Safety and Immunogenicity of the Zoster Vaccine GSK1437173A in Elderly Subjects

NCT00434577 PHASE2 COMPLETED Results posted

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.

Details

Lead sponsor	GlaxoSmithKline
Phase	PHASE2
Status	COMPLETED
Enrolment	715
Start date	Wed Feb 14 2007 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Wed Jul 14 2010 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Herpes Zoster

Interventions

• Herpes Zoster vaccine GSK1437173A Low Dose
• Herpes Zoster vaccine GSK1437173A Medium Dose
• Herpes Zoster vaccine GSK1437173A High Dose
• Herpes Zoster vaccine GSK1437173A Modified
• Placebo

Countries

Sweden, Netherlands, Germany, Czechia