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

Merck Sharp and Dohme0 个研究点目标入组 5,264 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Participant has been diagnosed with an STM or HM and is not likely to undergo hematopoietic cell transplant (HCT) and:
•Participant is >=18 years of age and receiving a cytotoxic or immunosuppressive chemotherapy regimen that does not include rituximab.
•Participant is >= 50 years of age with a hematologic malignancy that is not in remission, whether on therapy or not, and is not expected to need rituximab therapy within 3 months prior to enrollment on this study through 28 days after receiving vaccination dose 4.
•Participant has a life expectancy >= 12 months.
•Participant has prior history of varicella or antibodies to VZV due to exposure to the disease in a country where the disease is common.

•-articipant has a history of allergic reaction to any vaccine component (including gelatin) or an anaphylactic/anaphylactoid reaction to neomycin.
•Participant has a prior history of HZ within 1 year of enrollment.
•Participant has received any varicella or zoster vaccine.
•Participant is currently receiving or expected to receive long-term antiviral prophylaxis (4 weeks duration) with activity against herpes simplex virus (HSV), VZV or cytomegalovirus (CMV).
•Participant is receiving or expected to receive a chemotherapy regimen containing Rituximab.
•Participant is pregnant or breastfeeding or expecting to conceive within the period of 2 weeks prior to enrollment throughout 6 months after last vaccination dose.
•Participant has had any live virus vaccine administered or scheduled in the period from 4 weeks prior to Dose 1 through 28 days post vaccination dose 4.
•Participant has had inactivated vaccine administered or scheduled within the period from 7 days prior to, through 7 days following, any dose of study vaccine.

发起方

Merck Sharp and Dohme