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NCT01798056Phase 3
Key facts
Phase 3, randomised, double-blind trial in herpes zoster (HZ) comparing GSK1437173A Group with Placebo Group (2 arms). Primary endpoints: Adjusted Geometric Means for Anti-glycoprotein E (gE) Antibodies in PreChemo Groups at Month 2, Anti-Varicella Zoster Virus (VZV) gE Antibody Concentrations at Month 2 and 7 more. Started Mar 2013; status: completed.
GSK1437173A Group
Shingrix Vaccine (2 doses)
Placebo Group
Placebo (2 doses)
Adults 18+ with solid tumors receiving or scheduled to receive chemotherapy, with a life expectancy >1 year. Excludes those with prior HZ vaccination, HIV, or chronic systemic glucocorticoids.
Adjusted Geometric Means for Anti-glycoprotein E (gE) Antibodies in PreChemo Groups
Anti-Varicella Zoster Virus (VZV) gE Antibody Concentrations
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Number of Days With Solicited Local Symptoms
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Anti-VZV gE Antibody Concentrations
Number of Subjects With Vaccine Responses for Anti-gE Antibody ELISA Concentrations
Descriptive Statistics of the Frequency of gE-specific CD4[2+] T-cells in PreChemo Groups
Number of Subjects With Vaccine Responses for gE-specific CD4[2+] T-cells in PreChemo Groups
Number of Subjects With Serious Adverse Events (SAEs)
Number of Subjects With Any Potential Immune Mediated Diseases (pIMDs)
Beyond the preview
Full results, competitive context and analysis are in the Gosset platform.
Available in the Gosset platform where reported.
Available in the Gosset platform where reported.
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