KCT0000393招募中未知
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
MSD Korea0 个研究点目标入组 5,264 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 5,264
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Patient has been diagnosed with a solid tumor or hematologic malignancy AND is not likely to undergo hematopoietic cell transplant (HCT) and meets one of the criteria specified below.
- •-Is 18 years of age or older and is receiving a cytotoxic or immunosuppressive chemotherapy regimen that does not include an anti-CD20 monoclonal antibody
- •-Is 50 years of age or older with a hematologic malignancy, not in remission, regardless of whether the patient is or is not receiving chemotherapy
- •-Is not receiving and not expected to require anti-CD20 monoclonal antibody therapy beginning 3 months prior to enrollment through 28 days postvaccination dose 4.
- •2. Life expectancy = 12 months.
- •3. Signed an informed consent prior to any study procedures.
- •4. Patient has prior history of varicella, antibodies to VZV (documented prior to receipt of blood products), or residence (for =30 years) in a country with endemic VZV infection, or if participant is <30 years old, attended primary or secondary school in a country with endemic VZV infection (see Section 3.2.8 for more details).
- •5. All female patients of childbearing potential (as defined below under #7) must have a negative serum or urine pregnancy test (sensitive to 25IU ß-hCG).
- •6. Able to understand and complete study questionnaires.
- •7. Patient is highly unlikely to conceive during the time period starting 2 weeks prior to enrollment through 6 months from last vaccination dose, as indicated by at least one yes” answer to the following questions:
- •-Patient is male.
- •-Patient is female who agrees to remain abstinent or use (or have their partner use) adequate contraception during the time period starting 2 weeks prior to enrollment through 6 months from the last vaccination dose. Note that simultaneous use of two reliable forms of contraception is recommended.
- •-Patient is a female who is not of reproductive potential. A female patient who is not of reproductive potential is defined as: one who has either (1) reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum follicle stimulating hormone [FSH] levels in the postmenopausal range as determined by a laboratory, or 12 months of spontaneous amenorrhea), (2) post-surgical bilateral oophorectomy and/or hysterectomy, or (3) bilateral tubal ligation.
- •8.Patients with STM will be eligible for enrollment if they have not received (nor are expected to require receipt of) blood products within 3 months prior to enrollment through 28 days Postvaccination 4.
排除标准
- •1.A history of allergic reaction to any vaccine component (including gelatin) or an anaphylactic/anaphylactoid reaction to neomycin (a history of contact dermatitis to neomycin is not a criterion for study exclusion).
- •2.Prior history of HZ within 1 year of enrollment.
- •3.Prior or expected receipt of any varicella or non-study zoster vaccine.
- •4.Patient is currently receiving or expected to receive long-term antiviral prophylaxis (greater than 4 weeks duration) with activity against herpes simplex virus (HSV), VZV or cytomegalovirus (CMV).
- •5.Patient is receiving or expected to receive a chemotherapy regimen containing an anti-CD20 monoclonal antibody at any time during the time period beginning 3 months prior to enrollment through 28 days postvaccination dose 4.
- •6.Patient is pregnant or breastfeeding or expecting to conceive within the period of 2 weeks prior to enrollment throughout 6 months after last vaccination dose.
- •7.Any live virus vaccine administered or scheduled in the period from 4 weeks prior to Dose 1 through 28 days postvaccination dose 4.
- •8.Any inactivated vaccine administered or scheduled within the period from 7 days prior to, through 7 days following, any dose of study vaccine.
- •9.Unlikely to adhere to the study procedures or attend study visits.
- •10.Any other reason that in the opinion of the investigator might interfere with the evaluation required by the study.
- •11. Patients with STM will be excluded from study if they have received (or are expected to require receipt of) blood products within 3 months prior to enrollment through 28 days Postvaccination 4.
研究者
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