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首页> 外文期刊>Vaccine >Immunogenicity, reactogenicity, and safety of inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine in healthy adults aged = 18 years: A phase III, randomized trial
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Immunogenicity, reactogenicity, and safety of inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine in healthy adults aged = 18 years: A phase III, randomized trial

机译：≥18岁健康成年人体内灭活的四价流感疫苗候选物与灭活的三价流感疫苗的免疫原性，反应原性和安全性：III期随机试验

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摘要

Background: Two influenza B lineages have been co-circulating since the 1980s, and because inactivated trivalent influenza vaccine (TIV) contains only one B strain, it provides littleo protection against the alternate B-lineage. We assessed a candidate inactivated quadrivalent influenza vaccine (QIV) containing both B lineages versus TIV in healthy adults. Methods: Subjects received one dose of QIV (lot 1, 2, or 3) or one of two TIVs (B strain from Victoria or Yamagata lineage); randomization was 2:2:2:1:1. Hemagglutination-inhibition assays were performed 21-days post-vaccination; superiority of QIV versus TIV for the alternate B-lineage was demonstrated if the 95% confidence interval (CI) lower limit for the GMT ratio was >= 1.5, and non-inferiority against the shared strains was demonstrated if the 95% CI upper limit for the GMT ratio was <= 1.5. Reactogenicity and safety were assessed during the post-vaccination period. NCT01196975. Results: Immunogenicity of QIV lots was consistent, QIV was superior to TIV for the alternate B-lineage strain, and QIV was non-inferior versus TIVs for shared strains (A/H1N1, A/H3N2, B-strain). Reactogenicity and safety profile of the QIV was consistent with seasonal influenza vaccines. Conclusion: QIV provided superior immunogenicity for the added B strain without affecting the antibody response to the TIV strains, and without compromising safety
机译：背景：自1980年代以来，两种B型流感谱系一直在流行，并且由于灭活的三价流感疫苗（TIV）仅包含一种B株，因此它对替代B型谱系几乎没有保护。我们评估了健康成年人中同时包含B谱系和TIV的候选灭活四价流感疫苗（QIV）。方法：受试者接受一剂QIV（1、2或3号批次）或两种TIV（来自Victoria或Yamagata谱系的B株）之一;随机为2：2：2：1：1。接种后21天进行血凝抑制试验;如果GMT比的95％置信区间（CI）下限> = 1.5，则表明QIV对TIV优于替代B谱系;如果95％CI上限，则证明对共用菌株无劣GMT比为<= 1.5。疫苗接种后评估了反应原性和安全性。 NCT01196975。结果：QIV批次的免疫原性是一致的，对于替代的B谱系菌株，QIV优于TIV，对于共享株（A / H1N1，A / H3N2，B株），QIV较TIV不劣。 QIV的反应原性和安全性与季节性流感疫苗一致。结论：QIV为添加的B株提供了优异的免疫原性，而不会影响对TIV株的抗体反应，并且不会影响安全性

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