Efficacy, Safety, and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 50 Years or Older
Efficacy, Safety, and Immunogenicity Study of GSK Biologicals' Herpes Zoster Vaccine GSK1437173A in Adults Aged 50 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 ≥ 50 years.
Two studies [ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229)] are being 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. The protocol posting of study ZOSTER-022 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 and the analyses of the objectives in 2 steps.
Step 1 will include analyses of the following objectives of ZOSTER-006 (NCT01165177): all HZ VE objectives and all reactogenicity/safety and immunogenicity objectives. At step 2, all objectives of study ZOSTER-006 (NCT01165177) will be analyzed. Objectives already analyzed at step 1 will be re-analyzed (confirmatory descriptive in case of inferential analysis at step 1 or descriptive analysis otherwise). At step 2, pooled analyses of studies ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) are planned; overall PHN VE in subjects ≥ 70 YOA, and other pre-specified endpoints will be analyzed.
Inclusion Criteria:
For this study population, non-childbearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.
OR Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination, and has a negative urine pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series;
Exclusion Criteria:
Umina, New South Wales 2257, Australia
Curitiba/Paraná, Paraná 80810-050, Brazil
Curitiba/Paraná, Paraná 80810-, Brazil
Curitiba/PR, 80240-280, Brazil
Curitiba/PR, 80240-, Brazil
Saint Cyr Sur Loir, 37540, France
Duelmen, Lower Saxony 48249, Germany
Zapopan, Jalisco, Jalisco 45190, Mexico
Kangwon-do, 220-701, South Korea
Kangwon-do, 220-70, South Korea
BalenyĂ (Barcelona), 08550, Spain
Vic/ Barcelona, 08500, Spain
Newtonabbey, BT37 9QW, United Kingdom
Newtonabbey, BT37 9, United Kingdom
Waterloo, Liverpool, L22 0LG, United Kingdom
Waterloo, Liverpool, L22 0L, United Kingdom