Cross-vaccination Study of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine (GSK 1437173A) in Subjects Who Previously Received Placebo in ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) Studies.
NCT02690207 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8687
Last updated 2021-03-04
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).
Conditions
- Herpes Zoster
Interventions
- BIOLOGICAL
-
Herpes Zoster Vaccine GSK1437173A
Intramuscular injection
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
GSK Clinical Trials · GlaxoSmithKline
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-03-16
- Primary Completion
- 2019-03-15
- Completion
- 2019-03-15
Countries
- United States
- Australia
- Brazil
- Canada
- Czechia
- Estonia
- Finland
- France
- Germany
- Hong Kong
- Italy
- Japan
- Mexico
- South Korea
- Spain
- Sweden
- Taiwan
- United Kingdom
Study Locations
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