Trial intelligence / Profile preview

Shingrix in Solid Tumor Patients on Chemotherapy

NCT01798056Phase 3

Key facts

Status
Completed
Start
Mar 2013
Primary completion
Jun 2015
Countries
6
Sponsor
GSK
Modality
Vaccines & Immunotherapeutics
Conditions
herpes zoster (HZ)
01

Overview

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.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • GSK1437173A Group

    Shingrix Vaccine (2 doses)

  • Placebo Group

    Placebo (2 doses)

03

Who it enrols

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.

04

Endpoints

Primary

  • 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

Secondary

  • 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)

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