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    EudraCT Number:2014-004491-31
    Sponsor's Protocol Code Number:M12-420
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-02-03
    Trial results View results
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    A. Protocol Information
    A.2EudraCT number2014-004491-31
    A.3Full title of the trial
    Multi-center, Open-label, Uncontrolled Clinical Study of Palivizumab in Japanese Newborns, Infants and
    Young Children at the Age of 24 Months or Less with Immunocompromised Medical Conditions
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multi-center, Open-label, Uncontrolled Clinical Study of Palivizumab in Japanese Newborns, Infants and
    Young Children at the Age of 24 Months or Less with Immunocompromised Medical Conditions
    A.4.1Sponsor's protocol code numberM12-420
    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 SponsorAbbott Japan Co., Ltd
    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 supportAbbott Japan Co., Ltd
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbvie Ltd
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbott House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4XE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628773355
    B.5.5Fax number+441628644330
    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. name Synagis
    D. of the Marketing Authorisation holderAbbvie GK
    D.2.1.2Country which granted the Marketing AuthorisationJapan
    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 namePalivizumab
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation Yes
    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 INNPALIVIZUMAB
    D.3.9.1CAS number 188039-54-5
    D.3.9.4EV Substance CodeSUB03606MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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) No
    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
    Respiratory Syncytial Virus Infection
    E.1.1.1Medical condition in easily understood language
    Respiratory Tract Infection
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10061603
    E.1.2Term Respiratory syncytial virus 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 evaluate safety, efficacy and pharmacokinetics of palivizumab in children at the age of 24 months or less with immunocompromised medical conditions.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study was to evaluate the trough serum concentration (Ctrough) of palivizumab obtained from Japanese subjects with immunocompromised medical conditions, compared to the Ctrough of palivizumab numerically with available previous data in Japanese premature newborns and infants, and children with bronchopulmonary dysplasia (BPD), and children with hemodynamically significant congenital heart disease (CHD).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Availability of parent or legal guardian who is capable and willing to give written informed consent for his/her newborn, infant or young child to participate this study.
    2.Japanese newborn, infant or young child at age of 24 months or less.
    3. The subject must meet at least one of the following immunocompromised medical conditions (from [a] to [h]), and must be considered by the investigator to be a suitable candidate to receive prophylactic treatment of palivizumab:
    a.Subject has been diagnosed with combined immunodeficiency (severe combined immunodeficiency, X-linked hyper-immunoglobulin M (IgM) syndrome, etc.), antibody deficiency (X-linked agammaglobulinemia, common variable immunodeficiency, non-X-linked hyper-IgM syndrome, etc.) or other immunodeficiency (Wiskott-Aldrich syndrome, DiGeorge syndrome, etc.) at the time of informed consent, or
    b.Subject has been diagnosed with human immunodeficiency virus infection, or
    c.Subject has been diagnosed with Down syndrome without a current hemodynamically significant congenital heart disease at the time of informed consent (subject must have an experience with persistent respiratory symptom or regular outpatient treatment due to respiratory tract infection prior to current RSV season), or
    d.Subject has a history of post organ transplantation at the time of informed consent, or
    e.Subject has a history of post bone marrow transplantation at the time of informed consent, or
    f.Subject is receiving immunosuppressive chemotherapy at the start of study drug administration, or
    g.Subject is receiving systemic high dose corticosteroid therapy (prednisone equivalents 0.5 mg/kg or more every other day, other than inhaler or topical use) at the start of study drug administration, or
    h.Subject is receiving other immunosuppressive therapy (azathioprine, methotrexate, mizoribine, mycophenolate mofetil, cyclophosphamide, cyclosporine, tacrolimus, cytokine inhibitors, etc.) at the start of study drug administration.

    E.4Principal exclusion criteria
    Subject who meets one of the palivizumab indications already approved in Japan.
    ◦Subject born at 28 weeks of gestation or less and who is age of 12 months or less at the start of study drug administration.
    ◦Subject born at 29 - 35 weeks of gestation and who is age of 6 months or less at the start of study drug administration.
    ◦Subject is age of 24 months or less with a history of bronchopulmonary dysplasia requiring medical management within the 6 months prior to the study drug administration.
    ◦Subject is age of 24 months or less with a current hemodynamically significant congenital heart disease at the start of study drug administration.
    2.Subject requires oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure or other mechanical respiratory or cardiac support at Screening and at the start of study drug administration.
    3.Subject has a current active infection including respiratory syncytial virus infection at Screening and at the start of study drug administration.
    4.Subject has a serious concurrent medical condition (hepatic dysfunction, persistent seizure disorder, etc.) except those resulting in an immune deficiency condition or renal failure.
    5.Subject has received palivizumab prior to the study drug administration.
    6.Subject has received any other investigational agents in the past 3 months or 5 half lives prior to the investigational drug administration (whichever is longer).
    7.Subject has a history of an allergic reaction or hypersensitivity to constituents of the study drug.
    8.Subject has a history of serious adverse reactions or serious allergic reaction to immunoglobulin products or has a history of hypersensitivity to immunoglobulin products, blood products, or other foreign proteins.
    9.Subject whose remaining days of life are expected to be less than one year at the time of informed consent.
    10.It will be impossible to collect blood as scheduled from the subject.
    11.Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
    E.5 End points
    E.5.1Primary end point(s)
    Serum trough concentrations of palivizumab obtained 30 days after the initial administration and 30 days
    after the 4th administration (Day 121) of the study drug.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days after the initial administration and 30 days after the 4th administration (Day 121) of the study drug.
    E.5.2Secondary end point(s)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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 Yes
    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. 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 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 No
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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: 28
    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. of subjects for this age range: 28
    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 No
    F.3.2Patients Yes
    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. of subjects incapable of giving consent
    Paediatrics aged 24 months or less
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 20
    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)
    Upon completion of the study, the subjects will be treated in accordance with the Investigator's best clinical judgement.
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Japan
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