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    Summary
    EudraCT Number:2010-022265-10
    Sponsor's Protocol Code Number:IC51-325
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2011-12-28
    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 number2010-022265-10
    A.3Full title of the trial
    LONG TERM IMMUNITY AND SAFETY WITH OR WITHOUT A BOOSTER DOSE FOLLOWING PRIMARY VACCINATION WITH THE JAPANESE ENCEPHALITIS VACCINE IC51 (IXIARO®) IN A PEDIATRIC POPULATION IN A JEV-ENDEMIC COUNTRY.
    OPEN-LABEL, RANDOMIZED, PHASE 3 STUDY.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    LONG TERM IMMUNITY AND SAFETY WITH OR WITHOUT A BOOSTER DOSE FOLLOWING PRIMARY VACCINATION WITH THE JAPANESE ENCEPHALITIS VACCINE IC51 (IXIARO®) IN A PEDIATRIC POPULATION.
    A.4.1Sponsor's protocol code numberIC51-325
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01296360
    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 organisationIntercell AG
    B.5.2Functional name of contact pointVera Kadlecek
    B.5.3 Address:
    B.5.3.1Street AddressCampus Vienna Biocenter 3
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1030
    B.5.3.4CountryAustria
    B.5.4Telephone number00431206200
    B.5.5Fax number0043120620810
    B.5.6E-mailinfo@intercell.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 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 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.3.9.2Current sponsor codeIC51 or IXIARO
    D.3.9.3Other descriptive nameJAPANESE ENCEPHALITIS VIRUS STRAIN SA14-14-2 (INACTIVATED) PRODUCED IN VERO CELLS
    D.3.9.4EV Substance CodeSUB30400
    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 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
    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 PT
    E.1.2Classification code 10014596
    E.1.2Term Encephalitis Japanese B
    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 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 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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To assess the immune response (geometric mean titers [GMTs] and seroconversion rates [SCRs]) 28 days after one single booster vaccination with the purified inactivated Japanese Encephalitis (JE) vaccine IXIARO administered at 12 months after primary immunization in a pediatric population from JEV endemic regions
    E.2.2Secondary objectives of the trial
    1. To assess persistence of immunity (GMTs and rate of subjects with PRNT50 titers of ≥ 1:10) following primary vaccination with IXIARO in a pediatric population from JEV endemic regions (without booster)
    2. To assess persistence of immunity (GMTs and rate of subjects with PRNT50 titers of ≥ 1:10) following a booster vaccination with IXIARO in a pediatric population from JEV endemic regions
    3. To assess the long term safety profile of IXIARO and the safety profile of a booster dose in a pediatric population from JEV endemic regions
    4. To assess age-dependent differences in the persistence of the immunity, immune response to a booster dose and the safety profile of IXIARO
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Children and adolescents who have completed study IC51-323 and received both IXIARO vaccinations according to protocol.
    2. Children who have received the dose confirmed for their age group.
    3. Male or female healthy children and adolescents aged ≥9 months to <17 years and 7 months at the time of enrolment into this study.
    4. Written informed consent by the subject’s legal representative(s), according to local requirements, and written informed assent of the subject, if applicable.
    5. Female subjects: either no childbearing potential or negative pregnancy test (pregnancy test to be performed in female subjects after onset of menarche) at Visits 1, 2 and 2a as stipulated by the protocol. For females after menarche willingness to practice a reliable method of contraception as specified in Section 6.4.
    E.4Principal exclusion criteria
    1. Vaccination against JE virus (JEV) (except within study IC51-323 and IC51 325), Yellow fever, West Nile virus and Dengue fever at any time prior to or planned during the study.
    2. History of or clinical manifestation of any Flavivirus disease during IC51-323 or IC51 325.
    3. Participation in another study with an investigational drug during IC51 323 or IC51 325.
    4. Planned active or passive immunization within 2 weeks before and 1 week after the IXIARO booster.
    5. History of or development of any immunodeficiency including post-organ-transplantation after inclusion into IC51-323 or IC51 325.
    6. History of or development of an autoimmune disease during study IC51-323 or IC51 325.
    7. Administration of chronic (defined as more than 14 days) immunosuppressants or other immune-modifying medications started during IC51-323 or IC51 325. (For corticosteroids, this would mean prednisone or equivalent at >=0.05 mg/kg/day; topical and inhaled steroids are allowed).
    8. Acute febrile infection at Visit 2 (only for the Booster Group).
    9. Pregnancy (positive pregnancy test at Visit 1 and Visit 2), lactation or unreliable contraception in female subjects after onset of menarche.
    10. Hypersensitivity reactions to IXIARO or adverse events in study IC51-323 requiring withdrawal from further vaccination or anaphylaxis or severe cases of atopy requiring emergency treatment or hospital admission during IC51-323 or IC51 325.
    11. History of urticaria after hymenoptera envenomation, drugs, physical or other provocations or of idiopathic cause during IC51-323 or IC51 325.
    12. Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) (measurement of Hepatitis B surface antigen [HBsAg] titers) or hepatitis C virus (HCV).
    13. Illicit drug use and/or current drug or alcohol addiction.
    14. Inability or unwillingness by the legal representative(s) and/or the subject (where applicable) to provide informed consent/assent and to abide by the requirements of the study.
    15. Persons who have been committed to an institution (by a court or by an authority).
    E.5 End points
    E.5.1Primary end point(s)
    1-SCRs as defined by percentage of subjects with plaque reduction neutralization test (PRNT50) titers of ≥1:10 at 1 month after the booster dose.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after Month 13 (including data up to 1 month after the booster in the Booster Group)
    E.5.2Secondary end point(s)
    1-Rate of subjects achieving a ≥ 4-fold increase in JEV neutralizing antibody titers at 1 month after the booster dose
    2-GMTs for JEV neutralizing antibodies measured using a validated PRNT at 1 month after the booster dose
    3-GMTs and rate of subjects with a PRNT50 titer of ≥1:10 at Months 12, 24 and 36 after first IXIARO vaccination in IC51-323 with and without booster vaccination
    4-Rate of subjects with serious adverse events (SAEs) following immunization and medically attended adverse events (AEs) up to Months 12, 24 and 36 after the first IXIARO vaccination in IC51 323 with and without booster vaccination. Severity, duration and relationship to vaccinations.
    5-Rate of subjects with unsolicited AEs up to Months 12, 24 and 36 after the first IXIARO vaccination in IC51 323 with and without booster vaccination. Severity, duration and relationship to vaccinations.
    6-Rate of subjects with SAEs and medically attended AEs within 1 month following the booster dose. Severity, duration and relationship to vaccinations.
    7-Rate of subjects with unsolicited AEs within 1 month following the booster dose. Severity, duration and relationship to vaccinations.
    8-Rate of subjects with solicited AEs for up to 7 days following the booster dose. Severity and duration.
    E.5.2.1Timepoint(s) of evaluation of this end point
    after Month 13 (including data up to 1 month after the booster in the Booster Group) and after Month 24 and Month 36
    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
    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 Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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
    lack of booster vaccination
    E.8.2.4Number of treatment arms in the trial2
    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
    Philippines
    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
    Study duration per subject from first visit to last visit is estimated to be about 30 months for both arms.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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: 300
    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: 95
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 145
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    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 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 300
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Philippines
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