Herpes Zoster (HZ) and its related complications MedDRA version: 14.1 Level: PT Classification code 10019974 Term: Herpes zoster System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Vacuna herpes zoster GSK1437173A
Product Code: HZ/su
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: -
Current Sponsor code: gE
Other descriptiv
Sponsors
GlaxoSmithKline S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol. - A male or female, aged 18 years or older, and having reached the age of legal consent, on the date the informed consent is signed. - Written informed consent obtained from the subject. - Subject who has received an allogeneic renal transplant. - Subject receiving maintenance immunosuppressive therapy for the prevention of allograft rejection. - Subject without an episode of allograft rejection over the previous three months. - Subject not more than 1.5 years after allograft transplantation. - Female subjects of non-childbearing potential may be enrolled in the study. - 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 pregnancy test on the day of the first vaccination, and *has agreed to continue adequate contraception during the primary treatment period and for 2 months after completion of the vaccination series. 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 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: - Use of rituximab as induction and/or maintenance immunosuppressive therapy for the prevention of allograft rejection. - 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. - Concurrent or planned participation in another clinical study, at any time during the study period, which has exposed or will expose the subject to an investigational or a non-registered vaccine/product. - Administration or planned administration of a live vaccine within 30 days prior to the first dose of study vaccine and ending 30 days after the last dose of study vaccine, or, administration or planned administration of a non-replicating vaccine within 8 days prior to or within 14 days after either dose of study vaccine. - Any confirmed or suspected HIV, primary immunodeficiency disease, disseminated or untreated malignancy, or systemic infection. - Occurrence of varicella or HZ per clinical history, within the 12 months preceding the first dose of study vaccine/placebo. - 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 varicella or HZ vaccine other than the study vaccine. - History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine or study material and equipment. - Any other condition 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 vaccination. *Fever is defined as temperature ? 37.5°C /99.5°F on oral, axillary or tympanic route. 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. - Failure to fully complete the 7-day pre-vaccination diary card distributed at the Pre-vaccination visit. - Any condition which, in the judgment of the investigator, would make intramuscular injection unsafe. - Pregnant or lactating female. - Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 3.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To evaluate vaccine response rate (VRR) for anti-gE humoral immune responses at Month 2, following a two-dose administration of the HZ/su vaccine, in all subjects. - To evaluate the safety and reactogenicity following administration of HZ/su vaccine as compared to placebo from the first vaccination up to 30 days post last vaccination in all subjects.;Secondary Objective: - To evaluate the anti-gE humoral immune response at Month 2, following a two-dose administration of the HZ/su vaccine, as compared to placebo, in all subjects. - To characterise anti-gE humoral immune responses at Months 0, 1, 2, 7 and 13, within the HZ/su and placebo groups, in all subjects. - To evaluate VRR for gE-specific CD4+ T-cell mediated immune responses at Month 2, following a two-dose administration of the HZ/su vaccine, in the CMI sub-cohort. - To evaluate gE-specific CD4+ T-cell mediated immune (CMI) response at Month 2 following a two-dose administration of the HZ/su vaccine, as compared to placebo, in the CMI sub-cohort. - To characterise gE-specific CD4+ T-cell mediated immune responses at Months 0, 2 and 13, within the HZ/su and placebo groups, in the CMI sub-cohort. - To evaluate safety following administration of HZ/su vaccine, as compared to placebo, from 30 days post last vaccination until study end in all subjects.;Primary end point(s): - Evaluation of anti-gE humoral immunogenicity, in all subjects, in terms of vaccine response: *Vaccine response for anti-gE humoral immunogenicity, as determined by ELISA. - Occurrence of solicited local and general symptoms: *Occurrence, intensity and duration of each solicited local symptom. *Occurrence, intensity, duration and relationship to vaccination of each solicited general symptom. - Occurrence of unsolicited symptoms: *Occurrence, intensity and relationship to vaccination of unsolicited adverse events (AEs), according to the MedDRA classification. - Occurrence of serious adverse events (SAEs): *Occurrence and r | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Evaluation of anti-gE humoral immunogenicity in terms of antibody concentrations: *Anti-gE Ab concentrations, as determined by ELISA in all subjects. *Vaccine response for anti-gE humoral immunogenicity, as determined by ELISA in all subjects. - gE-specific CD4+ T-cell mediated immunogenicity, in the CMI sub-cohort: *Frequencies of gE-specific CD4+ T-cells, expressing at least two activation markers, as determined by in vitro ICS. *Vaccine response for gE-specific CD4+ T-cells expressing at least two activation markers, as determined by in vitro ICS. - Occurrence of SAEs: *Occurrence and relationship to vaccination of all SAEs. - Occurrence of AESIs: *Occurrence of any pIMDs. *Occurrence of renal allograft rejection.;Timepoint(s) of evaluation of this end point: - Anti-gE Ab concentrations: at Months 0, 1, 2, 7 and 13 - Vaccine response for anti-gE humoral immunogenicity: at Months 1, 7 and 13 - Frequencies of gE-specific CD4+ T cells: at Months 0, 2 and 13 - Vaccine response for gE-specific CD4+ T cells: at Months 2 and 13 - SAEs: from 30 days post last vaccination until study end - AESIs: from 30 days post last vaccination until study end | — |
Countries
Belgium, Canada, Colombia, Czech Republic, Finland, Korea, Republic of, Panama, Spain, Taiwan
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed