CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,877 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/NCT01610414
NCT01610414Phase 3Completed
CompareCT.gov

Observer-blind Study to Evaluate Efficacy, Safety, and Immunogenicity of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A

GlaxoSmithKline·interventional·Posted Jun 4, 2012·Updated Jan 23, 2018

In Brief

A Phase 3 clinical trial evaluating Herpes Zoster vaccine GSK1437173A and Placebo for Herpes Zoster. Completed, enrolled 1,877 participants across 178 sites in 28 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy of GSK Biologicals' vaccine GSK1437173A in the prevention of Herpes zoster (HZ) in autologous haematopoietic cell transplant recipients 18 years of age and older. To this end, the study will evaluate vaccine efficacy (VE) of the GSK1437173A vaccine, administered on a 2-dose schedule, compared to placebo in reducing the risk of developing HZ in this population.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHerpes Zoster
CountriesAustralia, Belgium, Bulgaria, Canada, Czechia, Estonia, Finland, France, Germany, Greece, Hong Kong, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Panama, Poland, Romania, Russia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 4, 2012
Enrollment StartJul 13, 2012
Primary CompletionNov 4, 2016
Study CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 14.1 years ago

Interventions

Herpes Zoster vaccine GSK1437173Abiological

2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm

Placebobiological

2 doses administered IM in deltoid region of non-dominant arm