Observer-blind Study to Evaluate Efficacy, Safety, and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,877
- 试验地点
- 179
- 主要终点
- Number of Subjects With Confirmed Herpes Zoster (HZ) Episode
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of GSK Biologicals' vaccine GSK1437173A in the prevention of Herpes zoster (HZ) in autologous haematopoietic cell transplant recipients 18 years of age and older. To this end, the study will evaluate vaccine efficacy (VE) of the GSK1437173A vaccine, administered on a 2-dose schedule, compared to placebo in reducing the risk of developing HZ in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study entry (enrollment) occurs at the Pre-vaccination visit.
- •Subjects who the investigator believes can and will comply with the requirements of the protocol.
- •Written informed consent obtained from the subject.
- •A male or female aged 18 years or older at the time of study entry.
- •Has undergone or will undergo autologous HCT within 50-70 days prior to the first vaccination with the study vaccine/placebo, and there are no plans for additional HCTs.
- •Female subjects of non-childbearing potential may be enrolled in the study. For this study population, non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.
- •OR Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination with the study vaccine/placebo, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 12 months after completion of the vaccination series (i.e., until Month 13).
排除标准
- •Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo, or planned use during the study period. However, the investigational use of a registered or non-registered product to treat the subject's underlying disease for which the HCT was undertaken, or a complication of the underlying disease, is allowed.
- •Previous vaccination against HZ or varicella within the 12 months preceding the first dose of study vaccine/placebo.
- •Planned administration during the study of a HZ vaccine other than the study vaccine.
- •Occurrence of a varicella or HZ episode by clinical history within the 12 months preceding the first dose of study vaccine/placebo.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or study material and equipment.
- •Prophylactic antiviral therapy with activity against Varicella Zoster Virus (VZV) expected to last more than 6 months after transplantation.
- •Administration and/or planned administration of a vaccine not foreseen by the study protocol between HCT and 30 days after the last dose of study vaccine/placebo. However, licensed non-replicating vaccines may be administered up to 8 days prior to dose 1and/or 2, and/or at least 14 days after any dose of study vaccine/placebo.
- •HIV infection by clinical history.
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 13 (i.e., one year after the last dose of study vaccine/placebo).
研究组 & 干预措施
GSK1437173A Group
Subjects received 2 doses of the candidate HZ vaccine GSK 1437173A, administered intramuscularly (IM) in deltoid region of non-dominant arm, according to a 0, 1 Month schedule.
干预措施: Herpes Zoster vaccine GSK1437173A (Biological)
Placebo Group
Subjects received 2 doses of placebo (saline solution), administered intramuscularly (IM) in deltoid region of non-dominant arm, according to a 0, 1 Month schedule.
干预措施: Placebo (Biological)
结局指标
主要结局
Number of Subjects With Confirmed Herpes Zoster (HZ) Episode
时间窗: From Month 0 until the cut-off date for final analysis (median follow-up was of 21 months)
A suspected case of HZ was defined as (1) a new rash characteristic of HZ (e.g., unilateral, dermatomal and accompanied by pain broadly defined to include allodynia, pruritus or other sensations), or a vesicular rash suggestive of VZV infection regardless of the distribution, and no alternative diagnosis; or (2) a clinical presentation (symptoms and/or signs) and specific laboratory findings\* suggestive of VZV infection in the absence of characteristic HZ or VZV rash. A suspected case of HZ was confirmed either: by Polymerase Chain Reaction (PCR) or by the HZ Ascertainment Committee (HZAC), consisting of physicians with HZ expertise.
次要结局
- Number of Subjects With Confirmed HZ-associated Complications(From Month 0 until the cut-off date for final analysis (median follow-up was of 21 months))
- Duration of 'Worst' HZ-associated Pain(From Month 0 until study end (4 years approximately), from the onset of a confirmed HZ rash over the entire pain reporting period)
- Number of Subjects With Postherpetic Neuralgia (PHN)(From Month 0 until study end (21 months median follow-up))
- Number of Subjects With Any Relapse(From Month 0 until study end (approximate median of 29 months follow-up - minimum 1 year and maximum 4 years))
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 7-day (Days 0-6) post-vaccination period following each dose and across doses)
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(During the 30-day (Days 0-29) post-vaccination period)
- Number of Subjects With Any Serious Adverse Events (SAEs) and Related SAEs to GSK Study Vaccine/Placebo(From Month 0 until 365 days post last vaccination (approximate median of 29 months follow-up - minimum 1 year and maximum 4 years))
- Antigen-glycoprotein E (gE) Antibody Concentrations in a Sub-cohort of Subjects(At Months 0, 1, 2, 13 and 25)
- Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)(From Month 0 up to 365 days post last vaccination)
- Number of Subjects With Fatal SAEs and SAEs Related to Study Participation or to a GSK Concomitant Medication or Vaccination(From the Pre-vaccination visit (Up to 110 days prior Month 0) until study end (approximate median of 29 months follow-up minimum 1 year and maximum 4 years))
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(During the 7-day (Days 0-6) post-vaccination period following each dose and across doses)