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    Summary
    EudraCT Number:2012-003438-18
    Sponsor's Protocol Code Number:116428
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-01-08
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-003438-18
    A.3Full title of the trial
    A Phase III, randomised, observer-blind, placebo-controlled, multicentre study to assess the safety and immunogenicity of GSK Biologicals’ Herpes Zoster HZ/su candidate vaccine when administered intramuscularly on a two-dose schedule to adults aged 18 years and older with haematologic malignancies
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to check safety and immune response of GSK Biologicals' Herpes Zoster vaccine GSK1437173A in adults aged 18 years and older with blood cancers
    A.3.2Name or abbreviated title of the trial where available
    ZOSTER-039
    A.4.1Sponsor's protocol code number116428
    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
    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
    Vaccination against HZ in adults with haematologic malignancies.
    E.1.1.1Medical condition in easily understood language
    Vaccination against shingles in adults with blood cancers.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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 the safety and reactogenicity following administration of the HZ/su vaccine compared to placebo from the first vaccination up to 30 days post last vaccination in subjects with haematologic malignancies, aged 18 years and older.
    - To evaluate vaccine response rate for anti-gE humoral immune responses at Month 2 following a two-dose administration of the HZ/su vaccine in subjects with haematologic malignancies excluding subjects with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia.
    E.2.2Secondary objectives of the trial
    In subjects with haematologic malignancies aged 18 years and older:
    - Evaluate safety following administration of HZ/su vaccine compared to placebo: from 1st vaccination up to 6 months post vaccination in at least 50% of the total vaccinated cohort, and, from 30 days post vaccination until study end.
    - Evaluate anti-gE humoral immune responses at Month 2 following two doses of the HZ/su vaccine: compared to placebo, excluding subjects with NHBCL and CLL, and excluding subjects with NHBCL; and VRR, excluding subjects with NHBCL.
    - Evaluate incidence of confirmed HZ cases.
    - Characterize anti-gE humoral immune responses at Month 0, 1, 2 and 13 within HZ/su and placebo groups by underlying disease strata.
    - Characterize gE-specific CD4+ T-cell mediated immune responses at Month 0, 1, 2 and 13 within HZ/su and placebo groups in the CMI sub-cohort and by underlying disease strata.
    - Assess correlation of HZ/su vaccine-induced humoral immune responses with protection against HZ.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Subjects who the investigator believes can and will comply with the requirements of the protocol;
    - Written informed consent obtained from the subject;
    - A male or female, aged 18 years or older at the time of study entry;
    - Subject who has been diagnosed with one or more haematologic malignancies prior to the first vaccination and who is receiving, is scheduled to receive or has just finished immunosuppressive cancer therapy to treat this condition;
    - Life expectancy greater than or equal to 12 months, as assessed by the investigator;
    - Female subjects of non-childbearing potential may be enrolled in the study;

    For this study population, non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause
    OR
    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 vaccination, 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
    - Subject diagnosed with chronic lymphocytic leukaemia (CLL) who is receiving only oral cancer therapy (subject receiving intra-venous cancer therapy for CLL or intra-venous cancer therapy in combination with oral therapy may be enrolled);
    - Subject receiving radiotherapy alone as treatment for his/her haematologic malignancy;
    - Planned haematopoietic stem cell transplant (HCT) during the study period. (If a HCT occurred prior to enrolment in the study, the subject may not receive study vaccine until at least 50 days after the transplant procedure.);
    - HIV infection by clinical history;
    - 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/placebo, or planned use during the study period. However, the investigational use of a registered product to treat the subject’s underlying disease, is allowed;
    - 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 HZ or varicella vaccine (including an investigational or non-registered vaccine) other than the study vaccine;
    - Occurrence of a varicella or HZ episode by clinical history within the 12 months preceding the first dose of study vaccine/placebo;
    - History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine;
    - Administration or planned administration of a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine;
    - Administration or planned administration of a non-replicating vaccine* within 8 days prior to or within 14 days after either dose of study vaccine (* inactivated and subunit vaccines, including inactivated and subunit influenza vaccines and pneumococcal conjugate vaccines):
    - Pregnant or lactating female;
    - Female planning to become pregnant or planning to discontinue contraceptive precautions before Month 3 (i.e., 2 months after the last dose of study vaccine/placebo).
    E.5 End points
    E.5.1Primary end point(s)
    * Occurrence of solicited local and general symptoms.
    - Occurrence, intensity and duration of each solicited local symptom in all subjects.
    - Occurrence, intensity, duration and relationship to vaccination of each solicited general symptom in all subjects.
    * Occurrence of unsolicited adverse events (AEs).
    - Occurrence, intensity and relationship to vaccination of unsolicited AEs according to the Medical Dictionary for Regulatory Activities (MedDRA) classification, in all subjects.
    * Occurrence of serious adverse events (SAEs).
    - Occurrence and relationship to vaccination of all SAEs in all subjects.
    * Occurrence of AEs of specific interest.
    - Occurrence and relationship to vaccination of any potential Immune-Mediated Diseases (pIMDs) in all subjects.
    * Anti gE humoral immunogenicity in all vaccinated subjects excluding subjects with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia.
    - Vaccine response for anti-gE humoral immunogenicity, as determined by ELISA.

    E.5.1.1Timepoint(s) of evaluation of this end point
    Solicited symptoms: Up to 7 days (Days 0-6) after each vaccination
    Unsolicited AEs: Up to 30 days (Days 0-29) after each vaccination
    SAEs and AEs of specific interest: Up to 30 days post last vaccination
    Anti-gE humoral immunogenicity: At Month 2
    E.5.2Secondary end point(s)
    * Occurrence of SAEs
    1. Occurrence and relationship to vaccination of all SAEs in at least 50% of the total vaccinated cohort.
    2. Occurrence and relationship to vaccination of all SAEs in all subjects.
    * Occurrence of AEs of specific interest.
    1. Occurrence of any pIMDs in at least 50% of the total vaccinated cohort.
    2. Occurrence of any pIMDs in all subjects.
    * Anti gE humoral immunogenicity in all vaccinated subjects excluding subjects with Non-Hodgkin B-cell Lymphoma.
    - Vaccine response for anti-gE humoral immunogenicity, as determined by ELISA.
    - Anti-gE antibody concentrations, as determined by ELISA.
    * Anti gE humoral immunogenicity in all vaccinated subjects excluding subjects with Non-Hodgkin B-cell Lymphoma and Chronic Lymphocytic Leukaemia.
    - Anti-gE antibody concentrations, as determined by ELISA.
    * Occurrence of confirmed HZ cases
    * Anti-gE humoral immunogenicity in all vaccinated subjects.
    1. Anti-gE antibody concentrations, as determined by ELISA.
    2. Vaccine response for anti-gE humoral immunogenicity, as determined by ELISA.
    * gE-specific CD4+ T-cell-mediated immunogenicity response in the CMI sub-cohort.
    1. Frequencies of gE-specific CD4+ T-cells, expressing at least 2 activation markers (from among IFN-γ, IL-2, TNF-α and CD40L), as determined by in vitro intracellular cytokine staining (ICS).
    2. Vaccine response for gE-specific CD4+ T-cells expressing at least 2 activation markers (from among IFN-γ, IL-2, TNF-α and CD40L), as determined by in vitro ICS
    * Anti-gE humoral immunogenicity in subjects with confirmed HZ and matched controls.
    - Anti-gE antibody concentrations, as determined by ELISA.
    E.5.2.1Timepoint(s) of evaluation of this end point
    SAEs and AEs of specific interest:
    1. From first vaccination up to 6 months post last vaccination,
    2. From 30 days post last vaccination until study end
    Anti-gE humoral immunogenicity excluding subjects with Non-Hodgkin b-cell Lymphoma and/or Chronic Lymfocytic Leukaemia: At Month 2
    HZ cases: From Month 0 until study end
    Anti-gE humoral immunogenicity in all vaccinated subjects and CMI in the CMI sub-cohort:
    1. At Month 0, Month 1, Month 2 and Month 13,
    2. At Month 1, Month 2 and Month 13
    Anti-gE humoral immunogenicity in subjects with confirmed HZ cases and matched controls: At Month 0 and at Month 2
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA47
    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
    Australia
    Belgium
    Brazil
    Canada
    Czech Republic
    Finland
    France
    Hong Kong
    India
    Italy
    Korea, Republic of
    New Zealand
    Pakistan
    Panama
    Poland
    Russian Federation
    Singapore
    Spain
    Sweden
    Taiwan
    Turkey
    United Kingdom
    United States
    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 years
    E.8.9.1In the Member State concerned months
    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 months2
    E.8.9.2In all countries concerned by the trial days0
    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: 377
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 125
    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 177
    F.4.2.2In the whole clinical trial 502
    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)
    For their underlying condition, the subjects will continue to receive standard care, as provided by their physician.
    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 Decision2013-01-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-01-06
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