NCT04091451

Safety and Immunogenicity Study of GlaxoSmithKline's Herpes Zoster Subunit Vaccine (HZ/su) When Given on a Two-dose Schedule to Adults at Least 50 Years of Age (YOA) With a Prior Episode of Herpes Zoster

A Phase III, Randomized, Observer-blind, Placebo Controlled, Multicenter Clinical Trial to Assess Herpes Zoster Recurrence and the Reactogenicity, Safety and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine (HZ/su) When Administered Intramuscularly on a 0 and 2 Month Schedule to Adults ≥50 Years of Age With a Prior Episode of Herpes Zoster

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,430 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to assess the safety and immunogenicity of GSK Biologicals' HZ/su vaccine when given on a two-dose schedule to adults aged 50 years and above who had a previous episode of Herpes Zoster (HZ).

Conditions

• Herpes Zoster

Interventions

Type	Name	Description
BIOLOGICAL	Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A)	2 doses of HZ/su vaccine were administered intramuscularly according to a 0,2 months vaccination schedule, at Day 1 and Month 2.
DRUG	Placebo	2 doses of Placebo were administered intramuscularly according to a 0,2 months vaccination schedule, at Day 1 and Month 2.

Timeline

• Start date: 2019-09-17
• Primary completion: 2024-02-15
• Completion: 2024-02-15
• First posted: 2019-09-16
• Last updated: 2025-12-04
• Results posted: 2025-03-30

Locations

3 sites across 1 country: Russia

Regulatory

• FDA-regulated drug study