...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Vaccine >Immunogenicity, reactogenicity and safety of the human rotavirus vaccine RIX4414 oral suspension (liquid formulation) in Finnish infants
【24h】

Immunogenicity, reactogenicity and safety of the human rotavirus vaccine RIX4414 oral suspension (liquid formulation) in Finnish infants

机译：人类轮状病毒疫苗RIX4414口服混悬液（液体制剂）在芬兰婴儿中的免疫原性，反应原性和安全性

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

The lyophilized formulation of a human rotavirus vaccine, Rotarix (TM) (RIX4414) is highly immunogenic. In order to comply with the World Health Organization's (WHO) recommendation, a liquid formulation of the vaccine that does not require reconstitution was developed. The immunogenicity, reactogenicity and safety of the liquid formulation were compared with lyophilized formulation in two Finnish studies.In Study A infants aged 6-12 weeks received two doses of the lyophilized or liquid formulation of the vaccine or placebo following a 0,1 month schedule. In Study B, infants aged 10-17 weeks received two doses of either liquid or lyophilized formulation of the vaccine. In both studies, anti-rotavirus IgA antibodies were assessed pre-vaccination and one month post-Dose 2. In Study A, the anti-rotavirus seroconversion rate was 90% (95% CI: 81.2-95.6%) and 83.7% (95% Cl: 74.2-90.8%) in the groups that received the liquid and the lyophilized formulation of RIX4414, respectively; the respective anti-rotavirus IgA seroconversion rates in Study B were 88.6% (95% CI: 86.1-90.8%) and 90.5% (95% CI: 86.2-93.8%). Reactogenicity and safety profiles of the two vaccine formulations were similar.Liquid formulation of the rotavirus vaccine allows greater flexibility in supply and reduces logistical costs
机译：人轮状病毒疫苗Rotarix（TM）（RIX4414）的冻干制剂具有高度免疫原性。为了符合世界卫生组织（WHO）的建议，开发了无需重新配制的液体疫苗制剂。在两项芬兰研究中，将液体制剂与冻干制剂的免疫原性，反应原性和安全性进行了比较。在研究中，在0.1个月的时间表中，年龄为6-12周的婴儿接受了两剂疫苗或安慰剂的冻干制剂或液体制剂。在研究B中，年龄10-17周的婴儿接受了两剂疫苗的液体或冻干制剂。在两项研究中，在疫苗接种前和剂量2后一个月评估了抗轮状病毒IgA抗体。在研究A中，抗轮状病毒的血清转化率分别为90％（95％CI：81.2-95.6％）和83.7％（95）在分别接受RIX4414的液体制剂和冻干制剂的组中，％Cl：74.2-90.8％）;研究B中的抗轮状病毒IgA血清转化率分别为88.6％（95％CI：86.1-90.8％）和90.5％（95％CI：86.2-93.8％）。两种疫苗制剂的反应原性和安全性相似，轮状病毒疫苗的液体制剂可提供更大的供应灵活性并降低后勤成本

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