Clinical Trial: Immunogenicity and Safety of GSK Biologicals' Live Attenuated Varicella Vaccine (VARILRIXTM).

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

Official Title: A Phase III, Open-label, Multi-centre Study to Assess the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM), Given a

Brief Summary: This study aims to assess the immunogenicity and safety of varicella vaccination in a population of autologous peripheral stem cell/ bone marrow transplantation recipients who have reached at least four months post-transplantation.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Varicella vaccine response and Geometric mean titres (GMTs) [ Time Frame: At 8 months post-transplantation ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Vaccine response and GMTs [ Time Frame: A 6.5 months post-transplantation ]
  • Seroconversion/Seropositivity and GMTs [ Time Frame: At pre-transplantation, 4.5, 12 and 24 months post-transplantation. ]
  • Lymphoproliferation stimulation index [cell-mediated immunity (CMI)] [ Time Frame: At pre-transplantation, 4.5, 6.5, 8, 12 and 24 months post-transplantation. ]
  • Interferon-γ (IFN-γ) and Interleukin-5 (IL-5) index [ Time Frame: At pre-transplantation, 4.5, 6.5, 8, 12 and 24 months post-transplantation ]
  • Occurrence of varicella zoster virus (VZV) infections [ Time Frame: Up to 24 months post-transplantation ]
  • Occurrence of solicited local adverse events [ Time Frame: During the 8-day follow-up period after each vaccination ]
  • Occurrence of solicited general adverse events [ Time Frame: During the 43-day follow-up period after each vaccination ]
  • Occurrence of unsolicited symptoms [ Time Frame: During the 43 day follow-up period after each vaccination ]
  • Occurrence of Serious Adverse Events [ Time Frame: Over the active phase of the study ]
  • Retrospective analysis on the serological status, GMTs and stimulation index (CMI) and the occurrence of VZV infections to compare patients given fludarabine-based regimens compared to non-fludarabine regimens. [ Time Frame: At pre-transplantation, 4.5, 6.5, 8, 12 and 24 months post-transplantation ]
  • Retrospective analysis of the correlation between the CD4, CD8 and CD20 levels and the immune response (in terms of seropositivity rate) to the vaccine.


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: November 17, 2008
Date Started: September 2003
Date Completion:
Last Updated: November 3, 2016
Last Verified: November 2016