Study of Long Term Immune Responses and Safety of the GSK Herpes Zoster Vaccine in Healthy Subjects
Long Term Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Vaccine 1437173A in Healthy Subjects
The subjects included in this study are subjects that participated in study NCT00434577. These subjects were vaccinated with the candidate Herpes Zoster (HZ) vaccine at Month 0 and Month 2 and were then followed at Month 12, Month 24 and Month 36 (study NCT00434577) for safety and immunogenicity.
This long term follow up study (ZOSTER-024 [114825]) will evaluate immune responses to and safety of the previously administered candidate HZ vaccine at Months 48, 60 and 72.
The study visits will be scheduled at approximately one year intervals after the first visit in ZOSTER-024. Blood samples for the evaluation of cellular and humoral immunity will be taken from all subjects at each visit. Information on safety and the occurrence of HZ will also be collected during these visits.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Berlin、德国、13347
- GSK Investigational Site
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Baden-Wuerttemberg
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Mannheim、Baden-Wuerttemberg、德国、68161
- GSK Investigational Site
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Bayern
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Wuerzburg、Bayern、德国、97070
- GSK Investigational Site
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Niedersachsen
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Hannover、Niedersachsen、德国、30625
- GSK Investigational Site
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Nordrhein-Westfalen
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Essen、Nordrhein-Westfalen、德国、45359
- GSK Investigational Site
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Koeln、Nordrhein-Westfalen、德国、51069
- GSK Investigational Site
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Hradec Kralove、捷克语、500 01
- GSK Investigational Site
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Eskilstuna、瑞典、SE-631 88
- GSK Investigational Site
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Uppsala、瑞典、SE-751 85
- GSK Investigational Site
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Amsterdam、荷兰、1018 WT
- GSK Investigational Site
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Rotterdam、荷兰、3011 EN
- GSK Investigational Site
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Subjects who the investigator believes can and will comply with the requirements of the protocol
- Previous participation in study NCT00434577 as a member of the intermediate dose active vaccine group
- Written informed consent obtained from the subject
Exclusion Criteria:
- Having participated in another study at any time after NCT00434577 study end in which the subject was exposed to an investigational or non-investigational product 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
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first blood draw
- Having received a vaccine containing some vaccine components, any time after study end of study NCT00434577
- Having received a vaccine against HZ any time after study end of study NCT00434577
- Subject who did not receive a complete vaccination course of 2 doses of the intermediate dose active vaccine in study NCT00434577
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:GSK1437173A Group
Subjects who received 2 doses of HZ vaccine in the intermediate dose study group in study 108494 (NCT00434577).
No treatment was given in this current study (NCT01295320).
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Blood sample will be collected at Month 48, Month 60 and Month 72
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells
大体时间:Month 48
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-Frequencies of CD4 T cells with antigen-specific Interferon gamma (IFN-γ) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-α) and/or CD40 Ligand (CD40L) secretion/expression to glycoprotein E (gE) and Varicella Zoster Virus (VZV) as determined by Intracellular Cytokine Staining (ICS)
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Month 48
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Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells
大体时间:Month 60
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Frequencies of CD4 T cells with antigen-specific Interferon gamma (IFN-γ) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-α) and/or CD40 Ligand (CD40L) secretion/expression to glycoprotein E (gE) and Varicella Zoster Virus (VZV) as determined by Intracellular Cytokine Staining (ICS)
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Month 60
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Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells
大体时间:Month 72
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Frequencies of CD4 T cells with antigen-specific Interferon gamma (IFN-γ) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-α) and/or CD40 Ligand (CD40L) secretion/expression to glycoprotein E (gE) and Varicella Zoster Virus (VZV) as determined by Intracellular Cytokine Staining (ICS)
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Month 72
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Antigen-specific Antibody (Ab) Concentrations
大体时间:Month 48
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-Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)
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Month 48
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Antigen-specific Antibody (Ab) Concentrations
大体时间:Month 60
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-Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)
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Month 60
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Antigen-specific Antibody (Ab) Concentrations
大体时间:Month 72
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-Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)
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Month 72
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Number of Subjects With Any Serious Adverse Events (SAEs) Related to the Study Participation
大体时间:Month 48 to Month 72
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Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
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Month 48 to Month 72
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Number of Subjects With Any SAEs Related to Previous Vaccination and Not Already Documented
大体时间:Month 0 to Month 72
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Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
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Month 0 to Month 72
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Number of Subjects With Any Fatal SAEs
大体时间:Month 48 to Month 72
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Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
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Month 48 to Month 72
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Number of Subjects With Any Suspected Cases of HZ Episodes
大体时间:Month 48 to Month 72
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Month 48 to Month 72
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Number of Subjects With Any Suspected Cases of HZ Episodes Following Participation in 108494 Study and Its Follow-ups (108516, 108518 and 108520) and Not Already Documented
大体时间:Month 48 to Month 72
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Month 48 to Month 72
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Number of Subjects and Relationship to Vaccination of Any Potential Immune Mediated Diseases (pIMDs) Following Participation in 108494 Study and Its Follow-ups (108516, 108518 and 108520) and Not Already Documented
大体时间:Month 48 to Month 72
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Month 48 to Month 72
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 114825
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
研究数据/文件
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数据集规范
信息标识符:114825信息评论:For additional information about this study please refer to the GSK Clinical Study Register
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统计分析计划
信息标识符:114825信息评论:For additional information about this study please refer to the GSK Clinical Study Register
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带注释的病例报告表
信息标识符:114825信息评论:For additional information about this study please refer to the GSK Clinical Study Register
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临床研究报告
信息标识符:114825信息评论:For additional information about this study please refer to the GSK Clinical Study Register
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研究协议
信息标识符:114825信息评论:For additional information about this study please refer to the GSK Clinical Study Register
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个人参与者数据集
信息标识符:114825信息评论:For additional information about this study please refer to the GSK Clinical Study Register
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知情同意书
信息标识符:114825信息评论:For additional information about this study please refer to the GSK Clinical Study Register
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