A Study to Evaluate the Safety and Efficacy of Inactivated Varicella-zoster Vaccine (VZV) as a Preventative Treatment for Herpes Zoster (HZ) and HZ-related Complications in Adult Participants With Solid Tumor or Hematologic Malignancy (V212-011)

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIISupportive careClosed18 and overPharmaceutical / IndustryV212-011
CTRI/2012/05/002673, NCT01254630

Trial Description

Summary

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.

Eligibility Criteria

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
  • 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.

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 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Merck and Company, Incorporated

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT01254630
    ClinicalTrials.gov processed this data on May 11, 2015

    Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.