At a glance
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Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 70 Years or Older
In Brief
A Phase 3 clinical trial evaluating Herpes Zoster Vaccine GSK1437173A and Placebo for Herpes Zoster and Herpes Zoster Vaccine. Completed, enrolled 14,819 participants across 213 sites in 18 countries.
Detailed Summary
The purpose of this observer-blind study is to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 70 years. Two studies (Zoster-006 \[NCT01165177\] and Zoster-022 \[NCT01165229\]) will be conducted concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both studies combined will be conducted contingent on each study achieving its objectives. This protocol posting also deals with the outcome measures related to the pooled analysis.
Study Details
Timeline
Interventions
Intramuscular injection
Intramuscular injection.