Study to evaluate efficacy, safety, and immunogenicity of GSK Biologicals’ Herpes Zoster vaccine GSK1437173A

INTERVENTION: Product Name: Herpes Zoster vaccine GSK 1437173A Product Code: HZ/su or gE/AS01B Pharmaceutical Form: Powder and solvent for suspension for injection Current Sponsor code: gE Other descriptive name: gE antigen Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 50‐ Pharmaceutical form of the placebo: Powder and solution for solution for injection Route of administration of the placebo: Intramuscular use CONDITION: Therapeutic area: Diseases [C] ‐ Virus Diseases [C02] Vaccination against herpes zoster (HZ) in adult autologous HCT recipients ; MedDRA version: 15.0 Level: PT Classification code 10019974 Term: Herpes zoster System Organ Class: 10021881 ‐ Infections and infestations PRIMARY OUTCOME: Main Objective: •To evaluate VE in the prevention of HZ in autologous HCT recipients 18 years of age and older Primary end point(s): Occurrence of confirmed HZ cases:; Incidence of confirmed HZ cases. Secondary Objective: •To evaluate VE in reducing the total duration of ‘worst’ HZ‐associated pain over the entire pain reporting period in autologous HCT recipients 18 years of age and older with confirmed HZ;; •To evaluate VE in the reduction of confirmed HZ‐associated complications in autologous HCT recipients 18 years of age and older;; •To evaluate VE in the prevention of Postherpetic Neuralgia (PHN) in autologous HCT recipients 18 years of age and older;; •To evaluate humoral immune responses to the study vaccine, when administered according to a 2‐dose schedule in a sub‐cohort of subjects;; •To evaluate vaccine safety and reactogenicity in autologous HCT recipients 18 years of age and older.; Timepoint(s) of evaluation of this end point: From Month 0 until study end (4 years approximately) SECONDARY OUTCOME: Secondary end point(s): 1. Duration of ‘worst’ HZ‐associated pain:Duration of HZ‐associated pain rated as 3 or greater on the ‘worst pain’ Zoster Brief Pain Inventory (ZBPI) question, following the onset of a confirmed HZ rash over the entire pain reporting period in subjects with confirmed HZ. ; 2. Occurrence of confirmed HZ‐associated complications: Incidence of confirmed HZ complications following the onset of HZ. ; 3. Occurrence of PHN: Incidence of PHN. ; 4. Antigen‐specific Antibody (Ab) concentrations in a sub‐cohort of subjects:Anti‐ gE Ab concentrations as determined by ELISA in a sub‐cohort of subjects. ; 5. Occurrence of solicited local and general symptoms:‐Occurrence and intensity of each solicited local symptom in all subjects ; ‐Occurrence, intensity and relationship to vaccination of each solicited general symptom in all subjects. ; 6. Occurrence of unsolicited adverse events (AEs):Occurrence, intensity and relationship to vaccination of unsolicited AEs, according to the Medical Dictionary for Regulatory Activities (MedDRA) classification in all subjects. ; 7. Occurrence of Serious Adverse Events (SAEs):‐ Occurrence and relationship to vaccination of all SAEs in all subjects; ; ‐Occurrence of SAEs related to the GSK study vaccine/placebo in all subjects; ; ‐Occurrence of SAEs related to study participation or to a concurrent GSK medication/vaccine in all subjects; ; ‐Occurrence of any fatal SAEs in all subjects. ; 8. Occurrence of AEs of specific interest:Occurrence of AEs of specific interest: ‐Occurrence and relationship to vaccination of any potential Immune Mediated Diseases (pIMDs) ; ‐Occurrence of relapse cases in all subjects. ; ; ; ; Timepoint(s) of evaluation of this end point: 1. From Month 0 until study end (4 years approximately), from the onset of a confirmed HZ rash over the entire pain reporting period. ; 2. From Month 0 up until study end (4 years approximately. ; 3. From Month 0 until study end (4 years approximately). ; 4. At Month 0, Month 1, Month 2, Month 13 and Month 25. ; 5. Within 7 days (Days 0‐6) after each vaccination. ; 6. During 30 days (Days 0‐29) after each vaccination. ; 7. From the Pre‐vaccination visit (Up to 110 days prior Month 0) until study end (4 years approximately). ; 8. From Month 0 until study end (4 years, approximately). INCLUSION CRITERIA: Study entry (enrolment) occurs at the Pre‐vaccination visit. •Subjects who the investigator believes can and will comply with the requirements of the protocol ; •Written informed consent obtained from the subject; •A male or female aged 18 years or older at the time of the first vaccination with the study vaccine/placebo. •Has undergone or will undergo autologous HCT within 50‐70 days prior to the first vaccination with the study vaccine/placebo, and there are no plans for additional HCTs; •Female subjects of non‐childbearing potential may be enrolled in the study; 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 with the study vaccine/placebo, and has a negative pregnancy test on th