EUCTR2010-023156-89-AT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
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 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
- •- 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
- •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. 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:
- •- 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.
- •7. 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.
- •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 1316
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3948
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 pregnant or breastfeeding or expecting to conceive within the period of 2 weeks prior to enrollment throughout 6 months after last vaccination dose.
- •6. Any live virus vaccine administered or scheduled in the period from 4 weeks prior to Dose 1 through 28 days postvaccination dose 4.
- •7. Any inactivated vaccine administered or scheduled within the period from 7 days prior to, through 7 days following, any dose of study vaccine.
- •8. Patients with STM will be excluded from the ELISPOT substudy 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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