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