Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 70 Years or Older
Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 70 Years or Older
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.
This protocol summary has been updated following Protocol Amendment 4 changes to study objectives and endpoints. Pooled analyses of ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) will only be conducted if the primary objective herpes zoster vaccine efficacy (HZ VE) is demonstrated in both ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) separately.
Inclusion Criteria:
Exclusion Criteria:
Umina, New South Wales 2257, Australia
Curitiba/Paraná, Paraná 80810-050, Brazil
Curitiba/PR, 80240-280, Brazil
Saint Cyr Sur Loir, 37540, France
Duelmen, Lower Saxony 48249, Germany
Zapopan, Jalisco, Jalisco 45190, Mexico
Kangwon-do, 220-701, South Korea
Balenyà (Barcelona), 08550, Spain
Vic/ Barcelona, 08500, Spain
Newtonabbey, BT37 9QW, United Kingdom
Waterloo, Liverpool, L22 0LG, United Kingdom