At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 8,687 enrolled
Drug / intervention
Herpes Zoster Vaccine GSK1437173Abiological
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.
Cross-vaccination Study of GSK Biologicals' Lyophilized Formulation of the Herpes Zoster Subunit (HZ/su) Vaccine (GSK 1437173A) in Subjects Who Previously Received Placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) Studies
In Brief
A Phase 3 clinical trial evaluating Herpes Zoster Vaccine GSK1437173A for Herpes Zoster. Completed, enrolled 8,687 participants across 195 sites in 18 countries.
Detailed Summary
The purpose of this study is to cross-vaccinate and collect safety data in terms of unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs) and potential Immune Mediated Disease (pIMD) from subjects \>= 50 Years of age (YOA) who previously received placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229).
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
20162017201820192020202120222023202420252026
First PostedFeb 2016
Enrollment StartMar 2016
Primary CompletionMar 2019
TodayJul 2026
First PostedFeb 24, 2016
Enrollment StartMar 16, 2016
Primary CompletionMar 15, 2019
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 10.4 years ago
Interventions
Herpes Zoster Vaccine GSK1437173Abiological
Intramuscular injection