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    Summary
    EudraCT Number:2018-004674-94
    Sponsor's Protocol Code Number:WI237607
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-03-18
    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 ConcernedLatvia - SAM
    A.2EudraCT number2018-004674-94
    A.3Full title of the trial
    Open-label Phase IV Study to Investigate Broad-and Cross-neutralizing Antibodies after Primary Vaccination with Two Different TBE Vaccines
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Antibodies after Primary Vaccination with Two Different TBE Vaccines
    A.4.1Sponsor's protocol code numberWI237607
    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 SponsorRiga Stradiņš University
    B.1.3.4CountryLatvia
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRiga Stradiņš University (Latvia); Pfizer,Inc. (United States)
    B.4.2CountryLatvia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRiga Stradiņš University
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressDzirciema 16
    B.5.3.2Town/ cityRiga
    B.5.3.3Post codeLV-1007
    B.5.3.4CountryLatvia
    B.5.4Telephone number+371 26494938
    B.5.6E-maildace.zavadska@rsu.lv
    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 TicoVac 0.5 mL
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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.3.8INN - Proposed INNJ07 BA01
    D.3.9.1CAS number 8000029723
    D.3.9.2Current sponsor codePF-06830414
    D.3.9.3Other descriptive nameTICK-BORNE ENCEPHALITIS VIRUS (INACTIVATED), NEUDOERFL STRAIN
    D.3.9.4EV Substance CodeSUB26470
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.4
    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.IMP: 2
    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 TicoVac 0.25 mL
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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.3.8INN - Proposed INNJ07 BA01
    D.3.9.1CAS number 8000029723
    D.3.9.2Current sponsor codePF-06830414
    D.3.9.3Other descriptive nameTICK-BORNE ENCEPHALITIS VIRUS (INACTIVATED), NEUDOERFL STRAIN
    D.3.9.4EV Substance CodeSUB26470
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.2
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Adults 0.5mL
    D.2.1.1.2Name of the Marketing Authorisation holderGSK Vaccines GmbH, Emil-von-Behring-Str. 76, 35041 Marburg, Germany
    D.2.1.2Country which granted the Marketing AuthorisationLatvia
    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.3.8INN - Proposed INNJ07 BA01
    D.3.9.1CAS number 8000029723
    D.3.9.3Other descriptive nameTICK-BORNE ENCEPHALITIS VIRUS (INACTIVATED), STRAIN K23
    D.3.9.4EV Substance CodeSUB29400
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5
    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.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 Children 0.25 mL
    D.2.1.1.2Name of the Marketing Authorisation holderGSK Vaccines GmbH, Emil-von-Behring-Str. 76, 35041 Marburg, Germany
    D.2.1.2Country which granted the Marketing AuthorisationLatvia
    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.3.8INN - Proposed INNJ07 BA01
    D.3.9.1CAS number 8000029723
    D.3.9.3Other descriptive nameTICK-BORNE ENCEPHALITIS VIRUS (INACTIVATED), STRAIN K23
    D.3.9.4EV Substance CodeSUB29400
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.75
    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
    Active (prophylactic) immunization against tick-borne encephalitis
    E.1.1.1Medical condition in easily understood language
    Prevention of disease caused by a virus that can be passed to humans from the bite of a tick or unpasteurized dairy products (tick-borne encephalitis)
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10043847
    E.1.2Term Tick-borne viral 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
    To describe the immune response induced by FSME-IMMUN/TicoVac or Encepur against two virus strains Neudorfl (Nd) used to manufacture FSME/IMMUN/TicoVac and mutated Karsruhe (mK23) (one homologous strain and one heterologous strain to each vaccine), as measured by NT using an established hybrid virus assay platform.
    E.2.2Secondary objectives of the trial
    To describe the immune response induced by FSME-IMMUN/TicoVac or Encepur against the vaccine virus strains (Neudorfl (Nd) used to manufacture FSME/IMMUN/TicoVac and the mutated Karsruhe strain (mK23) used to manufacture Encepur), as measured by ELISA (IMMUNOZYM and ENZYGNOST).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Healthy subjects age 1 year and older
    2. Subject/ parent (s)/ legal guardian(s) provide(s) written informed consent according to national law
    3. Subject provides written assent to the study according to local law, age, and capacity of understanding if applicable
    4. Subject/ parent (s)/ legal guardian(s) understand(s) the nature of the study and is/are willing to comply with the requirements of the protocol (e.g., return for all visits)
    E.4Principal exclusion criteria
    1. History of infection with or vaccination against a flavivirus (e.g., TBE, Dengue, Yellow Fever, Japanese B Encephalitis, West Nile)
    2. Contraindication to TBE vaccination per the SmPC
    3. Pregnant or lactating females and all breastfed young children (at any time prior to completion of the primary vaccination series [first 3 doses]}
    4. Females of childbearing potential who do not agree to using at least an acceptable birth control method (See Section 9.4) from 28 days before the first vaccination until 28 days after the last vaccination in the study
    5. Not clinically healthy (i.e., physician would have reservations in vaccinating with a TBE vaccine outside the scope of this study)
    6. Suffering from a disease or have undergone any treatment such as corticosteroids or immunosuppressants that could influence immunological functions within 28 days prior to study start or during the study
    7. Surgery requiring hospitalization within 28 days of study start or planned surgery during the study that would require an immunomodulating treatment
    8. Severe medical condition requiring hospitalization within 3 months of study start or during the study
    9. Malignancy within 5 years of study start
    10. Known or suspected substance abuse disorder or mental disability
    11. Received any other vaccine within 28 days of study start through 28 days after the second vaccination or 28 days before through 28 days after the third vaccination
    12. Received blood, blood fractions, plasma, or immunoglobulins within 3 months of study start and during the study
    13. Participation in another clinical trial involving receipt of an investigational product within 1 month of study start or during study
    14. Investigator, site staff members directly involved in the conduct of the study, or site staff members otherwise supervised by an Investigator
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for the primary objective is the %composite response of neutralizing titers against both homologous and heterologous antigens to the vaccines at each visit. The composite response is defined as a subject with NT≥=10 for both Nd and mK23.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of Trial
    E.5.2Secondary end point(s)
    The secondary endpoint for the primary objective will include:
    • % of subjects with NT ≥10 for Nd;
    • % of subjects with NT >10 for mK23;
    • % of subjects with NT >20 for Nd, mK23, and for both Nd and mK23;
    • GMT for Nd;
    • GMT for mK23.
    The secondary endpoint for the primary objective will include:
    • %of subjects with ELISA >126 for Nd
    • %of subjects with ELISA >126 for mK23
    • GMC for Nd
    • GMC for mK23
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of Trial
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenic
    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 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 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 years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 200
    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: 100
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 100
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    children under the age of 14
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state400
    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)
    None
    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 Decision2019-04-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-05
    P. End of Trial
    P.End of Trial StatusOngoing
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