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    Summary
    EudraCT Number:2011-000476-34
    Sponsor's Protocol Code Number:V59_40
    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:2012-03-20
    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 number2011-000476-34
    A.3Full title of the trial
    A Phase IV,PlaceboControlled,Randomized Study to Evaluate the Immunogenicity and Safety of a Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine (Tdap, Boostrix) and Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18]Recombinant Vaccine (Gardasil) in Healthy Adolescents when Administered with MenACWY Conjugate Vaccine
    Studio Clinico di fase IV, Randomizzato, controllato con Placebo per valutare la Immunogenicita' e la Sicurezza della vaccino combinato contro Tetano, Tossoide Difterico Ridotto e Pertosse Acellulare (Tdap, Boostrix) e il vaccino Ricombinante Umano, Quadrivalente Papillomavirus [Tipo 6, 11, 16, 18] (Gardasil), in adolescenti sani quando somministrato con il Vaccino Coniugato MenACWY
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate the immune response and safety of a combined Tdap vaccine(Boostrix, GSK) and antipapilloma human virus vaccine (Gardasil) vaccine when administered with the meningococcal conjugate ACWY Novartis or placebo.
    Studio clinico per valutare la risposta immunitaria e la sicurezza di un vaccino combinato Tdap (BOOSTRIX, GSK) e del vaccino antipapilloma virus umano (Gardasil), quando somministrati in concomitanza del vaccino meningococcico ACWY coniugato di Novartis o placebo.
    A.4.1Sponsor's protocol code numberV59_40
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01424644
    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 Diagnostic
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Vaccines and Diagnostic
    B.5.2Functional name of contact pointCR&D Southern Europe
    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+39 0577 249226
    B.5.5Fax number+39 0577 245340
    B.5.6E-mailnoemi.giglioli@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*IM 1FL+1FL 0,5ML
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS VACCINES AND DIAG.Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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.3.9.2Current sponsor codeMenA-CRM
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeMenC-CRM
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeMenW-CRM
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeMenY-CRM
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Menveo is indicated for active immunization of adolescents (from 11 years of age) and adults at risk of exposure to Neisseria meningitidis groups A, C, W135 and Y, to prevent invasive disease.
    Menveo e` indicato per l`€™immunizzazione attiva di adolescenti (dall`€™eta` di 11 anni) e adulti a rischio di esposizione ai gruppi A, C, W135 e Y di Neisseria meningitidis per impedire l`€™insorgenza di patologie invasive.
    E.1.1.1Medical condition in easily understood language
    active immunization of adolescents and adults at risk of exposure to Neisseria meningitidis groups A, C, W135 and Y, to prevent invasive disease.
    l`€™immunizzazione attiva di adolescenti e adulti a rischio di esposizione ai gruppi A, C, W135 e Y di Neisseria meningitidis per impedire l`€™insorgenza di patologie invasive.
    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 SOC
    E.1.2Classification code 10021881
    E.1.2Term Infections and infestations
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10027276
    E.1.2Term Meningococcal meningitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Immunogenicity Objectives: Co-primary 1. To demonstrate that the immune response of Tdap given concomitantly with MenACWY and HPV is non-inferior to the response of Tdap when given with placebo and HPV when measured at 1 month after 1 dose of Tdap. 2. To demonstrate that the immune response of HPV vaccine given concomitantly with MenACWY and Tdap is non-inferior to the response when HPV is given with placebo and Tdap when measured at 1 month after the third dose of HPV vaccination. Safety objectives: - To describe the safety profile of Tdap + HPV + MenACWY versus Tdap + HPV + placebo
    Obiettivi di immunogenicita`: Coprimari: 1.Dimostrare che la risposta immunitaria di Tdap, somministrato in concomitanza con MenACWY e anti-HPV, e` non inferiore alla risposta di Tdap, se somministrato con placebo e anti-HPV, quando viene misurata 1 mese dopo la prima dose di Tdap. 2.Dimostrare che la risposta immunitaria del vaccino anti-HPV, somministrato in concomitanza con MenACWY e Tdap, e` non inferiore alla risposta dell`€™anti-HPV, se somministrato con placebo e Tdap, quando viene misurata 1 mese dopo la terza dose del vaccino anti-HPV. Obiettivi di sicurezza: •Descrivere il profilo di sicurezza di Tdap + anti-HPV + MenACWY versus Tdap + anti-HPV + placebo
    E.2.2Secondary objectives of the trial
    Immunogenicity objectives Secondary: To assess the immune response of MenACWY when administered with Tdap and HPV at 1 month after 1 dose of MenACWY vaccination.
    Valutare la risposta immunitaria di MenACWY, quando somministrato con Tdap e anti-HPV 1 mese dopo la prima dose del vaccino MenACWY.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 11-18 years of age inclusive who have given their written consent/assent and if applicable, whose parents or legal guardians have given written informed consent at the time of enrollment; - available for all visits and telephone calls scheduled for the study; - in good health as determined by: - medical history - physical assessment -clinical judgment of the investigator 2. have been properly vaccinated against diphtheria, tetanus, and pertussis per local regulations; 3. Subjects should be current with childhood DTP-containing vaccinations per local guidelines. Any previous vaccinations containing DTP should be at least 5 years before study enrollment and no prior adolescent vaccinations (11-18 years of age) vaccines containing DTP are allowed 4. for female subjects, have a negative urine pregnancy test. 5. any female subject who is sexually active must commit to practice appropriate birth control.
    1. sono di eta` compresa tra 11 e 18 anni (estremi compresi) che hanno dato il proprio consenso/assenso scritto e, se applicabile, i cui genitori o tutori legali hanno dato il consenso informato scritto al momento dell`€™arruolamento; - sono disponibili per tutte le visite dello studio e le telefonate previste per lo studio; - godono di buona salute, come stabilito in base a: - anamnesi;valutazione fisica;giudizio clinico dello Sperimentatore 2. sono stati adeguatamente vaccinati contro la difterite, il tetano e la pertosse, in conformita` alle normative locali 3. sono in regola con le vaccinazioni infantili contenenti DTP, in conformita` alle linee guida locali; tutte le vaccinazioni precedenti contenenti DTP devono risalire ad almeno 5 anni prima dell`€™arruolamento allo studio e non sono consentite precedenti vaccinazioni contenenti DTP durante l`€™adolescenza (11-18 anni di eta`) 4. ottengono un esito negativo del test di gravidanza mediante esame delle urine (per i soggetti di sesso femminile) 5. si impegnano ad utilizzare metodi contraccettivi appropriati se il soggetto e` di sesso femminile e ha una vita sessuale attiva
    E.4Principal exclusion criteria
    1.who are unwilling to give their written assent / consent 2.who are breastfeeding 3. who and/or whose parents or legal guardians are perceived to be unreliable or unavailable for the duration of the study period 4. who had a previous confirmed or suspected disease caused by N. meningitidis 5. who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrollment 6. who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational). (Exception: Receipt of OMP-containing Hib vaccines is permitted) 7. who have received prior human papillomavirus (HPV) vaccine 8. who have received investigational agents or vaccines within 30 days prior to enrollment or who expect to receive an investigational agent or vaccine prior to completion of the study 9. who have received live licensed vaccines within 30 days and inactive vaccine within 15 days prior to enrollment or for whom receipt of a licensed vaccine is anticipated during the study period. (Exception: Influenza vaccine may be administered up to 15 days prior to each studyimmunization and no less than 15 days after each study immunization.) 10. who have experienced, within the 7 days prior to enrollment, significant acute or chronic infection (for example requiring systemic antibiotic treatment or antiviral therapy) or have experienced fever (defined as body temperature `‰¥ 38°C) within 3 days prior to enrollment 11.who have any serious acute, chronic or progressive disease such as -history of cancer -complicated diabetes mellitus - advanced arteriosclerotic disease - autoimmune disease - HIV infection or AIDS -blood dyscrasias -congestive heart failure -renal failure -severe malnutrition (Note: Subjects with mild asthma are eligible for enrollment. Subjects with moderate or severe asthma requiring routine use of inhaled or systemic corticosteroids are not eligible for enrollment) 12. who have epilepsy, any progressive neurological disease or history of Guillain-Barre syndrome 13. who have a history of anaphylaxis, serious vaccine reactions, or allergy to any vaccine component, including latex allergy 14. who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example): - receipt of immunosuppressive therapy within 30 days prior to enrollment (systemic corticosteroids administered for more than 5 days, or in a daily dose > 1 mg/kg/day prednisone or equivalent during any of 30 days prior to enrollment, or cancer chemotherapy) -receipt of immunostimulants - receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrollment and for the full length of the study 15. who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time; 16. who have Down`€™s syndrome or other known cytogenic disorders; 17. who and/or whose families are planning to leave the area of the study site before the end of the study period; 18. who have any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives. 19. who are relatives of the study personnel.
    1.soggetti che non intendono dare il proprio assenso/consenso scritto 2.madri in allattamento 3.soggetti che sono considerati, e/o i cui genitori o tutori legali sono considerati, inaffidabili o non disponibili per la durata del periodo dello studio 4.soggetti che hanno avuto una patologia pregressa confermata o sospetta causata da N. meningitidis 5.soggetti che hanno avuto un contatto familiare con e/o un`€™esposizione intima a un individuo con infezione da N. meningitidis, confermata da coltura, nei 60 giorni precedentiall`€™arruolamento 6.soggetti che sono stati precedentemente immunizzati con un vaccino antimeningococco o un vaccino contenente antigeni di meningococco (autorizzati o in fase di studio). (Eccezione: e` consentita l`€™eventuale immunizzazione con vaccini HiB contenenti OMP)7.soggetti che hanno precedentemente ricevuto il vaccino anti-papillomavirus umano (HPV) 8.soggetti che hanno ricevuto agenti o vaccini oggetto di studio nei 30 giorni precedenti all`€™arruolamento o che prevedono di ricevere un agente o un vaccino oggetto di studio prima del completamento dello studio 9.soggetti che hanno ricevuto vaccini autorizzati vivi nei 30 giorni precedenti e vaccini inattivi nei 15 giorni precedenti all`€™arruolamento o i soggetti per i quali e` prevista la somministrazione di un vaccino autorizzato durante il periodo di studio.(Eccezione: e` possibile somministrare il vaccino antinfluenzale fino a 15 giorni prima a ciascuna immunizzazione dello studio e almeno 15 giorni dopo ciascuna immunizzazione dello studio)10.soggetti che, nei 7 giorni precedenti all`€™arruolamento, hanno avuto un`€™infezione cronica o acuta significativa (ad esempio, tale da richiedere un trattamento antibiotico sistemico o una terapia antivirale) o hanno avuto febbre (definita come temperatura corporea `‰¥ 38°C) nei 3 giorni precedenti all`€™arruolamento 11.soggetti che hanno avuto una grave patologia progressiva, cronica o acuta, come, ad esempio -anamnesi di cancro;diabete mellito complicato;patologia arteriosclerotica avanzata;patologia autoimmune;infezione da HIV o AIDS;discrasia ematica;insufficienza cardiaca congestizia;insufficienza renale;malnutrizione severa(Nota:i soggetti con asma lieve sono idonei all`€™arruolamento;non sono invece idonei all`€™arruolamento i soggetti con asma moderata o grave che richiedono un uso abituale di corticosteroidi per via sistemica o per inalazione)12.soggetti affetti da epilessia, patologie neurologiche progressive oppure con pregressa sindrome di Guillain-Barre13.i soggetti che hanno un`€™anamnesi di anafilassi, reazioni gravi ai vaccini o allergia a qualsiasi componente del vaccino, ivi compresa l`€™allergia al lattice14.soggetti che hanno un`€™alterazione o un disturbo, sospetto o comprovato, della funzione immunitaria,sia essa congenita, acquisita o risultante da (ad esempio):ricezione di terapia immunosoppressiva nei 30 giorni precedenti all`€™arruolamento(corticosteroidi sistemici somministrati per oltre 5 giorni o in una dose giornaliera &gt; 1mg/kg/di` di prednisone o equivalente nel corso dei 30 giorni precedenti all`€™arruolamento o chemioterapia antitumorale);ricezione di immunostimolanti;ricezione di preparazioni di immunoglobulina per via parenterale,prodotti ematici e/o derivati del plasma nei 90 giorni precedenti all`€™arruolamento e per l`€™intera durata dello studio15.soggetti con diatesi emorragica nota o qualsiasi condizione che puo` essere associata a un tempo di sanguinamento prolungato;16.soggetti affetti da sindrome di Down o altre patologie citogenetiche note;17.soggetti che intendono,e/o i cui familiari intendono,lasciare la zona della sede dello studio prima della fine del periodo di studio;18.soggetti che presentano una qualsiasi condizione che, secondo lo Sperimentatore, potrebbe interferire con la valutazione degli obiettivi dello studio19.soggetti chehanno un legame di parentela con il personale dello studio
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity Endpoints Primary Endpoints: - Seroprotection rates for Diphtheria and Tetanus at one month after Tdap vaccination: - Percentage of subjects with diphtheria antitoxin `‰¥ 1.0 IU/mL - Percentage of subjects with tetanus antitoxin `‰¥ 1.0 IU/mL - GMCs for anti-PT, anti-FHA and anti-PRN at one month after Tdap vaccination - Seroconversion rates for Human Papillomavirus (HPV) Types 6, 11, 16 and 18 at one month after 3 HPV vaccinations: - Percentage of subjects with HPV 6 `‰¥ 20 mMU/mL - Percentage of subjects with HPV 11 `‰¥ 16 mMU/mL - Percentage of subjects with HPV 16 `‰¥ 20 mMU/mL - Percentage of subjects with HPV 18 `‰¥ 24 mMU/mL Safety Endpoints: Safety will be assessed for all subjects in terms of the frequency and percentage of subjects with post-injection local or systemic reactions, reported SAEs or medically attended AEs.
    Endpoint dell`€™immunogenicita` Endpoint primari: •Tassi di sieroprotezione per la difterite e il tetano a un mese dopo la vaccinazione con Tdap: -Percentuale di soggetti con antitossina difterica `‰¥ 1,0 IU/mL -Percentuale di soggetti con antitossina tetanica `‰¥ 1,0 IU/mL •Medie geometriche delle concentrazioni (GMC) per anti-PT, anti-FHA e anti-PRN un mese dopo la vaccinazione con Tdap •Tassi di sieroconversione per i ceppi 6, 11, 16 e 18 del Papillomavirus umano (HPV) un mese dopo le 3 vaccinazioni anti-HPV: -Percentuale di soggetti con HPV 6 `‰¥ 20 mMU/mL -Percentuale di soggetti con HPV 11 `‰¥ 16 mMU/mL -Percentuale di soggetti con HPV 16 `‰¥ 20 mMU/mL -Percentuale di soggetti con HPV 18 `‰¥ 24 mMU/mL Endpoint di sicurezza: La sicurezza verra` valutata per tutti i soggetti in termini di frequenza e percentuale di soggetti con reazioni sistemiche o locali post-iniezione, eventi avversi seri segnalati o eventi avversi osservati clinicamente
    E.5.1.1Timepoint(s) of evaluation of this end point
    one month after vaccination
    un mese dopo la vaccinazione
    E.5.2Secondary end point(s)
    Secondary Endpoints: - Seroresponse rates for Meningococcal Serogroups A, C, W and Y at 1 month after MenACWY vaccination: - For a subject with baseline hSBA titer <1:4, seroresponse is defined as a postvaccination hSBA titer `‰¥ 1:8; for a subject with baseline hSBA titer `‰¥ 1:4, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
    Secondari: Valutare la risposta immunitaria di MenACWY, quando somministrato con Tdap e anti-HPV 1 mese dopo la prima dose del vaccino MenACWY.
    E.5.2.1Timepoint(s) of evaluation of this end point
    un mese dopo la vaccinazione
    one month after vaccination
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    observer- blind
    observer- blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    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 months11
    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 months11
    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: 150
    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: 50
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 100
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 800
    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)
    The trial is conducted to healthy subject.If an AE is unresolved at the conclusion of the study, a clinical assessment will be made by the investigator and medical monitor whether continued follow-up of the AE is warranted.
    Lo studio verra' condotto su soggetti sani. Se un AE non si e' risolto alla conclusione dello studio, lo sperimentatore e un medico qualificato faranno una valutazione clinica per garantire un monitoraggio appropriato dello stesso.
    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 Decision2011-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-12-20
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