Clinical Trial: Safety & Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Safety and Immunogenicity of GlaxoSmithKline Biologicals' Herpes Zoster Vaccine 1437173A

Brief Summary: The purpose of this observer-blind study is to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals' investigational Herpes Zoster vaccine GSK1437173A when administered as 2 doses or 3 doses to hematopoietic stem cell transplant (HCT) recipients.

Detailed Summary: The Protocol Posting has been updated following Protocol amendment 2, Sep 2009. The sections impacted are: eligibility criteria.
Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • Occurrence, intensity of solicited local and general adverse events (AEs) [ Time Frame: Days 0-6 after each vaccination ]
  • Occurrence, intensity of unsolicited AEs [ Time Frame: Days 0-29 after each vaccination ]
  • Occurrence, intensity of unsolicited AEs [ Time Frame: Any time during the study up to Day 29 after the last vaccination ]
  • Occurrence of all serious adverse events (SAEs) [ Time Frame: During the entire study period ]
  • Occurrence and relationship to vaccination of any new onset of autoimmune diseases and other immune mediated inflammatory disorders [ Time Frame: During the entire study period ]
  • Hematological and biochemical evaluations [ Time Frame: Months 0, 1, 2, 3 and 4 ]
  • Frequency of CD4 T cells specific for Varicella Zoster Virus (VZV) antigens. [ Time Frame: Month 4 ]
  • VZV-specific antibody concentrations [ Time Frame: Month 4 ]


Original Primary Outcome:

  • Occurrence, intensity of unsolicited AEs [ Time Frame: Days 0-29 after each vaccination ]
  • Occurrence, intensity of unsolicited AEs [ Time Frame: Any time during the study up to Day 29 after the last vaccination ]
  • Occurrence of all serious adverse events (SAEs) [ Time Frame: During the entire study period ]
  • Occurrence and relationship to vaccination of any new onset of autoimmune diseases and other immune mediated inflammatory disorders [ Time Frame: During the entire study period ]
  • Hematological and biochemical evaluations [ Time Frame: Months 0, 1, 2, 3 and 4 ]
  • Frequency of CD4 T cells specific for Varicella Zoster Virus (VZV) antigens. [ Time Frame: Month 4 ]
  • VZV-specific antibody concentrations [ Time Frame: Month 4 ]
  • Occurrence, intensity of solicited local and general adverse events (AEs) [ Time Frame: Days 0-6 after each vaccination ]


Current Secondary Outcome:

  • Frequency of CD4 T cells specific for VZV antigens [ Time Frame: Months 0, 1, 2, 3, 4 and 15 ]
  • VZV-specific antibody concentrations [ Time Frame: Months 0, 1, 2, 3, 4 and 15 ]
  • Confirmed Herpes Zoster (HZ) cases [ Time Frame: During the entire study period ]
  • HZ pain severity in subjects with confirmed HZ [ Time Frame: 4-week period following the onset of the HZ rash ]
  • HZ disease severity as determined by the total score of HZ-associated disease in subjects with confirmed HZ [ Time Frame: 4-week period following the onset of the HZ rash ]
  • Occurrence of Postherpetic Neuralgia (PHN) in the entire study cohort [ Time Frame: During the entire study period ]
  • Incidence of other HZ-associated complications following the onset of HZ rash in subjects with confirmed HZ in the entire study cohort. [ Time Frame: During the entire study period ]


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: June 12, 2009
Date Started: July 2009
Date Completion:
Last Updated: May 7, 2015
Last Verified: June 2011