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    The EU Clinical Trials Register currently displays   36397   clinical trials with a EudraCT protocol, of which   5997   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2006-001676-21
    Sponsor's Protocol Code Number:V48P7E1
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-05-23
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedCzech Republic - SUKL
    A.2EudraCT number2006-001676-21
    A.3Full title of the trial
    A phase IV, open-label, single-center study in adolescents and adults: Evaluation of immunogenicity and safety of the first booster immunization with Chiron’s TBE vaccine for adults in participants of study V48P7 and long-term evaluation of immunogenicity up to 5 years after first booster immunization
    A.4.1Sponsor's protocol code numberV48P7E1
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Vaccines and Diagnostics GmbH & Co. KG
    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 support
    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. of the Marketing Authorisation holderChiron Behring GmbH & Co KG
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    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 Information not present in EudraCT
    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) Information not present in EudraCT
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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
    TBE prophylaxis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10043847
    E.1.2Term Tick-borne viral encephalitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Descriptive evaluation of subjects with respect to antibody titers and percentage of subjects with neutralizing antibodies on Day 0 (i.e., day of first booster immunization after primary immunization in study V48P7 for subjects who did not get a booster immunization, or day of first blood draw for those who did receive a booster dose), on Day 21 (+7 days) and Year 1, 2, 3, 4, and 5 (± 30 days each) after booster immunization with Novartis Vaccines' (ex Chiron’s) TBE vaccine for adults as measured by Neutralization Test (NT, in-house, Novartis Vaccines). Subjects who have already received a booster immunization before this study, will only provide blood samples on Day 0 and Year 1, 2, 3, 4, and 5 (± 30 days each) thereafter
    E.2.2Secondary objectives of the trial
    Descriptive evaluation of subjects with respect to antibody concentrations and percentage of subjects with antibodies on Day 0 (i.e., day of first booster immunization after primary immunization in study V48P7), on Day 21 (+7 days) and Year 1, 2, 3, 4, and 5 (± 30 days each) after first booster immunization with Novartis Vaccines' (ex Chiron’s) TBE vaccine for adults as measured by ELISA, including avidity determination as determined by ELISA for selected time points (Enzygnost®, Dade Behring). Subjects who have already received a booster before this study, will only provide blood samples on Day 0 and Year 1, 2, 3, 4, and 5 (± 30 days each) thereafter.
    Evaluation of tolerability and safety of a single dose of Novartis Vaccines' (ex Chiron's) TBE vaccine for adults (using selected local and systemic reactions and adverse event reporting) when given as first booster immunization 3 years after the last dose of the primary immunization.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - healthy subjects who/whose parents/legal representative signed informed consent prior to study entry
    - subjects who have completed study V48P7
    - subjects who are in good health as determined by medical history, physical examination, and clinical judgment of the investigator
    E.4Principal exclusion criteria
    - subjects with acute disease at the day of booster immunization (acute disease means moderate or severe illness with or without fever. All vaccines can be administered to subjects with minor illness such as mild diarrhea or mild upper respiratory tract infection with oral temperature < 38.0°C.)*
    - subjects in whom a general decrease in resistance might be expected, e.g. those who have recently sustained major injury or undergone recent major surgical operations, are undernourished, or have disorders involving a decreased immune response
    - subjects:
    a) with organic brain disturbances, including seizure disorders*
    b) with progressive neurological disorders
    c) who have suffered febrile or afebrile convulsions*
    d) with major congenital defects
    e) with serious chronic illness (such as insulin dependent diabetes, cancer, autoimmune diseases)
    f) with evidence of hypersensitivity to the study vaccine or chemically related substances in their medical history*
    - subjects being treated with:
    a) immunosuppressants or systemic corticosteroids within the past 4 weeks or during the study period, except short term use of topic corticosteroids
    b) immunoglobulins, whole blood or plasma derivates up to 3 months before enrollment
    - subjects who have received another vaccine within 4 weeks before the administration of the study vaccine *
    - subjects enrolled in another investigational, clinical study at the same time or within the last 3 months
    - women who are pregnant (in case of uncertainty, pregnancy should be excluded by a pregnancy test) *
    - women of childbearing age who refuse to use an effective method of birth control (abstinence, oral or injected or implanted hormonal contraceptive, diaphragm or condom with spermicidal agent, intrauterine device) beginning 28 days before study entry and continuing through 28 days after the immunization*

    * Only apply to subjects receiving booster immunization
    E.5 End points
    E.5.1Primary end point(s)
    TBE antibody levels in serum on Days 0, Day 21 (except for subjects not receiving a booster within the study), Year 1, 2, 3, 4 and 5 as measured by NT (in-house, Novartis Vaccines) and ELISA (Enzygnost®, Dade Behring), including avidity determination as determined by ELISA for selected time points.
    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 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. 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 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 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 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    Last Subject Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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.4.1In the member state389
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 389
    F.4.2.2In the whole clinical trial 389
    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 Decision2006-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-08-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-10-07
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