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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Herpes Zoster

Thank you

Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The number of HZ cases per 1000 person-years of follow-up

Outcome Time Frame:

From study enrollment up to approximately 5 years

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

V212-011

NCT ID:

NCT01254630

Start Date:

June 2011

Completion Date:

June 2016

Related Keywords:

  • Herpes Zoster
  • Herpes zoster
  • vaccine
  • solid tumor malignancy
  • hematologic malignancy
  • immunocompromised
  • herpes-zoster-related complications
  • Neoplasms
  • Herpes Zoster
  • Hematologic Neoplasms

Name

Location

Call for Information (Investigational Site 0385)Little Rock, Arkansas  72205
Call for Information (Investigational Site 0326)Bakersfield, California  93309
Call for Information (Investigational Site 0015)Berkeley, California  94704
Call for Information (Investigational Site 0324)Burbank, California  91505
Call for Information (Investigational Site 0312)Campbell, California  95008
Call for Information (Investigational Site 0380)Fair Oaks, California  95628
Call for Information (Investigational Site 0430)Highland, California  92346
Call for Information (Investigational Site 0251)La Jolla, California  92093
Call for Information (Investigational Site 0121)Mission Hills, California  91345
Call for Information (Investigational Site 0381)Pleasant Hill, California  94522
Call for Information (Investigational Site 0350)Rancho Mirage, California  92270
Call for Information (Investigational Site 0341)Stanford, California  94305
Call for Information (Investigational Site 0242)Stockton, California  95204
Call for Information (Investigational Site 0304)Englewood, Colorado  80113
Call for Information (Investigational Site 0376)Torrington, Connecticut  06790
Call for Information (Investigational Site 0274)Newark, Delaware  19713
Call for Information (Investigational Site 0358)Washington, District of Columbia  20007
Call for Information (Investigational Site 0309)Washington, District of Columbia  20422
Call for Information (Investigational Site 0424)Washington, District of Columbia  20010
Call for Information (Investigational Site 0266)Boynton Beach, Florida  33435
Call for Information (Investigational Site 0340)Coral Gables, Florida  33134
Call for Information (Investigational Site 0020)Hialeah, Florida  33012
Call for Information (Investigational Site 0278)Hialeah, Florida  33016
Call for Information (Investigational Site 0267)Jacksonville, Florida  32204
Call for Information (Investigational Site 0384)Lakeland, Florida  33805
Call for Information (Investigational Site 0268)Miami, Florida  33144
Call for Information (Investigational Site 0284)Miami, Florida  33145
Call for Information (Investigational Site 0028)Miami, Florida  33135
Call for Information (Investigational Site 0365)Miami, Florida  33144
Call for Information (Investigational Site 0243)Miami, Florida  33175
Call for Information (Investigational Site 0419)Orlando, Florida  32806
Call for Information (Investigational Site 0339)Stuart, Florida  34994
Call for Information (Investigational Site 0437)Atlanta, Georgia  30318
Call for Information (Investigational Site 0271)Dublin, Georgia  31021
Call for Information (Investigational Site 0235)Honolulu, Hawaii  96814
Call for Information (Investigational Site 0285)Decatur, Illinois  62526
Call for Information (Investigational Site 0407)Joliet, Illinois  60436
Call for Information (Investigational Site 0273)Maywood, Illinois  60153
Call for Information (Investigational Site 0018)Niles, Illinois  60714
Call for Information (Investigational Site 0277)Peoria, Illinois  61615
Call for Information (Investigational Site 0303)Skokie, Illinois  60076
Call for Information (Investigational Site 0386)Skokie, Illinois  60077
Call for Information (Investigational Site 0205)Urbana, Illinois  61801-1645
Call for Information (Investigational Site 0025)Anderson, Indiana  46011
Call for Information (Investigational Site 0257)Avon, Indiana  46123
Call for Information (Investigational Site 0011)Evansville, Indiana  47713
Call for Information (Investigational Site 0427)Indianapolis, Indiana  46237
Call for Information (Investigational Site 0396)New Albany, Indiana  47150
Call for Information (Investigational Site 0249)Ames, Iowa  50010
Call for Information (Investigational Site 0286)Cedar Rapids, Iowa  52402
Call for Information (Investigational Site 0197)Des Moines, Iowa  50309
Call for Information (Investigational Site 0382)Waterloo, Iowa  50701
Call for Information (Investigational Site 0199)Wichita, Kansas  67214
Call for Information (Investigational Site 0269)Paducah, Kentucky  42001
Call for Information (Investigational Site 0283)Paducah, Kentucky  42003
Call for Information (Investigational Site 0310)Covington, Louisiana  70433
Call for Information (Investigational Site 0275)Metairie, Louisiana  70006
Call for Information (Investigational Site 0200)New Orleans, Louisiana  70121
Call for Information (Investigational Site 0293)Lewiston, Maine  04240
Call for Information (Investigational Site 0397)Annapolis, Maryland  21401
Call for Information (Investigational Site 0247)Baltimore, Maryland  21237
Call for Information (Investigational Site 0302)Baltimore, Maryland  21287-3923
Call for Information (Investigational Site 0318)Baltimore, Maryland  21218
Call for Information (Investigational Site 0400)Baltimore, Maryland  21225
Call for Information (Investigational Site 0012)Bethesda, Maryland  20817
Call for Information (Investigational Site 0279)Frederick, Maryland  21701
Call for Information (Investigational Site 0229)Detroit, Michigan  48201
Call for Information (Investigational Site 0282)Duluth, Minnesota  55802
Call for Information (Investigational Site 0202)St. Cloud, Minnesota  56303
Call for Information (Investigational Site 0150)Saint Louis, Missouri  63110
Call for Information (Investigational Site 0294)Saint Louis, Missouri  63117
Call for Information (Investigational Site 0368)Billings, Montana  59101
Call for Information (Investigational Site 0378)Great Falls, Montana  59405
Call for Information (Investigational Site 0349)Missoula, Montana  59802
Call for Information (Investigational Site 0256)Omaha, Nebraska  68124
Call for Information (Investigational Site 0387)Las Vegas, Nevada  89169
Call for Information (Investigational Site 0204)Dover, New Hampshire  03820
Call for Information (Investigational Site 0196)Denville, New Jersey  07834
Call for Information (Investigational Site 0327)Somerville, New Jersey  08876
Call for Information (Investigational Site 0263)Commack, New York  11725
Call for Information (Investigational Site 0033)East Syracuse, New York  13057
Call for Information (Investigational Site 0258)Great Neck, New York  11021
Call for Information (Investigational Site 0234)Great Neck, New York  11021
Call for Information (Investigational Site 0230)Lake Success, New York  11042
Call for Information (Investigational Site 0408)New York, New York  10025
Call for Information (Investigational Site 0409)New York, New York  10019
Call for Information (Investigational Site 0198)Rochester, New York  14642
Call for Information (Investigational Site 0014)Charlotte, North Carolina  28203
Call for Information (Investigational Site 0375)Gastonia, North Carolina  28054
Call for Information (Investigational Site 0315)Winston-Salem, North Carolina  27157
Call for Information (Investigational Site 0030)Bismarck, North Dakota  58501
Call for Information (Investigational Site 0224)Bismarck, North Dakota  58503
Call for Information (Investigational Site 0305)Bismarck, North Dakota  58501
Call for Information (Investigational Site 0301)Fargo, North Dakota  58103
Call for Information (Investigational Site 0323)Akron, Ohio  44304
Call for Information (Investigational Site 0250)Akron, Ohio  44302
Call for Information (Investigational Site 0422)Canton, Ohio  44710
Call for Information (Investigational Site 0019)Columbus, Ohio  43219
Call for Information (Investigational Site 0399)Toledo, Ohio  43623
Call for Information (Investigational Site 0325)Oklahoma City, Oklahoma  73104
Call for Information (Investigational Site 0401)Beaverton, Oregon  97006
Call for Information (Investigational Site 0417)Bethlehem, Pennsylvania  18015
Call for Information (Investigational Site 0026)Philadelphia, Pennsylvania  19104
Call for Information (Investigational Site 0346)Sayre, Pennsylvania  18840
Call for Information (Investigational Site 0016)West Reading, Pennsylvania  19611
Call for Information (Investigational Site 0248)Willow Grove, Pennsylvania  19090
Call for Information (Investigational Site 0316)Charleston, South Carolina  29406
Call for Information (Investigational Site 0241)Rapid City, South Dakota  57701
Call for Information (Investigational Site 0151)Sioux Falls, South Dakota  57104
Call for Information (Investigational Site 0225)Watertown, South Dakota  57201
Call for Information (Investigational Site 0405)Germantown, Tennessee  38138
Call for Information (Investigational Site 0295)Amarillo, Texas  79106
Call for Information (Investigational Site 0404)Austin, Texas  78701
Call for Information (Investigational Site 0372)Corpus Christi, Texas  78404
Call for Information (Investigational Site 0406)Corpus Christi, Texas  78412
Call for Information (Investigational Site 0366)Dallas, Texas  75390
Call for Information (Investigational Site 0027)Galveston, Texas  77555
Call for Information (Investigational Site 0355)Houston, Texas  77024
Call for Information (Investigational Site 0314)Killeen, Texas  76549
Call for Information (Investigational Site 0272)Lubbock, Texas  79410
Call for Information (Investigational Site 0441)New Braunfels, Texas  78130
Call for Information (Investigational Site 0245)Round Rock, Texas  78665
Call for Information (Investigational Site 0317)San Antonio, Texas  78229
Call for Information (Investigational Site 0300)San Antonio, Texas  78229
Call for Information (Investigational Site 0343)Temple, Texas  76504
Call for Information (Investigational Site 0034)Temple, Texas  76508
Call for Information (Investigational Site 0239)Ogden, Utah  84403
Call for Information (Investigational Site 0313)Salt Lake City, Utah  84106
Call for Information (Investigational Site 0347)Seattle, Washington  98104
Call for Information (Investigational Site 0029)Tacoma, Washington  98405
Call for Information (Investigational Site 0428)Wenatchee, Washington  98801
Call for Information (Investigational Site 0270)Morgantown, West Virginia  26506
Call for Information (Investigational Site 0122)Green Bay, Wisconsin  54303
Call for Information (Investigational Site 0236)La Crosse, Wisconsin  54601
Call for Information (Investigational Site 0311)Madison, Wisconsin  53705
Call for Information (Investigational Site 0425)Corona, California  92879
Call for Information (Investigational Site 0252)Mission Hills, California  91345
Call for Information (Investigational Site 0433)Orange, California  92868
Call for Information (Investigational Site 0418)Riverside, California  92501
Call for Information (Investigational Site 0444)Aurora, Colorado  80012
Call for Information (Investigational Site 0259)Port St. Lucie, Florida  34952
Call for Information (Investigational Site 0454)Chicago, Illinois  60608
Call for Information (Investigational Site 0023)Chicago, Illinois  60637
Call for Information (Investigational Site 0024)Chicago, Illinois  60612
Call for Information (Investigational Site 0443)Rockford, Illinois  61108
Call for Information (Investigational Site 0442)Kokomo, Indiana  46902
Call for Information (Investigational Site 0360)Cedar Rapids, Iowa  52403
Call for Information (Investigational Site 0423)Grand Rapids, Michigan  49503
Call for Information (Investigational Site 0383)Lansing, Michigan  48912
Call for Information (Investigational Site 0022)Minneapolis, Minnesota  55417
Call for Information (Investigational Site 0448)Camden, New Jersey  08103
Call for Information (Investigational Site 0451)Armonk, New York  10504
Call for Information (Investigational Site 0201)Bronx, New York  10461
Call for Information (Investigational Site 0233)Manhasset, New York  11030
Call for Information (Investigational Site 0370)New York, New York  10019
Call for Information (Investigational Site 0432)Wilmington, North Carolina  28401
Call for Information (Investigational Site 0153)Fargo, North Dakota  58122
Call for Information (Investigational Site 0021)Philadelphia, Pennsylvania  19107
Call for Information (Investigational Site 0447)Philadelphia, Pennsylvania  19102
Call for Information (Investigational Site 0255)Houston, Texas  77055