NCT01165229

Study to Evaluate Efficacy, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 70 Years and Older

Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 70 Years or Older

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 14,819 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

This protocol summary has been updated following Protocol Amendment 4 changes to study objectives and endpoints. Pooled analyses of ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) will only be conducted if the primary objective herpes zoster vaccine efficacy (HZ VE) is demonstrated in both ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) separately.

Conditions

• Herpes Zoster
• Herpes Zoster Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Herpes Zoster Vaccine GSK1437173A	Intramuscular injection
BIOLOGICAL	Placebo	Intramuscular injection.

Timeline

• Start date: 2010-08-02
• Primary completion: 2015-07-24
• Completion: 2015-07-24
• First posted: 2010-07-19
• Last updated: 2020-04-27
• Results posted: 2017-11-20

Locations

213 sites across 18 countries: United States, Australia, Brazil, Canada, Czechia, Estonia, Finland, France, Germany, Hong Kong, Italy, Japan, Mexico, South Korea, Spain, Sweden, Taiwan, United Kingdom