CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 16,165 enrolled
Drug / intervention
Herpes Zoster Vaccine GSK1437173A +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01165177
NCT01165177Phase 3Completed
CompareCT.gov

Efficacy, Safety, and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 50 Years or Older

GlaxoSmithKline·interventional·Posted Jul 19, 2010·Updated Feb 10, 2021

In Brief

A Phase 3 clinical trial evaluating Herpes Zoster Vaccine GSK1437173A and Placebo for Herpes Zoster. Completed, enrolled 16,165 participants across 274 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 ≥ 50 years. Two studies \[ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229)\] are being 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. The protocol posting of study ZOSTER-022 also deals with the outcome measures related to the pooled analysis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHerpes Zoster
CountriesAustralia, Brazil, Canada, Czechia, Estonia, Finland, France, Germany, Hong Kong, Italy, Japan, Mexico, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 19, 2010
Enrollment StartAug 2, 2010
Primary CompletionMay 9, 2014
Study CompletionJul 27, 2015
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 16.0 years ago

Interventions

Herpes Zoster Vaccine GSK1437173Abiological

Intramuscular injection

Placebobiological

Intramuscular injection