CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 265 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/NCT02058589
NCT02058589Phase 3Completed

Observer-blind Study to Evaluate Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine GSK1437173A in Adults 18 Years of Age or Older With Renal Transplant

GlaxoSmithKline·interventional·Posted Feb 10, 2014·Updated Aug 1, 2018

In Brief

A Phase 3 clinical trial evaluating Herpes Zoster vaccine GSK1437173A and Placebo for Herpes Zoster. Completed, enrolled 265 participants across 34 sites in 9 countries.

Detailed Summary

The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine administered on a 0- and 1- to 2-months schedule in adults 18 years of age or older who are receiving chronic immunosuppressive therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHerpes Zoster
CountriesBelgium, Canada, Czechia, Finland, Italy, Panama, South Korea, Spain, Taiwan
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 10, 2014
Enrollment StartMar 20, 2014
Primary CompletionMay 11, 2016
Study CompletionApr 13, 2017
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 12.4 years ago

Interventions

Herpes Zoster vaccine GSK1437173Abiological

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

Placebodrug

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