NCT01165177已完成3 期
Efficacy, Safety, and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 50 Years or Older
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 16,165
- 试验地点
- 275
- 主要终点
- Number of Subjects With Confirmed Herpes Zoster (HZ) Cases
研究概览
简要总结
The purpose of this observer-blind study is to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 50 years.
Two studies [ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229)] are being conducted concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both studies combined will be conducted contingent on each study achieving its objectives. The protocol posting of study ZOSTER-022 also deals with the outcome measures related to the pooled analysis.
详细描述
This protocol summary has been updated following Protocol Amendment 4 changes to study objectives and endpoints and the analyses of the objectives in 2 steps.
Step 1 will include analyses of the following objectives of ZOSTER-006 (NCT01165177): all HZ VE objectives and all reactogenicity/safety and immunogenicity objectives. At step 2, all objectives of study ZOSTER-006 (NCT01165177) will be analyzed. Objectives already analyzed at step 1 will be re-analyzed (confirmatory descriptive in case of inferential analysis at step 1 or descriptive analysis otherwise). At step 2, pooled analyses of studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) are planned; overall PHN VE in subjects ≥ 70 YOA, and other pre-specified endpoints will be analyzed.
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
- 50 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 will comply with the requirements of the protocol;
- •Written informed consent obtained from the subject;
- •A male or female aged 50 years or older at the time of the first vaccination;
- •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, and has a negative urine pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series;
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, or planned use during the study period;
- •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;
- •Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy;
- •History of HZ;
- •Previous vaccination against varicella or HZ;
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Additionally, consider allergic reactions to other material or equipment related to study participation;
- •Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study;
- •Receipt of immunoglobulins and/or any blood products within the 90 days preceding the first dose of study vaccine or planned administration during the study period;
- •Administration or planned administration of any other immunizations within 30 days before the first or second study vaccination or scheduled within 30 days after study vaccination. However, licensed non-replicating vaccines may be administered up to 8 days prior to each dose and/or at least 14 days after any dose of study vaccine;
- •Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study;
- •Acute disease and/or fever at the time of enrollment;
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- •Pregnant or lactating female;
- •Female planning to become pregnant or planning to discontinue contraceptive precautions.
结局指标
主要结局
Number of Subjects With Confirmed Herpes Zoster (HZ) Cases
时间窗: During the entire study period (3 to 5 year period following Day 0)
Confirmed HZ cases during the study were assessed in the Modified Total Vaccinated Cohort (mTVc)
次要结局
- Number of Subjects With Any Episodes of Post-Herpetic Neuralgia (PHN)(During the entire study period (3 to 5 year period following Day 0))
- Number of Subjects With a Reduction of Duration of Severe 'Worst' HZ-associated Pain(During the entire study period (3 to 5 year period following Day 0))
- Number of Subjects With Confirmed HZ Episode Related Mortality(During the entire study period (3 to 5 year period following Day 0))
- Number of Subjects With HZ Related Complications(During the entire study period (3 to 5 year period following Day 0))
- Number of Subjects With Confirmed HZ Episode Related Hospitalizations(During the entire study period (3 to 5 year period following Day 0))
- Number of Subjects With a Confirmed HZ Episode Having a Reduction of Duration of Pain Medication Associated With HZ(During the entire study period (3 to 5 year period following Day 0))
- Number of Subjects With HZ Related Complications, by Complication Type(During the entire study period (3 to 5 year period following Day 0))
- Distribution of Pain Medication Associated With HZ(During the entire study period (3 to 5 year period following Day 0))
- Number of Days of Pain Medication Associated With HZ(During the entire study period (3 to 5 year period following Day 0))
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 7-day (Days 0-6) post-vaccination period)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(Within the 7-day (Days 0-6) post-vaccination period)
- Number of Subjects With Any and Grade 3 Symptoms (Solicited and Unsolicited)(Within the 7-day (Days 0-6) post-vaccination period)
- Number of Subjects With Any and Related Potential Immune Mediated Diseases (pIMDs)(During the entire study period (3 to 5 year period following Day 0))
- Number of Subjects With AEs With Any and Related Medically Attended Visit(From Month 0 to Month 8 post-vaccination)
- Number of Subjects With a Confirmed HZ Episode Taking Pain Medication Associated With HZ(During the entire study period (3 to 5 year period following Day 0))
- Number of Days With Severe 'Worst' HZ-associated Pain.(During the entire study period (3 to 5 year period following Day 0))
- Number of Subjects With Confirmed HZ Episode Related Mortality and Hospitalizations(During the entire study period (3 to 5 year period following Day 0))
- Number of Subjects With Unsolicited Adverse Events (AEs)(Within 30 days (Days 0 - 29) after each vaccination)
- Number of Subjects With Serious Adverse Events (SAEs)(Within the 30-day (Days 0-29) post-vaccination period, up to Month 14 and up to study end (3 to 5 year period following Day 0))
- Number of Subjects With SAEs Related to Study Participation or to a Concurrent GSK Medication/Vaccine(During the entire study period (3 to 5 year period following Day 0))
- Number of Subjects With Fatal SAEs(During the entire study period (3 to 5 years following day 0))
研究者
研究点 (275)
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