国 6 个月至 9 岁儿童的安全性和免疫原性。随机、观察者盲法、美国多中心 2 期研究评估了 474 名 6-35 个月或 3-9 岁儿童接种的 2 剂疫苗，间隔 21 天。每个年龄组的儿童被随机分配接受含有 7.5 或 15 微升血凝素 (HA) 的 2009 年 H1N1 流感大流行疫苗或安慰剂，比例为 4:4:1。主要结果是每次疫苗接种后 21 天的血凝抑制 (HI) 抗体反应。在整个研究过程中对安全性进行了监测。任何一种甲型 H1N1 疫苗制剂的第一剂在 3 岁以上儿童中比在年幼儿童中更具免疫原性。 45-50% 的 6-35 个月儿童和 69-75% 3-9 岁儿童的 HI 滴度≥1:40。第二剂甲型 H1N1 疫苗进一步增强了 HI 抗体反应，两个年龄组的血清保护和血清转化率均达到 90-99%。有趣的是，2009 年 H1N1 流感大流行疫苗配方引起的主动和主动注射部位以及全身反应的发生率与安慰剂相似。因此，数据表明 (H1N1) 2009 流感疫苗对婴儿和儿童具有高水平的免疫原性，其安全性和反应原性特征与安慰剂相似。 (C) 2011 Elsevier Ltd. 保留所有权利。
The goal of this pediatric clinical trial was to assess the safety and immunogenicity of two different doses of a monovalent inactivated pandemic (H1N1) 2009 vaccine in US children aged 6 months to 9 years of age. Randomized, observer-blinded, US multicenter phase 2 study assessing 2 doses of vaccine given 21 days apart in 474 children aged 6-35 months or 3-9 years. Children in each age group were randomly assigned to receive either a pandemic (H1N1) 2009 vaccine containing 7.5 or 15 lig of hemagglutinin (HA) or placebo in a 4:4:1 ratio. Primary outcome was hemagglutination inhibition (HI) antibody responses 21 days following each vaccination. Safety was monitored throughout the study. The first dose of either A H1N1 vaccine formulation was more immunogenic in children older than 3 years than in younger children. 45-50% of children aged 6-35 months and 69-75% of children aged 3-9 year-old attained HI titers of >= 1:40. A second dose of A H1N1 vaccine further increased HI antibody responses with seroprotection and seroconversion rates reaching 90-99% in both age groups. Interestingly, the pandemic (H1N1) 2009 vaccine formulations elicited similar rates of solicited and unsolicited injection site and systemic reactions as the placebo. The data therefore demonstrate the high level immunogenicity in infants and children of an (H1N1) 2009 influenza vaccine displaying a safety and reactogenicity profile similar to placebo. (C) 2011 Elsevier Ltd. All rights reserved.