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Study to Evaluate Efficacy, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster (HZ) Vaccine GSK1437173A in Adults Aged 70 Years and Older

NCT01165229 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 14819

Last updated 2020-04-27

Study results available
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Summary

The purpose of this observer-blind study is to evaluate the efficacy, safety and immunogenicity of GSK Biologicals' candidate Herpes Zoster (HZ) vaccine in adults aged ≥ 70 years.

Two studies (Zoster-006 \[NCT01165177\] and Zoster-022 \[NCT01165229\]) will be conducted concurrently to evaluate efficacy of GSK1437173A vaccine. A pooled analysis of data from both studies combined will be conducted contingent on each study achieving its objectives. This protocol posting also deals with the outcome measures related to the pooled analysis.

Conditions

  • Herpes Zoster
  • Herpes Zoster Vaccine

Interventions

BIOLOGICAL

Herpes Zoster Vaccine GSK1437173A

Intramuscular injection

BIOLOGICAL

Placebo

Intramuscular injection.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-02
Primary Completion
2015-07-24
Completion
2015-07-24

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

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 NCT01165229 on ClinicalTrials.gov