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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00434577 |
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.
Condition | Intervention | Phase |
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Herpes Zoster (Shingles) Shingles |
Biological: Herpes Zoster vaccine GSK1437173A |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Vaccination Study to Evaluate the Safety and Immune Response of the GSK Biologicals Zoster Vaccine, GSK1437173A, and to Compare 3 Dosages of GSK1437173A in Healthy Elderly Subjects, Aged 60 Years and Above. |
Estimated Enrollment: | 715 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group A: Active Comparator
Modified formulation of GSK1437173A vaccine (1st dose) followed by placebo (2nd dose).
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Biological: Herpes Zoster vaccine GSK1437173A
Single or two-dose intramuscular injection.
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Group E: Placebo Comparator
Placebo (1st dose) followed by GSK1437173A high dose (2nd dose).
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Biological: Herpes Zoster vaccine GSK1437173A
Single or two-dose intramuscular injection.
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Group B: Experimental
Two doses of GSK1437173A low dose.
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Biological: Herpes Zoster vaccine GSK1437173A
Single or two-dose intramuscular injection.
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Group C: Experimental
Two doses of GSK1437173A medium dose.
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Biological: Herpes Zoster vaccine GSK1437173A
Single or two-dose intramuscular injection.
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Group D: Experimental
Two doses of GSK1437173A high dose.
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Biological: Herpes Zoster vaccine GSK1437173A
Single or two-dose intramuscular injection.
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The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Ages Eligible for Study: | 60 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Czech Republic | |
GSK Investigational Site | |
Hradec Kralove, Czech Republic, 500 01 | |
Germany | |
GSK Investigational Site | |
Berlin, Germany, 13347 | |
Germany, Baden-Wuerttemberg | |
GSK Investigational Site | |
Mannheim, Baden-Wuerttemberg, Germany, 68161 | |
Germany, Bayern | |
GSK Investigational Site | |
Wuerzburg, Bayern, Germany, 97070 | |
Germany, Niedersachsen | |
GSK Investigational Site | |
Hannover, Niedersachsen, Germany, 30625 | |
Germany, Nordrhein-Westfalen | |
GSK Investigational Site | |
Koeln, Nordrhein-Westfalen, Germany, 51069 | |
GSK Investigational Site | |
Essen, Nordrhein-Westfalen, Germany, 45359 | |
Netherlands | |
GSK Investigational Site | |
AMSTERDAM, Netherlands, 1018 WT | |
Sweden | |
GSK Investigational Site | |
UPPSALA, Sweden, SE-751 85 | |
GSK Investigational Site | |
ESKILSTUNA, Sweden, SE-631 88 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 108494, 108516, 108518, 108520 |
Study First Received: | February 12, 2007 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00434577 |
Health Authority: | Czech Republic: State Institute for Drug Control |
Herpes Zoster (HZ) Shingles Varicella Zoster Virus (VZV) Vaccine GSK Biologicals |
Virus Diseases Herpes Zoster Chickenpox DNA Virus Infections |
Chicken pox Healthy Varicella Zoster Herpesviridae Infections |