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    Summary
    EudraCT Number:2009-015791-94
    Sponsor's Protocol Code Number:113077
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-06-28
    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 ConcernedGermany - PEI
    A.2EudraCT number2009-015791-94
    A.3Full title of the trial
    A phase III, randomized, observer-blind, placebo-controlled, multicentre, clinical vaccination trial to assess the prophylactic efficacy, safety and immunogenicity of GSK Biologicals’ gE/AS01B vaccine when administered intramuscularly on a 0, 2-month schedule in adults aged 70 years and older.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate GSK Biologicals’ Herpes Zoster vaccine GSK1437173A in adults aged ≥70 years.
    A.3.2Name or abbreviated title of the trial where available
    ZOSTER-022
    A.4.1Sponsor's protocol code number113077
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01165229
    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+44208990 4466
    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 namegE recombinant protein formulated in AS01B Adjuvant System
    D.3.2Product code 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.3.9.2Current sponsor codegE
    D.3.9.3Other descriptive namegE recombinant protein
    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 placeboSolution 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
    Primary immunization of subjects ≥ 70 YOA against Herpes Zoster (HZ). The study population includes males and females without severely immunocompromising conditions in the age ranges 70-79 YOA and ≥ 80 YOA.
    E.1.1.1Medical condition in easily understood language
    Vaccination against shingles in elderly adults
    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
    *Primary Objectives for study ZOSTER-022
    •To evaluate vaccine efficacy (VE) in the prevention of HZ compared to placebo in adults ≥ 70 YOA, as measured by the reduction in HZ risk;
    •To evaluate VE in the prevention of overall PHN compared to placebo in subjects ≥ 70 YOA.

    *Primary objectives for pooled analysis of studies ZOSTER-006 (EudraCT nr 2008-000367-42; study 110390) and ZOSTER-022
    •To evaluate VE in the prevention of overall PHN compared to placebo in subjects ≥ 70 YOA;
    •To consolidate VE estimation in the prevention of HZ compared to placebo in subjects ≥ 70 YOA across both phase III studies;
    •To consolidate VE estimation in the prevention of PHN compared to placebo in subjects ≥ 70 YOA across both phase III studies.


    E.2.2Secondary objectives of the trial
    *For ZOSTER-022:
    To evaluate the following compared to placebo in subjects ≥70 YOA -
    •VE in the prevention of overall PHN;
    •VE in reducing the total duration of severe 'worst' HZ-associated pain over the entire pain reporting period, with confirmed HZ;
    •VE in the reduction of overall and HZ-related mortality and hospitalizations;
    •VE in the reduction in incidence of HZ-associated complications, with confirmed HZ;
    •VE in the reduction in use of pain medications, with confirmed HZ;
    •Vaccine safety and reactogenicity (all subjects).

    *For the pooled analysis of ZOSTER-006 (110390) and ZOSTER-022:
    To evaluate the following compared to placebo -
    •VE in the prevention of overall PHN in subjects ≥50 YOA;
    •VE in the prevention of PHN in subjects ≥50 YOA with confirmed HZ;
    •VE in reducing the total duration of severe 'worst' HZ-associated pain over the entire pain reporting period in subjects ≥ 70 YOA, with confirmed HZ;
    •Vaccine safety and reactogenicity in subjects ≥70 YOA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Subjects who the investigator believes will comply with the requirements of the protocol (e.g. completion of the diary cards/questionnaires, return for follow-up visits, have regular contact to allow evaluation during the study);
    •Written informed consent obtained from the subject;
    •A male or female aged 70 years or older at the time of the first vaccination.
    E.4Principal exclusion criteria
    •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, or planned use during the study period;
    •Concurrently participating 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 (pharmaceutical product or device);
    •Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, HIV infection) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders);
    •History of HZ;
    •Previous vaccination against varicella or HZ (either registered product or participation in a previous vaccine study, and including previous vaccination with childhood varicella vaccine);
    •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Additionally, consider allergic reactions to other material or equipment related to study participation (such as materials that may possibly contain latex -gloves, syringes, etc). Please note, the vaccine and vials in this study do not contain latex;
    •Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 4 years);
    •Receipt of immunoglobulins and/or any blood products within the 90 days preceding the first dose of study vaccine or planned administration during the study period;
    •Administration or planned administration of any other immunizations within 30 days before the first or second study vaccination or scheduled within 30 days after study vaccination. However, licensed non-replicating vaccines (i.e., inactivated and subunit vaccines, including inactivated and subunit influenza vaccines for seasonal or pandemic flu, with or without adjuvant) may be administered up to 8 days prior to each dose and/or at least 14 days after any dose of study vaccine;
    •Any other condition (e.g., extensive psoriasis, chronic pain syndrome, cognitive impairment, severe hearing loss) 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 enrolment; Fever is defined as temperature ≥ 37.5°C (99.5°F) on oral, axillary or tympanic setting, or ≥ 38.0°C (100.4°F) on rectal setting. 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.
    •Chronic administration (defined as more than 15 consecutive days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone < 20 mg/day, or equivalent, is allowed. Inhaled and topical steroids are allowed.
    E.5 End points
    E.5.1Primary end point(s)
    *Primary endpoint in study ZOSTER-022:
    •Confirmed HZ cases: Confirmed HZ cases during the study in the mTVc.

    *Primary endpoints in pooled analysis of studies ZOSTER-006 and ZOSTER-022:
    •Occurrence of overall PHN: Incidence of PHN calculated using the mTVc during the entire study period in subjects ≥70 YOA;
    •Occurrence of confirmed HZ: Occurrence of confirmed HZ during the entire study period in subjects ≥70 YOA.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 to 5 year period following Day 0
    E.5.2Secondary end point(s)
    *Secondary endpoints in study ZOSTER-022:
    •1. PHN cases: PHN cases in the mTVc;
    •2. Duration of severe ‘worst’ HZ-associated pain: Duration of severe ‘worst’ HZ-associated pain following the onset of a confirmed HZ rash as measured by the ZBPI in subjects with confirmed HZ;
    •3. Incidence of overall and HZ-related mortality;
    •4. Incidence of HZ complications in subjects with confirmed HZ;
    •5. Incidence of overall and HZ-related hospitalizations;
    •6. Duration of pain medication administered for HZ in subjects with confirmed HZ;
    •7. Occurrence of solicited local and general symptoms in a subset of subjects;
    •8. Occurrence, intensity and relationship to vaccination of unsolicited adverse events (AEs), according to the Medical Dictionary for Regulatory Activities (MedDRA) classification, in all subjects;
    •9. Occurrence of Serious Adverse Events (SAEs) in all subjects;
    •10. Occurrence of SAEs related to study participation or to a concurrent GSK medication/vaccine in all subjects;
    •11. Occurrence of fatal SAEs in all subjects;
    12. Occurrence and relationship to vaccination of any pre-defined AEs in all subjects;
    •13. Occurrence and relationship to vaccination of any medically attended visits (defined as hospitalizations, emergency room visits or visits to or from medical personnel), other than routine health care visits, in all subjects.

    *Secondary endpoints for ZOSTER-006 and ZOSTER-022 pooled analysis:
    •14. Occurrence of overall PHN: Incidence of PHN calculated using the mTVc in subjects ≥50 YOA;
    •15. Occurrence of PHN in subjects ≥50 YOA with confirmed HZ;
    •16. Duration of severe ‘worst’ HZ-associated pain following the onset of a confirmed HZ rash as measured by the ZBPI in subjects ≥70 YOA with confirmed HZ;
    •17. Occurrence of solicited local and general symptoms in subjects ≥70 YOA included in a subset of subjects;
    •18. Occurrence, intensity and relationship to vaccination of unsolicited AEs, according to the MedDRA classification, in subjects ≥70 YOA;
    •19. Occurrence of SAEs in subjects ≥70 YOA;
    •20. Occurrence of SAEs related to study participation or to a concurrent GSK medication/vaccine in subjects ≥70 YOA;
    •21. Occurrence of fatal SAEs in subjects ≥70 YOA;
    •22. Occurrence and relationship to vaccination of any pre-defined AEs in subjects ≥70 YOA;
    •23. Occurrence of medically attended visits and relationship to vaccination of any of medically attended visits(defined as hospitalizations, emergency room visits or visits to or from medical personnel), other than routine health care visits, in subjects ≥70 YOA.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints numbered
    •1 to •6: 3 to 5 year period following Day 0;
    •7: 7 days (Days 0-6) after each vaccination;
    •8: 30 days (Days 0-29) after each vaccination;
    •9: From Month 0 to Month 14;
    Secondary endpoints numbered
    •10 to •12: 3 to 5 year period following Day 0;
    •13: From Month 0 to Month 8;
    Secondary endpoints numbered
    •14 to •16: 3 to 5 year period following Day 0;
    •17: 7 days (Days 0-6) after each vaccination;
    •18: 30 days (Days 0-29) after each vaccination;
    •19: From Month 0 to Month 14;
    Secondary endpoints numbered
    •20 to •22: 3 to 5 year period following Day 0;
    •23. From Month 0 to Month 8.
    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 Yes
    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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    reactogenicity, 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 concerned40
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA116
    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
    Brazil
    Canada
    Czech Republic
    Estonia
    Finland
    France
    Germany
    Hong Kong
    Italy
    Japan
    Korea, Republic of
    Mexico
    Spain
    Sweden
    Taiwan
    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
    Last subject last contact. Study end will take place when both conditions for final analysis are met and a minimum 90 days follow-up is completed for each HZ case of confirmed or clinically diagnosed suspected HZ that occurs prior to the cut-off date for final analysis.
    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 months1
    E.8.9.1In the Member State concerned days6
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days6
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 14512
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state570
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 7525
    F.4.2.2In the whole clinical trial 14512
    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)
    At study conclusion, if the study vaccine demonstrates sufficient evidence of efficacy and safety such that a clinically important benefit may be reasonably expected, placebo recipients will be offered cross-over immunization with the study vaccine.
    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 Decision2010-08-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-07-24
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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