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)

This study is currently recruiting participants.
Verified March 2014 by Merck Sharp & Dohme Corp.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01254630
First received: December 3, 2010
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Herpes Zoster
Biological: V212
Biological: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • The number of HZ cases per 1000 person-years of follow-up [ Time Frame: From study enrollment up to approximately 5 years ] [ Designated as safety issue: No ]
  • The number of participants experiencing serious adverse events [ Time Frame: From vaccination day 1 through 28 days post vaccination dose 4 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The number of HZ cases per 1000 person-years of follow-up in the STM population [ Time Frame: From study enrollment up to approximately 5 years ] [ Designated as safety issue: No ]
  • The number of HZ cases per 1000 person-years of follow-up in the HM population [ Time Frame: From study enrollment up to approximately 5 years ] [ Designated as safety issue: No ]
  • Incidence of moderate to severe HZ-associated pain [ Time Frame: From HZ onset through the end of the 6 month HZ-follow-up period ] [ Designated as safety issue: No ]
    Moderate to severe HZ-associated pain is defined as 2 or more occurrences of a score of 3 or greater (0 to 10 scale) on the Zoster Brief Pain Inventory (ZBPI)

  • Incidence of HZ complications [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
    HZ complications defined as the occurrence of any of the following during the study: hospitalization or prolongation of hospitalization due to HZ, disseminated HZ (including disseminated HZ rash or VZV viremia), visceral HZ, ophthalmic HZ, neurological impairment due to HZ, or administration of intravenous acyclovir therapy for treatment of HZ.

  • Incidence of postherpetic neuralgia (PHN) [ Time Frame: From HZ onset through the end of the 6 month HZ-follow-up period ] [ Designated as safety issue: No ]
    Postherpetic neuralgia (PHN) is defined as a worst pain score (in the last 24 hours) of 3 or greater (0 to 10 scale) on the Zoster Brief Pain Inventory (ZBPI) that persists or appears >= 90 days after the onset of the HZ rash.


Estimated Enrollment: 5264
Study Start Date: June 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: V212 Arm
0.5 mL subcutaneous (SC) injection per dose, in a four dose regimen.
Biological: V212
V212 viral antigen for HZ, 0.5 mL SC injection per dose, in a four dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.
Other Name: Inactivated Varicella-Zoster (VZV) vaccine
Placebo Comparator: Placebo Arm
0.5 mL SC injection per dose, in a four dose regimen.
Biological: Placebo
Vaccine stabilizer for V212 with no virus antigen, 0.5 mL SC injection per dose, in a four dose regimen, approximately 30 days apart, preferably in the deltoid area of the arm, alternating arms for each dose.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01254630

Contacts
Contact: Toll Free Number 1-888-577-8839

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Locations
United States, Arkansas
Call for Information (Investigational Site 0385) Recruiting
Little Rock, Arkansas, United States, 72205
United States, California
Call for Information (Investigational Site 0326) Recruiting
Bakersfield, California, United States, 93309
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Berkeley, California, United States, 94704
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Burbank, California, United States, 91505
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Campbell, California, United States, 95008
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Corona, California, United States, 92879
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Fair Oaks, California, United States, 95628
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Fountain Valley, California, United States, 92708
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Highland, California, United States, 92346
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La Jolla, California, United States, 92093
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Mission Hills, California, United States, 91345
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Mission Hills, California, United States, 91345
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Orange, California, United States, 92868
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Pleasant Hill, California, United States, 94523
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Rancho Mirage, California, United States, 92270
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Riverside, California, United States, 92501
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San Diego, California, United States, 92123
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Santa Monica, California, United States, 90404
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Stanford, California, United States, 94305
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Stockton, California, United States, 95204
United States, Colorado
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Aurora, Colorado, United States, 80012
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Englewood, Colorado, United States, 80113
United States, Connecticut
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Torrington, Connecticut, United States, 06790
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Newark, Delaware, United States, 19713
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Joliet, Illinois, United States, 60436
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Cedar Rapids, Iowa, United States, 52403
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Cedar Rapids, Iowa, United States, 52403
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Covington, Louisiana, United States, 70433
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Metairie, Louisiana, United States, 70006
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Baltimore, Maryland, United States, 21237
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Minneapolis, Minnesota, United States, 55417
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Las Vegas, Nevada, United States, 89169
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Camden, New Jersey, United States, 08103
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Denville, New Jersey, United States, 07834
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Armonk, New York, United States, 10504
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Bronx, New York, United States, 10461
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Commack, New York, United States, 11725
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East Syracuse, New York, United States, 13057
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Great Neck, New York, United States, 11021
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Lake success, New York, United States, 11042
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Lake Success, New York, United States, 11042
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Manhasset, New York, United States, 11030
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New York, New York, United States, 10019
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Rochester, New York, United States, 14642
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Stony Brook, New York, United States, 11794
United States, North Carolina
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Asheville, North Carolina, United States, 28801
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Charlotte, North Carolina, United States, 28203
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Gastonia, North Carolina, United States, 28054
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Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
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Bismarck, North Dakota, United States, 58501
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Bismarck, North Dakota, United States, 58503
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Bismarck, North Dakota, United States, 58501
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Fargo, North Dakota, United States, 58103
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Fargo, North Dakota, United States, 58122
United States, Ohio
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Akron, Ohio, United States, 44304
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Akron, Ohio, United States, 44302
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Canton, Ohio, United States, 44710
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Columbus, Ohio, United States, 43219
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Toledo, Ohio, United States, 43623
United States, Oregon
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Beaverton, Oregon, United States, 97006
United States, Pennsylvania
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Bethlehem, Pennsylvania, United States, 18015
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Philadelphia, Pennsylvania, United States, 19102
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Philadelphia, Pennsylvania, United States, 19104
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Sayre, Pennsylvania, United States, 18840
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West Reading, Pennsylvania, United States, 19611
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Willow Grove, Pennsylvania, United States, 19090
United States, South Carolina
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Charleston, South Carolina, United States, 29406
United States, South Dakota
Call for Information (Investigational Site 0241) Recruiting
Rapid City, South Dakota, United States, 57701
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Sioux Falls, South Dakota, United States, 57104
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Watertown, South Dakota, United States, 57201
United States, Tennessee
Call for Information (Investigational Site 0405) Recruiting
Germantown, Tennessee, United States, 38138
United States, Texas
Call for Information (Investigational Site 0295) Recruiting
Amarillo, Texas, United States, 79106
Call for Information (Investigational Site 0404) Recruiting
Austin, Texas, United States, 78701
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Corpus Christi, Texas, United States, 78412
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Corpus Christi, Texas, United States, 78404
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Dallas, Texas, United States, 75390
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Galveston, Texas, United States, 77555
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Houston, Texas, United States, 77055
Call for Information (Investigational Site 0355) Recruiting
Houston, Texas, United States, 77024
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Killeen, Texas, United States, 76549
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New Braunfels, Texas, United States, 78130
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Round Rock, Texas, United States, 78665
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San Antonio, Texas, United States, 78229
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San Antonio, Texas, United States, 78229
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Temple, Texas, United States, 76508
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Temple, Texas, United States, 76504
United States, Utah
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Ogden, Utah, United States, 84403
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Salt Lake City, Utah, United States, 84106
United States, Washington
Call for Information (Investigational Site 0440) Recruiting
Everett, Washington, United States, 98201
Call for Information (Investigational Site 0347) Recruiting
Seattle, Washington, United States, 98104
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Seattle, Washington, United States, 98109
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Tacoma, Washington, United States, 98405
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Wenatchee, Washington, United States, 98801
United States, West Virginia
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Morgantown, West Virginia, United States, 26506
United States, Wisconsin
Call for Information (Investigational Site 0122) Recruiting
Green Bay, Wisconsin, United States, 54303
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La Crosse, Wisconsin, United States, 54601
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Madison, Wisconsin, United States, 53705
Argentina
Merck Sharp & Dohme (Argentina) Inc. Recruiting
Buenos Aires, Argentina
Contact: Alfredo Wilkinson    54 11 4796 8200      
Australia
Merck Sharp & Dohme Recruiting
North Ryde, Australia
Contact: Gary Jankelowitz    61 2 8988 8246      
Austria
MSD ýterreich GmbH Recruiting
Vienna, Austria
Contact: Karl Boegl    43 126044130      
Belgium
MSD Belgium BVBA/SPRL Recruiting
Brussels, Belgium
Contact: Danny D'Hulster    32 23734310      
Brazil
MSD Brasil Recruiting
Sao Paulo, Brazil
Contact: Ricardo Germano    55 11 51897942      
Bulgaria
Merck Sharp & Dohme Bulgaria EOOD Recruiting
Sofia, Bulgaria
Contact: Eran Gefen    38 (044) 393 74 80      
Canada, Quebec
Merck Canada Recruiting
Kirkland, Quebec, Canada, H9H 3L1
Contact: Medical Information Centre / Centre de lýinformation medicale de Merck Canada    514-428-8600 / 1-800-567-2594      
Chile
Merck Sharp & Dohme (I.A.) Corp. Recruiting
Santiago, Chile
Contact: Maria Elena Azara Hernandez    56 2 6558958      
Colombia
MDS Colombia SAS Recruiting
Bogota, Colombia
Contact: Francesca Carvajal    57 1219109011090      
Croatia
Merck Sharp & Dohme d.o.o Recruiting
Zagreb, Croatia
Contact: Andina Hrabar    385 14878400      
Czech Republic
Merck Sharp and Dohme s.r.o. Recruiting
Praha, Czech Republic
Contact: Simona Martinkova    420 233010213      
Ecuador
MSD Ecuador Recruiting
Quito, Ecuador
Contact: Jaime Burbano    593 2 2941-700      
Estonia
Merck Sharp & Dohme OU Recruiting
Tallinn, Estonia
Contact: Andrius Bacevicius    370 52780243      
France
MSD France Recruiting
Paris, France
Contact: Dominique Blazy    33 147548990      
Germany
Merck Sharp & Dohme GmbH Recruiting
Haar, Germany
Contact: German Medical Information Center    49 800 673 673 673      
Greece
Vianex, S.A. / MSD Recruiting
Alimos, Greece
Contact: Platon Peristaris    30 2109897322      
Honduras
MSD CARD Recruiting
Tegucigalpa, Honduras
Contact: Soraya Cedraro    507-282-7200      
Hong Kong
Merck Sharp & Dohme (Asia) Ltd. Recruiting
Hong Kong, Hong Kong
Contact: Lai Hung Jen    886 2 2730 0030      
Italy
MSD Italia S.r.l. Recruiting
Rome, Italy
Contact: Patrizia Nardini    39 06 361911      
Jordan
MSD Idea, Inc. - LB BR Recruiting
Amman, Jordan
Contact: Amal Chalfoun    961 4542590      
Korea, Republic of
MSD Korea LTD Recruiting
Seoul, Korea, Republic of
Contact: Cem Ozesen    90 212 3361260      
Lebanon
MSD Idea, Inc. - LB BR Recruiting
Beirut, Lebanon
Contact: Amal Chalfoun    961 4542590      
Lithuania
UAB "Merck Sharp & Dohme" Recruiting
Vilnius, Lithuania
Contact: Andrius Bacevicius    370 52780243      
Mexico
MSD Recruiting
Mexico City, Mexico
Contact: Juan Marques    52 55254819608      
New Zealand
Merck Sharp & Dohme (New Zealand) Ltd., Recruiting
Wellington, New Zealand
Contact: Gary Jankelowitz    61 2 8988 8246      
Panama
MSD CARD Recruiting
Panama, Panama
Contact: Soraya Cedraro    507-282-7200      
Peru
Merck Sharp & Dohme, Peru S.R.L. Recruiting
Lima, Peru
Contact: Oscar Espinoza    (51-1) 411-5100      
Philippines
Merck Sharp & Dohme (I.A.) Corporation Recruiting
Makati, Philippines
Contact: Cesar Recto    632 784 9500      
Puerto Rico
Merck Sharp & Dohme (I.A.) Corp. Recruiting
Carolina, Puerto Rico
Contact: Felipe Arbelaez    (787) 474-8200      
Romania
Merck Sharp & Dohme Romania SRL Recruiting
Bucharest, Romania
Contact: Eran Gefen    38 (044) 393 74 80      
Russian Federation
Merck Sharp & Dohme IDEA, Inc. Recruiting
Moscow, Russian Federation
Contact: Maria Koroleva    7 0959410000      
Saudi Arabia
MSD (IA) Corp - SA Branch Recruiting
Riyadh, Saudi Arabia
Contact: Samer El-Ali    04 4269100      
Slovakia
Merck Sharp Dohme S.R.O. Recruiting
Bratislava, Slovakia
Contact: Eva Kaszasova    420 233010213      
South Africa
MSD (Pty) LTD South Africa Recruiting
Midrand, South Africa
Contact: Khanyi Mzolo    27 11 655 3140      
Spain
Merck Sharp and Dohme de Espana S.A. Recruiting
Madrid, Spain
Contact: Cesar Sanz Rodriguez    34 913210600      
Thailand
MSD (Thailand) Ltd. Recruiting
Bangkok, Thailand
Contact: Thanu Komolsai    66 2262 5746      
Turkey
Merck Sharp & Dohme Ilaclari Ltd. Sti Recruiting
Istanbul, Turkey
Contact: Alev Eren    90 212 336 12 63      
United Kingdom
Merck Sharp & Dohme Ltd. Recruiting
Hoddesdon, United Kingdom
Contact: Paul Robinson    44 1992452396      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01254630     History of Changes
Other Study ID Numbers: V212-011, CTRI/2012/05/002673
Study First Received: December 3, 2010
Last Updated: March 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Herpes zoster
vaccine
solid tumor malignancy
hematologic malignancy
immunocompromised
herpes-zoster-related complications

Additional relevant MeSH terms:
Neoplasms
Herpes Zoster
Hematologic Neoplasms
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Neoplasms by Site
Hematologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014