Vaccination against herpes zoster (HZ) in adult autologous HCT recipients MedDRA version: 18.0 Level: PT Classification code 10019974 Term: Herpes zoster System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Herpes Zoster vaccine GSK 1437173A
Product Code: HZ/su or gE/AS01B
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: gE antigen
Current Sponsor co
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
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 study entry. •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 the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 12 months after completion of the vaccination series (i.e., until Month 13). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1419 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 707
Exclusion criteria
Exclusion criteria: •Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo, or planned use during the study period. However, the investigational use of a registered or non-registered product to treat the subject’s underlying disease for which the HCT was undertaken, or a complication of the underlying disease, is allowed; •Previous vaccination against HZ or varicella within the 12 months preceding the first dose of study vaccine/placebo; •Planned administration during the study of a HZ vaccineother than the study vaccine; •Occurrence of a varicella or HZ episode by clinical history within the 12 months preceding the first dose of study vaccine/placebo; •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine or study material and equipment; •Prophylactic antiviral therapy with activity against VZV expected to last more than 6 months after transplantation; •Administration and/or planned administration of a vaccine not foreseen by the study protocol between HCT and 30 days after the last dose of study vaccine/placebo. However, licensed non-replicating vaccines may be administered up to 8 days prior to dose 1and/or 2, and/or at least 14 days after any dose of study vaccine/placebo; •HIV infection by clinical history; •Pregnant or lactating female; •Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 13 (i.e., one year after the last dose of study vaccine/placebo).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To evaluate VE in the prevention of HZ in autologous HCT recipients 18 years of age and older;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. ;Primary end point(s): Occurrence of confirmed HZ cases: Incidence of confirmed HZ cases.;Timepoint(s) of evaluation of this end point: From Month 0 until study end (4 years approximately) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Mo | — |
Countries
Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Czech Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Korea, Republic of, Malaysia, Netherlands, New Zealand, Panama, Poland, Romania, Russian Federation, South Africa, Spain, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed