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    Summary
    EudraCT Number:2012-005059-18
    Sponsor's Protocol Code Number:116886
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-06-29
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFinland - Fimea
    A.2EudraCT number2012-005059-18
    A.3Full title of the trial
    A Phase III, randomised, observer-blind, placebo-controlled, multicentre clinical study to assess the immunogenicity and safety of GSK Biologicals’ HZ/su candidate vaccine when administered intramuscularly on a 0- and 1- to 2-months schedule to adults ≥ 18 years of age with renal transplant.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity and safety of GlaxoSmithKline Biologicals’ Herpes Zoster subunit (HZ/su) vaccine in adults 18 years of age or older with renal transplant
    A.3.2Name or abbreviated title of the trial where available
    ZOSTER-041
    A.4.1Sponsor's protocol code number116886
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline Biologicals
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGlaxoSmithKline Biologicals
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Biologicals
    B.5.2Functional name of contact pointClinical Disclosure Advisor
    B.5.3 Address:
    B.5.3.1Street AddressRue de l'Institut 89
    B.5.3.2Town/ cityRixensart
    B.5.3.3Post code1330
    B.5.3.4CountryBelgium
    B.5.4Telephone number442089904466
    B.5.6E-mailGSKClinicalSupportHD@gsk.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameHerpes Zoster vaccine GSK1437173A
    D.3.2Product code HZ/su or gE/AS01B
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.2Current sponsor codegE
    D.3.9.3Other descriptive namegE antigen
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder and solution for solution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Herpes Zoster (HZ) and its related complications
    E.1.1.1Medical condition in easily understood language
    Herpes zoster (Shingles) disease
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10019974
    E.1.2Term Herpes zoster
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - 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.
    E.2.2Secondary objectives of the trial
    - 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.
    E.2.3Trial contains a sub-study No
    E.3Principal 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 ABO compatible allogeneic renal transplant.
    - Subject receiving maintenance immunosuppressive therapy for the prevention of allograft rejection for a minimum of one month (30 days) prior to the first vaccination.
    - Subject without an episode of allograft rejection over the previous three months (90 days) prior to the first vaccination.
    - Subject with stable renal function. Stability defined as: - less than 20% variability between last two creatinine measurements or calculated glomerular filtration rate [GFR]; - or in the opinion of the investigator after investigator review of more than the last two creatinine measurements or calculated GFRs.
    - Subject not less than 4 months (120 days) and not more than 18 months (547 days) after allograft transplantation at the time of the first vaccination.
    - Subjects with multiple dialysis options (peritoneal and/or more than one anatomical access site for haemodialysis) in the event acute or chronic dialysis is needed.
    - 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.
    E.4Principal exclusion criteria
    - Any primary kidney disease with a high incidence of recurrent primary kidney disease.
    - Evidence of recurrent primary kidney disease within the current allograft.
    - Previous allograft loss secondary to recurrent primary kidney disease.
    * Multiple kidney transplants are allowed if the reason for a previous alograft's loss is not recurrent primary kidney disease.
    - More than one organ transplanted (i.e., kidney-liver, double-kidney or kidney-other organ(s) transplanted).
    - History of events that, in the opinion of the investigator, may put subject at increased risk for chronic allograft dysfunction (e.g., delayed graft function, peri-operative complications).
    - Histologic reports of chronic allograft injury (e.g., transplant glomerulopathy, arteriopathy, C4d deposition).
    - Evidence of significant proteinuria in the opinion of the investigator.
    - Panel reactive antibody score (PRA or cPRA) that is unknown at the time of transplant.
    - Any autoimmune or potential immune-mediated disease, including primary kidney disease.
    - Any confirmed or suspected HIV, primary immunodeficiency disease, disseminated or untreated malignancy, or systemic infection.
    - Use of anti-CD20 or other B-cell monoclonal antibody agents (e.g., rituximab) as induction, maintenance and/or therapeutic immunosuppressive therapy for the prevention of allograft rejection within 9 months (274 days) of first dose of study vaccine/placebo.
    - 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 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.
    - Planned administration during the study of a varicella or HZ vaccine other than the study vaccine.
    - Previous vaccination against HZ or varicella within the 12 months preceding the first dose of study vaccine/placebo.
    - Occurrence of varicella or HZ per clinical history, within the 12 months preceding the first dose of study vaccine/placebo.
    - Failure to fully complete the 7-day pre-vaccination diary card distributed at the Pre-vaccination visit.
    - Evidence or high suspicion, in the opinion of the investigator, of noncompliance or nonadherence to use of induction and/or maintenance immunosuppressive therapies.
    - History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine or study material and equipment.
    - Any condition which, in the judgment of the investigator, would make intramuscular injection unsafe.
    - 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 by oral route. The preferred route for recording temperature in this study will be oral.
    *Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
    - Pregnant or lactating female.
    - Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 3.
    E.5 End points
    E.5.1Primary 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 relationship to vaccination of all SAEs.
    - Occurrence of adverse events of specific interest (AESIs):
    *Occurrence of any potential Immune-Mediated Diseases (pIMDs).
    *Occurrence of biopsy-confirmed renal allograft rejection.
    - Evaluation of allograft function:
    *Allograft function as measured by serum creatinine.
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Anti-gE humoral immunogenicity: Month 2
    - Solicited local and general symptoms: within 7 days (Days 0-6) after each vaccination
    - Unsolicited symptoms: during 30 days (Days 0-29) after each vaccination
    - SAEs: from the first vaccination up to 30 days post last vaccination
    - AESIs: from first vaccination up to 30 days post last vaccination
    - Allograft function: from first vaccination up to 30 days post last vaccination
    E.5.2Secondary 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 biopsy confirmed renal allograft rejection.
    - Evaluation of allograft function:
    *Allograft function as measured by serum creatinine.
    E.5.2.1Timepoint(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 (Month 13)
    - AESIs: from 30 days post last vaccination until study end (Month 13)
    - Allograft function: from 30 days post last vaccination until study end (Month 13)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    observer-blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Canada
    Czech Republic
    Finland
    Italy
    Korea, Republic of
    Panama
    Spain
    Taiwan
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 115
    F.4.2.2In the whole clinical trial 250
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-07-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-15
    P. End of Trial
    P.End of Trial StatusCompleted
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