Last updated on November 2017

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


Brief description of study

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

Detailed Study Description

This is a randomized, double-blind, placebo-controlled study to assess the safety and tolerability of V212 when administered to adults with solid tumor malignancy (STM) or hematologic malignancy (HM) and to determine whether V212 reduces the incidence of herpes zoster (HZ) in adults with STM or HM, as compared to placebo.

Patient Inclusion Criteria:

  • 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.

Patient Exclusion Criteria:

  • Participant 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.

Clinical Study Identifier: TX13217

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Tyler Prater

Community Clinical Research Center
Anderson, IN USA
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