Conditions: Herpes Zoster
Keywords: Immunocompromised Safety ≥ 18 years of age Renal transplant Adults Immunosuppressed Immunogenicity Herpes zoster
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 265
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine administered on a 0- and 1- to 2-months schedule in adults 18 years of age or older who are receiving chronic immunosuppressive therapy.

Detailed description:

Arms:
arm 1: Subjects, aged 18 years or older, received 2 doses of the GSK 1437173A vaccine, adjuvanted with AS01B at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm. arm 2: Subjects, aged 18 years or older, received 2 doses of Placebo (lyophilised sucrose reconstituted with saline \[NaCl\] solution) at Day 0, and Month 1, administered intramuscularly, in the deltoid muscle of an arm.

Interventions: intervention 1: Herpes Zoster vaccine GSK1437173A intervention 2: Placebo
Intervention descriptions: intervention 1: 2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm. intervention 2: 2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.

Protocol document: