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    Summary
    EudraCT Number:2014-005135-13
    Sponsor's Protocol Code Number:V37_07E1
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-11-28
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2014-005135-13
    A.3Full title of the trial
    A Phase III Observer blind Single-Coordinating Center Pediatric Study in China Comparing a Booster Dose of
    Vaxem™ Hib to HIBERIX® When Given as Part of a Local Dosing Regimen in Infants
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity and Safety of a Booster Dose of Monovalent Glycoprotein-Conjugated (non-toxic mutant of Diptheria Toxin -CRM197) Hib Vaccine in 365-569 Days Old Healthy Infants
    A.4.1Sponsor's protocol code numberV37_07E1
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01226953
    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
    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 Vaccines and Diagnostics
    B.5.2Functional name of contact pointPosting Director
    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.5.6E-mailRegistryContactVaccinesUS@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 Vaxem Hib
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Vaccine and Diagnostics 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.3.1Product nameHaemophilus influenzae type b conjugate vaccine (CRM197 Conjugate)
    D.3.4Pharmaceutical form Suspension 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 INNcapsular oligosaccharide of Haemophilus influenzae type b conjugated to CRM 197
    D.3.9.3Other descriptive nameHAEMOPHILUS INFLUENZAE TYPE B CONJUGATE VACCINE (DIPHTHERIA CRM197 PROTEIN CONJUGATE)
    D.3.9.4EV Substance CodeSUB25293
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Hiberix
    D.2.1.1.2Name of the Marketing Authorisation holderSmithKline & French Portuguesa
    D.2.1.2Country which granted the Marketing AuthorisationPortugal
    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 nameHaemophilus influenzae type b Conjugate Vaccine (Tetanus Toxoid Conjugate)
    D.3.4Pharmaceutical form Powder and solvent for 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 INNcapsular oligosaccharide of Haemophilus influenzae type b conjugated to tetanus
    D.3.9.3Other descriptive nameHAEMOPHILUS INFLUENZA TYPE B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE)
    D.3.9.4EV Substance CodeSUB14050MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Meningitis, epiglottitis, pneumonia, arthritis caused by Haemophilus influenzae type b.
    E.1.1.1Medical condition in easily understood language
    Meningitis, epiglottitis, pneumonia, arthritis caused by Haemophilus influenzae type b.
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    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 demonstrate that the immune response of Vaxem™ Hib booster is non-inferior to the
    immune response of comparator vaccine HIBERIX® booster as assessed by the
    percentage of subjects with anti-PRP (polyribosyl-ribitol-phosphate) antibody levels
    ≥1.0μg/mL 30 days after booster vaccination.
    E.2.2Secondary objectives of the trial
    To demonstrate that the immune response of Vaxem™ Hib booster is non-inferior to the
    immune response of comparator vaccine HIBERIX®booster, as assessed by the
    percentage of subjects with anti-PRP antibody levels ≥0.15 μg/mL, 30 days after
    booster vaccination.
    To demonstrate that the immune response of Vaxem™ Hib booster is non-inferior to the immune response of comparator vaccine HIBERIX® booster, as assessed by anti-PRP antibody geometric mean concentrations (GMCs), 30 days after booster vaccination.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Toddlers 365-569 days of age who previously participated in study V37_07
    - Children's parents or legal guardian who gave written consent after the nature of the
    study had been explained according to local regulatory requirements
    - Availability for both visits scheduled in the study and able to comply with all study
    regulations
    E.4Principal exclusion criteria
    - Parent(s) or legal guardian(s) who were unwilling or unable to give written informed
    consent to participate in study
    - Subjects who had already received a Hib booster dose or who had experienced
    Haemophilus influenzae type b illness
    - History of anaphylactic shock, asthma, urticaria or other allergic reaction after
    previous vaccinations or hypersensitivity to any vaccine component
    - Fever ≥ 37.5°C (axillary) or/and significant acute or chronic infection requiring
    systemic antibiotic or antiviral therapy within the past 7 days before enrollment
    - Subjects with any serious chronic disease such as cardiac, neurological, metabolic,
    hematologic, or neoplastic disease
    - Known/suspected immunodeficiency or any immunologic disorder.
    - Subjects with any neurological disorder, e.g. epilepsy or history of seizure disorder
    - Subjects with a genetic anomaly
    - Treatment with corticosteroids or other immunosuppressive/immunostimulant drugs
    as defined below:
    - Chronic use of oral steroids (>/= 15 days of use) within 60 days prior to visit 1
    (use of inhaled, intranasal, or topical corticosteroids was allowed).
    - Receipt of parenteral steroids within 60 days prior to visit 1
    - Receipt of immunostimulants within 60 days prior to visit 1
    Previous receipt of parenteral immunoglobulin preparation, blood products, and/or
    plasma derivatives with in 3 months prior to visit 1 or planned during the full length
    of the trial
    - Vaccination with any other vaccine 7 days before or after the study booster dose was
    given
    - Simultaneous participation in any other investigational clinical trial
    - Planned surgery during the study period
    - Any condition, which, in the opinion of the investigator, interfered with the evaluation
    of the study objective
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of subjects achieving an anti-PRP concentration ≥1.0 μg/mL 30 days after booster vaccination.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days after booster vaccination.
    E.5.2Secondary end point(s)
    1) Percentage of subjects achieving an anti-PRP concentration ≥0.15 μg/mL 30 days
    after booster vaccination
    2) Geometric mean anti-PRP antibody concentration 30 days after booster vaccination
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days after booster 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 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 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 No
    E.8.1.2Open No
    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 Yes
    E.8.1.7.1Other trial design description
    OBSERVER-BLIND
    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 trial2
    E.8.3 Will this trial be conducted at a single site globally? Yes
    E.8.4 Will this trial be conducted at multiple sites globally? No
    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
    China
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial months2
    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: 670
    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: 670
    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 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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 670
    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)
    NA
    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: China
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