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    Summary
    EudraCT Number:2012-002718-38
    Sponsor's Protocol Code Number:111670
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-06-10
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2012-002718-38
    A.3Full title of the trial
    A phase II, open, controlled, multi-center study to evaluate the long-term antibody persistence at 1 year, 3 years and 5 years after the administration of one dose of GlaxoSmithKline (GSK) Biologicals’ meningococcal serogroups A, C, W-135, Y-tetanus toxoid conjugate (MenACWY-TT) vaccine versus one dose of sanofi-pasteur’s meningococcal serogroups A, C, W-135 and Y-diphtheria toxoid conjugate vaccine (Menactra®) in healthy adolescents/adults aged 10-25 years and to evaluate the safety and immunogenicity of a booster response to MenACWY-TT vaccine administered at 5 years post-primary vaccination with MenACWY-TT or Menactra® and of a primary vaccination of MenACWY-TT in a newly enrolled group aged 15-<31 years.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The long-term antibody persistence of GSK Biologicals’ meningo-coccal vaccine GSK134612 in healthy adolescents/adults.
    A.3.2Name or abbreviated title of the trial where available
    MENACWY-TT-059 EXT 052 Y1, 3, 5
    A.4.1Sponsor's protocol code number111670
    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 I'institut 89
    B.5.3.2Town/ cityRixensart
    B.5.3.3Post code1300
    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.3.2Product code MenACWY-TT
    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 INN-
    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 INN-
    D.3.9.2Current sponsor codeMenC-TT
    D.3.9.3Other descriptive nameN. MENINGITIDIS GROUP C (STRAIN C11) POLYSACCHARIDE (DE-O-ACETYLATED) CONJUGATED TO TETANUS TOXOID
    D.3.9.4EV Substance CodeSUB26116
    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 INN-
    D.3.9.2Current sponsor codeMen-W-135-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 INN-
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Menactra
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.4Pharmaceutical form 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 INN-
    D.3.9.3Other descriptive nameMeningococcal (Serogroup A) Polysaccharide (Monovalent Conjugate)
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.3Other descriptive nameMeningococcal (Serogroup C) Polysaccharide (Monovalent Conjugate)
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.3Other descriptive nameMeningococcal (Serogroup W-135) Polysaccharide (Mono-valent Conjugate)
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.3Other descriptive nameMeningococcal (Serogroup Y) Polysaccharide (Monovalent Conjugate)
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    Invasive disease caused by Neisseria meningitidis serogroups 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 18.0
    E.1.2Level LLT
    E.1.2Classification code 10028910
    E.1.2Term Neisseria meningitides meningitis
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10051931
    E.1.2Term Neisseria infection NOS
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the long-term persistence of the immunogen-icity induced by MenACWY-TT vaccine as compared to Menactra at 11-25 years of age in terms of the percentage of subjects with N. meningitidis serogroup A (MenA), N. meningitidis serogroup C (MenC), N. meningitidis serogroup W-135 (MenW-135), and N. meningitidis serogroup Y (MenY) titers >= 1:8 as measured by a serum bactericidal assay using human complement (hSBA).
    E.2.2Secondary objectives of the trial
    •persistence of MenACWY-TT or Menactra with respect to the percent of subjects with hSBA-MenA/C/W-135/Y titers ≥ 1:4 and GMTs 1, 3, and 5 years after vac-cination with MenACWY-TT and Menactra
    •persistence of MenACWY-TT with respect serogroups A, C, W-135 and Y utilizing ELISA 1 year after vaccination with MenACWY-TT and Menactra
    One month post primary (naïve control group) and booster vaccination with MenACWY-TT:
    •immunogenicity of MenACWY-TT with respect to the per-cent of subjects with hSBA-MenA/C/W-135/Y titers ≥ 1:4, ≥ 1:8, GMTs and vaccine response
    •immunogenicity of MenACWY-TT 5 years after a priming dose of MenACWY-TT compared to the immunogenicity of MenACWY-TT in subjects not previously vaccinated any meningococcal vaccine
    •To evaluate the safety of MenACWY-TT after vaccination with respect to:
    -Local and general solicited symptoms
    -Unsolicited serious and non-serious adverse events
    -Serious adverse events and new onset chronic illness(es)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Persistence phase:
    •A male or female who was between and including 10 and 25 years of at the time of primary vaccination in the study with NCT number = 00454909.
    •Written informed consent obtained from parents/guardian of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday.
    •Healthy subjects as established by medical history.
    •Having completed the active phase of the vaccination study with NCT number = 00454909..

    Booster phase:
    •Written informed consent obtained from parents/guardian of the subject and written informed assent obtained from the subject if the subject is less than 18 years of age, or written informed consent obtained from the subject if the subject has achieved the 18th birthday.
    •Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
    •Healthy subjects as established by medical history and history-directed physical examination before entering into the study.
    •If the subject is female, she must be of non-childbearing potential, i.e., pre-menarche, have a current tubal ligation, hysterectomy, oopherectomy or be post-menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test on the day of vaccination and continue adequate contraception for 2 months after vaccination.

    Additional inclusion criterion for the naïve control group:
    •A male or female between, and including, 15 and 30 years of age (has not attained his/her 31st birthday) at the time of the vaccination.
    E.4Principal exclusion criteria
    Persistence phase:
    •Use of any investigational or non-registered product within 30 days of each persistence time point.
    •Vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C, W-135, and/or Y outside of study with NCT number = 00454909.
    •History of any meningococcal disease due to serogroup A, B, C, W-135, or Y.
    •Any confirmed or suspected immunosuppressive or im-munodeficient condition, based on medical history
    •Administration of immunoglobulins and/or any blood prod-ucts within the three months preceding each persistence time point.
    •Concurrently participating in another clinical study within 30 days of each persistence time point, in which the subject has been or will be exposed to an investigational or a non-investigational product
    •Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
    •Chronic alcohol or drug abuse.
    •Subjects withdrew consent to be contacted for follow-up studies.
    Booster phase (to be checked at Year 5 for all subject, including naïve control group):
    •Child in care
    •Not enrolled in the Kaiser Healthcare system.
    •Use of any investigational or non-registered product within 30 days preceding administration of the study vaccine, or planned use throughout the extended safety follow-up period.
    •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to administration of the booster dose
    •Previous vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup A, C, W-135, and/or Y outside of study with NCT number = 00454909.
    •History of any meningococcal disease
    •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection based on medical history and physical examination
    •Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination or planned administration through Day 30 after vaccination.
    •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
    •Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
    •History of chronic alcohol consumption and/ or drug abuse.
    •Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before until 30 days after the day of administration of the dose of vaccine(s) with the exception of any licensed inactivated influenza vaccine
    •Previous vaccination with tetanus and diphtheria toxoids within the last month.
    •A family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vac-cine recipient is demonstrated.
    •History of allergic disease or any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine, including latex.
    •Major congenital defects or serious chronic illness.
    •History of any neurological disorders or seizures.
    •Previous history of Guillain-Barré syndrome
    •Acute disease at the time of vaccination.
    •Pregnant or lactating female.
    •Female planning to become pregnant or planning to discontinue contraceptive precautions within 2 months after vaccination.
    •For subjects who participated in the primary study NCT number = 00454909: Subjects withdrew consent to be contacted for follow-up studies
    •Note: If the subject is female, prior to vaccination she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test on the day of vaccination and continue adequate contraception for 2 months after vaccination.
    E.5 End points
    E.5.1Primary end point(s)
    Meningococcal serum bactericidal titers using human complement antibody assay
    E.5.1.1Timepoint(s) of evaluation of this end point
    One year, three years, and five years after primary vaccination
    E.5.2Secondary end point(s)
    Meningococcal serum bactericidal titers using human complement antibody titers assay ≥ 1:4 and GMTs
    Meningococcal serum bactericidal titers using human comple-ment antibody assay ≥ 1:4 , ≥ 1:8, GMTs and vaccine response
    Meningococcal polysaccharides antibody concentration
    Occurrence of solicited local and general symptoms
    Occurrence of non-serious adverse events
    Occurrence of serious adverse events and new onset chronic illness(es)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 3 and 5 years post primary vaccination and 1 month post booster vaccination with GSK134612 vaccine at year 5 after primary vaccination and one month post-primary vaccination in newly enrolled
    At one month post booster and at year 5 after primary vaccina-tion
    One year after primary vaccination
    4 days following vaccination
    31 days following vaccination
    6 months following 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 No
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    United States
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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 Yes
    F.1.1Number of subjects for this age range: 68
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 68
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 580
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 749
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
    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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