Clinical Trial: Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine 1437173A in Healthy Ethnic Japanese Adults

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

Official Title: Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine 1437173A in Healthy Ethnic Japanese Adults

Brief Summary: The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in healthy ethnic Japanese adults.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • Solicited local and general symptoms [ Time Frame: Day 0-6 after each vaccination ]
  • Unsolicited adverse events [ Time Frame: Day 0 -29 ]
  • Serious adverse events [ Time Frame: From dose 1 up to the end of the study ]
  • Occurrence of pre-defined adverse events [ Time Frame: From dose 1 up to study end ]
  • Haematological and biochemical parameters [ Time Frame: Months 0, 1 and 3 ]


Original Primary Outcome:

  • Serious adverse events [ Time Frame: From dose 1 up to the end of the study ]
  • Occurrence of pre-defined adverse events [ Time Frame: From dose 1 up to study end ]
  • Haematological and biochemical parameters [ Time Frame: Months 0, 1 and 3 ]
  • Solicited local and general symptoms [ Time Frame: Day 0-6 after each vaccination ]
  • Unsolicited adverse events [ Time Frame: Day 0 -29 ]


Current Secondary Outcome: Antigen and virus-specific antibody concentrations at protocol-defined time points [ Time Frame: Months 0, 1 and 3 ]

Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: March 4, 2010
Date Started: March 4, 2010
Date Completion:
Last Updated: May 12, 2017
Last Verified: May 2017