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    Summary
    EudraCT Number:2016-003722-16
    Sponsor's Protocol Code Number:205419
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-05-12
    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 number2016-003722-16
    A.3Full title of the trial
    A Phase IIIB, randomized, observer-blind, multicenter study to assess the safety and immunogenicity of GSK’s meningococcal group B vaccine when administered concomitantly with GSK’s meningococcal MenACWY conjugate vaccine to healthy subjects of 16-18 years of age.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess the immunogenicity and safety of GSK’s meningococcal group B vaccine when administered concomitantly with GSK’s meningococcal MenACWY conjugate vaccine in healthy subjects of 16-18 years of age.
    A.3.2Name or abbreviated title of the trial where available
    MENB REC 2ND GEN-045 (V72_79)
    A.4.1Sponsor's protocol code number205419
    A.5.4Other Identifiers
    Name:V72_79Number:V72_79
    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 S.A.
    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 S.A.
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline
    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 number442089904460
    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
    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 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.IMP: 2
    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.3.11 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboIntramuscular use
    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 against invasive meningococcal
    disease caused by 5 different serogroups of N. meningitidis by concomitant
    administration of meningococcal group B vaccine and meningococcal
    MenACWY conjugate vaccine).
    E.1.1.1Medical condition in easily understood language
    Meningitis, invasive meningococcal disease
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10027199
    E.1.2Term Meningitis
    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
    • Safety and tolerability of rMenB+OMV NZ and MenACWY administered concomitantly/alone
    • Demonstrate non-inferiority of the antibody response to rMenB+OMV NZ given concomitantly with MenACWY compared to rMenB+OMV NZ administered alone, as measured by hSBA GMTs against serogroup B strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA) and M07-0241084 (NHBA), at 1 month after the second vaccination with rMenB+OMV NZ
    Criterion: lower limit of the 2-sided 95% confidence interval (CI) of the between-group ratio of hSBA GMTs (rMenB+OMV NZ with MenACWY versus rMenB+OMV NZ alone) is >0.5.
    • Demonstrate non-inferiority of antibody response to MenACWY given concomitantly with rMenB+OMV NZ compared to MenACWY administered alone, as measured by hSBA GMTs against each of the serogroups A, C, W and Y, at 1 month after the (study) vaccination with MenACWY
    Criterion: lower limit of the 2-sided 95% CI of the between-group ratio of hSBA GMTs (rMenB+OMV NZ with Men ACWY versus MenACWY alone) is >0.5.
    E.2.2Secondary objectives of the trial
    • Assess the non-inferiority of the responses to MenACWY when given concomitantly with rMenB+OMV NZ compared to MenACWY administered alone as measured by ELISA GMCs against each of the serogroups A, C, W and Y, at 1 month after the (study) vaccination with MenACWY.
    Criterion for demonstrating non-inferiority of the antibody response: lower limit of the 2-sided 95% CI of the between-group ratio of ELISA GMCs (MenACWY with rMenB+OMV NZ versus MenACWY alone) is >0.5.
    • To assess the immune response to rMenB+OMV NZ against serogroup B test strains M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA) and M07-0241084 (NHBA), at 1 month after the first and the second vaccination with rMenB+OMV NZ.
    • To assess the immune response to MenACWY in healthy subjects 16-18 years of age against each of the serogroups A, C, W and Y, at 1 month after the (study) vaccination with MenACWY.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol or/and 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.
    • Previous vaccination with 1 dose of quadrivalent meningococcal conjugate vaccine (MenACWY, Menveo or Menactra) at least 4 years prior to informed consent and assent as applicable.
    • Written or /witnessed/thumb printed informed consent obtained from the subject/parent(s)/LAR(s) of the subject prior to performance of any study specific procedure.
    • Written informed assent obtained from the subject (if applicable) along with informed consent from the subject's parent(s)/LAR(s) prior to performing any study specific procedure.
    • A male or female between, and including, 16 and 18 years of age at the time of the first vaccination.
    • Healthy subjects as established by medical history and clinical examination before entering into the study.
    • Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
    • Female subjects of childbearing potential may be enrolled in the study, if the subject:
    has practiced adequate contraception for 30 days prior to vaccination, and
    has a negative pregnancy test on the day of vaccination, and
    has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
    E.4Principal exclusion criteria
    Medical conditions
    • Progressive, unstable or uncontrolled clinical conditions.
    • Clinical conditions representing a contraindication to intramuscular 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 study vaccination. This will mean prednisone ≥20 mg/day (for adult subjects) or ≥0.5 mg/kg/day or 20 mg/day whichever is the maximum dose for paediatric subjects, or equivalent. Inhaled and topical steroids are allowed.
    Administration of antineoplastic or immunomodulating agents or radiotherapy within 90 days prior to informed consent.
    • Are obese at screening (obesity is defined as a BMI of ≥ 95th percentile for age and gender).
    • Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study.
    • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
    • History of any reaction or hypersensitivity likely to be exacerbated by any medicinal products or medical equipment whose use is foreseen in this study.
    • Current or previous, confirmed or suspected disease caused by N. meningitidis.
    • Known contact to an individual with any laboratory-confirmed N. meningitidis infection within 60 days, prior to enrolment.
    • History of neuroinflammatory or autoimmune condition.
    • Recurrent history or un-controlled neurological disorders or seizures.
    Prior/Concomitant therapy
    • Use of any investigational or non-registered product other than the study vaccine(s) during the period starting 30 days before the informed consent or planned use during the study period.
    • Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 180 days before the informed consent or planned administration during the study period.
    • Previous vaccination with any group B meningococcal vaccine at any time prior to informed consent and assent as applicable.
    • Previous vaccination with 2 doses of quadrivalent meningococcal conjugate vaccine (MenACWY, Menveo or Menactra).
    Prior/Concurrent clinical study experience
    • Subject 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, will not be enrolled.
    Other exclusions
    • Child in care.
    • Pregnant or lactating female.
    • Female planning to become pregnant or planning to discontinue contraceptive precautions.
    • Any study personnel or immediate dependants, family, or household member.
    E.5 End points
    E.5.1Primary end point(s)
    A. Percentage of subjects with solicited local adverse events (AEs)
    An adverse event is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
    Solicited local adverse events assessed are injection site pain, erythema, swelling, induration.
    Any erythema, swelling and swelling is defined as a symptom with a surface diameter equal or greater than 25 millimeter.
    B. Percentage of subjects with solicited systemic adverse events
    Solicited systemic adverse events assessed are (i.e., fever [temperature ≥ 38.0°C/100.4°F], nausea, fatigue, myalgia, arthralgia, headache).
    C. Percentage of subjects with any unsolicited adverse events, Serious Adverse Events (SAEs), AEs leading to withdrawal and medically attended AEs .
    Unsolicited adverse events are defined as any AE reported in addition to those solicited during the clinical study. Also, any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms are reported as an unsolicited adverse event.
    SAEs are any untoward medical occurrence that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject
    Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider.
    D. Percentage of subjects with any SAEs, AEs leading to withdrawal and medically attended AEs.
    Serious adverse events, AEs leading to withdrawal and medically attended AEs throughout the study period are assessed.
    E. Percentage of subjects with adverse events of special interest (AESI).
    AESIs are predefined (serious or non-serious) adverse events of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation in order to characterize and understand it.
    F. hSBA GMTs against each of the N. meningitidis serogroup B strains after the second vaccination with rMenB+OMV NZ.
    Immune responses to rMenB+OMV NZ given with or without MenACWY, as measured by serum bactericidal assay using human complement (hSBA), are expressed as Geometric Mean Titers (GMTs) against N. meningitidis serogroup B indicator strains (M14459, 96217, NZ98/254 and M07-0241084).
    G. hSBA GMTs against each of the N. meningitidis serogroups A, C, W and Y after vaccination with MenACWY.
    Immune responses to MenACWY given with or without rMenB+OMV NZ, as measured by serum bactericidal assay using human complement (hSBA) are expressed as Geometric Mean Titers (GMTs) against each of the 4 serogroups A, C, W and Y





    E.5.1.1Timepoint(s) of evaluation of this end point
    A. During the 7 days (including the day of vaccination) after each vaccination (Administered on day 1, day 61 and day 91)
    B. During the 7 days (including the day of vaccination) after each vaccination (Administered on day 1, day 61 and day 91)
    C. During the 30 days (including the day of vaccination) after each vaccination (Administered at Day 1, Day 61 and Day 91)
    D. Throughout the study period (Day 1 to Day 451).
    E. Throughout the study period (Day 1- Day 451).
    F. At 1 month after the second vaccination with rMenB+OMV NZ in MenB+MenACWY and MenB groups (i.e. at Day 91).
    G. At 1 month after the vaccination with MenACWY in MenACWY and MenB+MenACWY groups (i.e. at Day 31).

    E.5.2Secondary end point(s)
    A. hSBA GMCs measured by ELISA against each of the serogroups after MenACWY vaccination.
    Immune response to MenACWY given with or without rMenB+OMV NZ, as measured by ELISA GMCs against each of the serogroups A, C, W and Y.
    B. hSBA GMTs against each of the serogroup B strains in both MenB+MenACWY and MenB Groups after first rMenB+OMV NZ vaccination.
    Immune response to rMenB+OMV NZ given with or without MenACWY, as measured by bactericidal activity against N. meningitidis serogroup B indicator strains (M14459, 96217, NZ98/254 and M07-0241084) and expressed in GMTs.
    C. GMRs against each of the serogroup B strains in both MenB+MenACWY and MenB groups after the first rMenB+OMV NZ dose.
    Immune response to rMenB+OMV NZ given with or without MenACWY as measured by bactericidal activity against N. meningitidis serogroup B indicator strains (M14459, 96217, NZ98/254 and M07-0241084) in terms of GMRs at one month after the first rMenB+OMV NZ vaccination compared to the baseline at Day 1/Month 0.
    D. GMRs against each of the serogroup B strains in both MenB+MenACWY and MenB groups after the second rMenB+OMV NZ dose.
    Immune response to rMenB+OMV NZ given with or without MenACWY, as measured by bactericidal activity against serogroup B indicator strains (M14459, 96217, NZ98/254 and M07-0241084) in terms of GMRs at one month after the second rMenB+OMV NZ vaccination compared to the baseline at Day 1/Month 0.
    E. Percentage of subjects with hSBA titers ≥ lower limit of quantitation (LLOQ) for each of the serogroup B test strains in both MenB+MenACWY and MenB Groups after the first rMenB+OMV NZ dose.
    The immune response to rMenB+OMV NZ vaccine is evaluated by measuring bactericidal activity in terms of subjects with hSBA titers ≥ LLOQ against serogroup B test strains
    F. Percentage of subjects with hSBA titers ≥ lower limit of quantitation (LLOQ) for each of the serogroup B test strains in both MenB+MenACWY and MenB Groups after the second rMenB+OMV NZ dose.
    The immune response to rMenB+OMV NZ vaccine is evaluated by measuring bactericidal activity in terms of subjects with hSBA titers ≥ LLOQ against serogroup B test strains.
    G. Percentage of subjects with 4-fold increase in hSBA titers relative to baseline in both MenB+MenACWY and MenB Groups after the first rMenB+OMV NZ dose.
    The immune response to rMenB+OMV NZ vaccine is evaluated by measuring bactericidal activity against each of serogroup B test strains in terms of the Four-fold increase defined as:
    - For a pre-vaccination titer < limit of detection (LOD), a post-vaccination titer of ≥ 4-fold the LOD or ≥ LLOQ, whichever is greater,
    - For a pre-vaccination titer ≥LOD but <LLOQ, a post vaccination titer of at least 4-fold the LLOQ,
    - For a pre-vaccination titer ≥ LLOQ, a post vaccination titer of at least 4-fold the pre-vaccination titer
    H. Percentage of subjects with 4-fold increase in hSBA titers relative to baseline in both MenB+MenACWY and MenB Groups after the second rMenB+OMV NZ dose
    The immune response to rMenB+OMV NZ vaccine is evaluated by measuring bactericidal activity against each of the serogroup B test strains in terms of the Four-fold increase defined as:
    - For a pre-vaccination titer < limit of detection (LOD), a post-vaccination titer of ≥ 4-fold the LOD or ≥ LLOQ, whichever is greater,
    - For a pre-vaccination titer ≥LOD but <LLOQ, a post vaccination titer of at least 4-fold the LLOQ,
    - For a pre-vaccination titer ≥ LLOQ, a post vaccination titer of at least 4-fold the pre-vaccination titer.
    I. Percentage of subjects with hSBA titers ≥ lower limit of quantitation (LLOQ) for each of the serogroup A, C, W and Y in both MenB+MenACWY and MenACWY Groups after MenACWY vaccination
    The immune response to MenACWY vaccines is expressed in terms of percentage of subjects with hSBA titers ≥ lower limit of quantitation (LLOQ) for each of the serogroup A, C, W and Y
    J. Geometric mean ratios (GMRs) against each of the N. meningitidis serogroup A, C, W and Y in both MenB+MenACWY and MenACWY Groups after MenACWY vaccination.
    Immune response to MenACWY given with or without rMenB+OMV NZ as measured by bactericidal activity against the four serogroups A, C, W and Y in terms of GMRs at one month after MenACWY vaccination compared to the baseline at Day 1/Month 0.
    K. Percentage of subjects with 4-fold increase in hSBA titers relative to baseline in both MenB+MenACWY and MenACWY Groups after MenACWY vaccination
    The immune response to MenACWY vaccine is evaluated by measuring for the four serogroups A, C, W and Y, the Four-fold increase defined as:
    - For a pre-vaccination titer < limit of detection (LOD), a post-vaccination titer of ≥ 4-fold the LOD or ≥ LLOQ, whichever is greater,
    - For a pre-vaccination titer ≥LOD but <LLOQ, a post vaccination titer of at least 4-fold the LLOQ,
    - For a pre-vaccination titer ≥ LLOQ, a post vaccination titer of at least 4-fold the pre-vaccination titer.















    E.5.2.1Timepoint(s) of evaluation of this end point
    A. 1 month/D31 after the vaccination of MenACWY in MenACWY and MenB+MenACWY groups
    B. 1 month/D31 after first vaccination with rMenB+OMV NZ
    C. 1 month/D31 after first rMenB+OMV NZ vaccination compared to the baseline (Day 1).
    D. 1 month/D91 after second rMenB+OMV NZ vaccination compared to the baseline (Day 1).
    E. 1 month/D31 after first rMenB+OMV NZ vaccination.
    F. 1 month/D91 after second rMenB+OMV NZ vaccination.
    G. 1 month/D31 after first rMenB+OMV NZ vaccination relative to baseline (Day 1).
    H. 1 month/D91 after second rMenB+OMV vaccination relative to baseline (Day 1).
    I. 1 month/D31 after MenACWY vaccination.
    J. At 1 month/D31 after MenACWY vaccination compared to the baseline (Day 1).
    K. At 1 month/D31 after MenACWY vaccination relative to baseline (i.e. Day 1).
    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
    Tolerability and 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) 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 No
    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 Yes
    E.8.1.7.1Other trial design description
    Observer-blinded study. Recipients & study evaluators will be unaware of vaccine administered.
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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
    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+8 months; the date of release of the last testing results, to be achieved not later than 8 months after LSLV.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial months15
    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: 445
    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: 445
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 500
    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 945
    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
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