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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.
Arkansas
  Little Rock
 Call for Information (Investigational Site 0385)
California
  Bakersfield
 Call for Information (Investigational Site 0326)
  Berkeley
 Call for Information (Investigational Site 0015)
  Burbank
 Call for Information (Investigational Site 0324)
  Campbell
 Call for Information (Investigational Site 0312)
  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)
  Pleasant Hill
 Call for Information (Investigational Site 0381)
  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)
  Stanford
 Call for Information (Investigational Site 0341)
  Stockton
 Call for Information (Investigational Site 0242)
Colorado
  Aurora
 Call for Information (Investigational Site 0444)
  Englewood
 Call for Information (Investigational Site 0304)
Connecticut
  Torrington
 Call for Information (Investigational Site 0376)
Delaware
  Newark
 Call for Information (Investigational Site 0274)
District of Columbia
  Washington
 Call for Information (Investigational Site 0309)
 Call for Information (Investigational Site 0358)
 Call for Information (Investigational Site 0424)
Florida
  Jacksonville
 Call for Information (Investigational Site 0267)
  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 0268)
 Call for Information (Investigational Site 0278)
 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)
Georgia
  Dublin
 Call for Information (Investigational Site 0271)
Hawaii
  Honolulu
 Call for Information (Investigational Site 0235)
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)
  Peoria
 Call for Information (Investigational Site 0277)
  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)
 Call for Information (Investigational Site 0410)
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)
Louisiana
  Covington
 Call for Information (Investigational Site 0310)
  Metairie
 Call for Information (Investigational Site 0275)
Maryland
  Annapolis
 Call for Information (Investigational Site 0397)
  Baltimore
 Call for Information (Investigational Site 0247)
 Call for Information (Investigational Site 0302)
 Call for Information (Investigational Site 0318)
 Call for Information (Investigational Site 0400)
  Bethesda
 Call for Information (Investigational Site 0012)
  Frederick
 Call for Information (Investigational Site 0279)
Michigan
  Grand Rapids
 Call for Information (Investigational Site 0423)
  Lansing
 Call for Information (Investigational Site 0383)
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)
Montana
  Billings
 Call for Information (Investigational Site 0368)
  Great Falls
 Call for Information (Investigational Site 0378)
  Missoula
 Call for Information (Investigational Site 0349)
Nebraska
  Omaha
 Call for Information (Investigational Site 0256)
Nevada
  Las Vegas
 Call for Information (Investigational Site 0387)
New Hampshire
  Dover
 Call for Information (Investigational Site 0204)
New Jersey
  Camden
 Call for Information (Investigational Site 0448)
  Denville
 Call for Information (Investigational Site 0196)
  Somerville
 Call for Information (Investigational Site 0327)
New York
  Armonk
 Call for Information (Investigational Site 0451)
  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)
  Lake success
 Call for Information (Investigational Site 0234)
  Manhasset
 Call for Information (Investigational Site 0233)
  New York
 Call for Information (Investigational Site 0370)
  Rochester
 Call for Information (Investigational Site 0198)
  Stony Brook
 Call for Information (Investigational Site 0254)
North Carolina
  Asheville
 Call for Information (Investigational Site 0342)
  Charlotte
 Call for Information (Investigational Site 0014)
  Gastonia
 Call for Information (Investigational Site 0375)
  Winston-Salem
 Call for Information (Investigational Site 0315)
North Dakota
  Bismarck
 Call for Information (Investigational Site 0030)
 Call for Information (Investigational Site 0224)
 Call for Information (Investigational Site 0305)
  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)
  Columbus
 Call for Information (Investigational Site 0019)
  Toledo
 Call for Information (Investigational Site 0399)
Oregon
  Beaverton
 Call for Information (Investigational Site 0401)
Pennsylvania
  Bethlehem
 Call for Information (Investigational Site 0417)
  Philadelphia
 Call for Information (Investigational Site 0026)
 Call for Information (Investigational Site 0447)
  Sayre
 Call for Information (Investigational Site 0346)
  West Reading
 Call for Information (Investigational Site 0016)
  Willow Grove
 Call for Information (Investigational Site 0248)
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)
Tennessee
  Germantown
 Call for Information (Investigational Site 0405)
Texas
  Amarillo
 Call for Information (Investigational Site 0295)
  Austin
 Call for Information (Investigational Site 0404)
  Corpus Christi
 Call for Information (Investigational Site 0372)
 Call for Information (Investigational Site 0406)
  Dallas
 Call for Information (Investigational Site 0366)
  Galveston
 Call for Information (Investigational Site 0027)
  Houston
 Call for Information (Investigational Site 0255)
 Call for Information (Investigational Site 0355)
  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 0300)
 Call for Information (Investigational Site 0317)
  Temple
 Call for Information (Investigational Site 0034)
 Call for Information (Investigational Site 0343)
Utah
  Ogden
 Call for Information (Investigational Site 0239)
  Salt Lake City
 Call for Information (Investigational Site 0313)
Washington
  Everett
 Call for Information (Investigational Site 0440)
  Seattle
 Call for Information (Investigational Site 0013)
 Call for Information (Investigational Site 0347)
  Tacoma
 Call for Information (Investigational Site 0029)
  Wenatchee
 Call for Information (Investigational Site 0428)
West Virginia
  Morgantown
 Call for Information (Investigational Site 0270)
Wisconsin
  Green Bay
 Call for Information (Investigational Site 0122)
  La Crosse
 Call for Information (Investigational Site 0236)
  Madison
 Call for Information (Investigational Site 0311)
Argentina
  Buenos Aires
 Merck Sharp & Dohme (Argentina) Inc.
 Alfredo Wilkinson Ph: 54 11 4796 8200
Australia
  North Ryde
 Merck Sharp & Dohme
 Gary Jankelowitz Ph: 61 2 8988 8246
Austria
  Vienna
 MSD ýterreich GmbH
 Karl Boegl Ph: 43 126044130
Belgium
  Brussels
 MSD Belgium BVBA/SPRL
 Danny D'Hulster Ph: 32 23734310
Brazil
  Sao Paulo
 MSD Brasil
 Ricardo Germano Ph: 55 11 51897942
Canada
Quebec
  Kirkland
 Merck Canada
 Medical Information Centre / Centre de lýinformation medicale de Merck Canada Ph: 514-428-8600 / 1-800-567-2594
Chile
  Santiago
 Merck Sharp & Dohme (I.A.) Corp.
 Maria Elena Azara Hernandez Ph: 56 2 6558958
Colombia
  Bogota
 MDS Colombia SAS
 Francesca Carvajal Ph: 57 1219109011090
Croatia
  Zagreb
 Merck Sharp & Dohme d.o.o
 Andina Hrabar Ph: 385 14878400
Czech Republic
  Praha
 Merck Sharp and Dohme s.r.o.
 Simona Martinkova Ph: 420 233010213
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
Germany
  Haar
 Merck Sharp & Dohme GmbH
 German Medical Information Center Ph: 49 800 673 673 673
Greece
  Alimos
 Vianex, S.A. / MSD
 Platon Peristaris Ph: 30 2109897322
Honduras
  Tegucigalpa
 MSD CARD
 Soraya Cedraro Ph: 507-282-7200
Hong Kong
  Hong Kong
 Merck Sharp & Dohme (Asia) Ltd.
 Lai Hung Jen Ph: 886 2 2730 0030
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
Lithuania
  Vilnius
 UAB "Merck Sharp & Dohme"
 Andrius Bacevicius Ph: 370 52780243
Mexico
  Mexico City
 MSD
 Juan Marques Ph: 52 55254819608
New Zealand
  Wellington
 Merck Sharp & Dohme (New Zealand) Ltd.,
 Gary Jankelowitz Ph: 61 2 8988 8246
Panama
  Panama
 MSD CARD
 Soraya Cedraro Ph: 507-282-7200
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
  Carolina
 Merck Sharp & Dohme (I.A.) Corp.
 Felipe Arbelaez Ph: (787) 474-8200
Republic of Bulgaria
  Sofia
 Merck Sharp & Dohme Bulgaria EOOD
 Eran Gefen Ph: 38 (044) 393 74 80
Republic of Korea
  Seoul
 MSD Korea LTD
 Cem Ozesen Ph: 90 212 3361260
Republic of South Africa
  Midrand
 MSD (Pty) LTD South Africa
 Khanyi Mzolo Ph: 27 11 655 3140
Romania
  Bucharest
 Merck Sharp & Dohme Romania SRL
 Eran Gefen Ph: 38 (044) 393 74 80
Russia
  Moscow
 Merck Sharp & Dohme IDEA, Inc.
 Maria Koroleva Ph: 7 0959410000
Saudi Arabia
  Riyadh
 MSD (IA) Corp - SA Branch
 Samer El-Ali Ph: 04 4269100
Slovakia
  Bratislava
 Merck Sharp Dohme S.R.O.
 Eva Kaszasova Ph: 420 233010213
Spain
  Madrid
 Merck Sharp and Dohme de Espana S.A.
 Cesar Sanz Rodriguez Ph: 34 913210600
Thailand
  Bangkok
 MSD (Thailand) Ltd.
 Thanu Komolsai Ph: 66 2262 5746
Turkey
  Istanbul
 Merck Sharp & Dohme Ilaclari Ltd. Sti
 Alev Eren Ph: 90 212 336 12 63
United Kingdom
  Hoddesdon
 Merck Sharp & Dohme Ltd.
 Paul Robinson Ph: 44 1992452396

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01254630
ClinicalTrials.gov processed this data on March 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.

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