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

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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

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.
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