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    Summary
    EudraCT Number:2012-002575-34
    Sponsor's Protocol Code Number:116727
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-07-23
    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 number2012-002575-34
    A.3Full title of the trial
    A phase IIIb, open, multi-center study to evaluate the immunogenicity, reactogenicity and safety of a booster dose of GSK Biologicals’ MenACWY-TT vaccine administered at 6 years post-primary vaccination with either GSK Biologicals’ Hib-MenC-TT vaccine (Menitorix™) or Hiberix™ and Meningitec™, in healthy subjects aged 12-18 months at primary vaccination and to evaluate the long-term antibody persistence at 2 and 4 years after MenACWY-TT booster vaccination.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The vaccine response and long-term antibody persistence of GSK Biologicals’ MenACWY-TT vaccine (GSK134612) administered as one dose at 6 years post-MenC primary vaccination in healthy subjects aged 12-18 months at primary vaccination.
    A.3.2Name or abbreviated title of the trial where available
    MENACWY-TT-106 EXT:HIB-MENC-TT-016 Y6,8,10
    A.4.1Sponsor's protocol code number116727
    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.3.2Product 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 codeMenW-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.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
    Active immunization against invasive meningococcal diseases 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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •To evaluate the immunogenicity of MenACWY-TT conjugate vaccine in terms of the percentage of subjects with an rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY vaccine response*.
    *Vaccine response to meningococcal antigens (A, C, W-135 and Y) is defined as:
    - For initially seronegative subjects (pre-vaccination rSBA titer below 1:8): rSBA antibody titer ≥ 1:32 one month after vaccination, and
    - For initially seropositive subjects (pre-vaccination rSBA titer ≥ 1:8): at least four-fold increase in rSBA titers from pre-vaccination to one month after vaccination.
    E.2.2Secondary objectives of the trial
    One month post booster vaccination with MenACWY-TT vaccine:
    •To evaluate the immunogenicity of a booster dose of MenACWY-TT conjugate vaccine with respect to the percentage of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY antibody titers ≥ 1:8, ≥ 1:128 and GMTs.
    •To evaluate the percentage of subjects with anti-TT concentrations ≥ 0.1 IU/mL, ≥ 1.0 IU/mL and GMCs.

    Long-term persistence phase: two and four years after MenACWY-TT booster vaccination:
    •To evaluate the long-term antibody persistence induced by MenACWY-TT conjugate vaccine in terms of the percent-age of subjects with rSBA-MenA, rSBA-MenC, rSBA-MenW-135, and rSBA-MenY titers ≥1:8, ≥1:128 and GMTs.

    One month post booster vaccination with MenACWY-TT vaccine:
    •To evaluate the safety and reactogenicity of a booster dose of MenACWY-TT conjugate vaccine.
    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, 84 and 95 months of age at the time of the booster vaccination.
    •Written informed consent obtained from the parent(s)/LAR(s) of the subject and written informed assent obtained from the subject in accordance with local laws and regulations.
    •Healthy subjects as established by medical history and history-directed physical examination before entering into the study.
    •Having completed the vaccination in study HIB-MENC-TT-016 (106445) as per protocol.
    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.
    •Administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after the study vaccine dose, with the exception of a licensed inactivated influenza vaccine which can be administered at any time during the study according to the local recommendations.
    •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 with meningococcal vaccine except the meningococcal vaccination received in the HIB-MENC-TT-016 study.
    •History of meningococcal disease.
    •Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including Human Immunodeficiency Virus (HIV) infection, 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, and history of serious allergic reaction (anaphylaxis) following the administration of vaccine(s).
    •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 enrollment.
    •Administration of immunoglobulins and/or any blood products within the 3 months preceding the study vaccination or planned administration during the booster vaccination phase of the study (i.e., between Visit 1 and Visit 2) and within 3 months preceding the blood sampling at Visit 3 and Visit 4.

    The following criteria should be checked for the long-term persistence phase at two and four years after booster vaccination (Visit 3 and Visit 4):
    •Previous administration of a meningococcal vaccine with the exception of the meningococcal vaccination given in HIB-MENC-TT-016 and the booster vaccination in this particular study.
    •History of meningococcal disease
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity with respect to the components of the investigational vaccine with MenACWY-TT vaccine (primary readouts):
    •rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY vaccine response.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 month after booster vaccination
    E.5.2Secondary end point(s)
    1. Immunogenicity with respect to the components of the Men-ACWY-TT vaccine (secondary readouts):
    •rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥1:8, ≥1:128 and GMTs.
    •Anti-TT concentrations ≥0.1 IU/mL, ≥1.0 IU/mL and GMCs.

    2. Long-term persistence phase: Immunogenicity with respect to the components of the MenACWY-TT vaccine (secondary readouts)
    •rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titres ≥1:8, ≥1:128 and GMTs

    3. Occurrence of solicited local and general symptoms

    4. Occurrence of unsolicited adverse events, serious adverse events (SAEs), Guillain-Barré syndrome and new onset of chronic illness(es) (NOCIs)

    5. Occurrence of SAEs related to MenACWY-TT booster vaccination or related to study participation or concurrent GSK medication/vaccine or any fatal SAE
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 1 month after booster vaccination

    2. 2 and 4 years after booster vaccination

    3. Within 4 days (Day 0 to Day 3) following booster vaccination

    4. Within 31 days (Day 0 to Day 30) following booster vaccination

    5. Through the entire study period (Day 0 to study end)
    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 No
    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) 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 Yes
    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 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
    Australia
    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.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days1
    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: 156
    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: 156
    F.1.1.6Adolescents (12-17 years) No
    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 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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 156
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation GSK Biologicals Global Vaccine Clinical Laboratory, Rixensart
    G.4.3.4Network Country Belgium
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation GSK Biologicals Global Vaccine Clinical Laboratory, North America- Laval
    G.4.3.4Network Country Canada
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation GSK Biologicals Global Vaccine Clinical Laboratory, Wavre-Nord Noir Epine
    G.4.3.4Network Country Belgium
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation Public Health England (PHE)
    G.4.3.4Network Country United Kingdom
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Australia
    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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