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    Summary
    EudraCT Number:2009-015595-10
    Sponsor's Protocol Code Number:IC51-322
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-11-11
    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 ConcernedGermany - PEI
    A.2EudraCT number2009-015595-10
    A.3Full title of the trial
    IMMUNOGENICITY AND SAFETY OF THE JAPANESE ENCEPHALITIS VACCINE IC51 (IXIARO®, JESPECT®) IN A PEDIATRIC POPULATION IN NON‐ENDEMIC COUNTRIES. UNCONTROLLED, OPEN‐LABEL PHASE 3 STUDY
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic Countries
    A.4.1Sponsor's protocol code numberIC51-322
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01047839
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/87/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorIntercell AG
    B.1.3.4CountryAustria
    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 supportIntercell AG
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Ixiaro
    D.2.1.1.2Name of the Marketing Authorisation holderIntercell AG
    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 No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeIC51 or IXIARO or JESPECT
    D.3.9.3Other descriptive nameNA
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    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 Information not present in EudraCT
    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
    Japanese Encephalitis (JE)
    E.1.1.1Medical condition in easily understood language
    healthy volunteers "Japanese encephalitis virus"
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10023123
    E.1.2Term Japanese encephalitis
    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 10023120
    E.1.2Term Japanese B viral encephalitis
    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 10023122
    E.1.2Term Japanese B virus encephalitis
    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 10023119
    E.1.2Term Japanese B encephalitis
    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 PT
    E.1.2Classification code 10014596
    E.1.2Term Encephalitis Japanese B
    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
    1- To assess the safety profile of IC51in a pediatric population from regions where JEV is not endemic
    E.2.2Secondary objectives of the trial
    1- To assess immunogenicity of the purified inactivated Japanese Encephalitis (JE) vaccine IC51 using the Seroconversion rates (SCRs) and Geometric Mean Titers (GMTs) at Day 56 in a pediatric population from regions where JE is not endemic
    2- To assess differences in the immunogenicity and safety profile of IC51 in subjects depending on age groups and dose groups.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1- Male or female healthy children and adolescents aged ≥ 2 months to < 18 years at the time of first vaccination
    2- Written informed consent by the subject’s legal representative(s), according to local requirements, and written informed assent of the subject, if applicable
    3- Female subjects: either no childbearing potential or negative pregnancy test (pregnancy test to be performed in female subjects after onset of menarche). For females after menarche willingness to practice a reliable method of contraception as specified in Section 6.4. is required
    4- The subject is planning to travel to an area where JE is endemic after completion of the vaccination schedule.
    Exposure to JE should be avoided until 1 week after the second IC51 dose and subjects should return from travel to JE endemic areas before the Month 7 visit. The planned travel to JE endemic areas should not interfere with the study visits and can take place between Visit 2 + 7 days to Month 7
    E.4Principal exclusion criteria
    1- Clinical manifestation or history of any Flavivirus disease
    2- Vaccination against JE (except within this protocol), Yellow fever, West Nile virus and Dengue at any time prior or during the study
    3- Active or passive immunization within 1 week before and 1 week after each IC51 vaccination.
    4- Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days prior to the first vaccination at Visit 1
    5- Immunodeficiency including post-organ-translpantation or a family history of congenital or hereditary immunodeficiency.
    6- History of autoimmune disease.
    7- Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying drugs within 4 weeks prior to vaccination at Visit 1 and during the study (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.05 mg/kg/day. Topical and inhaled steroids are allowed).
    8- Acute febrile infection at each visit during which the subject receives a vaccination
    9- History of hypersensitivity reactions to vaccines
    10- Known HIV, HBV or HCV infection
    E.5 End points
    E.5.1Primary end point(s)
    Rate of subjects with serious adverse events (SAEs) and medically attended AEs up to Day 56 after the first vaccination.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after the end of the study
    E.5.2Secondary end point(s)
    - Rate of subjects with serious adverse events (SAEs) and medically attended AEs and up to Month 7 after the first vaccination
    -Rate of subjects with solicited local and systemic AEs assessed with a subject diary for 7 consecutive days after each vaccination
    - Rate of subjects with unsolicited AEs up to Day 56 and up to Month 7 after the first vaccination
    - Rate of subjects with abnormal laboratory parameters (hematology, serum chemistry, urinalysis) up to Day 56 and up to Month 7 after the first vaccination
    - SCRs as defined as percentage of subjects with JEV neutralizing antibody titers of PRNT50 ≥ 1:10 at Day 56 and Month 7, measured using a validated Plaque Reduction Neutralization Test (PRNT)
    - GMTs for JEV neutralizing antibodies measured using a validated Plaque
    Reduction Neutralization Test (PRNT) at Day 56 and Month 7
    -SCRs and GMTs at Day 56 and Month 7 stratified according to dose groups and age groups
    E.5.2.1Timepoint(s) of evaluation of this end point
    after the end of the study
    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 (limited to a subgroup)
    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 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) 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 trial1
    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 EEA6
    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
    Australia
    Germany
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Overall study duration (First subject in – last subject out) is estimated to be 24 months.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    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: 100
    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.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Children (≥ 2 months to < 3 years), children (>=3 to <12 years) and adolescents (≥ 12 to < 18 years)
    F.4 Planned number of subjects to be included
    F.4.1In the member state55
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 100
    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
    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 Decision2010-01-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-08-09
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