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    Summary
    EudraCT Number:2013-004778-84
    Sponsor's Protocol Code Number:116775
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-01-16
    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 ConcernedSweden - MPA
    A.2EudraCT number2013-004778-84
    A.3Full title of the trial
    A Phase IIIb, open-label, multi-centric study to evaluate the immunogenicity of one dose of GSK Biologicals’ MenACWY-TT conjugate vaccine administered intramuscularly in healthy adolescents aged 10 to 15 years, previously primed with a MenC conjugate vaccine.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity and safety study of one dose of GSK Biologicals’ meningococcal conjugate vaccine (GSK134612) in healthy adolescents aged 10 to 15 years.
    A.3.2Name or abbreviated title of the trial where available
    MENACWY-TT-089
    A.4.1Sponsor's protocol code number116775
    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 Yes
    D.2.1.1.1Trade name NIMENRIX
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Biologicals
    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 nameNimenrix
    D.3.4Pharmaceutical form Powder and solvent for solution 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 INNNeisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein
    D.3.9.2Current sponsor codeMenA-TT
    D.3.9.3Other descriptive nameNeisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein
    D.3.9.4EV Substance CodeSUB36479
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein
    D.3.9.2Current sponsor codeMenC-TT
    D.3.9.3Other descriptive nameNeisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein
    D.3.9.4EV Substance CodeSUB36480
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid carrier protein
    D.3.9.2Current sponsor codeMenW-TT
    D.3.9.3Other descriptive nameNeisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid carrier protein
    D.3.9.4EV Substance CodeSUB36481
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein
    D.3.9.2Current sponsor codeMenY-TT
    D.3.9.3Other descriptive nameNeisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein
    D.3.9.4EV Substance CodeSUB36482
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 No
    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
    Healthy subjects (active immunisation of individuals from the age of 12 months against invasive meningococcal diseases caused by Neisseria meningitidis serogroup A, C, W-135 and Y).
    E.1.1.1Medical condition in easily understood language
    Inflammation of the brain and infection of the blood.
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10028911
    E.1.2Term Neisseria meningitidis infection NOS
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10070124
    E.1.2Term Neisseria meningitidis test positive
    E.1.2System Organ Class 100000004848
    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 vaccine response induced by one dose of MenACWY-TT administered to MenC-primed and MenC unprimed subjects.
    E.2.2Secondary objectives of the trial
    To evaluate the immunogenicity of a booster vaccination in MenC-primed subjects and immunogenicity of MenACWY-TT vaccination in unprimed subjects with respect to the percentage of subjects with hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY antibody titres ≥ 1:4, ≥ 1:8 and GMTs.
    To evaluate the immunogenicity of MenACWY-TT vaccination in terms of percentage of subjects with anti-TT concentrations ≥ 0.1 IU/mL, ≥ 1.0 IU/mL and geometric mean concentrations (GMCs).
    To evaluate the safety and reactogenicity of one dose of the MenACWY-TT conjugate vaccine in terms of solicited symptoms, unsolicited symptoms, serious adverse events (SAEs) and new onset of chronic illnesses (NOCIs).
    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.
    • A male or female between, and including, 10 and 15 years of age at the time of vaccination.
    • For the MenC-TT group, a subject who has been vaccinated with a MenC-TT conjugate vaccine in infancy and/or at toddler age (i.e., according to schedule 3+1, 2+1, 1+1, 1), and for whom vaccination is documented.
    • For the MenC-CRM group, a subject who has been vaccinated with a MenC-CRM conjugate vaccine in infancy and/or at toddler age (i.e., according to schedule 3+1, 2+1, 1+1, 1), and for whom vaccination is documented.
    • For the noMenC group, a subject who has not previously received any dose of MenC vaccine per documentation.
    • Written informed consent obtained from the subject/subject’s parent(s)/LAR(s) as applicable according to local regulations.
    • Written informed assent obtained from the subjects when applicable according to local regulations.
    • Healthy subjects as established by medical history and clinical examination before entering into the study.
    • For female subjects of non-childbearing potential:
    These subjects may be enrolled in the study.
    - In this study, non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy or ovariectomy.
    • For female subjects of childbearing potential:
    These subjects 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 two months after completion of the vaccination series
    E.4Principal exclusion criteria
    • Child in care
    • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
    • Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. (For corticosteroids, this will mean prednisone ≥ 0.5 mg/kg/day with an upper limit of 10 mg/kg or equivalent. Inhaled and topical steroids are allowed.)
    • Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of vaccine (i.e., after blood sampling Visit 2), with the exception of a licensed inactivated influenza vaccine.
    • 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 vaccine/product (pharmaceutical product or device).
    • Previous vaccination against N. meningitidis with the exception of MenC vaccine for the MenC-TT and MenC-CRM groups.
    • For the MenC-TT and MenC-CRM groups, vaccination against N. meningitidis serogroup C after two years of age.
    • For the noMenC group, previous vaccination with any meningococcal vaccine.
    • Previous vaccination with any TT-containing vaccine within 30 days prior to the first visit.
    • History of, or intercurrent, meningococcal disease.
    • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
    • Family history of congenital or hereditary immunodeficiency.
    • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
    • Major congenital defects or serious chronic illness.
    • History of any neurological disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted.
    • Acute disease and/or fever at the time of enrolment.
    - Fever is defined as temperature >=37.5°C for oral, axillary or tympanic route, or >= 38.0°C on rectal route. The preferred route for recording temperature in this study will be axillary. The oral route is also allowed.
    - Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever, may be enrolled at the discretion of the investigator
    • Administration of immunoglobulins and/or any blood products within the three months preceding the study vaccination or planned administration during the study period.
    • History of chronic alcohol consumption and/or drug abuse.
    • Anaphylaxis following the administration of vaccine(s).
    • Pregnant or lactating female.
    • Female planning to become pregnant or planning to discontinue contraceptive precautions.
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity with respect to the components of the investigational vaccine
    - hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY vaccine response
    E.5.1.1Timepoint(s) of evaluation of this end point
    One month after vaccination with MenACWY-TT
    E.5.2Secondary end point(s)
    1) Immunogenicity with respect to the components of the investigational vaccine
    - hSBA-MenA, hSBA-MenC, hSBA-MenW-135 an hSBA-MenY antibody titres ≥ 1:4, ≥ 1:8 and GMTs.
    - Anti-TT concentrations ≥ 0.1 IU/mL, ≥ 1.0 IU/mL and concentrations.
    2) Solicited local and general symptoms
    - Occurrence of each solicited local symptoms
    - Occurrence of each solicited general symptoms
    3) Unsolicited AEs
    - Occurrence of unsolicited AEs according to the Medical Dictionary for Regulatory Activities (MedDRA) classification.
    4) SAEs
    - Occurrence of SAEs
    5) New onset of chronic illness (NOCIs)
    - Occurrence of NOCI(s) (e.g. asthma, autoimmune disorders, type I diabetes, and allergies)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Immunogenicity: Pre- and one month after vaccination with MenACWY-TT
    2) Solicited local and general symptoms : Within 4 days (Days 0-3) after vaccination
    3) Unsolicited AEs: Within 31 days (Days 0-30) after vaccination
    4) SAEs: From study vaccine administration up to 6 months post study vaccination
    5) New onset of chronic illness (NOCIs): From study vaccine administration up to 6 months post study vaccination
    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 No
    E.8.1.2Open Yes
    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 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
    Active control (noMenC group)
    E.8.2.4Number of treatment arms in the trial3
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days17
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days17
    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: 600
    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: 200
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 400
    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 Yes
    F.3.2Patients No
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 600
    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)
    A plan for treatment or care after the subject has ended the participation in this trial is not provided for prophylactic vaccine studies as the subjects are healthy and do not need any treatment or care after end of the study.
    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 Decision2014-03-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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