EUCTR2010-022248-19-NL进行中（未招募）1 期
An open, phase II long term extension study to evaluate the immune responses to and safety of GSK Biologicals’ candidate herpes zoster vaccine, (gE/AS01B), at Months 48, 60 and 72 post-vaccination in healthy subjects aged 60 years of age and older. - ZOSTER-024
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 166
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
- •1)Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g. return for follow-up visits)
- •2)Previous participation in study ZOSTER-003 as a member of the 50µg gE/AS01B vaccine group;
- •3)Written informed consent obtained from the subject.
- •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
- •1)Having participated in another study at any time after ZOSTER-003 study end in which the subject was exposed to an investigational or non-investigational product (pharmaceutical product or device) or; concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device);
- •2)Administration of immunoglobulins and/or any blood products within the 3 months preceding the first blood draw;
- •3)Having received a vaccine containing 3-O-desacyl-4’-Monophosphoryl Lipid A (MPL) and/or Quillaja saponaria Molina, fraction 21 (QS21), any time after ZOSTER-003 study end;
- •4)Having received a vaccine against HZ any time after ZOSTER-003 study end;
- •5)Subject who did not receive a complete vaccination course of 2 doses of 50µg gE/AS01B in study ZOSTER-003;
研究者
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