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12至23月龄健康儿童中,四价麻疹-腮腺炎-风疹-水痘疫苗与一剂白喉-破伤风-无细胞百日咳-乙型肝炎-灭活脊髓灰质炎病毒- b型流感嗜血杆菌结合疫苗加强剂联合接种的免疫原性和安全性。

Immunogenicity and safety of a tetravalent measles-mumps-rubella-varicella vaccine co-administered with a booster dose of a combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b conjugate vaccine in healthy children aged 12-23 months.

作者信息

Zepp Fred, Behre Ulrich, Kindler Klaus, Laakmann Karl-Heinz, Pankow-Culot Heidemarie, Mannhardt-Laakmann Wilma, Beckers François, Descamps Dominique, Willems Paul

机构信息

Department of Paediatrics, Johannes-Gutenberg-Universität, Langenbeckstrasse 1, 55101 Mainz, Germany.

出版信息

Eur J Pediatr. 2007 Aug;166(8):857-64. doi: 10.1007/s00431-007-0506-z. Epub 2007 May 31.

Abstract

This study was undertaken to assess the co-administration of an experimental measles-mumps-rubella-varicella vaccine (MMRV, GlaxoSmithKline Biologicals) with a combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b conjugate (DTPa-HBV-IPV/Hib) vaccine in healthy children. Healthy children aged 12-23 months (N = 451) were randomised to one of three parallel groups to receive one dose of MMRV vaccine co-administered with a booster dose of DTPa-HBV-IPV/Hib vaccine (co-administration group), or one dose of MMRV vaccine alone (MMRV group), or a booster dose of DTPa-HBV-IPV/Hib vaccine alone (DTPa-HBV-IPV/Hib group). No differences in seroconversion rates for measles (>95%), mumps (>80%), rubella (>99%) and varicella (>98%) were seen between the co-administration group and the MMRV group. No differences in geometric mean titres (GMTs) were observed between the two groups with the exception of anti-measles titres, which were observed to be higher in the MMRV group than in the co-administration group (4,419.2 vs. 3,441.8 mIU/ml respectively). Immune response to the booster dose of DTPa-HBV-IPV/Hib vaccine was observed to be similar in the co-administration group and the DTPa-HBV-IPV/Hib group. Co-administration of the MMRV vaccine with a booster dose of DTPa-HBV-IPV/Hib vaccine was well-tolerated and did not exacerbate the reactogenicity profile of either vaccine. In summary, GlaxoSmithKline Biologicals' experimental MMRV vaccine was immunogenic and well-tolerated when administered with a booster dose of DTPa-HBV-IPV/Hib vaccine during the second year of life. The ability to co-administer the MMRV vaccine at the same time as other routine childhood immunisation vaccines could increase compliance with varicella vaccination in countries where this vaccine is already recommended and may facilitate implementation of varicella vaccination elsewhere.

摘要

本研究旨在评估在健康儿童中同时接种一种实验性麻疹-腮腺炎-风疹-水痘疫苗(MMRV,葛兰素史克生物制品公司)和白喉-破伤风-无细胞百日咳-乙型肝炎-灭活脊髓灰质炎病毒-b型流感嗜血杆菌结合疫苗(DTPa-HBV-IPV/Hib)的情况。12至23个月大的健康儿童(N = 451)被随机分为三个平行组之一,分别接受一剂MMRV疫苗与一剂DTPa-HBV-IPV/Hib疫苗加强剂同时接种(联合接种组),或仅接受一剂MMRV疫苗(MMRV组),或仅接受一剂DTPa-HBV-IPV/Hib疫苗加强剂(DTPa-HBV-IPV/Hib组)。联合接种组和MMRV组在麻疹(>95%)、腮腺炎(>80%)、风疹(>99%)和水痘(>98%)的血清转化率方面没有差异。除抗麻疹抗体滴度外,两组之间未观察到几何平均滴度(GMT)的差异,MMRV组的抗麻疹抗体滴度高于联合接种组(分别为每毫升4419.2和3441.8毫国际单位)。联合接种组和DTPa-HBV-IPV/Hib组对DTPa-HBV-IPV/Hib疫苗加强剂的免疫反应相似。MMRV疫苗与DTPa-HBV-IPV/Hib疫苗加强剂同时接种耐受性良好,且未加剧任何一种疫苗的反应原性。总之,葛兰素史克生物制品公司的实验性MMRV疫苗在生命的第二年与DTPa-HBV-IPV/Hib疫苗加强剂同时接种时具有免疫原性且耐受性良好。在已推荐该疫苗的国家,MMRV疫苗与其他常规儿童免疫疫苗同时接种的能力可能会提高水痘疫苗接种的依从性,并可能有助于在其他地方实施水痘疫苗接种。

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