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Safety and Immunogenicity of the Zoster Vaccine GSK1437173A in Elderly Subjects

NCT00434577 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 715

Last updated 2019-03-15

Study results available
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Summary

Based on the results of a previous clinical PhaseI/II study, GSK1437173A is the lead GSK candidate Herpes Zoster (HZ) vaccine to prevent episodes of HZ (shingles). This phase II study will be subdivided into a primary study (108494) and three extension studies (108516, 108518 \& 108520), consisting of one additional visit each at months 12, 24 and 36, respectively, from the first visit of the Zoster-003 primary study onwards. The aim of the primary 108494 study is to evaluate the immunogenicity \& safety of different dosages of the GSK1437173A vaccine in healthy elderly population. The study population will be stratified by age. The primary objective of this trial is to select the best dosage of GSK1437173A. The aim of the extension studies is to evaluate the persistence of the immune response induced by the candidate HZ vaccine during a long term period.

No new subjects will be enrolled during the extension phases of the study.

Conditions

  • Herpes Zoster

Interventions

BIOLOGICAL

Herpes Zoster vaccine GSK1437173A Low Dose

Single or two-dose intramuscular injection.

BIOLOGICAL

Herpes Zoster vaccine GSK1437173A Medium Dose

Single or two-dose intramuscular injection.

BIOLOGICAL

Herpes Zoster vaccine GSK1437173A High Dose

Single or two-dose intramuscular injection.

BIOLOGICAL

Herpes Zoster vaccine GSK1437173A Modified

Single or two-dose intramuscular injection.

BIOLOGICAL

Placebo

Single intramuscular injection

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-02-14
Primary Completion
2007-10-04
Completion
2010-07-14

Countries

  • Czechia
  • Germany
  • Netherlands
  • Sweden

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 NCT00434577 on ClinicalTrials.gov