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临床试验/EUCTR2013-002451-15-FI
EUCTR2013-002451-15-FI进行中(未招募)1 期

A Phase 2b, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Immunogenicity and Safety of GSK Meningococcal ABCWY Vaccine Administered at Different Schedules Compared to GSK Meningococcal group B vaccine, in Healthy Adolescents

GlaxoSmithKline Biologicals SA0 个研究点目标入组 1,050 人开始时间: 2014年5月27日最近更新:

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
1,050

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Adolescents from 10-18 years of age, generally in good health, and available for all study visits, who/whose legally acceptable representative has given written informed consent at the time of enrollment. Female subjects of childbearing potential must have a negative urine pregnancy test.
  • Are the trial subjects under 18? yes
  • Number of subjects for this age range: 1050
  • F.1.2 Adults (18-64 years) no
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Serious, acute, or chronic illnesses. Previous or suspected disease caused by N. meningitidis. Previous immunization with any meningococcal vaccine or Hepatitis A vaccine. Exposure to individuals with clinically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characterization

研究者

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