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
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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