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Study to Evaluate Efficacy, Safety, and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Vaccine GSK1437173A

NCT01610414 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1877

Last updated 2018-01-23

Study results available
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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.

Conditions

  • Herpes Zoster

Interventions

BIOLOGICAL

Herpes Zoster vaccine GSK1437173A

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

BIOLOGICAL

Placebo

2 doses administered IM in deltoid region of 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
2012-07-13
Primary Completion
2016-11-04
Completion
2017-02-01

Countries

  • United States
  • Australia
  • 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

Study Locations

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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 NCT01610414 on ClinicalTrials.gov