Primary immunization of subjects = 70 YOA against Herpes Zoster (HZ). The study population includes males and females without severely immunocompromising conditions in the age ranges 70-79 YOA and = 80 YOA. MedDRA version: 17.0 Level: LLT Classification code 10019982 Term: Herpes zoster NOS System Organ Class: 100000004862
Conditions
Interventions
Product Name: gE recombinant protein formulated in AS01B Adjuvant System
Product Code: gE/AS01B
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: NA
Current Spo
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Subjects who the investigator believes will comply with the requirements of the protocol (e.g. completion of the diary cards/questionnaires, return for follow-up visits, have regular contact to allow evaluation during the study); •Written informed consent obtained from the subject; •A male or female aged 70 years or older at the time of the first vaccination. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14512
Exclusion criteria
Exclusion criteria: •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period; •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device); •Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, HIV infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders); •History of HZ; •Previous vaccination against varicella or HZ (either registered product or participation in a previous vaccine study, and including previous vaccination with childhood varicella vaccine); •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Additionally, consider allergic reactions to other material or equipment related to study participation (such as materials that may possibly contain latex -gloves, syringes, etc). Please note, the vaccine and vials in this study do not contain latex; •Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 4 years); •Receipt of immunoglobulins and/or any blood products within the 90 days preceding the first dose of study vaccine or planned administration during the study period; •Administration or planned administration of any other immunizations within 30 days before the first or second study vaccination or scheduled within 30 days after study vaccination. However, licensed non-replicating vaccines (i.e., inactivated and subunit vaccines, including inactivated and subunit influenza vaccines for seasonal or pandemic flu, with or without adjuvant) may be administered up to 8 days prior to each dose and/or at least 14 days after any dose of study vaccine; •Any other condition (e.g., extensive psoriasis, chronic pain syndrome, cognitive impairment, severe hearing loss) that, in the opinion of the investigator, might interfere with the evaluations required by the study; •Acute disease and/or fever at the time of enrolment; Fever is defined as temperature = 37.5°C (99.5°F) on oral, axillary or tympanic setting, or = 38.0°C (100.4°F) on rectal setting. The preferred route for recording temperature in this study will be oral. Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator. •Chronic administration (defined as more than 15 consecutive days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone < 20 mg/day, or equivalent, is allowed. Inhaled and topical steroids are allowed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 3 to 5 year period following Day 0;Main Objective: *Primary objective for study ZOSTER-022: •To evaluate vaccine efficacy (VE) in the prevention of HZ compared to placebo in adults =70 YOA, as measured by the reduction in HZ risk; *Primary objectives for pooled analysis of studies ZOSTER-006 (EudraCT nr 2008-000367-42; study 110390) and ZOSTER-022: •To evaluate VE in the prevention of PHN compared to placebo in subjects =70 YOA across both phase III studies; •To consolidate VE estimation in the prevention of HZ compared to placebo in subjects =70 YOA across both phase III studies.;Secondary Objective: *For ZOSTER-022: To evaluate the following compared to placebo in subjects =70 YOA - •VE in the prevention of overall PHN; •VE in reducing the total duration of severe 'worst' HZ-associated pain over the entire pain reporting period, with confirmed HZ; •VE in the reduction of overall and HZ-related mortality and hospitalizations; •VE in the reduction in incidence of HZ-associated complications, with confirmed HZ; •VE in the reduction in use of pain medications, with confirmed HZ; •Vaccine safety and reactogenicity (all subjects). *For the pooled analysis of ZOSTER-006 (110390) and ZOSTER-022: To evaluate the following compared to placebo - •VE in the prevention of overall PHN in subjects =50 YOA; •VE in the prevention of PHN in subjects =50 YOA with confirmed HZ; •VE in reducing the total duration of severe 'worst' HZ-associated pain over the entire pain reporting period in subjects = 70 YOA, with confirmed HZ; •Vaccine safety and reactogenicity in subjects =70 YOA. ;Primary end point(s): *Primary endpoint in study ZOSTER-022: •Confirmed HZ cases: Confirmed HZ cases during the study in the mTVc. *Primary endpoints in pooled analysis of studies ZOSTER-006 and ZOSTER-022: •Occurrence of overall PHN: Incidence of PHN calculated using the mTVc during the entire study period in subjects =70 YOA; •Occurrence of confirmed | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): *Secondary endpoints in study ZOSTER-022: •1. PHN cases: PHN cases in the mTVc; •2. Duration of severe ‘worst’ HZ-associated pain: Duration of severe ‘worst’ HZ-associated pain following the onset of a confirmed HZ rash as measured by the ZBPI in subjects with confirmed HZ; •3. Incidence of overall and HZ-related mortality; •4. Incidence of HZ complications in subjects with confirmed HZ; •5. Incidence of overall and HZ-related hospitalizations; •6. Duration of pain medication administered for HZ in subjects with confirmed HZ; •7. Occurrence of solicited local and general symptoms in a subset of subjects; •8. Occurrence, intensity and relationship to vaccination of unsolicited adverse events (AEs), according to the Medical Dictionary for Regulatory Activities (MedDRA) classification, in all subjects; •9. Occurrence of Serious Adverse Events (SAEs) in all subjects; •10. Occurrence of SAEs related to study participation or to a concurrent GSK medication/vaccine in all subjects; •11. Occurrence of fatal SAEs in all subjects; 12. Occurrence and relationship to vaccination of any pre-defined AEs in all subjects; •13. Occurrence and relationship to vaccination of any medically attended visits (defined as hospitalizations, emergency room visits or visits to or from medical personnel), other than routine health care visits, in all subjects. *Secondary endpoints for ZOSTER-006 and ZOSTER-022 pooled analysis: •14. Occurrence of overall PHN: Incidence of PHN calculated using the mTVc in subjects =50 YOA; •15. Occurrence of PHN in subjects =50 YOA with confirmed HZ; •16. Duration of severe ‘worst’ HZ-associated pain following the onset of a confirmed HZ rash as measured by the ZBPI in subjects =70 YOA with confirmed HZ; •17. Occurrence of solicited local and general symptoms in subjects =70 YOA included in a subset of subjects; •18. Occurrence, intensity and relationship to vaccination of unsolicited AEs, according to the MedDRA class | — |
Countries
Australia, Brazil, Canada, Czech Republic, Estonia, Finland, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of, Mexico, Spain, Sweden, Taiwan, United Kingdom, United States
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed