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Therapeutic Areas: Oncology | Hematology
Disease Category: Hematologic Cancer
Trial Information
A Phase I/IIa Randomized, Observer-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Immunogenicity of the GSK Biologicals' Herpes Zoster Vaccine, gE/AS01B, in Comparison to gE Combined With 1/2 Dose AS01B Adjuvant (gE/AS01E) and to Saline (Placebo) When Administered as 2 Doses or 3 Doses to Autologous Hematopoietic Stem Cell Transplantation (HCT) Recipients.
You have been asked to participate in this research study because you have had an autologous hematopoietic cell transplant and are at higher risk of developing shingles (a painful viral rash). The purpose of this research study is to determine which dose and formulation of the investigational drug Herpes Zoster (varicella-zoster virus, or VZV) Vaccine 1437173A out of a possible three compared to placebo that can trigger the best immune response (blood test results that show your immune system recognizes VZV and is responding to it). Side effects will also be evaluated. Your participation on this study is expected to last 15 months (64 weeks from your first visit). During the first three months you will receive vaccinations. Follow up will continue through month 15. The study will include 6 visits to the study center.
Patient Inclusion/Exclusion Criteria:
- See http://clinicaltrials.coh.org for additional information.
City of Hope
1500 East Duarte Road
Duarte, CA 91010-3000
Phone: 866-896-HOPE (4673)
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Research Center Information: City of Hope
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