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