In English | En español
Questions About Cancer? 1-800-4-CANCER

Clinical Trials (PDQ®)

Page Options

  • Print This Page
  • Email This Document
Clinical Trial Questions?
Get Help:
1-800-4-CANCER
LiveHelp online chat

Clinical Trials (PDQ®)

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)

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIISupportive careActive18 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

Toll Free NumberPh: 1-888-577-8839

Trial Sites

U.S.A.
California
  Bakersfield
 Call for Information (Investigational Site 0326)
  Burbank
 Call for Information (Investigational Site 0324)
  Corona
 Call for Information (Investigational Site 0425)
  Fair Oaks
 Call for Information (Investigational Site 0380)
  Fountain Valley
 Call for Information (Investigational Site 0431)
  Highland
 Call for Information (Investigational Site 0430)
  La Jolla
 Call for Information (Investigational Site 0251)
  Mission Hills
 Call for Information (Investigational Site 0121)
 Call for Information (Investigational Site 0252)
  Orange
 Call for Information (Investigational Site 0433)
  Rancho Mirage
 Call for Information (Investigational Site 0350)
  Riverside
 Call for Information (Investigational Site 0418)
  San Diego
 Call for Information (Investigational Site 0354)
  Santa Monica
 Call for Information (Investigational Site 0344)
Colorado
  Englewood
 Call for Information (Investigational Site 0304)
Delaware
  Newark
 Call for Information (Investigational Site 0274)
District of Columbia
  Washington
 Call for Information (Investigational Site 0309)
Florida
  Lakeland
 Call for Information (Investigational Site 0384)
  Miami
 Call for Information (Investigational Site 0028)
 Call for Information (Investigational Site 0243)
 Call for Information (Investigational Site 0284)
 Call for Information (Investigational Site 0340)
  Orlando
 Call for Information (Investigational Site 0419)
  Port St. Lucie
 Call for Information (Investigational Site 0259)
  Stuart
 Call for Information (Investigational Site 0339)
Illinois
  Chicago
 Call for Information (Investigational Site 0023)
 Call for Information (Investigational Site 0024)
 Call for Information (Investigational Site 0454)
  Decatur
 Call for Information (Investigational Site 0285)
  Joliet
 Call for Information (Investigational Site 0407)
  Rockford
 Call for Information (Investigational Site 0443)
  Skokie
 Call for Information (Investigational Site 0303)
 Call for Information (Investigational Site 0386)
  Urbana
 Call for Information (Investigational Site 0205)
Indiana
  Anderson
 Call for Information (Investigational Site 0025)
  Avon
 Call for Information (Investigational Site 0257)
  Evansville
 Call for Information (Investigational Site 0011)
  Indianapolis
 Call for Information (Investigational Site 0427)
  Kokomo
 Call for Information (Investigational Site 0442)
  New Albany
 Call for Information (Investigational Site 0396)
Iowa
  Ames
 Call for Information (Investigational Site 0249)
  Cedar Rapids
 Call for Information (Investigational Site 0286)
 Call for Information (Investigational Site 0360)
  Des Moines
 Call for Information (Investigational Site 0197)
  Waterloo
 Call for Information (Investigational Site 0382)
Kansas
  Wichita
 Call for Information (Investigational Site 0199)
Kentucky
  Paducah
 Call for Information (Investigational Site 0283)
Maryland
  Baltimore
 Call for Information (Investigational Site 0247)
Michigan
  Grand Rapids
 Call for Information (Investigational Site 0423)
Minnesota
  Duluth
 Call for Information (Investigational Site 0282)
  Minneapolis
 Call for Information (Investigational Site 0022)
  St. Cloud
 Call for Information (Investigational Site 0202)
Missouri
  Saint Louis
 Call for Information (Investigational Site 0150)
Nebraska
  Omaha
 Call for Information (Investigational Site 0256)
New Jersey
  Somerville
 Call for Information (Investigational Site 0327)
New York
  Bronx
 Call for Information (Investigational Site 0201)
  Commack
 Call for Information (Investigational Site 0263)
  East Syracuse
 Call for Information (Investigational Site 0033)
  Great Neck
 Call for Information (Investigational Site 0258)
  Lake Success
 Call for Information (Investigational Site 0230)
  Manhasset
 Call for Information (Investigational Site 0233)
  Rochester
 Call for Information (Investigational Site 0198)
  Stony Brook
 Call for Information (Investigational Site 0254)
North Carolina
  Asheville
 Call for Information (Investigational Site 0342)
  Winston-Salem
 Call for Information (Investigational Site 0315)
North Dakota
  Fargo
 Call for Information (Investigational Site 0153)
 Call for Information (Investigational Site 0301)
Ohio
  Akron
 Call for Information (Investigational Site 0250)
 Call for Information (Investigational Site 0323)
  Canton
 Call for Information (Investigational Site 0422)
Pennsylvania
  Bethlehem
 Call for Information (Investigational Site 0417)
  Philadelphia
 Call for Information (Investigational Site 0026)
 Call for Information (Investigational Site 0447)
  West Reading
 Call for Information (Investigational Site 0016)
South Carolina
  Charleston
 Call for Information (Investigational Site 0316)
South Dakota
  Rapid City
 Call for Information (Investigational Site 0241)
  Sioux Falls
 Call for Information (Investigational Site 0151)
  Watertown
 Call for Information (Investigational Site 0225)
Texas
  Amarillo
 Call for Information (Investigational Site 0295)
  Austin
 Call for Information (Investigational Site 0404)
  Corpus Christi
 Call for Information (Investigational Site 0372)
  Dallas
 Call for Information (Investigational Site 0366)
  Galveston
 Call for Information (Investigational Site 0027)
  Houston
 Call for Information (Investigational Site 0255)
  Killeen
 Call for Information (Investigational Site 0314)
  New Braunfels
 Call for Information (Investigational Site 0441)
  Round Rock
 Call for Information (Investigational Site 0245)
  San Antonio
 Call for Information (Investigational Site 0317)
  Temple
 Call for Information (Investigational Site 0034)
 Call for Information (Investigational Site 0343)
Utah
  Salt Lake City
 Call for Information (Investigational Site 0313)
Wisconsin
  Green Bay
 Call for Information (Investigational Site 0122)
  La Crosse
 Call for Information (Investigational Site 0236)
  Madison
 Call for Information (Investigational Site 0311)
Belgium
  Brussels
 MSD Belgium BVBA/SPRL
 Frederik Tack Ph: 32 2 373 4324
Ecuador
  Quito
 MSD Ecuador
 Jaime Burbano Ph: 593 2 2941-700
Estonia
  Tallinn
 Merck Sharp & Dohme OU
 Andrius Bacevicius Ph: 370 52780243
France
  Paris
 MSD France
 Dominique Blazy Ph: 33 147548990
Italy
  Rome
 MSD Italia S.r.l.
 Patrizia Nardini Ph: 39 06 361911
Jordan
  Amman
 MSD Idea, Inc. - LB BR
 Amal Chalfoun Ph: 961 4542590
Lebanon
  Beirut
 MSD Idea, Inc. - LB BR
 Amal Chalfoun Ph: 961 4542590
Peru
  Lima
 Merck Sharp & Dohme, Peru S.R.L.
 Oscar Espinoza Ph: (51-1) 411-5100
Philippines
  Makati
 Merck Sharp & Dohme (I.A.) Corporation
 Cesar Recto Ph: 632 784 9500
Puerto Rico
  San Juan
 Call for Information (Investigational Site 0098)
Republic of Bulgaria
  Sofia
 Merck Sharp & Dohme Bulgaria EOOD
 Eran Gefen Ph: 38 (044) 393 74 80
Republic of South Africa
  Midrand
 MSD (Pty) LTD South Africa
 Khanyi Mzolo Ph: 27 11 655 3140
Spain
  Madrid
 Merck Sharp and Dohme de Espana S.A.
 Cesar Sanz Rodriguez Ph: 34 913210600

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01254630
ClinicalTrials.gov processed this data on September 16, 2014

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.

Back to TopBack to Top