Langley Joanne M, Wang Long, Aggarwal Naresh, Bueso Agustin, Chandrasekaran Vijayalakshmi, Cousin Luis, Halperin Scott A, Li Ping, Liu Aixue, McNeil Shelly, Mendez Lourdes Peña, Rivera Luis, Innis Bruce L, Jain Varsha K
Canadian Center for Vaccinology, IWK Health Centre and Capital Health, Dalhousie University, Halifax, Nova Scotia, Canada.
GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania.
J Pediatric Infect Dis Soc. 2015 Sep;4(3):242-51. doi: 10.1093/jpids/piu098. Epub 2014 Oct 20.
Influenza attack rates are high in 6- to 35-month-old children; vaccines containing both lineages of influenza B (Yamagata and Victoria), in addition to the H3N2 and H1N1 antigens, may improve protection rates.
In a randomized double-blind controlled trial, the immunogenicity and reactogenicity of an inactivated quadrivalent influenza vaccine (QIV) and a trivalent control vaccine (TIV) were assessed.
Six hundred one children (QIV, n = 299; TIV, n = 302) were enrolled at 8 sites in 3 countries. The primary immunogenicity objective was met: the lower limit (LL) of the 2-sided 95% confidence interval (CI) for the seroconversion rate in QIV recipients ranged from 66.6% to 81.3%, which was ≥40% against all 4 strains. The immunogenic superiority of the additional B/Victoria strain in the QIV compared to that in the TIV was confirmed: the LL of the 2-sided 95% CI of the geometric mean titer ratio (QIV/TIV) (6.28 [95% CI, 5.32-7.41]) was greater than 1.5, and the LL of the 2-sided 95% CI for the difference in the seroconversion rate (QIV - TIV) (64.19% [95% CI, 57.65%-69.95%]) was greater than 10%. Injection-site pain and irritability/fussiness were the most commonly reported solicited injection-site and general adverse events, respectively, from days 0 to 6 and were similar in frequency between the groups.
In children aged 6 to 35 months, a QIV has superior immunogenicity for the added B strain and acceptable immunogenicity for shared strains, with no notable difference in reactogenicity and safety when compared to a TIV.
6至35个月大的儿童流感感染率很高；除了H3N2和H1N1抗原外，包含两种乙型流感谱系（山形株和维多利亚株）的疫苗可能会提高保护率。
在一项随机双盲对照试验中，评估了一种四价灭活流感疫苗（QIV）和一种三价对照疫苗（TIV）的免疫原性和反应原性。
来自3个国家8个地点的601名儿童（QIV组，n = 299；TIV组，n = 302）参与了研究。主要免疫原性目标达成：QIV接种者血清转化率的双侧95%置信区间（CI）下限范围为66.6%至81.3%，对所有4种毒株均≥40%。与TIV相比，QIV中额外的B/维多利亚株的免疫原性优势得到证实：几何平均滴度比（QIV/TIV）的双侧95%CI下限（6.28 [95%CI，5.32 - 7.41]）大于1.5，血清转化率差异（QIV - TIV）的双侧95%CI下限（64.19% [95%CI，57.65% - 69.95%]）大于10%。从第0天到第6天，注射部位疼痛和易激惹/烦躁分别是最常报告的注射部位和全身不良事件，两组频率相似。
在6至35个月大的儿童中，QIV对额外的B株具有卓越的免疫原性，对共同毒株具有可接受的免疫原性，与TIV相比，反应原性和安全性无显著差异。
