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   43857   clinical trials with a EudraCT protocol, of which   7284   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:2016-003186-25
    Sponsor's Protocol Code Number:205352
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2017-06-01
    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 number2016-003186-25
    A.3Full title of the trial
    A Phase 3b, Controlled, Open-Label, Multi-Center Study to Evaluate Safety and Immunogenicity of a Single Dose of GlaxoSmithKline’s Meningococcal ACWY Conjugate Vaccine (Menveo), Administered to Healthy Individuals 15 through 55 years of age, approximately 4-6 years after primary ACWY vaccination.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess the safety and immunogenicity of a single dose of GlaxoSmithKline’s (GSK) Meningococcal MenACWY-CRM vaccine (Menveo), administered to subjects 15 through 55 years of age, approximately 4-6 years after primary ACWY vaccination.
    A.3.2Name or abbreviated title of the trial where available
    MENACWY CONJ-038 (V59_77)
    A.4.1Sponsor's protocol code number205352
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02986854
    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 number44 2089904466
    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 Menveo
    D.2.1.1.2Name of the Marketing Authorisation holderGSK Vaccines S.r.l.
    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.3.4Pharmaceutical form Powder and solution 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-CRM197 conjugate
    D.3.9.3Other descriptive nameN. MENINGITIDIS GROUP A OLIGOSACCHARIDE CONJUGATED CRM197
    D.3.9.4EV Substance CodeSUB31082
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.2Current sponsor codeMenW-CRM197 conjugate
    D.3.9.3Other descriptive nameN. MENINGITIDIS GROUP W135 OLIGOSACCHARIDE CONJUGATED CRM197
    D.3.9.4EV Substance CodeSUB31083
    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-CRM197 conjugate
    D.3.9.3Other descriptive nameMENINGOCOCCAL GROUP Y OLIGOSACCHARIDE CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE CRM197 PROTEIN
    D.3.9.4EV Substance CodeSUB126362
    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-CRM197
    D.3.9.3Other descriptive nameN. MENINGITIDIS GROUP C (STRAIN C11) POLYSACCHARIDE CONJUGATED CRM197
    D.3.9.4EV Substance CodeSUB26743
    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 volunteers (Infections, Meningococcal)
    E.1.1.1Medical condition in easily understood language
    Meningitis
    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
    1) To demonstrate a sufficient immune response following a booster dose of MenACWY-CRM (Menveo) vaccine, given to subjects who previously received Menveo, as measured by the percentage of subjects with hSBA seroresponse against N. meningitidis serogroups A, C, W and Y at Day 29 after vaccination.
    2) To demonstrate a sufficient immune response following a booster dose of MenACWY-CRM (Menveo) vaccine, given to subjects who previously received Menactra (meningococcal diphtheria toxoid-conjugated MenACWY vaccine), as measured by the percentage of subjects with hSBA seroresponse against N. meningitidis serogroups A, C, W and Y at Day 29 after vaccination.
    E.2.2Secondary objectives of the trial
    1) To compare the immune responses over time following a booster dose of MenACWY-CRM vaccine, between subjects who previously received either Menveo, Menactra, or both (pooled vaccine group), and following a single dose in vaccine naive individuals, as measured by the percentages of subjects with hSBA seroresponse, hSBA titers ≥8 and ≥16, and hSBA GMTs against N. meningitides serogroups A, C, W and Y at Day 1, Day 4, Day 6, and Day 29 after vaccination.
    2) To assess persistence of bactericidal antibodies against serogroups A, C, W and Y at approximately 4-6 years after the primary vaccination with Menveo and after the primary vaccina-tion with Menactra in comparison with naturally-acquired level in vaccine-naive individuals, as measured by the percentages of subjects with hSBA titers ≥8 and hSBA GMTs at Day 1.
    3) To assess reactogenicity and safety of MenACWY-CRM vaccine when administered to subjects who previously received Menveo or Menactra and vaccine-naive individuals.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Individuals of 15 through 55 years of age on the day of informed consent or assent.
    2) Individuals who received Menveo 4 to 6 years prior to en-rolment at an age of 11 years or older
    OR
    Individuals who received Menactra 4 to 6 years prior to enrolment at an age of 11 years or older
    OR
    Individuals who have not received any previous meningo-coccal vaccine.
    3) Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. If the subject is under age 18 at the time of enrol-ment, the parent(s)/legal guardian(s) of the subject should have voluntarily given written informed consent.
    4) Individuals who can comply with study procedures including follow-up.
    5) Males
    Or
    Females of non-childbearing potential
    Or
    Females of childbearing potential who are using an effective birth control method which they intend to use for at least 30 days after the study vaccination.
    E.4Principal exclusion criteria
    1) History of any meningococcal vaccine administration other than the single vaccination given 4 to 6 years before
    OR
    History of any meningococcal vaccine administration.
    2) Current or previous, confirmed or suspected disease caused by N. meningitidis.
    3) Household contact with and/or intimate exposure to an individual with any laboratory confirmed N. meningitidis in-fection within 60 days prior to study vaccination.
    4) Progressive, unstable or uncontrolled clinical conditions.
    5) Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study.
    6) Clinical conditions representing a contraindication to in-tramuscular vaccination (IM) and blood draws.
    7) Abnormal function of the immune system resulting from:
    a. Clinical conditions.
    b. Systemic administration of corticosteroids for more than 14 consecutive days within 90 days prior to study vaccination.
    c. Administration of antineoplastic and immunomodulat-ing agents or radiotherapy within 90 days prior to study vaccination.
    8) Received immunoglobulins or any blood products within 180 days prior to informed consent.
    9) Received systemic antibiotic treatment within 3 days prior to study vaccination or blood draw.
    10) Received an investigational or non-registered medicinal product within 30 days prior to study vaccination.
    11) Study personnel as an immediate family or household member.
    12) Individuals who have received any other vaccines within 7 days or 14 days prior to vaccination in this study or who are planning to receive any vaccine within 28 days from the study vaccination.
    13) Individuals who have experienced a moderate or severe acute infection and/or fever defined as a temperature ≥38°C (100.4°F) within 3 days prior to study vaccination.
    14) Any other clinical condition that, in the opinion of the in-vestigator, might pose additional risk to the subject due to participation in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Percentages of subjects with hSBA seroresponse against N. meningitidis serogroups A, C, W and Y, from Menveo-Menveo and Menactra-Menveo groups
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Day 29
    E.5.2Secondary end point(s)
    1) Percentages of subjects with hSBA titer ≥8 and ≥16 against N. meningitidis serogroups A, C, W and Y and between-group differences.
    2) Percentages of subjects with hSBA seroresponse against N. meningitidis serogroups A, C, W and Y and between-group differences
    3) hSBA GMTs against N. meningitidis serogroup A, C, W and Y
    4) Ratios of hSBA GMTs (between study groups)
    5) hSBA Geometric Mean Ratios (GMRs) (within study groups).
    6) Any unsolicited Adverse Events (AEs) reported
    7) Solicited local and systemic AEs reported
    8) Other indicators of reactogenicity (eg, use of analge-sics/antipyretics, body temperature)
    9) All unsolicited AEs reported
    10) Medically-attended AEs, AEs leading to withdrawal and SAEs reported
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) At Day 1, Day 4, Day 6 and Day 29
    2) At Day 4, Day 6 and Day 29
    3) At Day 1, Day 4, Day 6 and Day 29
    4) At Day 1, Day 4, Day 6, and Day 29
    5) At Day 4, Day 6, Day 29 compared to Day 1
    6) Within 30 minutes after vaccination
    7) From Day 1 (6 hours) through Day 7 after vaccination
    8) From Day 1 (6 hours) through Day 7 after vaccination
    9) From Day 1 through Day 29 after vaccination
    10) From Day 1 through Day 181 (entire study period)
    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 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 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 trial3
    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
    Puerto Rico
    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
    The date of the last testing/reading released of human biologicals samples, related to primary and secondary end points, to be achieved no later than 8 months after Last Subject Last Visit (LSLV).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days14
    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: 250
    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: 250
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 450
    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 700
    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
    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-Thu Apr 25 00:05:30 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA