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 Participants Undergoing Hematopoietic Cell Transplants (HCTs) (Study No. V212-001 AM4)



Status:Completed
Conditions:Shingles, Infectious Disease
Therapuetic Areas:Dermatology / Plastic Surgery, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/30/2013
Start Date:November 2010
End Date:August 2014
Contact:Toll Free Number
Phone:1-888-577-8839

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A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Trial to Study the Safety, Tolerability, Efficacy, and Immunogenicity of V212 in Recipients of Autologous Hematopoietic Cell Transplants (HCTs)


This is a study to determine whether investigational V212 reduces the incidence of herpes
zoster (HZ) compared to placebo when administered to recipients of autologous hematopoietic
cell transplants (HCT).


Inclusion Criteria:

- Men and women at least 18 years of age

- Has prior history of varicella, antibodies to VZV (documented prior to receipt of
blood products), or residence in a country with endemic VZV infection for ≥30 years
or if participant is <30 years old, attended primary or secondary school in a country
with endemic VZV infection.

- Scheduled to undergo an autologous hematopoietic cell transplant within 60 days of
enrollment

- Is highly unlikely to conceive during the time period starting 2 weeks prior to
enrollment through 6 months from last vaccination dose

- Female participants of childbearing potential must have a negative serum or urine
pregnancy test.

Exclusion Criteria:

- History of hypersensitivity reaction to any vaccine component

- Prior history of herpes zoster within 1 year of enrollment

- Prior receipt of any varicella or zoster vaccine

- More than 2 relapses of the underlying cancer (participants with Hodgkin's lymphoma
may have had more than 2 relapses)

- Expectation of tandem transplant procedure

- Is expected to receive >6 months (>180 days) of prophylactic antiviral therapy
post-HCT.

- Is pregnant or breastfeeding or expecting to conceive within the period of 2 weeks
prior to enrollment through 6 months from last vaccination dose.

- Has received a live virus vaccine or is scheduled to receive a live virus vaccine in
the period from 4 weeks prior to Dose 1 through 28 days Postdose 4.

- Has received an inactivated vaccine or is scheduled to receive an inactivated vaccine
in the period between 7 days prior to and 28 days following Doses 1 through 4.
We found this trial at
50
sites
835
mi
from
Scottsdale, AZ
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1148
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Baltimore, MD
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1149
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Baltimore, MD
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683
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from
Birmingham, AL
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1444
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from
Boston, MA
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1444
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from
Boston, MA
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608
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from
Chicago, IL
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609
mi
from
Chicago, IL
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611
mi
from
Chicago, IL
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732
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from
Cincinnati, OH
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899
mi
from
Cleveland, OH
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349
mi
from
Dallas, TX
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322
mi
from
Dalllas, TX
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841
mi
from
Detroit, MI
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841
mi
from
Detroit, MI
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1052
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from
Durham, NC
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613
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from
Evanston, IL
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1049
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from
Gainesville, FL
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1285
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from
Hackensack, NJ
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1147
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from
Hershey, PA
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572
mi
from
Houston, TX
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643
mi
from
Indianapolis, IN
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643
mi
from
Indianapolis, IN
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1055
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from
Jacksonville, FL
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1118
mi
from
La Jolla, CA
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1177
mi
from
Los Angeles, CA
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1175
mi
from
Los Angeles, CA
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657
mi
from
Louisville, KY
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574
mi
from
Madison, WI
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620
mi
from
Marshfield, WI
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1320
mi
from
Miami, FL
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1290
mi
from
New York, NY
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1286
mi
from
New York, NY
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1195
mi
from
Newark, DE
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607
mi
from
Niles, IL
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Philadelphia, Pennsylvania 19107
1225
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from
Philadelphia, PA
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Philadelphia, Pennsylvania 19102
1225
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from
Philadelphia, PA
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1380
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from
Portland, OR
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1384
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from
Portland, OR
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1384
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from
Portland, OR
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1121
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from
Rochester, NY
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1282
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from
Sacramento, CA
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571
mi
from
San Antonio, TX
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1411
mi
from
Seattle, WA
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418
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from
St. Louis, MO
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1329
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from
Stanford, CA
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1358
mi
from
Stony Brook, NY
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149
mi
from
Tulsa, OK
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27
mi
from
Wichita, KS
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Winston-Salem, North Carolina 27157
979
mi
from
Winston-Salem, NC
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