...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Vaccine >Safety and immunogenicity of a DTaP-IPVvero (serum-free) combination vaccine in comparison to DTaP-IPVMkc when administered simultaneously with Haemophilus influenzae type b conjugate vaccine (PRP-T) in children at 2, 3.5, 5 and 16 months of age
【24h】

Safety and immunogenicity of a DTaP-IPVvero (serum-free) combination vaccine in comparison to DTaP-IPVMkc when administered simultaneously with Haemophilus influenzae type b conjugate vaccine (PRP-T) in children at 2, 3.5, 5 and 16 months of age

机译：DTaP-IPVvero（无血清）联合疫苗与DTaP-IPVMkc的安全性和免疫原性，与2、3.5、5和16个月大的儿童同时接种b型流感嗜血杆菌结合疫苗（PRP-T）

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

In a phase III, double blind, randomized, noninferiority, multi-centre clinical trial, 817 infants were included and randomly assigned to vaccination with DTaP-IPVvero (N = 410) or DTaP-IPVMkc (N = 407) vaccines (Statens Serum Institut (SSI), Denmark) in the right thigh. All infants were vaccinated with Act-HIB (R) (Sanofi Pasteur, France) in the left thigh at the same time. The vaccination schedule was 2, 3.5, 5 and 16 months and serum samples were obtained at 6, 16 and 17 months. The primary objective was to demonstrate noninferiority of DTaP-IPVvero to DTaP-IPVMkc as regards immunological protection against polio virus types 1, 2 and 3. Furthermore, the immunogenicity of all vaccine antigens and the safety profile of the vaccines were assessed. The study demonstrated that DTaP-IPVvero was noninferior to DTaP-IPVMkc. All antibody concentrations/titres remained at an acceptable level from the end of the primary vaccination series (i.e. 2, 3.5 and 5 months) until the time of the booster vaccination at 16 months. A good booster response was, furthermore, demonstrated for all antigens. No vaccine-related serious adverse events and no injection site granulomas OF swelling of the entire thigh Occurred. The frequencies of local injection site erythema and swelling as well as systemic adverse events such as fever, irritability, somnolence and decreased appetite were low and acceptable in both treatment groups. In conclusion, DTaP-IPVvero is immunogenic and safe for primary vaccination and for booster vaccination of healthy children. (C) 2008 Elsevier Ltd. All rights reserved.
机译：在一项三阶段，双盲，随机，非劣效，多中心临床试验中，纳入了817例婴儿，并随机分配接受DTaP-IPVvero（N = 410）或DTaP-IPVMkc（N = 407）疫苗（Statens血清研究所）的疫苗接种（SSI），丹麦）在右大腿上。所有婴儿同时在左大腿上接种Act-HIB（R）（法国萨诺菲·巴斯德）。接种时间表为2、3.5、5和16个月，并在6、16和17个月时获得血清样品。主要目标是证明针对1型，2型和3型脊髓灰质炎病毒的免疫保护方面，DTaP-IPVvero不亚于DTaP-IPVMkc。此外，评估了所有疫苗抗原的免疫原性和疫苗的安全性。研究表明DTaP-IPVvero不亚于DTaP-IPVMkc。从初次疫苗接种系列结束（即2、3.5和5个月）到加强疫苗接种时间（16个月），所有抗体浓度/滴度均保持在可接受的水平。此外，对于所有抗原都表现出良好的加强应答。没有发生与疫苗相关的严重不良事件，也没有发生整个大腿肿胀的注射部位肉芽肿。在两个治疗组中，局部注射部位红斑和肿胀的频率以及全身性不良事件（如发烧，烦躁，嗜睡和食欲下降）的发生率均较低，可以接受。总之，DTaP-IPVvero具有免疫原性，对于健康儿童的初次疫苗接种和加强免疫是安全的。 （C）2008 Elsevier Ltd.保留所有权利。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号