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    Summary
    EudraCT Number:2012-005137-37
    Sponsor's Protocol Code Number:POX-MVA-035
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-05-02
    Trial 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 number2012-005137-37
    A.3Full title of the trial
    Open-label, non-controlled, multicenter immunogenicity and safety study of MVA-BN® smallpox vaccine in children from birth to less than 12 years of age
    Offene, nicht kontrollierte, multizentrische klinische Prüfung zur Bestimmung der Immunogenität und Sicherheit des Pockenimpfstoffs MVA-BN® bei Kindern ab Geburt bis zum Alter von 11 Jahren
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Vaccination trial in children using a new smallpox vaccine
    Impfstudie in Kindern mit einem neu entwickelten Pockenimpfstoff
    A.4.1Sponsor's protocol code numberPOX-MVA-035
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/038/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBavarian Nordic A/S
    B.1.3.4CountryDenmark
    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 supportBavarian Nordic A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBavarian Nordic GmbH
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressFraunhoferstrasse 13
    B.5.3.2Town/ cityMartinsried
    B.5.3.3Post code82152
    B.5.3.4CountryGermany
    B.5.4Telephone number+49(0)89255446300
    B.5.5Fax number+49(0)89255446333
    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 No
    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 nameIMVANEX
    D.3.2Product code MVA-BN
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLive Modified Vaccinia Virus Ankara
    D.3.9.3Other descriptive nameMODIFIED VACCINIA ANKARA – BAVARIAN NORDIC LIVE VIRUS
    D.3.9.4EV Substance CodeSUB99928
    D.3.10 Strength
    D.3.10.1Concentration unit TCID50/dose tissue culture infective dose 50/dose
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number0.5
    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
    Prevention of smallpox infection in children
    Pocken
    E.1.1.1Medical condition in easily understood language
    Smallpox infection
    Pocken
    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 10041197
    E.1.2Term Smallpox
    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
    To assess the immunogenicity after two doses of MVA-BN® smallpox vaccine in children/infants and toddlers.
    E.2.2Secondary objectives of the trial
    To assess the safety and reactogenicity of MVA-BN® smallpox vaccine in children/infants and toddlers.
    To assess the immunogenicity in infants/children and toddlers after one compared to two doses of MVA-BN® smallpox vaccine
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Children from birth to < 12 years of age (depending on group allocation) in good health as determined by medical history, physical examination and clinical judgment.
    2. No prior smallpox or Modified Vaccinia Ankara (MVA) based vaccination or known exposure to smallpox prior to trial entry.
    3. The subject’s parents/guardian have read, signed and dated the informed consent form, having been advised of the risks and benefits of the trial in a language understood by the subject's parents and prior to performance of any trial specific procedures
    4. No history of chronic or known neurological disease or deficient development history.
    E.4Principal exclusion criteria
    1. Any clinically significant condition which in the opinion of the investigator would compromise the safety of the subject, i.e. the risk would outweigh the benefit of receiving the vaccine (i.e. any uncontrolled serious infection, i.e. not responding to antimicrobial therapy; known or suspected impairment of immunologic function; acute disease with or without pyrexia; temperature more than or equal to 38.0°C [more than or equal to100.4°F]; post organ transplant subjects whether or not receiving chronic immunosuppressive therapy; any other history or clinical manifestation of clinically significant haematological, pulmonary, central nervous, cardiovascular or gastrointestinal disorders).
    2. Administration or planned administration of immunoglobulins and/or any blood products during a period starting from 3 months prior to administration of the vaccine and ending at trial conclusion.
    3. History of or currently active autoimmune disease. Children with vitiligo or thyroid disease on thyroid replacement therapy are not excluded.
    4. History of malignancy, especially leukaemia or lymphoma.
    5. History of allergic disease or hypersensitivity likely to be exacerbated by any component of the vaccine.
    6. History of anaphylaxis or severe allergic reaction.
    7. Chronic administration (defined as more than 14 days) of systemic high dose immune-suppressant drugs during a period starting from six months prior to administration of vaccine and ending at trial conclusion. High dose is defined as 2 mg/kg/day or more of prednisolone or its equivalent, or 20 mg/day or more for children who weigh more than 10 kg.
    8. Use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the first dose of the study vaccine, or planned administration of such a drug during the trial period.
    E.5 End points
    E.5.1Primary end point(s)
    Geometric Mean Titer (GMT) measured by vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA) and Plaque Reduction Neutralization Test (PRNT) at Visit 5 i.e. 4 weeks after the second vaccination
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 weeks after the second vaccination
    E.5.2Secondary end point(s)
    Safety
    • Occurrence, relationship and intensity of any serious adverse events up to Day 56.Occurrence of any Grade 3 adverse events related to the trial vaccine within 28 days after any vaccination.
    • Occurrence, relationship to the trial vaccine and intensity of unsolicited non-serious Adverse Events (AEs) within 28 days after each vaccination.
    • Occurrence, intensity and duration of solicited local AEs (redness, swelling, induration, pruritus and pain) during the 8-day period (day of vaccination and the following 7 days) after each vaccination.
    • Occurrence, relationship to the trial vaccine, intensity and duration of solicited general AEs (pyrexia, headache, myalgia, nausea, fatigue and chills) during the 8-day period (day of vaccination and the following 7 days) after each vaccination.
    • Occurrence of smallpox disease in subjects.

    Immunogenicity
    • Seroconversion rates as determined by vaccinia-specific ELISA at Visit 3 and Visit 5, i.e. four weeks after the first and second vaccination respectively.
    • Seroconversion rates as determined by vaccinia-specific PRNT at Visit 3 and Visit 5, i.e. four weeks after the first and second vaccination respectively.
    • GMT calculated from individual vaccinia-specific ELISA titers at Baseline (Visit 1) and Visit 3 (four weeks after the first vaccination).
    • GMT calculated from individual vaccinia-specific PRNT titers at Baseline (Visit 1) and Visit 3 (four weeks after the first vaccination).
    E.5.2.1Timepoint(s) of evaluation of this end point
    see above
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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) 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 No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 342
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 12
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 130
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 200
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    children
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state342
    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, since the trial is a prophylactic vaccination trial
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-07-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-23
    P. End of Trial
    P.End of Trial StatusOngoing
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