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    Summary
    EudraCT Number:2014-005105-20
    Sponsor's Protocol Code Number:V48P4E3
    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 number2014-005105-20
    A.3Full title of the trial
    A phase IV, uncontrolled, open-label, multi-center study in children and adolescents: Evaluation of long-term immunogenicity in subjects boosted with a new pediatric TBE vaccine (free of protein-derived stabilizer) in study V48P4E1, five years after first booster immunization
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate long-term immunogenicity in subjects boosted with a new pediatric TBE vaccine (free of protein-derived stabilizer) In children and adolescents
    A.4.1Sponsor's protocol code numberV48P4E3
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00452621
    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.1.3.4CountryGermany
    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.4.2CountryGermany
    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-mailanh.phung@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 Encepur
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Vaccines and Diagnostics
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameTick-borne encephalitis vaccine (inactivated, adsorbed for pediatric use)
    D.3.2Product code V48
    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 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
    Prophylaxis: Tick-borne-encephalitis
    E.1.1.1Medical condition in easily understood language
    Tick-borne-encephalitis disease
    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 investigate the kinetics of the immune response of subjects who participated in studies V48P4 (primary immunization), V48P4E1 (first booster immunization 5 year follow up) and V48P4E2 (serological follow-up) with respect to antibody titers in terms of:
    • percentage of subjects with titers ≥ 10
    • percentage of subjects with titers ≥ 2
    • geometric mean titer (GMT) as measured by Neutralization Test (NT, in-house, Novartis Vaccines), from Day 0 as defined in protocol V48P4 to year 5 (± 90 days) after the first booster immunization with the new TBE vaccine..
    E.2.2Secondary objectives of the trial
    To investigate the kinetics of the immune response of subjects who participated in studies V48P4 (primary immunization), V48P4E1 (first booster immunization 5 year follow up) and V48P4E2 (serological follow-up) in terms of:
    • percentage of subjects with antibody concentrations ≥ detection limit/seroconversion limit
    • geometric mean concentration (GMC)
    • avidity determination for selected time points
    as measured by ELISA (Enzygnost®, Dade Behring) at 5 years (± 90 days) after the first booster immunization with the new TBE vaccine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Individuals meeting all of the following criteria were eligible for enrollment into the study:
    Healthy volunteers of both sexes aged >1 years at the time of enrollment in V48P4 who participated in studies V48P4E1 and V48P4E2, and who/whose parents or legal guardians are willing to sign informed consent.
    Informed consent was obtained for all the subjects before enrollment into the study.
    E.4Principal exclusion criteria
    In this study subjects who received a booster immunization since termination of study V48P4E2 were not excluded. They were asked to consent that the information of the booster immunization could be implemented in the database for statistical reason and to use the serum samples of previous studies for avidity determination.
    E.5 End points
    E.5.1Primary end point(s)
    1.percentage of subjects with titers ≥ 10 as measured by Neutralization Test (NT)
    2. percentage of subjects with titers ≥ 2 as measured by NT
    3. geometric mean titer (GMT) as measured by NT
    E.5.1.1Timepoint(s) of evaluation of this end point
    From Day 0 as defined in protocol V48P4 to year 5 (± 90 days) after the first booster immunization with the new TBE vaccine.
    E.5.2Secondary end point(s)
    1.percentage of subjects with antibody concentrations ≥ detection limit/ seroconversion limit as measured by ELISA
    2. geometric mean concentration (GMC) as measured by ELISA
    3. avidity determination for selected time pointsas measured by ELISA
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 5 years (± 90 days) after the first booster immunization with the new TBE vaccine
    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 No
    E.6.5Efficacy Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.2.4Number of treatment arms in the trial0
    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 No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Germany
    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
    LSLV-24 MAY 07
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days15
    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: 232
    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: 232
    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 232
    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)
    Novartis Vaccines or the investigator provided the ethics committee (EC) with all appropriate material, including the Informed Consent Form (ICF), according o local regulations. The EC should also was asked for a written statement regarding the composition of the committee and to comply with GCP (Good Clinical Practices) and with
    the applicable regulatory requirement(s). The trial was not initiated until appropriate EC approval of the protocol and the ICF was obtained.
    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: Germany
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