EUCTR2015-000979-27-Outside-EU/EEA进行中（未招募）不适用
A Phase 2b, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Effectiveness, Immunogenicity and Safety of Novartis Meningococcal ABCWY Vaccine Administered to Healthy Adolescents in the U.S.
ovartis Vaccines and Diagnostics0 个研究点目标入组 300 人开始时间: 2015年5月7日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
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: 300
- •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.
- •Exposure to individuals with clinically proven meningococcal disease or clinical bacterial meningitis without
- •further microbiologic characterization.
研究者
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