EUCTR2010-023156-89-GR进行中（未招募）1 期
A Phase III Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Efficacy of V212 in Adult Patients with Solid Tumor or Hematologic Malignancy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 5,136
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patient is =18 years of age with a solid tumor or hematologic malignancy receiving immunosuppressive or cytotoxic chemotherapy, has a prior history of varicella, antibodies to VZV, or residence in a country with endemic VZV infection for >30 years (if patient is <30 years old, attended primary or secondary school in a country with endemic VZV infection), is not likely to undergo hematopoietic cell transplant, and has not/will not be treated with rituximab in the time period from 3 months prior to enrollment through 28 days following the last dose of study vaccine, is not likely to received long-term antiviral prophylaxis of greater than 4 weeks duration, with activity against VZV, cytomegalovirus or herpes simplex virus.
- •Patient is =50 years of age with a hematologic malignancy not in remission, may or may not be receiving chemotherapy, has a prior history of varicella, antibodies to VZV, or residence in a country with endemic VZV infection for >30 years, is not likely to undergo hematopoietic cell transplant, and has not/will not be treated with rituximab from 3 months prior to enrolment through 28 days following the last dose of study vaccine is not likely to received long-term antiviral prophylaxis of greater than 4 weeks duration, with activity against VZV, cytomegalovirus or herpes simplex virus.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patient has a prior history of HZ within 1-year of enrolment, a prior history of receipt of any varicella or zoster vaccine, is likely to undergo hematopoietic cell transplant, and has been treated with rituximab or is expected to be treated with rituximab in the period from 3 months prior to enrolment through 28 days following the last dose of study vaccine and is likely to receive long term antiviral prophylaxis (greater than 4 weeks duration) with activity against varicella-zoster virus zoster, cytomegalovirus, or herpes simplex virus.
研究者
相似试验
进行中（未招募）
1 期
A Phase III Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Efficacy of V212 in Adult Patients with Solid Tumor or Hematologic Malignancy.Incidence of Herpes Zoster in adults with solid tumor or hematologic malignancy.MedDRA version: 16.1Level: PTClassification code 10019974Term: Herpes zosterSystem Organ Class: 10021881 - Infections and infestationsEUCTR2010-023156-89-BEMerck Sharp & Dohme Corp., a subsidiary of Merck & Co, Inc.5,264
进行中（未招募）
1 期
A clinical research study to test the safety, tolerability and effectiveness of the investigational vaccine to prevent shingles in individuals with weak immune system such as people with cancer.EUCTR2010-023156-89-LTMerck Sharp & Dohme Corp., a Subsidiary of Merck & Co, Inc.5,136
进行中（未招募）
1 期
A Phase III Randomized, Placebo-Controlled, Clinical Trial to Study the Safety and Efficacy of V212 in Adult Patients with Solid Tumor or Hematologic MalignancyEUCTR2010-023156-89-ATMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.5,264
招募中
不适用
A Phase III Clinical Trial to Study the Safety and Efficacy of V212 in Adult Patients with Solid Tumor or Hematologic MalignancyKCT0000393MSD Korea5,264
进行中（未招募）
1 期
ot availableEUCTR2010-023156-89-EEMerck Sharp & Dohme Corp., a Subsidiary of Merck & Co, Inc.5,264