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   43865   clinical trials with a EudraCT protocol, of which   7286   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:2019-001815-21
    Sponsor's Protocol Code Number:212340
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-09-09
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2019-001815-21
    A.3Full title of the trial
    A phase IIIB, open label, long term follow-up study to assess persistence of immune responses to GSK’s HZ/su vaccine 4-7 years after primary vaccination; and immunogenicity and safety assessment of revaccination with 2 additional doses of HZ/su vaccine, administered 1-2 months apart, 6-8 years after primary vaccination of adults with renal transplant from study ZOSTER-041.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test GlaxoSmithKline’s (GSK) Herpes Zoster (HZ) subunit vaccine’s long-term immune response in previously vaccinated kidney transplant adults and then to test if 2 additional doses of the vaccine are safe and able to generate an immune response.
    A.3.2Name or abbreviated title of the trial where available
    ZOSTER-073 EXT:041 Y4-10
    A.4.1Sponsor's protocol code number212340
    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 number+442089904466
    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 Yes
    D.2.1.1.1Trade name SHINGRIX
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Biologicals SA
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 subunit (HZ/su) vaccine (GSK1437173A)
    D.3.2Product code HZ/su
    D.3.4Pharmaceutical form Powder and suspension 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 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
    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
    Long-term follow-up (LTFU) phase - Immunogenicity assessment
    •To evaluate persistence of humoral immunity after primary vaccination course.
    Revaccination active phase - Immunogenicity assessment
    •To evaluate humoral immunity of Herpes zoster subunit (HZ/su) vaccine post-revaccination Doses 1 & 2.
    E.2.2Secondary objectives of the trial
    LTFU phase - Immunogenicity assessment
    •To evaluate persistence of cellular immunity after primary vaccination course.
    LTFU phase - safety assessment
    •To evaluate safety of HZ/su vaccine from the study ZOSTER-041 last visit to study ZOSTER-073 Visit 3.
    Revaccination active phase - Immunogenicity assessment
    •To evaluate cell-mediated immunity post-revaccination Doses 1 & 2.
    Revaccination follow-up phase – Immunogenicity assessment
    •To evaluate persistence of humoral and cell-mediated immune responses post-revaccination Dose 2.
    Revaccination active and follow-up phases - Safety assessment
    •To evaluate reactogenicity and safety of the HZ/su vaccine after each revaccination.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria for enrolment
    •Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol or/and subjects’ Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
    •Written informed consent obtained from the subject/LAR(s) of the subject prior to performance of any study-specific procedure.
    •Subjects who previously participated in study ZOSTER-041 and completed the full 2 dose HZ/su primary vaccination course

    Inclusion criteria for revaccination
    •Subjects receiving maintenance CIS therapy for the prevention of allograft rejection for a minimum of one month prior to the first revaccination.
    •Subjects without an episode of allograft rejection within 90 days prior to the first revaccination visit.
    •Female subjects of non-childbearing potential may be revaccinated. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
    •Female subjects of childbearing potential may be revaccinated, if the subject:
    –has practiced adequate contraception for 30 days prior to revaccination, and
    –has a negative pregnancy test on the day of revaccination, and
    –has agreed to continue adequate contraception up to 2 months after completion of the revaccination series.
    E.4Principal exclusion criteria
    Exclusion criteria for enrolment
    Medical conditions
    •Vaccination against HZ since completion of study ZOSTER-041
    •Significant underlying illness that, in the opinion of the investigator, is expected to prevent completion of the study
    •Any other condition that, in the opinion of the investigator, would interfere with the evaluations required by the study
    Prior/Concurrent clinical study experience
    •Concurrently participating in another interventional vaccine or immunosuppressive clinical study, in which the subject is exposed to an investigational or a non-investigational vaccine/product (drug) at any time during the ZOSTER-073 study

    Exclusion criteria for revaccination
    Medical conditions
    •History of confirmed HZ within one year before revaccination visit (Visit 3)
    •More than one organ transplanted
    •Any additional confirmed or suspected immunosuppressive or immunodeficient condition
    •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
    •Any other condition that, in the opinion of the investigator, would interfere with the evaluations required by the study or make vaccination unsafe
    Prior/Concomitant therapy
    •Administration or planned administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the first revaccination dose of study vaccine and ending at Visit 5 (Month 26)
    •Use of anti-CD20 or other B-cell monoclonal antibody agents as maintenance and/or therapeutic immunosuppressive therapy for the prevention of allograft rejection within 9 months of first revaccination dose of study vaccine
    •Evidence or high suspicion, in the opinion of the investigator, of noncompliance or nonadherence to use of maintenance immunosuppressive therapies
    •Planned administration/administration of a live vaccine in the period starting 30 days before the first dose and ending 30 days after the last dose of study vaccine administration
    •Planned administration/administration of a non-replicating or subunit vaccine, not foreseen by the study protocol, in the period starting 8 days before and ending 30 days after each dose of study vaccine
    Other exclusion criteria for revaccination
    •Pregnant or lactating female
    •Female planning to become pregnant or planning to discontinue contraceptive precautions up to 2 months post-revaccination Dose 2
    •Any condition which, in the judgment of the investigator, would make intramuscular injection unsafe
    E.5 End points
    E.5.1Primary end point(s)
    1. Evaluation of persistence of humoral immunity in terms of anti-glycoprotein E (anti-gE) antibody concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 1 in the LTFU phase
    2. Anti-gE antibody concentrations as determined by ELISA at Month 12, in the LTFU phase
    3. Anti-gE antibody concentrations as determined by ELISA at Month 24, in the LTFU phase
    4. Anti-gE antibody concentrations as determined by ELISA at pre-revaccination, in the revaccination active phase
    5. Anti-gE antibody concentrations as determined by ELISA at 1-month post-revaccination dose 1, in the revaccination active phase
    6. Anti-gE antibody concentrations as determined by ELISA at 1-month post-revaccination Dose 2 in the revaccination active phase
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. At Day 1
    2. At Month 12
    3. At Month 24
    4. At Month 24 (pre-vaccination)
    5. At Month 25
    6. At Month 26
    E.5.2Secondary end point(s)
    1. Evaluation of cell-mediated immune (CMI) responses in terms of frequencies of gE-specific CD4+ T-cells as determined by Intracellular Cytokine Staining (ICS) at day 1, in the LTFU phase
    2. Frequencies of gE-specific CD4+ T-cells as determined by ICS, at month 12, in the LTFU phase
    3. Frequencies of gE-specific CD4+ T-cells as determined by ICS, at month 24 in the LTFU phase
    4. Percentage of subjects with any Serious Adverse Events (SAEs) related to primary vaccination in the LTFU phase
    5. Number of subjects with history of suspected or confirmed Herpes Zoster (HZ) episode in the LTFU phase
    6. Number of subjects with a confirmed HZ episode in the LTFU phase
    7. Number of subjects with a history of suspected or biopsy-proven allograft rejections in the LTFU phase
    8. Number of subjects with biopsy-proven allograft rejections in the LTFU phase
    9. Number of subjects with allograft dysfunction related to allograft rejection episodes in the LTFU phase
    10. Number of subjects with allograft dysfunction related to HZ episodes in the LTFU phase
    11. Frequencies of gE-specific CD4+ T-cells as determined by ICS, at pre-vaccination in the Revaccination active phase
    12. Frequencies of gE-specific CD4+ T-cells as determined by ICS, at month 25 in the Revaccination active phase
    13. Frequencies of gE-specific CD4+ T-cells as determined by ICS, at month 26 in the Revaccination active phase
    14. Anti-gE antibody concentrations as determined by ELISA at 12 months post-revaccination Dose 2, in the Revaccination follow-up phase
    15. Anti-gE antibody concentrations as determined by ELISA at 24 months post-revaccination Dose 2, in the Revaccination follow-up phase
    16. Frequencies of gE-specific CD4+ T-cells as determined by ICS at month 37 in the Revaccination follow-up phase
    17. Frequencies of gE-specific CD4+ T-cells as determined by ICS at month 49 in the Revaccination follow-up phase
    18. Percentage of subjects with at least one solicited local Adverse event (AE) after each revaccination in the revaccination active and follow-up phases
    19. Percentage of subjects with any solicited general AE after each revaccination in the revaccination active and follow-up phases
    20. Percentage of subjects with any unsolicited AEs after each revaccination in the revaccination active and follow-up phases
    21. Percentage of subjects with any SAE, in the Revaccination active phase
    22. Percentage of subjects with any SAE, in the Revaccination follow-up phase
    23. Percentage of subjects with any related SAE, in the Revaccination active phase
    24. Percentage of subjects with any related SAE, in the Revaccination follow-up phase
    25. Number of subjects with biopsy-proven allograft rejections in the Revaccination active phase
    26. Number of subjects with biopsy-proven allograft rejections in the Revaccination follow-up phase
    27. Percentage of subjects with any Potential immune-mediated diseases (pIMD) in the Revaccination active phase
    28. Percentage of subjects with any Potential immune-mediated diseases (pIMD) in the Revaccination follow-up phase
    29. Number of subjects with a confirmed HZ episode in the Revaccination active phase
    30. Number of subjects with a confirmed HZ episode in the Revaccination follow-up phase
    31. Number of subjects with allograft dysfunction following revaccination in the revaccination active phase
    32. Number of subjects with allograft dysfunction following revaccination in the revaccination follow-up phase
    33. Number of subjects with allograft dysfunction related to allograft rejection in the Revaccination active phase
    34. Number of subjects with allograft dysfunction related to allograft rejection in the Revaccination follow-up phase
    35. Number of subjects with allograft dysfunction related to HZ episodes in the Revaccination active phase
    36. Number of subjects with allograft dysfunction related to HZ episodes in the Revaccination follow-up phase
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At Day 1
    2. At Month 12
    3. At Month 24
    4. From Month 13 (last visit in study ZOSTER-041) to Month 24 (Visit 3 in study ZOSTER-073)
    5 and 7. From Month 13 (last visit in study ZOSTER-041) to Day 1 (Visit 1 in study ZOSTER-073)
    6 and 8. From Day 1 to Month 24
    9 and 10. From Month 13 (last visit in study ZOSTER-041) to Month 24 (Visit 3 in study ZOSTER-073)
    11. At Month 24 (pre-vaccination)
    12. At Month 25
    13. At Month 26
    14, 16, 22 and 28. At Month 37
    15 and 17. At Month 49
    18 and 19. Within 7 days after each revaccination
    20. Within 30 days after each revaccination
    21, 23, 25, 27, 29, 31, 33 and 35. From Month 24 to Month 26
    24 and 26. At Month 37 and Month 49
    30, 34 and 36. From Month 26 to Month 49
    32. From Month 26 to Month 37
    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 No
    E.8.1.1Randomised No
    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 No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Canada
    Korea, Republic of
    Panama
    Taiwan
    Belgium
    Finland
    Spain
    E.8.7Trial has a data monitoring committee No
    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
    No later than 8 months after LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days22
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days22
    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: 71
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 Yes
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 53
    F.4.2.2In the whole clinical trial 86
    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 Decision2019-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-23
    P. End of Trial
    P.End of Trial StatusOngoing
    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-Sun Apr 28 23:47:12 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA