Clinical Trial: Study of Long Term Immune Responses and Safety of the GSK Herpes Zoster Vaccine in Healthy Subjects

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

Official Title: Long Term Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Vaccine 1437173A in Healthy Subjects

Brief Summary:

The subjects included in this study are subjects that participated in study NCT00434577. These subjects were vaccinated with the candidate Herpes Zoster (HZ) vaccine at Month 0 and Month 2 and were then followed at Month 12, Month 24 and Month 36 (study NCT00434577) for safety and immunogenicity.

This long term follow up study (ZOSTER-024 [114825]) will evaluate immune responses to and safety of the previously administered candidate HZ vaccine at Months 48, 60 and 72.

The study visits will be scheduled at approximately one year intervals after the first visit in ZOSTER-024. Blood samples for the evaluation of cellular and humoral immunity will be taken from all subjects at each visit. Information on safety and the occurrence of HZ will also be collected during these visits.


Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • Cell-Mediated Immunity (CMI) in terms of frequencies of antigen-specific CD4 T cells [ Time Frame: Month 48 ]
  • Cell-Mediated Immunity (CMI) in terms of frequencies of antigen-specific CD4 T cells [ Time Frame: Month 60 ]
  • Cell-Mediated Immunity (CMI) in terms of frequencies of antigen-specific CD4 T cells [ Time Frame: Month 72 ]
  • Antigen-specific antibody (Ab) concentrations [ Time Frame: Month 48 ]
  • Antigen-specific antibody (Ab) concentrations [ Time Frame: Month 60 ]
  • Antigen-specific antibody (Ab) concentrations [ Time Frame: Month 72 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Occurrence of all serious adverse events (SAEs) related to ZOSTER-024 (114825) study participation [ Time Frame: Month 48 to Month 72 ]
  • Occurrence of all SAEs related to previous vaccination and not already documented [ Time Frame: Month 0 to Month 72 ]
  • Occurrence of all fatal SAEs [ Time Frame: Month 48 to Month 72 ]
  • Occurrence of all predefined adverse events and not already documented [ Time Frame: Month 0 to Month 72 ]


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: February 11, 2011
Date Started: February 2011
Date Completion:
Last Updated: March 21, 2017
Last Verified: March 2017