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    Summary
    EudraCT Number:2013-001602-28
    Sponsor's Protocol Code Number:HXV02C
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-05-14
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-001602-28
    A.3Full title of the trial
    An open-label, controlled, multi-centre study of the immunogenicity and safety of a challenge dose of HBVAXPRO® to explore the anamnestic immune response in healthy children vaccinated 10 years ago with a primary series (3 doses) of either HEXAVAC® or INFANRIX®-HEXA
    Uno Studio in aperto, controllato, multicentrico, sull’immunogenicità e sicurezza di una dose challenge di HBVAXPRO®, per valutare la risposta immunitaria anamnestica in bambini sani vaccinati 10 anni prima con una serie primaria (3 dosi) di HEXAVAC® o INFANRIX®-HEXA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    study of the immunogenicity and safety of a decoy dose of HBVAXPRO®, in healthy children vaccinated 10 years ago with 3 doses of HEXAVAC® or INFANRIX®-HEXA.
    studio sull'immunogenicità e sulla sicurezza della dose di richiamo con HBVAXPRO®, in bambini sani vaccinati 10 prima con 3 dosi di HEXAVAC® o INFANRIX®-HEXA.
    A.3.2Name or abbreviated title of the trial where available
    HXV02C
    A.4.1Sponsor's protocol code numberHXV02C
    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 SponsorSanofi Pasteur MSD S.N.C.
    B.1.3.4CountryFrance
    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 MSD SNC
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi Pasteur MSD SNC
    B.5.2Functional name of contact pointClinical Trial Manager
    B.5.3 Address:
    B.5.3.1Street Address8 rue Jonas Salk
    B.5.3.2Town/ cityLyon cedex 07
    B.5.3.3Post code69367
    B.5.3.4CountryFrance
    B.5.4Telephone number+33(0)437282774
    B.5.5Fax number+33(0)437284451
    B.5.6E-mailsdard@spmsd.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 HBVAXPRO®
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur MSD S.N.C
    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 Suspension for injection
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product 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 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 CHILDREN
    BAMBINI SANI
    E.1.1.1Medical condition in easily understood language
    HEALTHY CHILDREN
    BAMBINI SANI
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    *To describe, in subjects vaccinated with 3 doses of HEXAVAC® as infants, the percentage of subjects with an anti-HBs concentration ≥10 mIU/mL one month after a challenge dose of HBVAXPRO® given at least 10 years later
    *To describe, in subjects vaccinated with 3 doses of INFANRIX®-HEXA as infants, the percentage of subjects with an anti-HBs concentration ≥10 mIU/mL one month after a challenge dose of HBVAXPRO® given at least 10 years later
    *Descrivere, nei soggetti vaccinati con tre dosi di HEXAVAC® in età infantile, la percentuale dei soggetti con una concentrazione di anti-HBs ≥10 mUI/mL un mese dopo la dose challenge di HBVAXPRO®, somministrata dopo un periodo di almeno 10 anni.
    *Descrivere, nei soggetti vaccinati con tre dosi di INFANRIX®-HEXA in età infantile, la percentuale dei soggetti con una concentrazione di anti-HBs ≥10mUI/mL un mese dopo la dose challenge di HBVAXPRO®, somministrata almeno 10 anni dopo.
    E.2.2Secondary objectives of the trial
    Immunogenicity objective:
    *To describe, in subjects vaccinated with 3 doses of HEXAVAC® or 3 doses of INFANRIX®-HEXA as infants, the level of antibody to HBs before and one month after a challenge dose of HBVAXPRO® given at least 10 years later,
    *To describe, in subjects vaccinated with 3 doses of HEXAVAC® or 3 doses of INFANRIX®-HEXA as infants, the level of antibody to HBs before and one month after a challenge dose of HBVAXPRO® given at least 10 years later, by subsets of subjects defined according to the pre-challenge anti-HBs concentration (<10 mIU/mL and ≥10 mIU/mL).
    Safety objective:
    *To describe the safety profile of HBVAXPRO®
    Obiettivi di immunogenicità:
    *Descrivere, nei soggetti vaccinati con tre dosi di HEXAVAC® o tre dosi di INFANRIX®-HEXA in età infantile, il livello di anticorpi anti-HBs prima e dopo un mese dalla challenge dose di HBVAXPRO®, somministrata dopo un periodo di almeno 10 anni.
    *Descrivere, nei soggetti vaccinati con tre dosi di HEXAVAC® o tre dosi di INFANRIX®-HEXA in età infantile, il livello di anticorpi anti-HBs prima e dopo un mese dalla challenge dose HBVAXPRO®, somministrata dopo un periodo di almeno 10 anni, attraverso sottogruppi di soggetti definiti in base alla concentrazione pre-challenge di anti-HBs (<10 mUI/mL e ≥10 mUI/mL).
    Obiettivo di sicurezza
    *Descrivere il profilo di sicurezza di HBVAXPRO®.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects have to meet all the following criteria to be eligible for inclusion:
    1.Healthy child of either gender
    2.Child vaccinated with 3 doses of HEXAVAC® or 3 doses of INFANRIX®-HEXA as infants (documented vaccination history)
    3.Child vaccinated with the third dose of HEXAVAC® or INFANRIX®-HEXA at least 10 years prior to challenge dose
    4.Subject and parent(s) or legal representative fully understand study procedures, alternative treatments available, the risks involved with the study, and voluntarily agree to participate by giving written informed consent and assent.
    I soggetti devono soddisfare tutti i seguenti criteri per risultare eleggibili:
    1.Bambino sano, di entrambi i sessi.
    2.Bambino vaccinato con tre dosi di HEXAVAC® o tre dosi di INFANRIX®-HEXA in età infantile (anamnesi vaccinale documentata).
    3.Bambino vaccinato con la terza dose di HEXAVAC® o INFANRIX®-HEXA almeno 10 anni prima della dose challenge.
    4.Il soggetto e i genitori o il tutore legale comprendono pienamente le procedure dello studio, le terapie alternative disponibili ed i rischi associati allo studio, a cui acconsentono volontariamente di partecipare fornendo il proprio consenso informato scritto ed assenso.
    E.4Principal exclusion criteria
    Subjects meeting at least one of the following criteria will be ineligible for inclusion. Please note for criteria marked with an asterisk, a subject can return to be entered into the study once these criteria no longer apply:
    1.*History of febrile illness (body temperature ≥38.0°C) in the 3 days prior to challenge dose
    2.Receipt of more than 3 doses of any Hepatitis B containing vaccine either alone or in any combination
    3.History of clinical diagnosis of infection due to Hepatitis B
    4.History or current close contact with known carriers of Hepatitis B virus
    5.Prior known sensitivity or allergy to any component of HBVAXPRO®
    6.Known blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms affecting the haematopoietic and lymphatic systems
    7.Severe thrombocytopenia or other coagulation disorder that would contraindicate intramuscular injection
    8.Immune impairment or humoral/cellular deficiency or depressed immunity
    9.Subject is pregnant (as determined by a urine pregnancy test provided by the sponsor)
    10.*High dose systemic corticosteroids (i.e. ≥ 1 mg/day/kg prednisone equivalent administered orally or parenterally) given ≥14 days in the 30 days prior to challenge dose. Inhaled, nasal or topical corticosteroids are not considered as systemic treatment
    11.Immunoglobulins, blood or blood-derived products in the 3 months prior to challenge dose
    12.*Inactivated vaccine in the 14 days prior to challenge dose
    13.*Live vaccine in the 28 days prior to challenge dose
    14.Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
    15.Subject that, in the investigator’s opinion, is likely to be lost to follow-up or to be poorly compliant with the study requirements
    16.Planned participation in another clinical study during the present study period
    I soggetti che soddisfano almeno uno dei seguenti criteri non saranno inclusi nello studio. Per i criteri contrassegnati con l’asterisco, il soggetto potrà essere incluso nello studio soltanto quando questi non saranno più applicabili:
    1.* Storia di malattia febbrile (temperatura corporea ≥38,0 °C) nei 3 giorni che precedono la dose challenge.
    2.Somministrazione di più di 3 dosi di un altro vaccino anti epatite B, da solo o in associazione.
    3.Precedente diagnosi clinica d’infezione da epatite B.
    4.Contatto ravvicinato, passato o recente, con portatori del virus dell’epatite B.
    5.Nota sensibilità o allergia pregressa a qualsiasi componente di HBVAXPRO®.
    6.Discrasia ematica documentata, leucemia, linfoma di qualsiasi tipo o altra neoplasia maligna che interessa il sistema ematopoietico e linfatico.
    7.Trombocitopenia grave o altro disordine della coagulazione controindicati per l’iniezione intramuscolare.
    8.Compromissione immunitaria o deficit umorale/cellulare o immunodeficienza.
    9.Gravidanza del soggetto (determinata da un test sulle urine fornito dallo sponsor).
    10.*Dosi elevate di corticosteroidi sistemici (per esempio ≥1 mg/die/kg in equivalenti di prednisone, somministrati per via orale o parenterale), somministrati per ≥14giorni nei 30 giorni che precedono la dose challenge. I corticosteroidi inalati o assunti per via nasale o topica non sono considerati trattamenti sistemici.
    11.Immunoglobuline, sangue o emoderivati nei tre mesi che precedono la dose challenge.
    12.*Vaccini inattivati nei 14 giorni precedenti la dose challenge.
    13.*Vaccini vivi nei 28 giorni precedenti la dose challenge.
    14.Qualsiasi condizione medica che, nell’opinione dello sperimentatore, possa interferire con la valutazione degli obiettivi dello studio.
    15.Soggetto che, nell’opinione dello sperimentatore, rischia di non seguire o di essere scarsamente aderente ai requisiti dello studio.
    16.Pianificata partecipazione ad un’altra sperimentazione clinica nel periodo del presente studio.
    E.5 End points
    E.5.1Primary end point(s)
    IMMUNOGENICITY
    •Percentage of subjects with an anti-HBs concentration ≥10 mIU/mL before and one month after the challenge dose
    •GMC before and one month after the challenge dose
    •GMCR from before to one month after the challenge dose
    IMMUNOGENICITÀ
    •Percentuale di soggetti con una concentrazione di anti-HBs ≥10mUI/mL prima e dopo un mese dalla somministrazione della dose challenge.
    •Media geometrica delle concentrazioni (GMC) prima e dopo un mese dalla somministrazione della dose challenge
    •Media geometrica dei rapporti delle concentrazioni individuali anti HBs (GMCR) da prima fino a un mese dopo la somministrazione della dose challenge.
    E.5.1.1Timepoint(s) of evaluation of this end point
    ONE MONTH
    UN MESE
    E.5.2Secondary end point(s)
    SAFETY
    •From Day 0 to Day 4 percentage of subjects with solicited events:
    oInjection-site adverse reactions (injection site erythema, injection site swelling and injection site pain),
    oPyrexia defined as a body temperature ≥38.0°C
    •From Day 0 to Day 14 percentage of subjects with:
    oUnsolicited (i.e. spontaneously reported) injection-site adverse reactions,
    oUnsolicited (i.e. spontaneously reported) systemic adverse events,
    •From study vaccination to the last visit: percentage of subjects with serious adverse events
    SICUREZZA
    •Dal Giorno 0 al Giorno 4, percentuale di soggetti con eventi sollecitati:
    oReazioni avverse nel sito di iniezione (eritema, gonfiore e dolore in corrispondenza del sito di iniezione);
    oPiressia, definita come temperatura corporea ≥38,0 °C.
    •Dal Giorno 0 al Giorno 14, percentuale di soggetti con:
    oReazioni avverse non sollecitate (ossia descritte spontaneamente) nel sito d’iniezione;
    oEventi avversi sistemici non sollecitati (ossia descritti spontaneamente)
    •Dalla vaccinazione all’ultima visita: percentuale di soggetti con eventi avversi seri.
    E.5.2.1Timepoint(s) of evaluation of this end point
    ONE MONTH
    UN MESE
    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
    IMMUNOGENICITY
    IMMUNOGENICITA'
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    il controllo è riferito al trattamento effettuato dai pazienti prima dell'inizio dello studio
    the comparator is referred to the treatment before the start of the this study
    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 concerned10
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    THE END OF THE STUDY WILL BE DEFINED AS THE END OF DATA COLLECTION INCLUDING AVAILABILITY OF SEROLOGY RESULTS
    LA FINE DELLO STUDIO SARA' DEFINITA COME LA FINE DELLA RACCOLTA DATI INCLUSI I RISULTATI DISPONIBILI DI SIERIOLOGIA
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 750
    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: 375
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 375
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state750
    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 Decision2013-07-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-02-04
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