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)



Status:Recruiting
Conditions:Shingles, Infectious Disease
Therapuetic Areas:Dermatology / Plastic Surgery, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/16/2015
Start Date:June 2011
End Date:June 2016
Contact:Toll Free Number
Phone:1-888-577-8839

Use our guide to learn which trials are right for you!

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

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.


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.
We found this trial at
78
sites
2373
mi
from 98109
Philadelphia, PA
Click here to add this to my saved trials
2041
mi
from 98109
Akron, OH
Click here to add this to my saved trials
2041
mi
from 98109
Akron, OH
Click here to add this to my saved trials
1450
mi
from 98109
Ames, IA
Click here to add this to my saved trials
1879
mi
from 98109
Anderson, IN
Click here to add this to my saved trials
?
mi
from 98109
Armonk, NY
Click here to add this to my saved trials
2187
mi
from 98109
Asheville, NC
Click here to add this to my saved trials
1026
mi
from 98109
Aurora, CO
Click here to add this to my saved trials
1775
mi
from 98109
Austin, TX
Click here to add this to my saved trials
1857
mi
from 98109
Avon, IN
Click here to add this to my saved trials
2316
mi
from 98109
Bethesda, MD
Click here to add this to my saved trials
2341
mi
from 98109
Bethlehem, PA
Click here to add this to my saved trials
2402
mi
from 98109
Bronx, NY
Click here to add this to my saved trials
953
mi
from 98109
Burbank, CA
Click here to add this to my saved trials
2052
mi
from 98109
Canton, OH
Click here to add this to my saved trials
1542
mi
from 98109
Cedar Rapids, IA
Click here to add this to my saved trials
1542
mi
from 98109
Cedar Rapids, IA
Click here to add this to my saved trials
Charleston, South Carolina 29412
2424
mi
from 98109
Charleston, SC
Click here to add this to my saved trials
1733
mi
from 98109
Chicago, IL
Click here to add this to my saved trials
1733
mi
from 98109
Chicago, IL
Click here to add this to my saved trials
1733
mi
from 98109
Chicago, IL
Click here to add this to my saved trials
982
mi
from 98109
Corona, CA
Click here to add this to my saved trials
1916
mi
from 98109
Corpus Christi, TX
Click here to add this to my saved trials
1682
mi
from 98109
Dallas, TX
Click here to add this to my saved trials
1463
mi
from 98109
Des Moines, IA
Click here to add this to my saved trials
1411
mi
from 98109
Duluth, MN
Click here to add this to my saved trials
1024
mi
from 98109
Englewood, CO
Click here to add this to my saved trials
623
mi
from 98109
Fair Oaks, CA
Click here to add this to my saved trials
1172
mi
from 98109
Fargo, ND
Click here to add this to my saved trials
1172
mi
from 98109
Fargo, ND
Click here to add this to my saved trials
Fountain Valley, California 92708
988
mi
from 98109
Fountain Valley, CA
Click here to add this to my saved trials
1937
mi
from 98109
Galveston, TX
Click here to add this to my saved trials
2412
mi
from 98109
Great Neck, NY
Click here to add this to my saved trials
970
mi
from 98109
Highland, CA
Click here to add this to my saved trials
1890
mi
from 98109
Houston, TX
Click here to add this to my saved trials
1867
mi
from 98109
Indianapolis, IN
Click here to add this to my saved trials
1720
mi
from 98109
Joliet, IL
Click here to add this to my saved trials
1727
mi
from 98109
Killeen, TX
Click here to add this to my saved trials
1846
mi
from 98109
Kokomo, IN
Click here to add this to my saved trials
1512
mi
from 98109
La Crosse, WI
Click here to add this to my saved trials
1049
mi
from 98109
La Jolla, CA
Click here to add this to my saved trials
2414
mi
from 98109
Lake Success, NY
Click here to add this to my saved trials
1346
mi
from 98109
Lincoln, NE
Click here to add this to my saved trials
1616
mi
from 98109
Madison, WI
Click here to add this to my saved trials
2413
mi
from 98109
Manhasset, NY
Click here to add this to my saved trials
2730
mi
from 98109
Miami, FL
Click here to add this to my saved trials
2730
mi
from 98109
Miami, FL
Click here to add this to my saved trials
2730
mi
from 98109
Miami, FL
Click here to add this to my saved trials
2730
mi
from 98109
Miami, FL
Click here to add this to my saved trials
1393
mi
from 98109
Minneapolis, MN
Click here to add this to my saved trials
Mission Hills, California 91345
945
mi
from 98109
Mission Hills, CA
Click here to add this to my saved trials
Mission Hills, California 91345
945
mi
from 98109
Mission Hills, CA
Click here to add this to my saved trials
1786
mi
from 98109
New Braunfels, TX
Click here to add this to my saved trials
2099
mi
from 98109
New Orleans, LA
Click here to add this to my saved trials
984
mi
from 98109
Orange, CA
Click here to add this to my saved trials
2544
mi
from 98109
Orlando, FL
Click here to add this to my saved trials
1678
mi
from 98109
Peoria, IL
Click here to add this to my saved trials
Rancho Mirage, California 90070
979
mi
from 98109
Rancho Mirage, CA
Click here to add this to my saved trials
949
mi
from 98109
Rapid City, SD
Click here to add this to my saved trials
980
mi
from 98109
Riverside, CA
Click here to add this to my saved trials
1656
mi
from 98109
Rockford, IL
Click here to add this to my saved trials
1758
mi
from 98109
Round Rock, TX
Click here to add this to my saved trials
701
mi
from 98109
Salt Lake City, UT
Click here to add this to my saved trials
1790
mi
from 98109
San Antonio, TX
Click here to add this to my saved trials
1065
mi
from 98109
San Diego, CA
Click here to add this to my saved trials
1263
mi
from 98109
Sioux Falls, SD
Click here to add this to my saved trials
1723
mi
from 98109
Skokie, IL
Click here to add this to my saved trials
1723
mi
from 98109
Skokie, IL
Click here to add this to my saved trials
2378
mi
from 98109
Somerville, NJ
Click here to add this to my saved trials
1336
mi
from 98109
St. Cloud, MN
Click here to add this to my saved trials
1743
mi
from 98109
Temple, TX
Click here to add this to my saved trials
1743
mi
from 98109
Temple, TX
Click here to add this to my saved trials
2322
mi
from 98109
Washington,
Click here to add this to my saved trials
1496
mi
from 98109
Waterloo, IA
Click here to add this to my saved trials
1214
mi
from 98109
Watertown, SD
Click here to add this to my saved trials
West Reading, Pennsylvania 19611
2324
mi
from 98109
West Reading, PA
Click here to add this to my saved trials
1435
mi
from 98109
Wichita, KS
Click here to add this to my saved trials
2275
mi
from 98109
Winston-Salem, NC
Click here to add this to my saved trials