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    Summary
    EudraCT Number:2011-003694-29
    Sponsor's Protocol Code Number:V72_37
    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:2012-02-20
    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 number2011-003694-29
    A.3Full title of the trial
    A Phase 3b, Multi-Center, Open-label Study to Assess the Safety of Novartis Meningococcal B Recombinant Vaccine When Administered at a 0, 2-Month Schedule in Healthy at-risk Adults
    Studio di Fase 3b, Multicentrico, in aperto, per Valutare la Sicurezza del Vaccino Ricombinante di Novartis contro il Meningococco B Somministrato a 0-2 mesi in Soggetti Adulti Sani a Rischio
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial conducted in more then one site to assess safety of the Novartis vaccine against meningititis B injected at 0 and after 2 months in adults at risk because managing meningoccocus type B or travelling in geographic area where Meningitis B is highly present
    Studio condotto in piu' centri per valutare la sicurezza del vaccino Novartis contro la meningite B quando somministrato a 0 e dopo due mesi in adulti a rischio poiche' sono a contatto con meningococco di tipo B o viaggiano in aree geografiche dove la meningite B e' altamente presente
    A.4.1Sponsor's protocol code numberV72_37
    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
    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
    B.5.2Functional name of contact pointRicerca Clinica
    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 number0039 0577 539247
    B.5.5Fax number0039 0577278491
    B.5.6E-mailsperclin.seuropa@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 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 nameNovartis Vaccines and Diagnostics Meningococcal B Recombinant Vaccine
    D.3.2Product code 4CMenB
    D.3.4Pharmaceutical form 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 INNMENINGOCOCCAL VACCINE
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNeisseria meningitidis 287/953 purified antigen
    D.3.9.4EV Substance CodeSUB26113
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMENINGOCOCCAL VACCINE
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNeisseria meningitidis 961c purified antigen
    D.3.9.4EV Substance CodeSUB26113
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMENINGOCOCCAL VACCINE
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNeisseria meningitidis 936/741 purified antigen
    D.3.9.4EV Substance CodeSUB26113
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMENINGOCOCCAL VACCINE
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNeisseria meningitidis Outer membrane vescicles from NZ strain
    D.3.9.4EV Substance CodeSUB26113
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Yes
    D.3.11.13.1Other medicinal product typeVaccino meningococcico di tipo B ricombinante
    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 (Meningitis B)
    Volontari Sani (Meningite B)
    E.1.1.1Medical condition in easily understood language
    Type B meningitis
    Meningite di tipo B
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10027249
    E.1.2Term Meningitis meningococcal
    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 descriptively assess the safety of Novartis rMenB+OMV NZ in healthy at-risk adults when administered at a 0, 2- month schedule, throughout the clinical study.
    valutare la sicurezza del vaccino Novartis rmenB+OMV NZ in soggetti sani adulti a rischio con schedula di somministrazione 0-2 mesi
    E.2.2Secondary objectives of the trial
    NA
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 18 – 60 years of age inclusive who have given written informed consent at the time of enrollment; 2. Able to comprehend and follow all required study procedures; 3. Who are available for all the visits scheduled in the study (i.e., not planning to leave the area before the end of the study period); 4. In good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator; 5. Who were or might be routinely exposed to N. meningitidis cultures and/or are travelling to geographical areas considered at high risk for epidemic Meningococcal B infection disease.
    1. soggetti ambosesso tra i 18 e i 60 anni inclusi che abbiano dato il consenso informato scritto al momento dell'arruolamento; 2:Capaci di comprendere e seguire le procedure di studio; 3.Disponibili per tutte le visite di studio (che non abbiano intenzione di trasferirsi prima della fine dello studio); 4. in buona salute come confermato da anamnesi,esame medico e giudizio clinico dello sperimentatore; 5.Che sono stati o che potrebbero essere esposti a colture cellulari di N.Meningitidis e/o viaggiano in aree geografiche considerate ad alto rischio epidemico per infezioni da Meningococco B
    E.4Principal exclusion criteria
    1.Significant acute or chronic infection within the previous 7 days or fever (defined as axillary temperature ≥ 38°C|100.4ºF) within the previous day; 2.Antibiotics within 3 days (72 hours) prior to enrollment; 3. Pregnancy or nursing (breastfeeding) mothers; 4. Females who have not used or do not plan to use acceptable birth control measures, for the 3 months duration of the study. Oral, injected or implanted hormonal contraceptive, diaphragm, condom, intrauterine device or sexual abstinence are considered acceptable forms of birth control. If sexually active the subject must have been using one of the accepted birth control methods for at least 30 days prior to study entry; 5.Any serious chronic or progressive disease (e.g., neoplasm, diabetes, cardiac disease, hepatic disease, progressive neurological disease or seizure disorder; autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition); 6.Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, including use of corticosteroids in immunosuppressive doses or chronic use of inhaled high-potency corticosteroids within the previous 60 days. [Use of topical corticosteroids administered during the study in limited areas (i.e., eczema on knees or face or elbows) of the body is allowed]; immunostimulants; 7.History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component; 8.Any condition which in the opinion of the investigator may interfere with evaluation of the study objectives.
    1.Infezioni rilevanti acute o croniche nei precedenti 7 giorni o febbre (definita come temperatura ascellare≥38°C|100.4ºF) il giorno precedente; 2.Assunzione di antibiotici nei 3 giorni (72ore) precedenti l'arruolamento; 3.Donne incinte o in fase di allattamento; 4.Donne che non hanno usato o che non pianificano di usare metodi contraccettivi accettabili per i 3 mesi della durata dello studio.Contraccettivi orali,ormonali iniettabili o impiantabili,diaframma,preservativo,dispositivi intrauterini o l'astinenza sessuale sono considerati metodi contraccettivi accettabili.Se sessualmente attivo il soggetto deve aver usato uno di questi metodi contraccettivi accettati per almeno 30 giorni prima l'entrata in studio. 5.Qualsiasi malattia seria,cronica o progressiva (es.neoplasie,diabete,malattie cardiache,malattie epatiche,malattie neurologiche progressive o disturbi epilettici,malattie autoimmuni,infezioni da HIV o AIDS,discrasia o diatesi del sangue,sintomi di deficienza cardiaca o renale o malnutrizione importante); 6.confermato o sospetto deterioramento/alterazione del sistema immunitario,terapie immunosoppressive incluso l'uso di corticosteroidi in dosi immunosoppressive o uso inalatorio cronico di corticosterodi ad alta potenza nei precedenti 60 giorni[l'uso di corticosterodi in aree limitate del corpo (ad esempio eczema alle ginocchia o al viso o ai gomiti)è permesso;uso di immunostimolanti; 7.Trascorso di serie reazioni allergiche a precedenti vaccinazioni o ipersensibilità ad ogni componente del vaccino; 8.Qualsiasi condizione che in opinione dello sperimentatore possa interferire con la valutazione degli obiettivi dello studio
    E.5 End points
    E.5.1Primary end point(s)
    NA
    NA
    E.5.1.1Timepoint(s) of evaluation of this end point
    NA
    NA
    E.5.2Secondary end point(s)
    NA
    NA
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    NA
    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 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
    To descriptively assess the safety of Novartis rMenB+OMV NZ in healthy at-risk adults when administ
    Valutare in termini descrittivi la sicurezza del vaccino rMenB+OMV NZ di Novartis in soggetti adulti
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months15
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months15
    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.1.1Number of subjects for this age range: 0
    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: 130
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    At risk population for meningitis B both external and internal in Novartis
    Personale a rischio per la meningite B sia esterno che interno in Novartis
    F.4 Planned number of subjects to be included
    F.4.1In the member state115
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 130
    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)
    NA
    NA
    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 Decision2013-03-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-21
    P. End of Trial
    P.End of Trial StatusCompleted
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