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英凡里尔六联苗(白喉、破伤风、百日咳、乙肝、脊髓灰质炎、b型流感嗜血杆菌六联疫苗)八年使用经验回顾

Review of 8 years of experience with Infanrix hexa (DTPa-HBV-IPV/Hib hexavalent vaccine).

作者信息

Zepp Fred, Schmitt Heinz-Josef, Cleerbout Jan, Verstraeten Thomas, Schuerman Lode, Jacquet Jeanne-Marie

机构信息

University Hospital, Department of Pediatrics, Johannes Gutenberg University, Langenbeckstrasse 1, 55131 Mainz, Germany.

出版信息

Expert Rev Vaccines. 2009 Jun;8(6):663-78. doi: 10.1586/erv.09.32.

Abstract

Combination vaccines that include multiple antigens within one formulation are now widely accepted as an effective means of eliciting protection against several diseases at the same time. Owing to improvements in quality and convenient modes of administration, they have become part of routine pediatric practice. Hexavalent vaccines, including diphtheria, tetanus, pertussis, hepatitis B, polio and Haemophilus influenzae type b antigens represent the latest advance in the development of combination vaccines. Over 8 years since its first licensure, this review looks at the immunogenicity, efficacy and safety profile of the only hexavalent pediatric vaccine currently in use--Infanrix hexa (diphtheria, tetanus, acellular pertusis-hepatitis B virus-inactivated poliovirus vaccine/Haemophilus influenzae type b vaccine [DTPa-HBV-IPV/Hib]; GlaxoSmithKline Biologicals, Rixensart, Belgium)--through published clinical trials and postmarketing surveillance data. These data show DTPa-HBV-IPV/Hib to be highly immunogenic and well tolerated across a range of different primary and booster vaccination schedules, as well as when administered concomitantly with other licensed vaccines (e.g., pneumococcal conjugate vaccine). Additional issues surrounding the use of hexavalent vaccines are also reviewed.

摘要

一种制剂中包含多种抗原的联合疫苗如今已被广泛认可为同时引发针对多种疾病的保护作用的有效手段。由于质量的提高和给药方式的便捷,它们已成为儿科常规诊疗的一部分。六价疫苗,包括白喉、破伤风、百日咳、乙型肝炎、脊髓灰质炎和b型流感嗜血杆菌抗原,代表了联合疫苗开发的最新进展。自首次获得许可以来的8年多时间里,本综述通过已发表的临床试验和上市后监测数据,研究了目前唯一使用的儿科六价疫苗——安尔宝(白喉、破伤风、无细胞百日咳-乙型肝炎病毒-灭活脊髓灰质炎病毒疫苗/b型流感嗜血杆菌疫苗 [DTPa-HBV-IPV/Hib];葛兰素史克生物制品公司,比利时里克森萨特)的免疫原性、疗效和安全性概况。这些数据表明,DTPa-HBV-IPV/Hib在一系列不同的基础免疫和加强免疫接种程序中,以及与其他已获许可的疫苗(如肺炎球菌结合疫苗)同时接种时,都具有高度免疫原性且耐受性良好。还对围绕六价疫苗使用的其他问题进行了综述。

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