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    Summary
    EudraCT Number:2017-002137-32
    Sponsor's Protocol Code Number:FV001
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-07-07
    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
    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 ConcernedSweden - MPA
    A.2EudraCT number2017-002137-32
    A.3Full title of the trial
    Immunological responses after concomitant vaccination with the yellow fever-vaccine Stamaril and the TBE-vaccine FSME Immun, or JE-vaccine Ixiaro
    Immunologiskt svar efter samtidig vaccinering med gula febern vaccinet Stamaril och TBE-vaccinet FSME Immun, respektive JE-vaccinet Ixiaro
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunological responses after concomitant vaccination with the yellow fever-vaccine and the TBE-vaccine, or JE-vaccine
    Immunologiskt svar efter samtidig vaccinering med gula febern vaccinet och TBE-vaccinet, respektive JE-vaccinet
    A.4.1Sponsor's protocol code numberFV001
    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 SponsorHans-Gustaf Ljunggren
    B.1.3.4CountrySweden
    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 supportKarolinska Institutet
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKarolinska Institutet
    B.5.2Functional name of contact pointKim Blom
    B.5.3 Address:
    B.5.3.1Street AddressKarolinska Institutet, Department of Medicine, Center for Infectious Medicine, F59
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code14186
    B.5.3.4CountrySweden
    B.5.6E-mailkim.blom@ki.se
    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 Stamaril
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 No
    D.3.7Routes of administration for this IMPSubcutaneous 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.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 FSME Immun
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Innovations
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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.3.11 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 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 holderValneva
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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.3.11 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 TBE or Japanece encephalitis by co-vaccination with the yellow fever vaccine
    Prevention mot TBE och Japansk encefalit genom samtidig vaccinering med gula febern vaccinet
    E.1.1.1Medical condition in easily understood language
    Prevention of TBE or Japanece encephalitis by co-vaccination with the yellow fever vaccine
    Förebyggande av TBE och Japansk encefalit genom samtidig vaccinering med gula febern vaccinet
    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
    We will study if individuals that have recieved concomittant vaccinations with FSME Immun and Stamaril will generate a better immune response against TBE compared to individuals that only recieved FSME Immun. We will study if individuals that have recieved concomittant vaccinations with Ixiaro and Stamaril will generate a better immune response against JE compared to individuals that only recieved Ixiaro. The immune responses generated in the groups that recieved concomittant vaccinations will in a later stage be compared with each other.
    I individer som blivit vaccinerade med Stamaril och FSME Immun vid samma tillfälle, vill vi studera om dessa individer erhåller ett bättre immunsvar mot TBE än de individer som enbart får FSME Immun. I individer som blivit vaccinerade med Stamaril och Ixiaro vid samma tillfälle, vill vi studera om dessa erhåller ett bättre immunsvar mot JE än de individer som enbart får Ixiaro. De samvaccinerade grupperna kommer också att jämföras med varandra i förhållande till antikroppar och cellförmedlat immunsvar.
    E.2.2Secondary objectives of the trial
    Not applicable
    Ej applicerbart
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Individuals that need prevention of TBE, Yellow fever and JE
    Induviduals that signed informed concent
    Individuals between 18-55 years of age
    Individer som önskar skydd mot TBE, gula febern eller JE
    Individer som har lämnat skriftligt samtycke till att delta i studien
    Individer som är mellan 18 och 55 år
    E.4Principal exclusion criteria
    Individuals that:
    Claim that they already had vaccination, or been infected with TBE, JE or Yellow fever
    Are allergic to eggs or something else in FSME Immun, Stamaril and Ixiaro
    Have an autoimmune disease
    Have difficulties donating blood
    Take drugs against cancer
    Take corticosteroids
    Have a disease that had affected the brain
    Have neurological disorders
    Have dampened immune function or that of other reason is evaluated by the investigator as inappropriate for inclusion
    Have HCV or HIV
    Had fever within a week from the time of vaccination
    Are pregnant or plan to be pregnant in the course of the study
    Have a bleeding disorder
    Breastfeed
    Participated in other clinical trials within the last three months
    Cannot fulfill the study
    Or for other reasons is evaluated not to be suitable for inclusion
    Individer som uppger att de tidigare haft TBE (grupp A och C), Japansk encefalit (grupp B och D) eller gula febern (grupp A och grupp B).
    Individer som uppger att de tidigare vaccinerats mot TBE (grupp A och C), JE (grupp B och D) eller gula febern (grupp A, grupp B och grupp E)
    Individer som uppger att de är allergiska mot ägg, hönsproteiner, fruktos eller något av innehållsämnena i Stamaril, Ixiaro eller FSME Immun.
    Individer som har en autoimmun sjukdom (såsom reumatoid artrit eller multipel skleros)
    Individer där blodprovstagning är uttalat svårt, t ex p g a djupt liggande vener
    Individer som tar läkemedel mot cancer
    Individer som tar läkemedel som kallas kortikosteroider (som dämpar inflammation)
    Individer som har något sjukdomstillstånd som drabbat hjärnan
    Individer som har neurologiska störningar eller krampsjukdomar
    Individer med annan nedsatt immunfunktion eller om prövaren av någon annan orsak bedömer forskningspersonen olämplig för inklusion (t ex på grund av sjukdomar såsom som kräver immunsuppressiv läkemedelsbehandling eller vid annan infektion)
    Individer med HIV eller HCV infektion
    Individer som har haft feber inom en vecka innan vaccinationstillfället
    Individer som är gravida eller planerar att bli gravida under studietiden
    Individer som har blödarsjukdom eller tar blodförtunnande läkemedel
    Individer som ammar
    Individer som ingår eller har ingått i andra läkemedelsstudier inom de senaste tre månaderna
    Individer som inte tror sig kunna fullfölja studien eller av prövare inte bedöms kunna fullfölja studien
    Individer som av annan orsak av prövare bedöms som ej lämpliga för inklusion
    E.5 End points
    E.5.1Primary end point(s)
    We expect to see higher number of plasmablasts, TBE and JE specific antibodies and a higher amount of specific CD8 and CD4 T cells against TBEV and JEV if these vaccines are administered simultaneously as the yellow fever vaccine
    Vi förväntar oss att individer som vaccineras mot TBE respektive JE erhåller en högre (kraftigare) immunaktivering, och därigenom bättre immunitet, mot TBE och JE om de samtidigt vaccineras mot gula febern. Mer konkret förväntar vi oss att samvaccinerade individer kommer att ha högre antal skyddande antikroppar mot TBE och JE jämfört med de individer som enbart får TBE- respektive JE-vaccin. Vi förväntar oss även att de samvaccinerade individerna genererar ett högre antal TBE- och JE-specifika T minnes celler som ger långvarig cellförmedlad immunitet, i jämförelse med de individer som enbart får TBE- respektive JE-vaccin. Immunaktiveringen i de båda samvaccinerade grupperna kommer att jämföras.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Last sampeling timepoint is 30 days (or 60 days) after the last vaccination. This sample will during later analyses be evaluated for levels of antibodies and specific T cells.
    Slutprovet i varje grupp tas 30 dagar (alternativt 60 dagar) efter sista vaccinering och kommer att användas till att bland annat fastställa antikroppsnivåer och specifika T celler efter genomgången studie.
    E.5.2Secondary end point(s)
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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 No
    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
    We will measure Immune responses induced after concomittant vaccinations
    Vi vill mäta det immunologiska svaret efter vaccinering av TBE vaccinet tillsammans med gula febernvaccinet, eller JE vaccinet tillsammans med gula febernvaccinet
    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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    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 years5
    E.8.9.1In the Member State concerned months6
    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 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 140
    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 Yes
    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.4.1In the member state140
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 140
    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 Decision2017-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-31
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