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    Summary
    EudraCT Number:2017-004731-36
    Sponsor's Protocol Code Number:MET58
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2018-10-19
    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
    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 number2017-004731-36
    A.3Full title of the trial
    Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine when Administered Concomitantly with Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe
    Studio sull’immunogenicità e sulla sicurezza di un vaccino coniugato
    meningococcico quadrivalente sperimentale somministrato in concomitanza
    con vaccini pediatrici di routine a neonati e bambini piccoli sani in Europa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine when co-administered with Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe
    Studio sull’immunogenicità e sulla sicurezza di un vaccino
    coniugato menigococcico quadrivalente somministrato in concomitanza con vaccini
    pediatrici di routine a neonati e bambini piccoli sani in Europa
    A.4.1Sponsor's protocol code numberMET58
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1183-6653
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/359/2017
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSanofi Pasteur Inc.
    B.1.3.4CountryUnited States
    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 supportSanofi Pasteur Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi S.p.A.
    B.5.2Functional name of contact pointCONTACT POINT
    B.5.3 Address:
    B.5.3.1Street AddressVIALE BODIO 37/B
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20158
    B.5.3.4CountryItaly
    B.5.4Telephone number+39800226343
    B.5.5Fax number+390239394168
    B.5.6E-mailinformazioni.medicoscientifiche@sanofi.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 nameMenACYW Conjugate Vaccine
    D.3.2Product code 395
    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 INNNeisseria Meningitidis Serogroup A Polysaccharide Conjugated to Tetanus Toxoid Carrier Protein
    D.3.9.3Other descriptive nameNEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
    D.3.9.4EV Substance CodeSUB36479
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10μg/0.5ml
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria Meningitidis Serogroup C Polysaccharide Conjugated to Tetanus Toxoid Carrier Protein
    D.3.9.3Other descriptive nameNEISSERIA MENINGITIDIS SEROGROUP C POLYSACCHARIDE (PSC) CONJUGATED TO TETANUS TOXOID (TT)
    D.3.9.4EV Substance CodeSUB31471
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10μg/0.5ml
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria Meningitidis Serogroup Y Polysaccharide Conjugated to Tetanus Toxoid Carrier Protein
    D.3.9.3Other descriptive nameNEISSERIA MENINGITIDIS GROUP Y POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
    D.3.9.4EV Substance CodeSUB36482
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10μg/0.5ml
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria Meningitidis Serogroup W Polysaccharide Conjugated to Tetanus Toxoid Carrier Protein
    D.3.9.3Other descriptive nameNEISSERIA MENINGITIDIS GROUP W-135 POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
    D.3.9.4EV Substance CodeSUB36481
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10μg/0.5ml
    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 holderPfizer Limited
    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 solvent for solution for injection in pre-filled syringe
    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 INNNeisseria Meningitidis Group A Polysaccharide Conjugated to Tetanus Toxoid Carrier Protein
    D.3.9.3Other descriptive nameNEISSERIA MENINGITIDIS GROUP A POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
    D.3.9.4EV Substance CodeSUB36479
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5μg/0.5ml
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria Meningitidis Group C Polysaccharide Conjugated to Tetanus Toxoid Carrier Protein
    D.3.9.3Other descriptive nameNEISSERIA MENINGITIDIS SEROGROUP C POLYSACCHARIDE (PSC) CONJUGATED TO TETANUS TOXOID (TT)
    D.3.9.4EV Substance CodeSUB31471
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5μg/0.5ml
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria Meningitidis Group Y Polysaccharide Conjugated to Tetanus Toxoid Carrier Protein
    D.3.9.3Other descriptive nameNEISSERIA MENINGITIDIS GROUP Y POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
    D.3.9.4EV Substance CodeSUB36482
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5μg/0.5ml
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNeisseria Meningitidis Group W Polysaccharide Conjugated to Tetanus Toxoid Carrier Protein
    D.3.9.3Other descriptive nameNEISSERIA MENINGITIDIS GROUP W-135 POLYSACCHARIDE CONJUGATED TO TETANUS TOXOID CARRIER PROTEIN
    D.3.9.4EV Substance CodeSUB36481
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5μg/0.5ml
    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 (active immunization against invasive meningogoccal disease (IMD) caused by Meningococcal serogroups A, C, Y or W)
    Volontari sani (immunizzazione
    attiva contro la malattia invasiva da meningococco (IMD) causata da sierogruppi
    meningococcici A, C, Y e W)
    E.1.1.1Medical condition in easily understood language
    Invasive meningococcal disease (IMD)
    Malattia
    invasiva da meningococco (IMD)
    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 10027274
    E.1.2Term Meningococcal infection
    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 demonstrate the non-inferiority of the antibody response against meningococcal serogroups A, C, Y, and W following the administration of a 3-dose series of MenACYW conjugate vaccine compared to a 3-dose series of a licensed meningococcal vaccine when each vaccine is given concomitantly with routine pediatric vaccines (10-valent pneumococcal vaccine and diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b [DTaP-IPV-HB-Hib vaccine]) to infants and toddlers 6 weeks to 18 months old
    Dimostrare la non inferiorità della risposta anticorpale ai sierogruppi meningococcici A,
    C, W e Y dopo la somministrazione di una serie di 3 dosi di vaccino coniugato MenACYW
    rispetto a una serie di 3 dosi di Nimenrix® quando ogni vaccino viene somministrato in
    concomitanza con i vaccini pediatrici di routine (PCV10 e vaccino esavalente) a neonati
    e bambini piccoli dalle 6 settimane ai 18 mesi di età
    E.2.2Secondary objectives of the trial
    To demonstrate the non-inferiority of the antibody response against meningococcal serogroups A, C, Y, and W following the administration of 2 doses in infancy of MenACYW conjugate vaccine compared to 2 doses of a licensed meningococcal vaccine when each vaccine is given concomitantly with routine pediatric vaccines (10-valent pneumococcal vaccine and DTaP-IPV-HB-Hib vaccine) to infants and toddlers 6 weeks to 18 months old
    To describe the antibody responses against meningococcal serogroups A, C, Y, and W when MenACYW conjugate vaccine is administered in a 3-dose series concomitantly with 13-valent pneumococcal vaccine, DTaP-IPV-HB-Hib vaccine and mumps, measles and rubella (MMR) vaccine
    To describe the antibody responses against the antigens of the routine pediatric vaccines administered in a 3-dose series concomitantly with MenACYW conjugate vaccine or a licensed meningococcal vaccine
    To describe the safety profile of MenACYW conjugate vaccine and a licensed meningococcal vaccine
    - Dimostrare la non inferiorità della risposta anticorpale ai sierogruppi
    meningococcici A, C, W e Y dopo la somministrazione di una serie di 2 dosi neonatali di
    vaccino coniugato MenACYW rispetto a 2 dosi neonatali di Nimenrix® quando ogni
    vaccino viene somministrato in concomitanza con i vaccini pediatrici di routine (PCV10
    e vaccino esavalente) a neonati e bambini piccoli dalle 6 settimane ai 18 mesi di età.
    - Descrivere le risposte anticorpali ai sierogruppi meningococcici A, C, W e Y quando il
    vaccino coniugato MenACYW viene somministrato in una serie di 3 dosi in concomitanza
    con PCV13, il vaccino esavalente e il vaccino MPR.
    - Descrivere le risposte anticorpali agli antigeni dei vaccini pediatrici di routine
    somministrati in una serie di 3 dosi in concomitanza con il vaccino coniugato MenACYW
    o Nimenrix®.
    - Descrivere il profilo di sicurezza del vaccino coniugato MenACYW e Nimenrix®.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Aged ≥ 42 to ≤ 89 days on the day of the first study visit
    - Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg
    - Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (and by an independent witness if required by local regulations)
    - Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all study procedures
    - Covered by health insurance according to local regulations
    1) Età da ≥ 42 a ≤ 89 giorni nel giorno della prima visita dello studio
    2) Nato a termine (≥ 37 settimane) e con un peso alla nascita ≥ 2,5 kg
    3) Modulo di consenso informato firmato e datato dal/i genitore/i o altro
    rappresentante legalmente riconosciuto
    4) Il soggetto e il genitore/rappresentante legalmente riconosciuto sono in grado di
    partecipare a tutte le visite programmate e di rispettare tutte le procedure dello studio
    5) Coperto da assicurazione sanitaria ai sensi delle normative locali
    E.4Principal exclusion criteria
    - Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
    - Receipt of any vaccine in the 4 weeks preceding the first study vaccination or planned receipt of any vaccine in the 4 weeks before and/or following any study vaccination except for influenza vaccination and rotavirus vaccination, which may be received at a gap of at least 2 weeks before or 2 weeks after any study vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
    - Receipt or planned to receipt during the study period vaccination against meningococcal disease with either the study vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine)
    - Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type B (Hib), poliovirus, Streptococcus pneumoniae, measles, mumps, or rubella
    - Receipt of immune globulins, blood or blood-derived products since birth
    - Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) since birth
    - Family history of congenital or hereditary immunodeficiency, unless the immune competence of the potential vaccine recipient is demonstrated
    - Individuals with blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems
    - Individuals with active tuberculosis
    - History of Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically
    - History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, measles, mumps, rubella, and of Haemophilus influenzae type b, and / or Streptococcus pneumoniae infection or disease
    - At high risk for meningococcal infection during the study (specifically, but not limited to, subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects traveling to countries with high endemic or epidemic disease)
    - Individuals with underlying conditions predisposing them to invasive pneumococcal disease (specifically, but not limited to, subjects with sickle cell disease or human immunodeficiency virus [HIV] infection)
    - History of any neurologic disorders, including seizures and progressive neurologic disorders
    - History of Guillain-Barré syndrome
    - Known systemic hypersensitivity to any of the vaccine components, or history of a severe allergic reaction (e.g., anaphylaxis) to the vaccine(s) used in the study or to a vaccine containing any of the same substances including neomycin, streptomycin, polymyxin B, glutaraldehyde, formaldehyde, and gelatin
    - Verbal report of thrombocytopenia, contraindicating intramuscular vaccination in the investigator’s opinion
    - Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the investigator’s opinion
    - Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
    - Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives, including planning to leave the area of the study site before the end of the study
    - Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
    - Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
    - Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
    1. Partecipazione al momento dell'arruolamento nello studio (o nelle 4 settimane
    precedenti la prima vaccinazione dello studio) o partecipazione prevista durante
    il periodo di svolgimento dello studio a un altro studio clinico volto a valutare
    vaccini, farmaci, dispositivi medici o procedure mediche
    2. Ricezione di qualsiasi vaccino nelle 4 settimane precedenti la prima vaccinazione
    dello studio o prevista ricezione di qualsiasi vaccino nelle 4 settimane precedenti
    e/o successive a qualsiasi vaccinazione dello studio, tranne la vaccinazione
    antinfluenzale e la vaccinazione contro il rotavirus, che possono essere ricevute
    a una distanza di almeno 2 settimane prima o 2 settimane dopo qualsiasi
    vaccino dello studio. Questa eccezione comprende i vaccini pandemici
    antinfluenzali monovalenti e i vaccini antinfluenzali multivalenti
    3. Ricezione o prevista ricezione durante il periodo dello studio della vaccinazione
    contro la meningite meningococcica con il vaccino dello studio o un altro vaccino
    (ovvero, vaccino meningococcico mono o polivalente, polisaccaridico o coniugato
    contenente i sierogruppi A, C, W o Y o vaccino meningococcico contenente il
    sierogruppo B)
    4. Vaccinazione pregressa contro difterite, tetano, pertosse, Haemophilus
    influenzae di tipo b (Hib), poliovirus, Streptococcus pneumoniae, morbillo,
    parotite o rosolia
    5. Ricevimento di immunoglobuline, sangue o prodotti emoderivati dalla nascita
    6. Nota o sospetta immunodeficienza congenita o acquisita o ricezione di una
    terapia immunosoppressiva, tra cui chemioterapia o radioterapia antitumorale, o
    di una terapia a base di corticosteroidi sistemici a lungo termine (prednisone o
    equivalente per più di 2 settimane consecutive) dalla nascita
    7. Anamnesi familiare di immunodeficienza congenita o ereditaria, a meno che non
    venga dimostrata la competenza immunitaria del candidato al vaccino
    8. Soggetti con discrasia ematica, leucemia, linfoma di qualsiasi tipo o altre
    neoplasie maligne a carico del midollo osseo o del sistema linfatico
    9. Soggetti con tubercolosi attiva
    10. Anamnesi di infezione da Neisseria meningitidis, confermata clinicamente,
    sierologicamente o microbiologicamente
    11. Anamnesi di difterite, tetano, pertosse, poliomielite, epatite B, morbillo,
    parotite, rosolia ed Haemophilus influenzae di tipo b e/o infezione o malattia da
    Streptococcus pneumoniae
    12. Ad alto rischio di infezione meningococcica durante lo studio (specificatamente,
    ma non solo, soggetti con deficit del complemento persistente, con asplenia
    anatomica o funzionale o soggetti che viaggiano in Paesi con malattia endemica
    o epidemica)
    13. Soggetti con condizioni di fondo che li predispongono alla malattia
    pneumococcica invasiva (specificatamente, ma non solo, soggetti con anemia
    falciforme o infezione da virus dell’immunodeficienza umana [HIV])
    14. Anamnesi di disturbi neurologici, comprese crisi convulsive e disturbi neurologici
    progressivi
    15. Anamnesi di sindrome di Guillain-Barré
    16. Nota ipersensibilità sistemica a un qualsiasi componente del vaccino o anamnesi di reazione allergica grave (ad esempio, anafilassi) al/i vaccino/i impiegato/i
    nello studio o a un vaccino contenente una delle stesse sostanze, comprese
    neomicina, streptomicina, polimixina B, glutaraldeide, formaldeide e gelatina
    17. Referto verbale di trombocitopenia che, a giudizio dello sperimentatore,
    costituisca una controindicazione alla vaccinazione intramuscolare
    18. Disturbo della coagulazione o ricezione di anticoagulanti nelle 3 settimane
    precedenti l'inclusione che, a giudizio dello sperimentatore, costituisca una
    controindicazione alla vaccinazione intramuscolare
    19. Malattia cronica che, a giudizio dello sperimentatore, sia in una fase che
    potrebbe interferire con la conduzione o il completamento dello studio
    20. Qualsiasi condizione che, a giudizio dello sperimentatore, possa interferire con la
    valutazione degli obiettivi dello studio, compresa pianificazione di trasferimento
    lontano dal centro sperimentale prima della fine dello studio
    21. Malattia/infezione acuta moderata o grave (a giudizio dello sperimentatore) il
    giorno della vaccinazione o malattia febbrile (temperatura ≥ 38 °C). Un
    soggetto prospettico non deve essere incluso nello studio fino a risoluzione della
    condizione o attenuazione dell'evento febbrile.
    22. Ricevimento di terapia antibiotica orale o iniettabile entro le 72 ore precedenti il
    primo prelievo di sangue
    23. Identificato come figlio naturale o adottivo dello sperimentatore o di un
    dipendente con un coinvolgimento diretto nello studio proposto
    E.5 End points
    E.5.1Primary end point(s)
    Antibody titers against meningococcal serogroups A, C, Y, and W (groups 1 and 2) - Antibody titers will be measured by the serum bactericidal assay using human complement (hSBA) and expressed as geometric mean titers (GMTs)
    Titoli anticorpali ai sierogruppi meningococcici A, C, W e Y (gruppi 1 e 2) – I titoli
    anticorpali saranno misurati tramite saggio battericida sierico con complemento umano
    (hSBA) ed espressi come titoli medi geometrici (GMT)
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days after dose 3
    30 giorni dopo la terza dose
    E.5.2Secondary end point(s)
    1. Antibody titers ≥ 1:8 against meningococcal serogroups A, C, Y, and W (groups 1 and 2) - % of participants achieving antibody titers ≥ predefined threshold of 1:8, measured by hSBA
    2. Antibody titers above pre-defined thresholds for meningococcal serogroups A, C, Y, and W (group 3) - % of participants achieving antibody titers ≥ predefined thresholds, measured by hSBA
    3. Antibody titers against meningococcal serogroups A, C, Y, and W (group 3) - Antibody titers will be measured by hSBA and expressed as GMTs
    4. Antibody concentrations against pre-defined thresholds for antigens of DTaP-IPV-HB-Hib vaccine (groups 1, 2, and 3) - % of participants with antibody concentrations ≥ established seroprotection cut-off levels for diphtheria, tetanus, polio, hepatitis B and Hib, and seroresponse rate for anti-pertussis antibodies
    5. Antibody concentrations/titers against antigens of DTaP-IPV-HB-Hib vaccine (groups 1, 2, and 3) - Antibody concentrations/titers will be measured by standard assays for the antigens contained in the vaccine
    6. Antibody concentrations above pre-defined thresholds for antigens of 10-valent pneumococcal vaccine (groups 1 and 2) - % of participants with antibody concentrations ≥ established seroprotection cut-off levels for antigens in the pneumococcal vaccine
    7. Antibody concentrations against antigens of 10-valent pneumococcal vaccine (groups 1 and 2) - Antibody concentrations will be measured by standard assays for the antigens contained in the vaccine
    8. Antibody concentrations above pre-defined thresholds for antigens of 13-valent pneumococcal vaccine (group 3) - % of participants with antibody concentrations ≥ established seroprotection cut-off levels for antigens in the pneumococcal vaccine
    9. Antibody concentrations against antigens of 13-valent pneumococcal vaccine (group 3) - Antibody concentrations will be measured by standard assays for the antigens contained in the vaccine
    10. Antibody concentrations above pre-defined thresholds for antigens of MMR vaccine (groups 1, 2, and 3) - % of participants with antibody concentrations ≥ established seroprotection cut-off levels for antigens in MMR vaccine
    11. Antibody concentrations against antigens of MMR vaccine (groups 1, 2, and 3) - Antibody concentrations will be measured by standard assays for the antigens contained in the vaccine
    12. Solicited injection site reactions and systemic reactions - Injection site reactions: pain, erythema, and swelling; Systemic reactions: fever, vomiting, crying abnormal, drowsiness, appetite lost, and irritability
    1. Titoli anticorpali ≥ 1: 8 contro i sierogruppi meningococcici A, C, Y e W (gruppi 1 e
    2) -% di partecipanti che ottengono titoli anticorpali ≥ della soglia predefinita di 1: 8,
    misurata da hSBA.
    2. Titoli anticorpali al di sopra delle soglie predefinite per i sierogruppi meningococcici
    A, C, Y e W (gruppo 3) - % dei partecipanti che raggiungano titoli anticorpali ≥ delle
    soglie predefinite, misurate da hSBA.
    3. Titoli anticorpali contro i sierogruppi meningococcici A, C, Y e W (gruppo 3) - I titoli
    anticorpali saranno misurati da hSBA ed espressi come GMT.
    4. Concentrazioni anticorpali contro soglie predefinite di antigeni di vaccino esavalente
    (DTaP-IPV-HB-Hib) (gruppi 1, 2 e 3) -% di partecipanti con concentrazioni di anticorpi
    ≥ dei livelli stabiliti di cut-off della sieroprotezione per difterite, tetano, poliomielite,
    epatite B e Hib e tasso di sierorisposte per anticorpi anti-antipertosse
    5. Concentrazioni / titoli anticorpali contro gli antigeni di vaccino esavalente (gruppi 1,
    2 e 3) - Le concentrazioni / titoli anticorpali saranno misurati con saggi standard per gli
    antigeni contenuti nel vaccino
    6. Concentrazioni di anticorpi superiori alle soglie predefinite per gli antigeni di PCV10 (gruppi 1 e 2) -% dei partecipanti con concentrazioni di anticorpi ≥ dei livelli
    stabiliti di cut-off della sieroprotezione per antigeni nel vaccino pneumococcico
    7. Concentrazioni anticorpali contro gli antigeni di vaccino pneumococco 10-valente
    (gruppi 1 e 2) - Le concentrazioni di anticorpi saranno misurate da analisi standard per
    gli antigeni contenuti nel vaccino.
    8. Concentrazioni di anticorpi oltre le soglie predefinite per gli antigeni del vaccino
    PCV13 (gruppo 3) -% dei partecipanti con concentrazioni di anticorpi ≥ dei livelli
    stabiliti di cut-off della sieroprotezione per antigeni nel vaccino pneumococcico
    9. Concentrazioni di anticorpi contro antigeni di PCV13 (gruppo 3) - Le concentrazioni
    di anticorpi saranno misurate da analisi standard per gli antigeni contenuti nel vaccino
    10. Concentrazioni di anticorpi superiori alle soglie predefinite per gli antigeni
    di vaccino PMR (gruppi 1, 2 e 3) -% di partecipanti con concentrazione di anticorpi ≥
    dei livelli stabiliti di cut-off della sieroprotezione per antigeni nel Vaccino PMR
    11. Concentrazioni anticorpali contro gli antigeni del vaccino PMR (gruppi 1,
    2 e 3) - Le concentrazioni di anticorpi saranno misurate mediante analisi standard
    per gli antigeni contenuti nel vaccino
    12. Reazioni attese al sito di iniezione e reazioni sistemiche –reazioni al sito di
    iniezione: dolore, eritema e gonfiore; Reazioni sistemiche: febbre, vomito, pianto
    anormale, sonnolenza, perdita di appetito e irritabilità
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 30 days after dose 2
    2. D0, 30 days after dose 2, before dose 3 and 30 days after dose 3
    3. D0, 30 days after dose 2, before dose 3 and 30 days after dose 3
    4. D0, 30 days after dose 2 and 30 days after dose 3
    5. D0, 30 days after dose 2 and 30 days after dose 3
    6. 30 days after dose 2 and 30 days after dose 3
    7. 30 days after dose 2 and 30 days after dose 3
    8. 30 days after dose 2 and 30 days after dose 3
    9. 30 days after dose 2 and 30 days after dose 3
    10. 30 days after dose 3
    11. 30 days after dose 3
    12. Within 7 days after any injection
    1. 30 giorni dopo la dose 2
    2. D0, 30 giorni dopo la dose 2, prima della dose 3 e 30 giorni dopo la dose 3
    3. D0, 30 giorni dopo la dose 2, prima della dose 3 e 30 giorni dopo la dose 3
    4. D0, 30 giorni dopo la dose 2 e 30 giorni dopo la dose 3
    5. D0, 30 giorni dopo la dose 2 e 30 giorni dopo la dose 3
    6. 30 giorni dopo la dose 2 e 30 giorni dopo la dose 3
    7. 30 giorni dopo la dose 2 e 30 giorni dopo la dose 3
    8. 30 giorni dopo la dose 2 e 30 giorni dopo la dose 3
    9. 30 giorni dopo la dose 2 e 30 giorni dopo la dose 3
    10. 30 giorni dopo la dose 3
    11. 30 giorni dopo la dose 3
    12. Entro 7 giorni dopo ciascuna iniezione
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 trial4
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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 months32
    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 months32
    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 Yes
    F.1.1Number of subjects for this age range: 1540
    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: 1540
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Infants and Toddlers
    Neonati e bambini piccoli
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1540
    F.4.2.2In the whole clinical trial 1540
    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
    Nessuno
    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 Decision2018-09-05
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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