Clinical Trial: Consistency, Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults ≥ 50 Years of Age

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

Official Title: Consistency, Immunogenicity and Safety Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults 50 Years of Age or Older

Brief Summary: The purpose of this study is to demonstrate lot-to-lot consistency in terms of immunogenicity, and evaluate safety of the Herpes Zoster subunit (HZ/su) vaccine. The study is designed as a randomized, double-blind study with three parallel groups.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Anti-gE humoral immunogenicity [ Time Frame: At Month 3 ]

Anti-gE antibody concentrations, as determined by enzyme-linked immunosorbent assay (ELISA)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Anti-gE humoral immunogenicity [ Time Frame: At Month 0 and Month 3 ]
    Anti-gE antibody concentrations, as determined by ELISA
  • Anti-gE humoral immunogenicity [ Time Frame: At Month 3 ]
    Vaccine response for anti-gE humoral immunogenicity, as determined by ELISA, at Month 3
  • Occurrence of solicited local and general symptoms [ Time Frame: Within 7 days (Days 0-6) after each vaccination ]
  • Occurrence of unsolicited symptoms [ Time Frame: During 30 days (Days 0-29) after each vaccination ]
  • Occurrence of Serious Adverse Events (SAEs) [ Time Frame: From first vaccination up to 30 days post last vaccination (Month 0-Month 3) ]
  • Occurrence of Serious Adverse Events (SAEs) [ Time Frame: During the period starting after 30 days post last vaccination until study end (Month 4 -Month 14) ]
  • Occurrence of AEs of specific interest [ Time Frame: From first vaccination up to 30 days post last vaccination (Month 0-Month 3) ]
  • Occurrence of AEs of specific interest [ Time Frame: During the period starting after 30 days post last vaccination until study end (Month 4 -Month 14) ]


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: February 27, 2014
Date Started: August 2014
Date Completion:
Last Updated: June 16, 2016
Last Verified: June 2016