EUCTR2014-003504-79-Outside-EU/EEA进行中(未招募)不适用
A Phase 3, Randomized, Observer-blind, Controlled, Multi-Center Study to Evaluate the Lot to Lot Consistencyof Investigational Meningococcal ACWY Conjugate Vaccine when One Dose is Administered to Healthy Adolescents 11-18 Years of Age and to Compare the Safety and Immunogenicity of Investigational Meningococcal ACWY Conjugate Vaccine with that of Licensed Meningococcal ACWY Conjugate Vaccine (Menactra™) when One Dose is Administered to Healthy Subjects 11-55 Years of Age
ovartis Vaccines & Diagnostics, Inc.0 个研究点目标入组 3,539 人开始时间: 2014年10月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 3,539
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
- •Healthy subjects who are 11-55 years of age inclusive and who have given appropriate written assent and/or consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1636
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1332
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Subjects with:
- •A previous or suspected disease caused by N. meningitidis
- •Previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
- •Previous or suspected disease caused by N. meningitidis
- •Any serious acute, chronic or progressive disease
- •Pregnant or breastfeeding
研究者
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