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
?
mi
from
Round Rock, TX
Click here to add this to my saved trials
?
mi
from
Akron, OH
Click here to add this to my saved trials
?
mi
from
Akron, OH
Click here to add this to my saved trials
?
mi
from
Ames, IA
Click here to add this to my saved trials
?
mi
from
Anderson, IN
Click here to add this to my saved trials
?
mi
from
Armonk, NY
Click here to add this to my saved trials
?
mi
from
Asheville, NC
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Avon, IN
Click here to add this to my saved trials
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
?
mi
from
Bronx, NY
Click here to add this to my saved trials
?
mi
from
Burbank, CA
Click here to add this to my saved trials
?
mi
from
Canton, OH
Click here to add this to my saved trials
?
mi
from
Cedar Rapids, IA
Click here to add this to my saved trials
?
mi
from
Cedar Rapids, IA
Click here to add this to my saved trials
Charleston, South Carolina 29412
?
mi
from
Charleston, SC
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Corona, CA
Click here to add this to my saved trials
?
mi
from
Corpus Christi, TX
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
?
mi
from
Duluth, MN
Click here to add this to my saved trials
?
mi
from
Englewood, CO
Click here to add this to my saved trials
?
mi
from
Fair Oaks, CA
Click here to add this to my saved trials
?
mi
from
Fargo, ND
Click here to add this to my saved trials
?
mi
from
Fargo, ND
Click here to add this to my saved trials
Fountain Valley, California 92708
?
mi
from
Fountain Valley, CA
Click here to add this to my saved trials
?
mi
from
Galveston, TX
Click here to add this to my saved trials
?
mi
from
Great Neck, NY
Click here to add this to my saved trials
?
mi
from
Highland, CA
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Joliet, IL
Click here to add this to my saved trials
?
mi
from
Killeen, TX
Click here to add this to my saved trials
?
mi
from
Kokomo, IN
Click here to add this to my saved trials
?
mi
from
La Crosse, WI
Click here to add this to my saved trials
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
?
mi
from
Lake Success, NY
Click here to add this to my saved trials
?
mi
from
Lincoln, NE
Click here to add this to my saved trials
?
mi
from
Madison, WI
Click here to add this to my saved trials
?
mi
from
Manhasset, NY
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Mission Hills, California 91345
?
mi
from
Mission Hills, CA
Click here to add this to my saved trials
Mission Hills, California 91345
?
mi
from
Mission Hills, CA
Click here to add this to my saved trials
?
mi
from
New Braunfels, TX
Click here to add this to my saved trials
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
?
mi
from
Orange, CA
Click here to add this to my saved trials
?
mi
from
Orlando, FL
Click here to add this to my saved trials
?
mi
from
Peoria, IL
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Rancho Mirage, California 90070
?
mi
from
Rancho Mirage, CA
Click here to add this to my saved trials
?
mi
from
Rapid City, SD
Click here to add this to my saved trials
?
mi
from
Riverside, CA
Click here to add this to my saved trials
?
mi
from
Rockford, IL
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
San Diego, CA
Click here to add this to my saved trials
?
mi
from
Sioux Falls, SD
Click here to add this to my saved trials
?
mi
from
Skokie, IL
Click here to add this to my saved trials
?
mi
from
Skokie, IL
Click here to add this to my saved trials
?
mi
from
Somerville, NJ
Click here to add this to my saved trials
?
mi
from
St. Cloud, MN
Click here to add this to my saved trials
?
mi
from
Temple, TX
Click here to add this to my saved trials
?
mi
from
Temple, TX
Click here to add this to my saved trials
?
mi
from
Washington,
Click here to add this to my saved trials
?
mi
from
Waterloo, IA
Click here to add this to my saved trials
?
mi
from
Watertown, SD
Click here to add this to my saved trials
West Reading, Pennsylvania 19611
?
mi
from
West Reading, PA
Click here to add this to my saved trials
?
mi
from
Wichita, KS
Click here to add this to my saved trials
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials