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    Summary
    EudraCT Number:2013-000862-13
    Sponsor's Protocol Code Number:V59_67
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-05-06
    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
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-000862-13
    A.3Full title of the trial
    A Phase 2, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Safety and Immunogenicity of One Dose of Novartis' Meningococcal ACWY-CRM Vaccine and GlaxoSmithKline Biologicals' Meningococcal ACWY-TT Vaccine in Healthy Toddlers
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, Randomized, Controlled, Observer-Blind, Multi-Center Study Assessing the Safety and Immunogenicity of One Dose of Novartis' Meningococcal ACWY-CRM Vaccine and GlaxoSmithKline Biologicals' Meningococcal ACWY-TT Vaccine in Healthy Toddlers
    A.4.1Sponsor's protocol code numberV59_67
    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 SponsorNovartis Vaccines and Diagnostics S.r.l.
    B.1.3.4CountryItaly
    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 supportNovartis Vaccines and Diagnostics S.r.l.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Vaccines and Diagnostics S.r.l.
    B.5.2Functional name of contact pointLaura Lulli
    B.5.3 Address:
    B.5.3.1Street AddressVia Fiorentina 1
    B.5.3.2Town/ citySiena
    B.5.3.3Post code53100
    B.5.3.4CountryItaly
    B.5.4Telephone number+390577539177
    B.5.5Fax number+390577245340
    B.5.6E-maillaura.lulli@novartis.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 holderNovartis Vaccines and Diagnostics 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.3.1Product nameMenveo
    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 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 S.A.
    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.3.1Product nameNimenrix
    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.3.11 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
    To assess the Safety and Immunogenicity of One Dose of Novartis' Meningococcal ACWY-CRM Vaccine and GlaxoSmithKline Biologicals' Meningococcal ACWY-TT Vaccine in Healthy Toddlers
    E.1.1.1Medical condition in easily understood language
    To assess the Safety and Immunogenicity of One Dose of Novartis' Meningococcal ACWY-CRM Vaccine and GlaxoSmithKline Biologicals' Meningococcal ACWY-TT Vaccine in Healthy Toddlers
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level PT
    E.1.2Classification code 10027202
    E.1.2Term Meningitis bacterial
    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 the reactogenicity of MenACWY-CRM and MenACWY-TT vaccines, given to healthy toddlers at 12-15 months of age, as measured by the percentage of subjects with at least one severe solicited AE reported between 6 hours and Day 7 post vaccination.
    E.2.2Secondary objectives of the trial
    To assess the immunogenicity of one dose of MenACWY-CRM or MenACWY-TT, as measured by: 1) the % of subjects with hSBA titer ≥8, the percentage of subjects with seroresponse, and hSBA GMTs directed against N. meningitidis serogroups A, C, W and Y on Day 29 after vaccination and by 2) the % of subjects with rSBA titer ≥8, the percentage of subjects with rSBA titer ≥ 128, four fold rise, and rSBA GMTs directed against N. meningitidis serogroups A, C, W and Y on Day 29 after vaccination;
    To assess the persistence of the immune response on Day 180 after vaccination with either one dose of MenACWY-CRM or MenACWY-TT, as measured by: 1) the % of subjects with hSBA titer ≥8, the percentage of subjects with seroresponse, and hSBA GMTs against N. meningitidis serogroups A, C, W and Y and by 2) the % of subjects with rSBA titer ≥8, the percentage of subjects with rSBA titer ≥ 128, four fold rise, and rSBA GMTs directed against N. meningitidis serogroups A, C, W and Y.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female children between 12 months and 15 months old inclusive (minimum 365 days of age and maximum 15 months plus 29 days of age), who were born with an estimated gestational age ≥ 37 weeks;
    2. For whom parent(s)/legal guardian(s) have given written informed consent after the nature of the study has been explained according to local regulatory requirements;
    3. Who the investigator believes that their parents/ guardians will be available for all the visits and would comply with the requirements of the protocol (e.g., completion of the Diary Cards, availability for study visits / safety phone calls);
    4. Individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator.
    E.4Principal exclusion criteria
    1. Subjects that had a previous confirmed or suspected disease caused by N. meningitidis.
    2. Who were previously exposed to clinically proven meningococcal disease or clinical bacterial meningitis without further microbiologic characterization, i.e. possible meningococcal disease.
    3. Who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational).
    4. Who have received within 90 days prior to enrollment or are expected to receive during the study period any investigational or non-registered product (drug or vaccine).
    5. Who have received or who are planning to receive any vaccines within 14 days before and 30 days after administration of the study vaccine (Exceptions: Injectable influenza vaccine may be administered up to 14 days prior to study vaccination and at least 14 days after study vaccination).
    6. Who have a major congenital defect or a serious chronic disease.
    7. Who have a history of any anaphylaxis, severe vaccine reactions, or allergy to any vaccine components including diphtheria toxoid (CRM197) or tetanus toxoid (TT) and latex.
    8. Who required chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the study vaccination. (For corticosteroids, this means prednisone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
    9. Who received immunoglobulins and/or any blood products within six months prior to study vaccination or who have administration planned during the study period.
    10. Who have any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
    11. Who have any bleeding disorder which is considered as a contraindication to intramuscular injection.
    12. Who have experienced a moderate or severe acute infection and/or fever (defined as temperature >= 38°C) within 3 days prior to enrollment.
    13. Who have received systemic antibiotic treatment within 7 days prior to enrollment.
    E.5 End points
    E.5.1Primary end point(s)
    • Percentage of subjects with at least one severe solicited AE* within 7 days after vaccination (6 hours through Day 7)

    *Solicited AEs will include tenderness, erythema, induration, irritability, sleepiness, change in eating habits, vomiting, diarrhea and fever.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 7 after vaccination
    E.5.2Secondary end point(s)
    Secondary immunogenicity endpoints:
    ▫ Percentage of subjects with hSBA titer ≥8 against serogroups A, C, W and Y at Day 1, Day 29 and Day 180 post vaccination.
    ▫ Percentage of subjects with hSBA seroresponse against serogroups A, C, W and Y at Day 29 and Day 180 post vaccination, defined as:
    - for subjects with pre-vaccination hSBA titer <4, post vaccination hSBA titer ≥8;
    - for subjects with pre-vaccination hSBA titer ≥4, an increase of at least four times the pre vaccination hSBA.
    ▫ hSBA GMTs for serogroups A, C, W and Y at Day 1, Day 29 and Day 180 post vaccination.
    ▫ Percentage of subjects with rSBA titer ≥8 against serogroups A, C, W and Y at Day 1, Day 29 and Day 180 post vaccination.
    ▫ Percentage of subjects with rSBA titer ≥ 128 against serogroups A, C, W and Y at Day 1, Day 29 and Day 180 post vaccination.
    ▫ Percentage of subjects with fourfold rise in rSBA titers against serogroups A, C, W and Y at Day 29 and Day 180 post vaccination.
    ▫ rSBA GMT for serogroups A, C, W and Y at Day 1, Day 29 and Day 180 post vaccination.
    Secondary safety endpoints:
    ▫ Solicited local and systemic AEs reported from Day 1 (6 hours) to Day 7 after vaccination;
    ▫ Other indicators of reactogenicity (e.g. use of analgesics / antipyretics, body temperature) during the 7 days after vaccination;
    ▫ Unsolicited AEs reported from Day 1 to Day 29 after vaccination;
    ▫ Medically-attended AEs reported during the entire study period;
    ▫ AEs leading to premature withdrawal during the entire study period;
    ▫ SAEs reported during the entire study period.
    Secondary safety endpoints:
    ▫ Solicited local and systemic AEs reported from Day 1 (6 hours) to Day 7 after vaccination;
    ▫ Other indicators of reactogenicity (e.g. use of analgesics / antipyretics, body temperature) during the 7 days after vaccination;
    ▫ Unsolicited AEs reported from Day 1 to Day 29 after vaccination;
    ▫ Medically-attended AEs reported during the entire study period;
    ▫ AEs leading to premature withdrawal during the entire study period;
    ▫ SAEs reported during the entire study period.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 7, Day 29 and day 180 after vaccination
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    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) 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 No
    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
    Cieco per l'osservatore
    Observer Blind
    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 trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 200
    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: 200
    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.4.1In the member state200
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-07-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-07
    P. End of Trial
    P.End of Trial StatusCompleted
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