Long Term Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Vaccine 1437173A in Healthy Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 12
- 主要终点
- Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells
时间窗: Month 72
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)
Antigen-specific Antibody (Ab) Concentrations
时间窗: Month 72
-Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)
次要结局
- Number of Subjects With Any Serious Adverse Events (SAEs) Related to the Study Participation(Month 48 to Month 72)
- Number of Subjects With Any SAEs Related to Previous Vaccination and Not Already Documented(Month 0 to Month 72)
- Number of Subjects With Any Fatal SAEs(Month 48 to Month 72)
- 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(Month 48 to Month 72)
- Number of Subjects With Any Suspected Cases of HZ Episodes(Month 48 to Month 72)
- 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(Month 48 to Month 72)