Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2016-004420-29
    Sponsor's Protocol Code Number:205213
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-12-14
    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 number2016-004420-29
    A.3Full title of the trial
    A Phase 2, Open-label, Controlled, Multi-Center Extension Study to Evaluate 4-Year Antibody Persistence and Booster Response Fol-lowing MenABCWY Vaccination in Healthy Adolescents and Young Adults who Previously Participated in Studies V102_02 (NCT01210885) and V102_02E1 (NCT01367158).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, Open-label, Controlled, Multi-Center Extension Study to Evaluate 4-Year Antibody Persistence and Booster Response Fol-lowing MenABCWY Vaccination in Healthy Adolescents and Young Adults who Previously Participated in Studies V102_02 (NCT01210885) and V102_02E1 (NCT01367158).
    A.3.2Name or abbreviated title of the trial where available
    MENABCWY-004 BST:002 (V102_02E2)
    A.4.1Sponsor's protocol code number205213
    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 nameMenABCWY
    D.3.4Pharmaceutical form Powder and suspension for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Healthy volunteers (Immunisation against meningococcal infections)
    E.1.1.1Medical condition in easily understood language
    Inflammation of brain and spinal cord membranes, caused by infection with N meningitidis
    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 19.0
    E.1.2Level SOC
    E.1.2Classification code 10021881
    E.1.2Term Infections and infestations
    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 assess antibody persistence against N. meningitidis serogroups (SP) A, C, W and Y and serogroup B test strains in subjects who previously received MenABCWY+OMV or MenACWY approximately 4 years earlier, as measured by the percentage of subjects with hSBA titers ≥ lower limit quantitation (LLQ) and other thresholds, hSBA Geometric Mean Titers (GMTs) and geometric mean ratios (GMRs).
    • To evaluate immune response against N. meningitidis serogroups A, C, W and Y and serogroup B test strains 30 days after a single dose of MenABCWY+OMV in previously vaccinated subjects, and in vaccine-naïve subjects (VNS) of similar age, as measured by the percentage of subjects with hSBA titers ≥LLQ and other thresholds, hSBA GMTs and GMRs.
    E.2.2Secondary objectives of the trial
    •To evaluate the safety & reactogenicity of the MenABCWY+OMV vaccine given as 1 or 2 doses in subjects previously vaccinated with MenABCWY+OMV or MenACWY & in VNSs
    •To describe the kinetics of immune response following a dose of MenABCWY+OMV in subjects who previously received 2 doses of MenABCWY+OMV or 1 dose of MenACWY as measured by % of subjects with hSBA titers ≥LLQ & other thresholds, hSBA GMT & GMRs against SPs A,C,W &Y and SP B test strains at Day 1, 4, 8, and 31
    •To describe the kinetics of immune response following 1 and 2 doses of MenABCWY+OMV in VNSs, as measured by % of subjects with hSBA titers ≥ LLQ & other thresholds, hSBA GMT and CMRs against SPs A,C,W & Y & SP B test strains at Day 1, 31, 34, 38 & 61
    •To assess immunogenicity of 2 doses of MenABCWY+OMV in subjects who previously received 1 dose of MenACWY & VNSs, as measured by percentage of subjects with hSBA titers ≥ LLQ & other thresholds, hSBA GMT & GMRs against SPs A, C, W and Y & SP B test strains at day 61
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Individuals who received either 2 doses of MenABCWY+OMV or a single dose of MenACWY followed by a dose of placebo, with the last study vaccine given approximately 48 to 56 months before study V102_02E2 (NCT01367158), who received Tdap only in V102_02E1 (NCT01367158) study and who received no other meningococcal vaccines;
    Or
    • A proportional number of subjects in each site aged 15 through 23 years on the day of informed consent/assent who did not participate in the V102_02 (NCT01210885) study and have not previously received any meningococcal vaccine.
    • Individuals who /whose parent(s)/legal guardian(s) have vol-untarily given written informed consent/assent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
    • Individuals who can comply with study procedures including blood draws and follow-up.
    • Males
    Or
    • Females of non-childbearing potential
    Or
    • Females of childbearing potential who are not pregnant or breastfeeding and who are using an effective birth control method which they have used for at least 30 days prior to study entry, and which they intend to use for at least 30 days after the last study vaccination.
    E.4Principal exclusion criteria
    • History of any meningococcal vaccine administration (study group C)
    Or
    • History of any meningococcal vaccine administration other than vaccination given in the parent V102_02 (NCT01210885) study (study groups A and B).
    • Progressive, unstable or uncontrolled clinical conditions.
    • Hypersensitivity, including allergy, to any component of vaccines (including diphtheria toxoid (CRM197) and latex) whose use is foreseen in this study.
    • Clinical conditions representing a contraindication to intra-muscular vaccination and blood draws.
    • Abnormal function of the immune system resulting from:
    Clinical conditions.
    • Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to enrollment.
    • Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
    • Received immunoglobulins or any blood products within 90 days prior to enrollment.
    • Received an investigational or non-registered medicinal product within 30 days prior to enrollment.
    • Received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 14 days from the study vaccines.
    • Study personnel as an immediate family or household mem-ber.
    • Who have experienced a moderate or severe acute infection and/or fever (defined as temperature >= 38°C) within 3 days prior to enrollment.
    • Who have received systemic antibiotic treatment within 3 days prior to enrollment.
    • Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    • Human Serum Bactericidal Assay (hSBA) Geometric Mean Ti-ters (GMTs) against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.
    • hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.
    • Percentages of subjects with hSBA titers ≥ Lower Limit of Quantitation (LLQ) against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.
    • Percentages of subjects with hSBA titers ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.
    • Percentages of subjects with hSBA titers ≥ 8 against N. meningitidis serogroups A, C, W and Y.
    • Percentages of subjects with hSBA titers ≥ 8 against N. meningitidis serogroups A, C, W and Y.
    • Percentages of subjects with hSBA titers ≥ 5 against serogroup B test strains.
    • Percentages of subjects with hSBA titers ≥ 5 against serogroup B test strains.
    • Between-group GMRs comparing GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.
    • Between-group GMRs comparing GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.
    • Within-group GMRs comparing baseline GMTs to GMTs at later time points against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.
    For MenABCWY+OMV Group, GMRs will be calculated with respect to the visit one month after the 2nd dose of MenABCWY+OMV in V102_02 (NCT02451514). For MenACWY Group, GMRs will be calculated with respect to the visit one month after the 1st dose of MenACWY in V102_02 (NCT02451514).
    • Within-group GMRs comparing baseline GMTs to GMTs at later time points against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1
    Day 31
    Day 1
    Day 31
    Day 1
    Day 31
    Day 1
    Day 31
    Day 1
    Day 31
    Day 1
    Day 31
    E.5.2Secondary end point(s)
    • hSBA GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.
    • Percentages of subjects with hSBA titers ≥ LLQ against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.
    • Percentages of subjects with hSBA titers ≥ 8 against N. meningitidis serogroups A, C, W and Y
    • Percentages of subjects with hSBA titers ≥ 5 against serogroup B test strains.
    • Between-group GMRs comparing GMTs against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.
    • Within-group GMRs comparing baseline GMTs to GMTs at later time points against N. meningitidis serogroups A, C, W and Y and serogroup B test strains.
    • Any unsolicited and solicited AEs reported
    • Solicited local (i.e., pain, erythema and induration) and systemic (i.e. chills, loss of appetite, headache, fatigue, myalgia, arthralgia, nausea, fever (body temperature ≥ 38°C (100.4°F))
    • All unsolicited AEs reported
    • Medically-attended AEs reported
    • AEs leading to premature withdrawal from the study
    • SAEs reported
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1, 4, 8 and 31 for MenABCWY+OMV Group (A), MenACWY Group (B1) and MenACWY Group (B2). Day 1, 31, 34, 38 and 61 for Naive Group (C1) and Naive Group (C2).
    Day 1, 4, 8, 31, 34, 38, 61
    Day 1, 4, 8, 31, 34, 38, 61
    Day 1, 4, 8, 31, 34, 38, 61
    Day 1, 4, 8, 31, 34, 38, 61
    Day 4, 8, 31, 34, 38, 61
    Within 30 min after vaccination
    From Day 1 (6 hrs) to Day 7 after each vaccination
    From Day 1 to Day 31 after each vaccination (Day 1 to Day 31 for MenABCWY+OMV Group and Day 1 to Day 61 for MenACWY and Naive Groups)
    During the entire study period (Day 1 to Day 31 for MenABCWY+OMV Group and Day 1 to Day 61 for MenACWY and Naive Groups)
    During the entire study period
    During the entire study period (Day 1 to Day 31 for MenABCWY+OMV Group and Day 1 to Day 61 for MenACWY and Naive Groups)
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    MenACWY
    E.8.2.4Number of treatment arms in the trial5
    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
    Chile
    Colombia
    Panama
    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 years0
    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: 171
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 171
    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 171
    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: Chile
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 26 17:39:00 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA