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Complete title: 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
|Research Study Number||2593.00|
|Principal Investigator||Michael Boeckh, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- 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
- Participant is >=50 years of age with a hematologic malignancy that is not in remission,
whether on therapy or not
- 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.
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- **Participant has a prior history of HZ within 1 year of enrollment.
- **Participant has received or is expected to receive any varicella or non-study 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 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.
Other exclusion criteria may apply.
Hematologic Malignancies; Solid Tumors
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