NCT01165229已完成3 期
Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 70 Years or Older
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 14,819
- 试验地点
- 214
- 主要终点
- Outcome Measure for the Pooled Analysis of Combined Data From Studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of Subjects With Post-herpetic Neuralgia (PHN)
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 ≥ 70 years.
Two studies (Zoster-006 [NCT01165177] and Zoster-022 [NCT01165229]) will be 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. This protocol posting 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. Pooled analyses of ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) will only be conducted if the primary objective herpes zoster vaccine efficacy (HZ VE) is demonstrated in both ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) separately.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（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 70 years or older at the time of the first vaccination.
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 enrolment.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
结局指标
主要结局
Outcome Measure for the Pooled Analysis of Combined Data From Studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229): Number of Subjects With Post-herpetic Neuralgia (PHN)
时间窗: During the entire study period (3 to 5 year period following Day 0)
Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥ 70 years of age (YOA).
Number of Subjects With Any Episodes of Herpes Zoster (HZ)
时间窗: During the entire study period (3 to 5 year period following Day 0)
Confirmed HZ cases during the study in the modified total vaccinated cohort (mTVc).
Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Confirmed HZ
时间窗: During the entire study period (3 to 5 year period following Day 0)
Occurrence of confirmed HZ during the entire study period in subjects ≥ 70 YOA.
次要结局
- Number of Subjects With Post-herpetic Neuralgia (PHN)(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 Receiving Pain Medication Associated With HZ(During the entire study period (3 to 5 year period following Day 0))
- Number of Days With Pain Medication Associated With HZ(During the entire study period (3 to 5 year period following Day 0))
- 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 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 Any, Grade 3 and Related Solicited General Symptoms(Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses)
- Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Duration of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ.(During the entire study period (3 to 5 year period following Day 0))
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(Within the 30 days (Days 0-29) after each vaccination)
- Number of Subjects With SAEs Related to Study Participation or Concomitant GSK Medication(During the entire study period (3 to 5 year period following day 0))
- Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With a Reduction of PHN Incidence in Subjects ≥ 50 YOA With Confirmed HZ(During the entire study period (3 to 5 year period following Day 0))
- Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With at Least One Day of Severe 'Worst' HZ-associated Pain in Subjects ≥ 70 YOA With Confirmed HZ.(During the entire study period (3 to 5 year period following Day 0))
- Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any,Grade 3 and Related Unsolicited AEs in Subjects ≥ 70 YOA(Within 30 days (Days 0 - 29) after each vaccination)
- Number of Subjects With Overall Mortality and HZ-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 Any and Grade 3 Solicited Local Symptoms(Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses)
- Number of Subjects With Any and Related Serious Adverse Events (SAEs)(From Month 0 to Month 14)
- Number of Subjects With Fatal Serious Adverse Events (SAEs)(During the entire study period (3 to 5 year period following Day 0))
- Number of Subjects With Any and Related Medically Attended Visits(From Month 0 to Month 8 post-vaccination)
- Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Grade 3 Solicited Local Symptoms(Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses)
- Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related SAEs(From Month 0 to Month 14)
- Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Fatal SAEs(During the entire study period (3 to 5 year period following Day 0))
- Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Overall Number of Subjects With PHN in Subjects ≥ 50 YOA(During the entire study period (3 to 5 year period following Day 0))
- Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(Within the 7-day (Days 0-6) post-vaccination period following each dose and across doses)
- Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related pIMDs(During the entire study period (3 to 5 year period following Day 0))
- Outcome Measure for the Pooled Analysis of Combined Data From Studies Zoster-006 (NCT01165177) and Zoster-022 (NCT01165229): Number of Subjects With Any and Related Medically Attended Visits(From Month 0 to Month 8 post-vaccination)
研究者
研究点 (214)
Loading locations...
相似试验
已完成
3 期
Study to Evaluate Efficacy, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 50 Years and OlderHerpes ZosterNCT01165177GlaxoSmithKline16,165
已完成
2 期
Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine GSK 134612 Versus Menactra® in Healthy Adolescents/AdultsInfections, MeningococcalNCT01165242GlaxoSmithKline1,013
已完成
1 期
Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Non-typeable Haemophilus Influenzae (NTHI) VaccineRespiratory DisordersNCT01657526GlaxoSmithKline48
已完成
2 期
Efficacy, Safety and Immunogenicity Study of GlaxoSmithKline(GSK) Biologicals' Candidate Malaria Vaccine 257049 in the Sporozoite Challenge Model in Healthy Malaria-naïve AdultsMalariaNCT01857869GlaxoSmithKline64
已完成
2 期
Efficacy, Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine Evaluating Different Dose Schedules in a Sporozoite Challenge Model in Healthy Malaria-naïve AdultsMalariaNCT03162614GlaxoSmithKline154