Clinical Trial: Study to Evaluate Efficacy, Safety, and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A

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

Official Title: Observer-blind Study to Evaluate Efficacy, Safety, and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A

Brief Summary: The purpose of this study is to evaluate the efficacy of GSK Biologicals' vaccine GSK1437173A in the prevention of Herpes zoster (HZ) in autologous haematopoietic cell transplant recipients 18 years of age and older. To this end, the study will evaluate vaccine efficacy (VE) of the GSK1437173A vaccine, administered on a 2-dose schedule, compared to placebo in reducing the risk of developing HZ in this population.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Occurrence of confirmed HZ cases [ Time Frame: From Month 0 until study end (4 years approximately) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Duration of 'worst' HZ-associated pain [ Time Frame: From Month 0 until study end (4 years approximately), from the onset of a confirmed HZ rash over the entire pain reporting period ]
  • Occurrence of confirmed HZ-associated complications [ Time Frame: From Month 0 up until study end (4 years approximately) ]
  • Occurrence of Postherpetic Neuralgia (PHN) [ Time Frame: From Month 0 until study end (4 years approximately) ]
  • Antigen-specific Antibody (Ab) concentrations in a sub-cohort of subjects [ Time Frame: At Month 0, Month 1, Month 2, Month 13 and Month 25 ]
  • Occurrence of solicited local and general symptoms [ Time Frame: Within 7 days (Days 0-6) after each vaccination ]
  • Occurrence of unsolicited adverse events (AEs) [ Time Frame: During 30 days (Days 0-29) after each vaccination ]
  • Occurrence of Serious Adverse Events (SAEs) [ Time Frame: From the Pre-vaccination visit (Up to 110 days prior Month 0) until study end (4 years approximately) ]
  • Occurrence of AEs of specific interest [ Time Frame: From Month 0 until study end (4 years, approximately) ]


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: May 31, 2012
Date Started: July 13, 2012
Date Completion:
Last Updated: April 6, 2017
Last Verified: April 2017