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    Summary
    EudraCT Number:2023-000764-58
    Sponsor's Protocol Code Number:219967
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2023-10-03
    Trial 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 number2023-000764-58
    A.3Full title of the trial
    A Phase 4, single-arm, open-label, multi-center study to assess the immune response and safety of the meningococcal Group B vaccine MenB+OMV NZ when administered to healthy infants from 2 months of age in the Republic of Korea
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study on the immune response and safety of a vaccine against Neisseria meningitidis serogroup B infection in healthy infants from 2 months of age
    A.3.2Name or abbreviated title of the trial where available
    MENB REC 2ND GEN-097
    A.4.1Sponsor's protocol code number219967
    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 SA
    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 SA
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Biologicals SA
    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 Bexsero Prefilled Syringe
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Korea Limited - Seoul
    D.2.1.2Country which granted the Marketing AuthorisationKorea, Republic of
    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 Suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInjection (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmeningococcal group B Vaccine (rDNA, component, adsorbed)
    D.3.9.2Current sponsor codeMeningococcal group B Vaccine (rDNA, component, adsorbed)
    D.3.9.3Other descriptive nameRECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN PRODUCED IN E. COLI CELLS BY RECOMBINANT DNA TECHNOLOGY ADSORBED ON ALUMINIUM HYDROXIDE
    D.3.9.4EV Substance CodeSUB96088
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 (active immunization of infants against invasive meningococcal disease (IMD) due to N. meningitidis serogroup B infection).
    E.1.1.1Medical condition in easily understood language
    N. meningitidis serogroup B is the most common cause of bacterial meningitis and septicaemia.
    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 humoral immune response to Bexsero both after completion of the primary series and after booster dose, when administered to healthy infants from 2 months of age in the Republic of Korea.
    E.2.2Secondary objectives of the trial
    To evaluate the safety of Bexsero, when administered to healthy infants from 2 months of age in the Republic of Korea.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Participant’s parent(s)/legally acceptable representative (LAR) (s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol
    • Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study specific procedure.
    • Healthy participants as established by medical history and clinical examination before entering the study.
    • A male or female between and including 2 to 5 months (8 to 20 weeks) of age at the time of the first study intervention administration.
    • Born full term
    E.4Principal exclusion criteria
    Medical Conditions
    • Current or previous, confirmed or suspected disease caused by N. meningitidis.
    • Known exposure from birth to an individual with laboratory confirmed N. meningitidis infection.
    • Progressive, unstable or uncontrolled clinical conditions.
    • Any contraindications to group B meningococcal vaccine, including but not limited to: history of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
    • Medical conditions representing a contraindication to intramuscular vaccination and blood draws.
    • Any neuroinflammatory condition (including but not limited to: demyelinating disorders, encephalitis or myelitis of any origin), any congenital neurological condition, encephalopathies, seizures (including all subtypes such as: absence seizures, generalized tonic-clinic seizures, partial complex seizures, partial simple seizures).
    • Congenital or peripartum disorders resulting in a chronic illness (including but not limited to: chromosomal abnormalities, cerebral palsy, metabolism or synthesis disorders, cardiac disorders).
    • Other serious chronic illness.
    • Hypersensitivity to latex.
    • • Abnormal function of the immune system resulting from clinical conditions, or administration of antineoplastic and immunomodulating agents or radiotherapy for any duration from birth or autoimmune disorders (including, but not limited to: blood, endocrine, hepatic, muscular, nervous system or skin autoimmune disorders) or immunodeficiency syndromes (including, but not limited to: acquired immunodeficiency syndromes and primary immunodeficiency syndromes).
    • Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.

    Prior/Concomitant Therapy
    • Use of any investigational or non-registered product since birth, or their planned use during the study period.
    • Previous vaccination with any group B meningococcal vaccine at any time prior to informed consent.
    • Administration of long acting (defined as administered once per week or less frequently) immunosuppressants, including monoclonal antibodies since birth and/or planned use at any time during the study period.
    • Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) since birth and/or planned use of long-acting immune-modifying treatments at any time during the study period. For corticosteroids, this will mean prednisone equivalent 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
    • Administration of immunoglobulins and/or any blood products or plasma derivatives since birth and/or planned use at any time during the study period.

    Prior/Concurrent Clinical Study Experience
    • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device).

    Other Exclusion Criteria
    • Child in care.
    • Any immediate dependents, family, or household member of study personnel.
    E.5 End points
    E.5.1Primary end point(s)
    1. Percentage of participants with hSBA titers ≥LLOQ against all MenB indicator strains for the vaccine antigens
    2. Percentage of participants with hSBA titers ≥LLOQ against all MenB indicator strains for the vaccine antigens
    3. Percentage of participants with hSBA titers ≥LLOQ against all MenB indicator strains for the vaccine antigens
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. At Visit 3 (30 days after completion of the primary series)
    2. At Visit 4 (before booster dose)
    3. At Visit 5 (30 days after booster dose)
    E.5.2Secondary end point(s)
    1. Percentage of participants with any unsolicited adverse events (AEs)
    2. Percentage of participants with any unsolicited AEs
    3. Percentage of participants with any unsolicited AEs
    4. Percentage of participants with adverse events of special interest (AESIs) (seizure [including febrile seizure] and arthritis)
    5. Percentage of participants with serious adverse events (SAEs)
    6. Percentage of participants with AEs leading to withdrawal
    7. Percentage of participants with medically attended AEs (MAAEs)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. During the 30 days (including the day of vaccination) after first dose
    2. During the 30 days (including the day of vaccination) after second dose
    3. During the 30 days (including the day of vaccination) after booster dose
    4. Throughout the study period
    5. Throughout the study period
    6. Throughout the study period
    7. Throughout the 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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    single-arm
    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.8.2.4Number of treatment arms in the trial1
    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
    Korea, Republic of
    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
    EoS: LSLV (Phone call 7) or Date of the last testing/reading released of the Human Biological Samples, related to primary and secondary endpoints, whichever occurs later.
    EoS must be achieved no later than 8 months after LSLV.
    EoS cannot be before LSLV.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days24
    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: 50
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 50
    F.1.1.5Children (2-11years) No
    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 50
    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:
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