NCT02690207

Cross-vaccination Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK 1437173A) in Subjects Who Previously Received Placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) Studies.

Cross-vaccination Study of GSK Biologicals' Lyophilized Formulation of the Herpes Zoster Subunit (HZ/su) Vaccine (GSK 1437173A) in Subjects Who Previously Received Placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) Studies

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8,687 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to cross-vaccinate and collect safety data in terms of unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and potential Immune Mediated Disease (pIMD) from subjects \>= 50 Years of age (YOA) who previously received placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229).

Detailed description

Since the HZ/su vaccine has not yet been licensed and marketed, this study is being conducted to enable potentially eligible subjects who previously received placebo in ZOSTER-006 (NCT01165177) or ZOSTER-022 (NCT01165229) to receive the HZ/su vaccine. Study ZOSTER-056 is an open-label, multi-centric and single arm study to cross-vaccinate and collect safety data in terms of of unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and pIMD from subjects \>= 50 YOA who previously received placebo.

Conditions

• Herpes Zoster

Interventions

Type	Name	Description
BIOLOGICAL	Herpes Zoster Vaccine GSK1437173A	Intramuscular injection

Timeline

• Start date: 2016-03-16
• Primary completion: 2019-03-15
• Completion: 2019-03-15
• First posted: 2016-02-24
• Last updated: 2021-03-04
• Results posted: 2020-03-12

Locations

195 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