EUCTR2005-000253-29-AT进行中（未招募）不适用
ONG TERM IMMUNOGENICITY OF THE JAPANESE ENCEPHALITIS VACCINEIC51 (JE-PIV). AN UNCONTROLLED PHASE 3 FOLLOW-UP STUDY - IC51-303
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Intercell AG
- 入组人数
- 3,300
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
- •-Subjects correctly included in and having completed clinical studies IC51-301 or
- •IC51-302 with at least one vaccination.
- •-Written informed consent for study IC51-303.
- •Only for the immunogenicity part:
- •-Subjects correctly included in and having completed study IC51-301 or IC51-302 according to the protocol with the required amount of injections (IC51-301: 3 / IC51-302: 2).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Inability or unwillingness to provide informed consent and to abide by the requirements of the study.
- •Only for the immunogenicity part:
- •-Known negative (< 1:10) anti-JEV neutralizing antibody titer (PRNT) 28 days after the last vaccination in the preceding study or thereafter.
- •-Subjects with any condition which in the opinion of the Investigator makes the subject unsuitable for inclusion.
- •-Known randomization to JE-VAX® or placebo
研究者
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