EUCTR2011-000475-14-DE进行中（未招募）不适用
A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines when Administered Concomitantly with Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Adults
ovartis Vaccines and Diagnostics S.r.l.0 个研究点目标入组 550 人开始时间: 2011年6月8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
- 550
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
- •Inclusion Criteria: Female and male subjects eligible to be enrolled in this study
- •? available for all study visits,
- •? able to give written informed consent,
- •? between 18 and 60 years of age, and
- •? generally in good health.
- •Subjects with previous vaccination with one or more antigens related to any of the
- •study vaccines, determined by history (interview of the subject) and/or by review of
- •his or her vaccination card, will be eligible to participate in the study if more than 5
- •years have elapsed since vaccination.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 550
- •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 are reasons for exclusion.
- •Women will be required to have a negative urine pregnancy test before being
- •enrolled in the study.
- •The full list of inclusion and exclusion criteria is included in protocol section 4.0.
- •Personal history of Neisseria meningitidis infection, typhoid fever, rabies, or any
- •flavivirus infection (e.g., Japanese encephalitis, tick-borne encephalitis, yellow
- •fever, dengue fever, West e virus infection) is considered exclusion criteria.
研究者
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