Clinical Trial: Study to Assess the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine in Adults Aged 18 Years and Older With Blood Cancers

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Study to Evaluate Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 18 Years and Older With Haematologic Malignancies

Brief Summary: The purpose of this study is to evaluate the safety and immunogenicity of GSK Biologicals' vaccine GSK1437173A in subjects aged 18 years and older with blood cancers. The study will evaluate safety-related events and antibody and cellular immune responses to the study vaccine, as compared to placebo.

Detailed Summary:

Amendment to protocol posting:

Increase in sample size, update of country/region-specific information (Sections 5, 6 and 9).

Promotion of secondary to primary objective; related update of primary and secondary outcome measures (Sections 4 and 7).


Sponsor: GlaxoSmithKline

Current Primary Outcome:

  • Occurrence of solicited local and general symptoms [ Time Frame: Up to 7 days (Days 0-6) after each vaccination ]
  • Occurrence of unsolicited adverse events (AEs) [ Time Frame: Up to 30 days (Days 0-29) after each vaccination ]
  • Occurrence of serious adverse events (SAEs) [ Time Frame: Up to 30 days post last vaccination ]
  • Occurrence of AEs of specific interest [ Time Frame: Up to 30 days post last vaccination ]
  • Anti gE humoral immunogenicity in all vaccinated subjects excluding subjects with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia [ Time Frame: At Month 2 ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Occurrence of serious adverse events (SAEs) [ Time Frame: From first vaccination up to 6 months post last vaccination ]
  • Occurrence of SAEs [ Time Frame: From 30 days post last vaccination until study end ]
  • Occurrence of AEs of specific interest [ Time Frame: From first vaccination up to 6 months post last vaccination ]
  • Occurrence of AEs of specific interest [ Time Frame: From 30 days post last vaccination until study end ]
  • Anti gE humoral immunogenicity in all vaccinated subjects excluding subjects with Non-Hodgkin B-cell Lymphoma [ Time Frame: At Month 2 ]
  • Anti gE humoral immunogenicity in all vaccinated subjects excluding subjects with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia [ Time Frame: At Month 2 ]
  • Occurrence of confirmed HZ cases [ Time Frame: From Month 0 until study end ]
  • Anti-gE humoral immunogenicity in all vaccinated subjects [ Time Frame: At Month 0, Month 1, Month 2 and Month 13 ]
  • Anti-gE humoral immunogenicity in all vaccinated subjects [ Time Frame: At Month 1, Month 2 and Month 13 ]
  • gE-specific CD4+ T-cell-mediated immunogenicity response in the CMI sub-cohort [ Time Frame: At Month 0, Month 1, Month 2 and Month 13 ]
  • gE-specific CD4+ T-cell-mediated immunogenicity response in the CMI sub-cohort [ Time Frame: At Month 1, Month 2 and Month 13 ]
  • Anti-gE humoral immunogenicity in subjects with confirmed HZ and matched controls [ Time Frame: At Month 0 and at Month 2 ]


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: January 10, 2013
Date Started: March 2013
Date Completion: January 2017
Last Updated: December 1, 2016
Last Verified: December 2016