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    Summary
    EudraCT Number:2011-004931-30
    Sponsor's Protocol Code Number:V72P12E2
    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:2012-09-03
    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 number2011-004931-30
    A.3Full title of the trial
    A Phase 3, Open Label, Multi-Center, Extension Study to Assess Antibody Persistence and Response to a Third or Fift Dose of Novartis Meningococcal B Recombinant Vaccine in 4-Year-Old Children Who Previously Participated in Study V72P12E1
    Studio di estensione multicentrico, in aperto, di fase 3 per la valutazione della persistenza e della risposta anticorpale a una terza o quinta dose del vaccino ricombinante antimeningococco B di Novartis in bambini di 4 anni che hanno giï ½ partecipato allo studio V72P12E1.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of persistence of Antibody Levels and Response to Third or Fifth dose of Meningococcal B Recombinant Vaccine in 4-year old Healthy Children who Previously Participated in Study V72P12E1
    Valutazione persistenza del livello anticorpale e risposta alla terza o quinta dose di vaccino ricombinante per il Meningococco B in bambini sani di 4 anni che hanno precedentemente partecipato allo studio V72P12E1
    A.4.1Sponsor's protocol code numberV72P12E2
    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 Vaccini
    B.5.2Functional name of contact pointDipartimento regione SudEuropa
    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 number00390577539247
    B.5.5Fax number+39 0577 245340
    B.5.6E-mailsperclin_seuropa.nvdit@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 meningococcal B recombinant+ OMV NZ Vaccine
    D.3.2Product code rMenB+OMV NZ
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMENINGOCOCCAL VACCINE
    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.3.9.3Other 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.3.9.3Other 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.3.9.3Other 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
    heathy volunteers (Meningitis B)
    Volontari sani (Meningite B)
    E.1.1.1Medical condition in easily understood language
    heathy volunteers (Meningitis B)
    Volontari sani (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 15.0
    E.1.2Level SOC
    E.1.2Classification code 10021881
    E.1.2Term Infections and infestations
    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
    The main aim of the second extension study is to explore the bactericidal antibody persistence in 4-year-old children after a fourth dose boost of rMenB+OMV NZ given at 12, 18, or 24 months of age or after a two-dose catch-up schedule of rMenB+OMV NZ administered at either 12 and 14, 18 and 20, or 24 and 26 months of age in study V72P12E1.
    Il principale scopo del secondo studio di estensione è esaminare la persistenza degli anticorpi con attività battericida in bambini di 4 anni dopo una quarta dose di richiamo di rMenB+OMV NZ somministrata a 12, 18 o 24 mesi di età, oppure dopo un programma di “catch-up” di due dosi di rMenB+OMV NZ a 12 e 14 ,18 e 20 o 24 e 26 mesi di età nello studio V72P12E1
    E.2.2Secondary objectives of the trial
    characterize the antibody response to a fifth dose boost in all children who received a three-dose primary series of rMenB+OMV NZ at 2, 3, 4 months of age (in parent study V72P12), and only in a subset of children who received a three-dose primary series of rMenB+OMV NZ at 2, 4, 6 months of age (in parent study V72P12). Antibody response will also be characterized to a third dose boost of rMenB+OMV NZ administered at 4 years of age. Finally, the safety and immunogenicity of two catch-up doses of rMenB+OMV NZ administered 2 months apart to healthy naïve children at 4 years of age will be assessed.
    Caratterizzazione della risposta anticorpale dopo una quinta dose di richiamo in tutti i bambini che hanno ricevuto le tre dosi primarie di rMenB+OMV NZ a 2, 3 e 4 mesi di età (nello studio V72P12), e soltanto in un sottogruppo nei bambini che hanno ricevuto le tre dosi primarie di rMenB+OMV NZ a 2, 4 e 6 mesi di età (nello studio V72P12). Sarà Inoltre caratterizzata la risposta anticorpale dopo una terza dose di richiamo di rMenB+OMV NZ somministrata a 4 anni di età. Verranno infine valutate la sicurezza e l'immunogenicità di due dosi “catch-up” di rMenB+OMV NZ somministrate a 2 mesi di distanza a bambini naïve sani di 4 anni di età.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A. Inclusion Criteria for naïve subjects, newly enrolled (Group 7): 1.4 years old (48 months ± 180 days window) healthy male and female subjects will be recruited from the same sites as in study V72P12E1. 2.for whom parent/legal guardian has given written informed consent after the nature of the study has been explained; 3.for whom parent/legal guardian confirmed availability for the visit scheduled in the study; 4.in good health as determined by medical history, physical examination, clinical judgment of the investigator B.Inclusion Criteria for follow-on participants (Groups 1, 2, 3, 4, 5, and 6): Inclusion criteria are the same as for Groups 7, with the addition that they are subjects who completed the vaccination course of V72P12E1 study, who are 4 years old and above (preferably closer to 4 years of age).
    A.Criteri di inclusione per i soggetti naïve, nuovi arruolati(Gruppo 7): 1.verranno arruolati soggetti sani maschi e femmine di 4 anni di età (48 mesi ± 180 giorni) presso gli stessi centri coinvolti nello studio V72P12E1; 2.per i quali il/i genitore/i/o il/i tutore/i legale/i ha/hanno concesso il consenso informato scritto dopo aver avuto spiegazioni sulla natura dello studio; 3.per i quali il/i genitore/i o il/i tutore/i legali ha/hanno confermato la disponibilità alle visite programmata nello studio; 4.in buona salute sulla base dell'anamnesi, della visita medica e del giudizio clinico dello sperimentatore. Criteri di inclusione per i partecipanti dell’estensione precedente (Gruppi 1, 2, 3, 4, 5 e 6): I criteri di inclusione sono identici a quelli del Gruppo 7, con l'aggiunta che i soggetti devono aver completato il programma di vaccinazione dello studio V72P12E1, che hanno più di 4 anni di età (preferibilmente più vicini ai 4 anni di età).
    E.4Principal exclusion criteria
    A.Exclusion Criteria for naïve subjects, newly enrolled (Group 7):1. subjects whose parents/legal guardians are unwilling or unable to give written informed consent to participate in the study; 2.history of any meningococcal B vaccine administration; 3. previous ascertained or suspected disease caused by N. meningitidis; 4. household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis; 5. history of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component; 6. significant acute or chronic infection within the previous 7 days or axillary temperature 38C within the day before Visit 1; 7. systemic use of antibiotics for treatment of significant acute or chronic infections within 7 days prior to Visit 1; 8. any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, progressive neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition); 9.known or suspected impairment/alteration of the immune system,immunosuppressive therapy, use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within 30 days prior to Visit 1; 10. receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within 90 days prior to Visit 1; 11. receipt of, or intent to immunize with any other vaccine, within 30 days prior to Visit 1 (with the exception of licensed flu vaccine, which can be administered at any time during the study period, but not within 14 days of vaccination with rMenB+OMV NZ); 12. participation in another clinical trial within 90 days prior to enrolment or planned for during study; 13. family members and household members of research staff; 14. any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives. B. Exclusion Criteria for follow-on participants (Groups 1, 2, 3, 4, 5, and 6): Exclusion criteria are the same as for Group 7, with the exception of criterion 2 and excluding participation in V72P12E1 for criterion 12.
    A.Criteri di esclusione per i soggetti naïve nuovi arruolati (Gruppo 7): 1.soggetti i cui genitori/tutori legali non intendono o non possono concedere il consenso informato scritto per l'arruolamento nello studio; 2.precedente somministrazione di un qualsiasi vaccino antimeningococco B; 3.patologia pregressa confermata o sospetta causata da N. meningitidis; 4.contatto familiare e/o un'esposizione stretta ad un individuo con infezione da N. meningitidis confermata in laboratorio; 5.anamnesi di reazioni allergiche gravi in seguito a vaccinazioni precedenti o ipersensibilità a qualsiasi componente del vaccino; 6.infezione cronica o acuta significativa nei 7 giorni precedenti o temperatura ascellare 38C nel giorno precedente alla Visita 1; 7.utilizzo sistemico di antibiotici per il trattamento di infezioni croniche o acute nei 7 giorni precedenti alla Visita 1; 8.qualunque patologia cronica o progressiva seria secondo il giudizio dello sperimentatore (es. neoplasia, diabete mellito Tipo I, cardiopatia, patologia epatica, patologia neurologica progressiva o convulsioni, sia in combinazione con febbre o nel quadro di un disturbo o di una sindrome di natura neurologica di base, patologia autoimmune, infezione da HIV o AIDS, oppure discrasia ematica o diatesi, sintomi di insufficienza cardiaca o renale oppure malnutrizione grave); 9.alterazione o disturbo noto o sospetto del sistema immunitario, terapia immunosoppressiva, uso di corticosteroidi per via sistemica o uso cronico di corticosteroidi ad alta potenza per inalazione nei 30 giorni precedenti alla Visita 1; 10.ricezione di sangue, prodotti ematici e/o derivati del plasma o una preparazione parenterale di immunoglobuline nei 90 giorni precedenti alla Visita 1; 11.vaccinazione effettuata o prevista con altri vaccini, nei 30 giorni precedenti alla Visita 1 (ad eccezione del vaccino antinfluenzale autorizzato, il quale può essere somministrato in qualsiasi momento nell'arco del periodo dello studio, ma non nell'arco di 14 giorni dalla vaccinazione con rMenB+OMV NZ); 12.partecipazione ad un altro studio clinico nei 90 giorni precedenti all'arruolamento o programmata durante lo studio; 13.familiari e conviventi del personale clinico; 14.qualsiasi condizione che, nell’opinione dello sperimentatore, potrebbe interferire con la valutazione degli obiettivi dello studio. B. Criteri di esclusione per i partecipanti dell’estensione precedente(Gruppi 1, 2, 3, 4, 5 e 6): I criteri di esclusione sono identici a quelli del Gruppo 7, ad eccezione del criterio 2 e l’esclusione della partecipazione nel V72P12E1 per il criterio 12.
    E.5 End points
    E.5.1Primary end point(s)
    For Groups 1 to 3: The persistence of serum bactericidal activity at 4 years of age will be measured against N. meningitidis serogroup B indicator strains H44/76, 5/99, NZ98/254 and M10713. Data will be summarized by calculating percentage of subjects with hSBA≥ 1:5, hSBA ≥ 1:8, hSBA geometric mean titers (GMTs), and geometric mean ratio (GMRs) over baselines at 4 years of age after the last rMenB+OMV NZ vaccination in the V72P12E1 study), to each of the four indicator strains. All immunogenicity analyses will be erformed on the MITT population.
    • Per i Gruppi da 1 a 3: La persistenza dell'attività battericida del siero, a 4 anni di età, verrà misurata contro gli indicatori di N. meningitidis sierogruppo B, H44/76, 5/99, NZ98/254 e M10713. I dati saranno riassunti calcolando la percentuale di soggetti con hSBA≥ 1:5, hSBA ≥ 1:8, le medie geometriche dei titoli hSBA (GMTs) e il rapporto delle medie geometriche (GMRs) basato su GMTs ad un mese dopo l’ultima vaccinazione di richiamo rMenB+OMV NZ nello studio V72P12E1, in rapporto ad ognuno dei quattro indicatori. Tutte le analisi dell'immunogenicità saranno effettuate sulla popolazione MITT.
    E.5.1.1Timepoint(s) of evaluation of this end point
    NA
    NA
    E.5.2Secondary end point(s)
    For Groups 4 to 6: The persistence of serum bactericidal activity at 4 years of age will be measured against N. meningitidis serogroup B indicator strains H44/76, 5/99, NZ98/254 and M10713. Data will be summarized by calculating percentage of subjects with hSBA≥ 1:5, hSBA ≥ 1:8, hSBA geometric mean titers (GMTs), and geometric mean ratio (GMRs) over baselines at 4 years of age after the last rMenB+OMV vaccination in the V72P12E1 study), to each of the four indicator strains. All immunogenicity analyses will be performed on the ITT population. For subset#2 of groups 1 and 2 (1/3 of each sub-group) and for all group 3:induction of bactericidal antibodies at 1 month following a fifth dose boost of rMenB+OMV vaccination will be characterized by calculating SBA GMTs, percentage of subjects with hSBA titers ≥ 1:5 and ≥ 1:8, and fourfold increase to each of the four indicator strains. For Groups 4 to 6: induction of bactericidal antibodies at 1 month following a third dose boost of rMenB+OMV vaccination will be characterized by calculating SBA GMTs, percentage of subjects with SBA titers ≥ 1:5 and ≥ 1:8, and fourfold increase to each of the four indicator strains. Baseline antibody levels measured in naïve subjects at approximately 4 years of age (Group 7) will serve as a descriptive comparator to evaluate antibody persistence at 4 years of age after the fourth rMenB+OMV dose in Groups 1 to 3, and after second dose in Groups 4 to 6, in V72P12E1 study. The immune response following the first dose will also serve as a comparator for the booster responses in the above mentioned vaccine groups. These naive subjects will also serve to gain experience with catch-up immunizations with rMenB+OMV in this older age group.
    •Per i Gruppi da 4 a 6: La persistenza dell'attività battericida nel siero, a 4 anni di età, verrà misurata contro gli indicatori di N. meningitidis sierogruppo B, H44/76, 5/99, NZ98/254 e M10713. I dati saranno riassunti calcolando la percentuale di soggetti con hSBA≥ 1:5, hSBA ≥ 1:8, le medie geometriche dei titoli hSBA (GMTs) e il rapporto delle medie geometriche (GMRs) basati sui GMTs ad un mese dopo l’ultima vaccinazione rMenB+OMV nello studio V72P12E1, in rapporto ad ognuno dei quattro indicatori Tutte le analisi dell'immunogenicità saranno effettuate sulla popolazione MITT. •Per il sottogruppo n. 2 dei gruppi 1 e 2 (1/3 di ciascun sottogruppo) e per l'intero gruppo 3: l'induzione di anticorpi battericidi un mese dopo la quinta dose di richiamo della vaccinazione con rMenB+OMV NZ verrà caratterizzata calcolando le GMTs di SBA, la percentuale dei soggetti con titoli hSBA ≥ 1:5 e ≥ 1:8, e un aumento di quattro volte in rapporto ad ognuno dei quattro indicatori. •Per i Gruppi da 4 a 6: l'induzione di anticorpi battericidi ad un mese in seguito a una terza dose di richiamo della vaccinazione con rMenB+OMV NZ verrà caratterizzata calcolando le GMTs dei titoli SBA, la percentuale dei soggetti con titoli hSBA ≥ 1:5 e ≥ 1:8, e incremento di quattro volte di ciascuno dei quattro ceppi indicatori. •I livelli degli anticorpi al valore basale misurati nei soggetti naïve a circa 4 anni di età (Gruppo 7) serviranno come valore di riferimento per valutare la persistenza anticorpale a 4 anni di età dopo la quarta dose di rMenB+OMV NZ nei Gruppi da 1 a 3, e dopo la seconda dose nei Gruppi da 4 a 6, ricevute nello studio V72P12E1. La risposta immunitaria dopo la prima dose paragone servirà come valore di riferimento delle risposte alla dose di richiamo nei gruppi vaccinati già menzionati. Tali soggetti serviranno inoltre ad acquisire esperienza nelle immunizzazioni “catch-up” con rMenB+OMV NZ in tale gruppo di età maggiore.
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 trial7
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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 months16
    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 months18
    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: 1560
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 1560
    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
    4 years old childrens
    Bambini di 4 anni di età circa
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state260
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1560
    F.4.2.2In the whole clinical trial 1560
    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)
    not applicable
    non applicabile
    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 Decision2012-10-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-04-09
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