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Study to Assess the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine in Adults Aged 18 Years and Older With Blood Cancers

NCT01767467 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 568

Last updated 2018-06-06

Study results available
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Summary

The purpose of this study is to evaluate the safety and immunogenicity of GSK Biologicals' vaccine GSK1437173A in subjects aged 18 years and older with blood cancers. The study will evaluate safety-related events and antibody and cellular immune responses to the study vaccine, as compared to placebo.

Conditions

  • Herpes Zoster

Interventions

BIOLOGICAL

Herpes zoster vaccine (GSK 1437173A)

2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm. Dose 1 administered at Day 0. Dose 2 administered 1-2 months post Dose 1.

DRUG

Placebo

2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm. Dose 1 administered at Day 0. Dose 2 administered 1-2 months post Dose 1.

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
2013-03-01
Primary Completion
2016-01-07
Completion
2017-01-06

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Czechia
  • Finland
  • France
  • Hong Kong
  • Italy
  • New Zealand
  • Pakistan
  • Panama
  • Poland
  • Russia
  • Singapore
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

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 NCT01767467 on ClinicalTrials.gov