Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2019-000607-33
    Sponsor's Protocol Code Number:200075
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-08-22
    Trial 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 ConcernedUK - MHRA
    A.2EudraCT number2019-000607-33
    A.3Full title of the trial
    A Phase II, randomized, open-label, multicentre study to assess the reactogenicity, safety and immunogenicity of GSK’s paediatric Herpes Zoster subunit candidate vaccine (PED-HZ/su) when administered intramuscularly on a two-dose schedule to immunocompromised paediatric renal transplant recipients from 1 to 17 years of age.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test GlaxoSmithKline’s (GSK) candidate vaccine-GSK1437173A for prevention of shingles in children with kidney transplant
    A.3.2Name or abbreviated title of the trial where available
    ZOSTER-047
    A.4.1Sponsor's protocol code number200075
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/222/2018
    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 number+44208990 44 66
    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 namePED-HZ/su (Pediatric Herpes Zoster subunit (HZ/su) vaccine)
    D.3.2Product code gE (50µg) + AS01E
    D.3.4Pharmaceutical form Powder and suspension for suspension for injection
    D.3.4.1Specific paediatric formulation Yes
    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 INNVaricella Zoster Virus glycoprotein E antigen
    D.3.9.2Current sponsor codegE antigen
    D.3.9.3Other descriptive nameRECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E
    D.3.9.4EV Substance CodeSUB31416
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Herpes Zoster
    Renal transplant
    Pediatric population
    E.1.1.1Medical condition in easily understood language
    Shingles
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    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 reactogenicity (up to Day 7) and safety (up to Month 2) following administration of PED-HZ/su in each age category (1-11 and 12-17 years)
    •To evaluate humoral immune responses following administration of PED-HZ/su in each age category (1-11 and 12-17 years) at Month 2
    E.2.2Secondary objectives of the trial
    •To evaluate safety following administration of PED-HZ/su in each age category (1-11 and 12-17 years) from Day 1 up to Month 13
    •To describe the occurrence of cases of HZ in each age category (1-11 and 12-17 years)
    •To evaluate reactogenicity and safety for the entire study population (1-17 years) following administration of PED-HZ/su
    •To characterise humoral immune responses following administration of PED-HZ/su
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Subjects’ parent(s)/Legally Acceptable Representative(s) [LAR(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol
    •Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the subject prior to performance of any study specific procedure.
    •Written informed assent obtained from the subjects when applicable according to local requirements.
    •A male or female between, and including, 1 and 17 years of age at the time of randomisation (Visit Day 1)
    •Body weight ≥ 6 kg/13.23 pounds.
    •A subject is eligible if they meet at least one of the following criteria:
    -Documented previous VZV vaccination OR
    -Medically verified varicella (with source documentation) OR
    -Seropositive for VZV prior to transplantation.
    •Subjects with renal transplant more than six months (180 days) prior randomization (Visit Day 1)
    •Subject who has received an ABO compatible allogeneic renal transplant (allograft).
    •Subject with stable renal function with stability defined as <20% variability between the last two creatinine measurements or based on investigator opinion after review of multiple creatinine measurements.
    •Subject receiving maintenance immunosuppressive therapy for the prevention of allograft rejection for a minimum of one month (30 days) prior to randomization (Visit Day 1).
    •Female subjects of childbearing potential may be enrolled in the study, if the subject
    -has practiced adequate contraception for 30 days prior to Visit Day 1 and has agreed to continue adequate contraception during the entire 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 within the allograft
    •Evidence of recurrent primary kidney disease within the current allograft
    •Previous allograft loss secondary to recurrent primary kidney disease
    •History of more than one organ transplanted (i.e. kidney-liver, simultaneous double kidney or kidney-other organ(s) transplanted).
    •Subjects with an episode of acute allograft rejection over the six months (180 days) prior to enrolment
    •Panel Reactive Antibodies (PRA) calculated PRA (cPRA) or Calculated Reaction Frequency (cRF) score that is unknown at the time of transplant
    •VZV serostatus unknown prior to transplant
    •Subjects with advanced chronic kidney disease
    •Evidence of significant proteinuria (≥ 200 g/mol creatinine) believed to be of renal origin (an example of non-renal origin is proteinuria from mucus in a reconstructed bladder).
    •Subjects without multiple dialysis options in the event acute or chronic dialysis needed.
    •History of unstable or progressive neurological disorder.
    •Subjects <= 5 years of age with a history of one or more simple or complex febrile seizures
    •Subjects > 5 years with history of one or more complex febrile seizures
    •Occurrence of a varicella or HZ episode by clinical history within the 6 months (180 days) preceding Visit Day 1
    •Any autoimmune disease, with the following exceptions which do not constitute an exclusion criterion:
    -IgA nephropathy
    -Rapidly progressive glomerulonephritis
    -Membranous glomerulonephritis
    -Idiopathic Type I membranoproliferative glomerulonephritis
    -Diabetes mellitus (type 1 and 2) with diabetic nephropathy
    •Confirmed or suspected Human Immunodeficiency Virus or primary immunodeficiency disease
    •Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study
    •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
    •Any condition which, in the judgement of the investigator would make intramuscular injection unsafe
    •Atypical Haemolytic Uraemic Syndrome
    •Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before Visit Day 1 (Day -29 to Day -1), or planned use during the study period.
    •Use of anti-CD20 or other B-cell monoclonal antibody agents within 1 year of Visit Day 1 or planned administration during the duration of the study
    •Administration of blood products 3 months (90 days) prior to Visit Day 1 or planned administration during the duration of the study
    •Administration of immunoglobulins 6 months (180 days) prior to Visit Day 1 or planned administration of immunoglobulins during the duration of the study
    •Administration or planned administration of a vaccine within 30 days prior to Visit Day 1 up to Visit Month 2 with the exception of an inactivated or subunit influenza vaccine which may be given 8 days prior to or 14 days after Visits Day 1 and 8 days prior to or 14 days after Visit Month 1.
    •Previous vaccination against HZ
    •Varicella vaccination within the 6 months (180 days) preceding Visit Day 1
    •Planned administration during the study of an HZ or varicella vaccine (including an investigational or non-registered vaccine) other than the study vaccine
    •Concurrent or planned participation 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
    -available locally through compassionate use programs,
    -submitted for and pending local/country registration,
    -approved and registered for use in other countries with well-documented Summary of Product Characteristics or Prescribing Information
    -The name of the active component(s) of these immunosuppressants must be provided in the concomitant medication listing
    •Child in care
    •Pregnant or lactating female
    •Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) between one month (30 days) prior to Visit Day 1 through two months (60 days) after Visit Month 1.
    •Evidence or high suspicion, in the opinion of the investigator, of non-compliance or non-adherence to use of induction and/or maintenance immunosuppressive therapies.
    •Failure to fully complete the 7-day pre-vaccination diary card distributed at the Pre-vaccination visit
    -Completion must cover the 7 days immediately prior to randomisation (Visit Day 1)
    -Completion is defined as a minimum of 6 days completed
    -Subjects with less than 6 days completed may be offered a new date for Visit Day 1 and the opportunity to comply with the completion of the 7-day pre-vaccination diary card prior to the new planned Visit Day 1
    •Any study personnel or their immediate dependants, family, or household member
    E.5 End points
    E.5.1Primary end point(s)
    1. Number of subjects from the interventional groups, with solicited local adverse events (AEs)
    2. Number of subjects from the interventional groups, with solicited general AEs
    3. Number of subjects from the control groups with solicited general symptoms
    4. Number of subjects from the control groups with solicited general symptoms
    5. Number of subjects from the interventional groups with unsolicited AEs after each vaccination
    6. Number of subjects from the control groups with unsolicited symptoms
    7. Number of subjects from the control groups with unsolicited symptoms
    8. Number of subjects with serious adverse events (SAEs), potential immune mediated diseases (pIMDs) and biopsy confirmed renal allograft rejection
    9. Number of subjects from the interventional groups with seizures
    10. Number of subjects from the non-interventional groups with seizures
    11. Number of subjects from the non-interventional groups with seizures
    12. Number of subjects from the interventional groups with generalized convulsive seizures
    13. Number of subjects from the non-interventional groups with generalized convulsive seizures
    14. Number of subjects from the non-interventional groups with generalized convulsive seizures
    15. Percentage of subjects with Anti-gE antibody concentrations in terms of Geometric Mean Concentrations (GMCs)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Within 7 days after each vaccination
    2. Within 7 days after each vaccination
    3. Within 7 days after Visit Day 1
    4. Within 7 days after Visit Month 1
    5. Within 30 days after each vaccination
    6. Within 30 days after Visit Day 1
    7. Within 30 days after Visit Month 1
    8. From Visit Day 1 up to Visit Month 2
    9. Within 30 days after each vaccination
    10. Within 30 days after Visit Day 1
    11. Within 30 days after Visit Month 1
    12. Within 7 days after each vaccination
    13. Within 7 days after Visit Day 1
    14. Within 7 days after Visit Month 1
    15. At Month 2 (one-month post-dose 2)
    E.5.2Secondary end point(s)
    1. Number of subjects with SAEs, pIMDs and biopsy confirmed renal allograft rejections from day 1 to month 13
    2. Occurrence of Herpes Zoster cases
    3. Number of subjects from the interventional pooled age group with solicited local AEs
    4. Number of subjects from the interventional pooled age group with solicited general AEs
    5. Number of subjects from the non-interventional pooled age group with solicited general symptoms
    6. Number of subjects from the interventional pooled age group with unsolicited AEs after each vaccination
    7. Number of subjects from the non-interventional pooled age group with unsolicited symptoms
    8. Number of subjects from the pooled age groups with any SAEs, pIMDs and biopsy confirmed renal allograft rejections
    9. Number of subjects from the pooled age groups with HZ
    10. Number of subjects from the interventional pooled age group with seizures
    11. Number of subjects from the non-interventional pooled age group with seizures
    12. Number of subjects from the interventional pooled age group with generalized convulsive seizures
    13. Number of subjects from the non-interventional pooled age group with generalized convulsive seizures
    14. Vaccine Response Rate (VRR) for Anti-glycoprotein (Anti-gE) antibody concentrations
    15. Median fold increase of anti-gE antibody concentrations
    16. Percentage of subjects with anti-gE antibody concentrations in terms of GMCs
    17. Percentage of subjects in the interventional pooled age group, with Anti-gE antibody concentrations in terms of GMCs
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. From Visit Day 1 up to Visit Month 13
    2. From Visit Day 1 until Visit Month 13
    3. Within 7 days after each vaccination
    4. Within 7 days after each vaccination
    5. Within 7 days after Visit Day 1 and visit Month 1
    6. Within 30 days after each vaccination
    7. Within 30 days after Visit Day 1 and Visit Month 1
    8. From Visit Day 1 until Visit Month 2 and From Visit Day 1 until Visit Month 13
    9. From Visit Day 1 until Visit Month 13
    10. Within 30 days after each vaccination
    11. Within 30 days after Visit Day 1 and Visit Month 1
    12. Within 7 days after each vaccination
    13. Within 7 days after Visit Day 1 and Visit Month 1
    14. At Month 2 and Month 13
    15. At Month 2 and Month 13
    16. At Day 1 (pre-vaccination) and Month 13
    17. At Day 1, Month 2 and Month 13
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    No study vaccination, treatment according to local standard of care, including routine vaccination
    E.8.2.4Number of treatment arms in the trial4
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Last testing results released of samples collected at Visit Month 13
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 184
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 92
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 92
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 184
    F.4.2.2In the whole clinical trial 184
    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 Decision2019-06-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-28
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 25 02:18:12 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA