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Therapeutic Areas: Oncology | Family Medicine
Disease Category: Solid Tumors
Location: United States, NY

Clinical Trial Details

Overview

Research Study Summary

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

Purpose

The purpose of this study is to test the safety and the human body's reaction to the research study vaccine, V212, in the prevention of shingles in subjects with solid tumor malignancy or hematologic malignancy. The study's purpose is also to see how well the study vaccine works in subjects with weakened immune systems (decreased ability to fight infection) in the prevention of shingles. Those who take part in this study will need to visit the research study doctor about 5 times and complete Vaccine Report Cards.

Patient Inclusion Criteria:

  • Diagnosed with a solid tumor or hematologic malignancy AND is not likely to undergo hematopoietic cell transplant
  • Is not receiving and not expected to require rituximab therapy beginning 3 months prior to enrollment through 28 days postvaccination dose 4
  • Has prior history of varicella, antibodies to VZV (documented prior to receipt of blood products), or residence (for =30 years) in a country with endemic VZV infection, or if participant is 30 years old, attended primary or secondary school in a country with endemic VZV infection

Patient Inclusion Criteria:

  • History of allergic reaction to any vaccine component (including gelatin) or an anaphylactic/anaphylactoid reaction to neomycin
  • Prior history of HZ within 1 year of enrollment
  • Prior receipt of any varicella or zoster vaccine
  • Pregnant or breastfeeding or expecting to conceive within the period of 2 weeks prior to enrollment throughout 6 months after last vaccination dose

To Learn more
Phase

3

Gender

Both Male and Female

Age

N/A

Overall Status

Recruiting

Facility Type

N/A

Contact

Mohammad Ghalib
The Harold & Muriel Block Institute for Clinical and Translational Research at Einstein & Montefiore
Montefiore Medical Center
Department of Oncology
111 East 210th Street
Bronx, NY 10467
Phone: 718-405-8515

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If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 181287

Date Last Changed: April 14, 2014


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