Trial record 3 of 8 for:    v212

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. (see Contacts and Locations)
Verified July 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: July 16, 2014
Last verified: July 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

  Hide Study Locations
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
Call for Information (Investigational Site 0015) Recruiting
Berkeley, California, United States, 94704
Call for Information (Investigational Site 0324) Recruiting
Burbank, California, United States, 91505
Call for Information (Investigational Site 0425) Recruiting
Corona, California, United States, 92879
Call for Information (Investigational Site 0380) Recruiting
Fair Oaks, California, United States, 95628
Call for Information (Investigational Site 0431) Recruiting
Fountain Valley, California, United States, 92708
Call for Information (Investigational Site 0430) Recruiting
Highland, California, United States, 92346
Call for Information (Investigational Site 0251) Recruiting
La Jolla, California, United States, 92093
Call for Information (Investigational Site 0121) Recruiting
Mission Hills, California, United States, 91345
Call for Information (Investigational Site 0252) Recruiting
Mission Hills, California, United States, 91345
Call for Information (Investigational Site 0433) Recruiting
Orange, California, United States, 92868
Call for Information (Investigational Site 0350) Recruiting
Rancho Mirage, California, United States, 92270
Call for Information (Investigational Site 0418) Recruiting
Riverside, California, United States, 92501
Call for Information (Investigational Site 0354) Recruiting
San Diego, California, United States, 92123
Call for Information (Investigational Site 0344) Recruiting
Santa Monica, California, United States, 90404
United States, Colorado
Call for Information (Investigational Site 0444) Recruiting
Aurora, Colorado, United States, 80012
Call for Information (Investigational Site 0304) Recruiting
Englewood, Colorado, United States, 80113
United States, Delaware
Call for Information (Investigational Site 0274) Recruiting
Newark, Delaware, United States, 19713
United States, District of Columbia
Call for Information (Investigational Site 0309) Recruiting
Washington, District of Columbia, United States, 20422
United States, Florida
Call for Information (Investigational Site 0384) Recruiting
Lakeland, Florida, United States, 33805
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Miami, Florida, United States, 33135
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Miami, Florida, United States, 33175
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Miami, Florida, United States, 33135
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Miami, Florida, United States, 33169
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Miami, Florida, United States, 33142
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Orlando, Florida, United States, 32806
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Port St. Lucie, Florida, United States, 34952
Call for Information (Investigational Site 0339) Recruiting
Stuart, Florida, United States, 34994
United States, Illinois
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Chicago, Illinois, United States, 60637
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Chicago, Illinois, United States, 60612
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Chicago, Illinois, United States, 60608
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Decatur, Illinois, United States, 62526
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Joliet, Illinois, United States, 60436
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Rockford, Illinois, United States, 61108
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Skokie, Illinois, United States, 60077
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Skokie, Illinois, United States, 60076
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Urbana, Illinois, United States, 61801-1645
United States, Indiana
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Anderson, Indiana, United States, 46011
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Avon, Indiana, United States, 46123
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Evansville, Indiana, United States, 47713
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Indianapolis, Indiana, United States, 46237
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Kokomo, Indiana, United States, 46902
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New Albany, Indiana, United States, 47150
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Cedar Rapids, Iowa, United States, 52403
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Cedar Rapids, Iowa, United States, 52403
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Des Moines, Iowa, United States, 50309
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Waterloo, Iowa, United States, 50701
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Wichita, Kansas, United States, 67214
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Paducah, Kentucky, United States, 42003
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Baltimore, Maryland, United States, 21237
United States, Michigan
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Grand Rapids, Michigan, United States, 49503
United States, Minnesota
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Duluth, Minnesota, United States, 55802
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Minneapolis, Minnesota, United States, 55417
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St. Cloud, Minnesota, United States, 56303
United States, Missouri
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Saint Louis, Missouri, United States, 63110
United States, Montana
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Billings, Montana, United States, 59101
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Great Falls, Montana, United States, 59405
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Missoula, Montana, United States, 59802
United States, Nebraska
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Omaha, Nebraska, United States, 68124
United States, Nevada
Call for Information (Investigational Site 0387) Recruiting
Las Vegas, Nevada, United States, 89169
United States, New Jersey
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Somerville, New Jersey, United States, 08876
United States, New York
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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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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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Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
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Fargo, North Dakota, United States, 58122
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Fargo, North Dakota, United States, 58103
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Akron, Ohio, United States, 44304
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Canton, Ohio, United States, 44710
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Bethlehem, Pennsylvania, United States, 18015
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Philadelphia, Pennsylvania, United States, 19104
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Philadelphia, Pennsylvania, United States, 19102
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West Reading, Pennsylvania, United States, 19611
United States, South Carolina
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Charleston, South Carolina, United States, 29406
United States, South Dakota
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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, Texas
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Amarillo, Texas, United States, 79106
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Austin, Texas, United States, 78701
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Corpus Christi, Texas, United States, 78404
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Corpus Christi, Texas, United States, 78412
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Dallas, Texas, United States, 75390
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Galveston, Texas, United States, 77555
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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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Temple, Texas, United States, 76504
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Temple, Texas, United States, 76508
United States, Utah
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Ogden, Utah, United States, 84403
Call for Information (Investigational Site 0313) Recruiting
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 0013) Recruiting
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, Wisconsin
Call for Information (Investigational Site 0122) Recruiting
Green Bay, Wisconsin, United States, 54303
Call for Information (Investigational Site 0236) Recruiting
La Crosse, Wisconsin, United States, 54601
Call for Information (Investigational Site 0311) Recruiting
Madison, Wisconsin, United States, 53705
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      
Colombia
MDS Colombia SAS Recruiting
Bogota, Colombia
Contact: Francesca Carvajal    57 1219109011090      
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      
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      
Lebanon
MSD Idea, Inc. - LB BR Recruiting
Beirut, Lebanon
Contact: Amal Chalfoun    961 4542590      
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
Call for Information (Investigational Site 0098) Recruiting
San Juan, Puerto Rico, 00927
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      
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: July 16, 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 July 20, 2014