NCT02723773

A Long-term Follow-up Study (ZOE-LTFU) of Two Studies 110390 (ZOSTER-006) and 113077 (ZOSTER-022) to Assess the Efficacy, Safety, and Immunogenicity Persistence of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine and Assessment of 1 or 2 Additional Doses in Two Subgroups of Older Adults

Efficacy, Safety and Immunogenicity of GSK Biologicals' HZ/su Vaccine GSK1437173A in a Phase IIIb, Open-label, Long-term Follow-up Study (ZOE-LTFU) of Studies 110390/113077 (ZOSTER-006/022) and Assessment of Additional Doses in Older Adults

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 7,539 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was a long-term follow-up of the two studies 110390 and 113077 (ZOSTER-006/022) to assess the efficacy, safety, and immunogenicity persistence of GSK Biologicals' Herpes Zoster subunit (HZ/su) vaccine and included an assessment of 1 or 2 additional doses in two subgroups of older adults.

Detailed description

This is the long-term follow-up study (ZOE-LTFU) of studies 110390 and 113077 (ZOSTER-006/022) to assess the prophylactic efficacy, safety, and immunogenicity persistence of GSK Biologicals' Herpes Zoster subunit (HZ/su) vaccine and included an assessment of 1 or 2 additional doses on a 0 or 0, 2-month schedule in two subgroups of older adults.

Conditions

• Herpes Zoster
• Herpes Zoster Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Herpes Zoster Vaccine GSK1437173A	Intramuscular injection

Timeline

• Start date: 2016-04-16
• Primary completion: 2023-06-28
• Completion: 2024-01-30
• First posted: 2016-03-30
• Last updated: 2025-12-12
• Results posted: 2024-09-19

Locations

161 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

Regulatory

• FDA-regulated drug study