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Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine in Adults 18 Years of Age or Older With Renal Transplant

NCT02058589 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 265

Last updated 2018-08-01

Study results available
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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.

Conditions

  • Herpes Zoster

Interventions

BIOLOGICAL

Herpes Zoster vaccine GSK1437173A

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

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-20
Primary Completion
2016-05-11
Completion
2017-04-13

Countries

  • Belgium
  • Canada
  • Czechia
  • Finland
  • Italy
  • Panama
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02058589 on ClinicalTrials.gov