Clinical Trial: Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine With Various Formulations in Adults >= 50 Years

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

Official Title: Immunogenicity and Safety Study of Different Formulations of GSK Biologicals' Herpes Zoster Vaccine 1437173A When Administered Twice in Adults Aged 50 Years and Older

Brief Summary: The goal of this randomized observer-blind trial is to further refine the formulation of vaccines containing GSK1437173A in older adults by comparing the cellular and humoral immune responses and the safety profiles of the different formulations.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • Cell mediated immune response (CMI) in terms of frequencies of CD4 T cells specific for VZV antigens [ Time Frame: 1 month after second vaccination ]
  • VZV-specific Ab concentrations [ Time Frame: 1 month after second vaccination ]


Original Primary Outcome:

  • VZV-specific Ab concentrations [ Time Frame: 1 month after second vaccination ]
  • Cell mediated immune response (CMI) in terms of frequencies of CD4 T cells specific for VZV antigens [ Time Frame: 1 month after second vaccination ]


Current Secondary Outcome:

  • Cell-mediated immunity (CMI) in terms of frequencies of CD4 T cells specific for varicella-zoster virus (VZV) antigens [ Time Frame: Month 0 ]
  • CMI in terms of frequencies of CD8 T cells specific for VZV antigens [ Time Frame: Months 0, 2 and 3 ]
  • VZV-specific Ab concentrations [ Time Frame: Months 0 and 2 ]
  • Occurrence, intensity and relationship to vaccination of solicited adverse events (AEs) [ Time Frame: Days 0-6 after each vaccination ]
  • Occurrence, intensity and relationship to vaccination of unsolicited AEs [ Time Frame: Days 0 to 29 after each vaccination ]
  • Occurrence and relationship to vaccination of all serious AEs (SAEs) [ Time Frame: From Month 0 until 12 months following the last vaccination (Month 14) ]
  • Occurrence and relationship to vaccination of all of all new onsets of autoimmune diseases (NOADs) [ Time Frame: from Month 0 until 12 months following the last vaccination (Month 14) ]
  • Occurrence of suspected cases of Herpes Zoster (HZ) [ Time Frame: from Month 0 until 12 months following the last vaccination (Month 14) ]
  • Haematological (complete blood count e.g. red blood cells, white blood cells and haemoglobin) and biochemical (e.g. creatine, liver enzymes and total protein) parameters Month 0 [ Time Frame: Month 0 ]
  • Haematological (complete blood count e.g. red blood cells, white blood cells and haemoglobin) and biochemical (e.g. creatine, liver enzymes and total protein) parameters Month 2 [ Time Frame: Month 2 ]
  • Haematological (complete blood count e.g. red blood cells, white blood cells and haemoglobin) and biochemical (e.g. creatine, liver enzymes and total protein) parameters Month 3 [ Time Frame: Minth 3 ]


Original Secondary Outcome:

  • CMI in terms of frequencies of CD4 T cells specific for VZV antigens [ Time Frame: Months 0 and 2 ]
  • CMI in terms of frequencies of CD8 T cells specific for VZV antigens [ Time Frame: Months 0, 2 and 3 ]
  • VZV-specific Ab concentrations [ Time Frame: Months 0 and 2 ]
  • Occurrence, intensity and relationship to vaccination of solicited adverse events (AEs) [ Time Frame: Days 0-6 after each vaccination ]
  • Occurrence, intensity and relationship to vaccination of unsolicited AEs [ Time Frame: Days 0 to 29 after each vaccination ]
  • Occurrence and relationship to vaccination of all serious AEs (SAEs) [ Time Frame: From Month 0 until 6 months following the last vaccination (Month 8) ]
  • Occurrence and relationship to vaccination of all of all new onsets of autoimmune diseases (NOADs) [ Time Frame: from Month 0 till 6 months following the last vaccination (Month 8) ]
  • Occurrence of suspected cases of HZ [ Time Frame: from Month 0 6 months following the last vaccination (Month 8) ]
  • Haematological and biochemical parameters [ Time Frame: Months 0, 2, and 3 ]


Information By: GlaxoSmithKline

Dates:
Date Received: December 4, 2008
Date Started: January 2009
Date Completion:
Last Updated: March 21, 2017
Last Verified: March 2017