Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44392   clinical trials with a EudraCT protocol, of which   7404   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2025-000501-16
    Sponsor's Protocol Code Number:EBSI-CV-317-007
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2026-03-16
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2025-000501-16
    A.3Full title of the trial
    A Phase 3b Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of an Adjuvanted Chikungunya Virus Virus-like Particle (CHIKV VLP) Vaccine for the Prevention of Chikungunya Disease in Adolescents (12 to
    <18 Years) and Adults (≥18 Years)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multi-country study to test the efficacy, safety, and immunogenicity of a Chikungunya Virus vaccine in adolescents aged 12 to 17 and adults aged 18 and over. The study is designed so that participants receiving the vaccine (active ingredient) or placebo (inactive substance), and the researchers administrating either one, is not aware of what type of vaccine is given.
    A.3.2Name or abbreviated title of the trial where available
    EBSI-CV-317-007
    A.4.1Sponsor's protocol code numberEBSI-CV-317-007
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/059/2024
    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
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBavarian Nordic
    B.5.2Functional name of contact pointMedical Information
    B.5.3 Address:
    B.5.3.1Street AddressPhilip Heymans Alle 3
    B.5.3.2Town/ cityHellerup
    B.5.3.3Post code2900
    B.5.3.4CountryDenmark
    B.5.6E-mailmedical.information_eu@bavarian-nordic.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 VIMKUNYA
    D.2.1.1.2Name of the Marketing Authorisation holderBavarian Nordic A/S
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameCHIKV VLP
    D.3.2Product code CHIKV VLP
    D.3.4Pharmaceutical form Suspension for injection
    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 Yes
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chikungunya virus infection
    E.1.1.1Medical condition in easily understood language
    Chikungunya virus infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10067256
    E.1.2Term Chikungunya virus infection
    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
    1. To evaluate the safety, immunogenicity, and efficacy of CHIKV VLP vaccine versus placebo in nonpregnant participants aged 12 and older at risk of CHIKV infection.
    E.2.2Secondary objectives of the trial
    1. To evaluate the vaccine efficacy of CHIKV VLP in the prevention of chronic CHIKV disease.
    2. To evaluate the CHIKV VLP vaccine for prevention of severe CHIKV disease.
    3. To evaluate the immunogenicity of CHIKV VLP vaccine.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able and willing to provide informed consent (and assent, as applicable) voluntarily signed by participant (and guardian, as applicable). Must verbalize understanding of the reason for and the procedures needed for the study and be willing to stay in the study for its entire duration.

    2. Male or nonpregnant female 12 years of age and older.

    3. In stable health per the investigator, and no hospital admission or major surgical procedure in the last 30 days before investigational product administration.

    4. Negative for CHIKV antibodies as determined by CHIK IgM/IgG rapid diagnostic test (RDT), except for the Safety Subset which may be enrolled regardless of serostatus.

    5. Women who are either:
    a. Not of CBP: premenarchal, surgically sterile (at least 6 weeks post bilateral tubal ligation, bilateral salpingectomy, bilateral oophorectomy, or hysterectomy); or postmenopausal (defined as a history of ≥12 consecutive months without menses prior to randomization in the absence of other pathologic or physiologic causes, following cessation of exogenous sex-hormonal treatment). or
    b. Meeting all the below criteria:
    • Negative urine pregnancy test at screening visit
    • Negative urine pregnancy test immediately prior to dosing
    • Using an acceptable form of contraception per local standards and agree to use this for at least 8 weeks after investigational product administration

    Note: Contraception requirements do not apply for participants in exclusively same-sex relationships and these participants should have no plans to become pregnant by any other means for at least 8 weeks after investigational product administration.
    E.4Principal exclusion criteria
    1. Currently pregnant or breastfeeding.

    2. Participation or planned participation in an investigational clinical study within 30 days of Day 1 (investigational product administration) and for the duration of the study. Note: Participation in an observational trial/study or follow-up phase of a trial/study may be eligible; however, participation in any other study should be discussed with the MM prior to enrollment.

    3. History of severe allergic reaction or anaphylaxis to any component of the investigational product.

    4. Prior receipt of any CHIKV vaccine (or therapeutic) or participation in a prior interventional CHIKV trial/study.

    5. Prior documented, laboratory confirmed CHIKV disease.

    6. History of any known congenital or acquired immunodeficiency or immunosuppressive condition that could impact response to investigational product administration (eg, leukemia, lymphoma, malignancy, functional or anatomic asplenia, alcoholic cirrhosis). Notes: i) history of basal cell and squamous cell carcinoma of the skin or carcinoma in situ of the cervix considered cured is not exclusionary; ii) history of malignancy considered cured from over 5 years from the date of screening with minimal risk of reoccurrence or relapse is not exclusionary; iii) documented controlled HIV infection (most recent tests show undetectable viral load and a CD4 cell count over 350 at the time of investigational product administration) is not exclusionary.

    7. Prior receipt or anticipated use of systemic immunomodulatory or immunosuppressive medications including hyperimmune products, monoclonal antibody therapies, systemic corticosteroids, and/or therapy with alkylating agents, antimetabolites, or radiation from 6 months prior to screening through Day 22 visit (21 days [-3/+5] after investigational product administration). Note: i) for systemic corticosteroid uses at a dose or equivalent dose of 20 mg of prednisone daily for 14 days or more within 90 days of screening through Day 22 visit is exclusionary, and ii) use of inhaled, intranasal, topical, or ocular steroids is not exclusionary.

    8. Receipt or anticipated receipt of any vaccine from 30 days prior to Day 1 through Day 22 visit.

    9. Unstable medical condition in the last 30 days prior to Day 1.

    10. Acute illness with or without fever (oral temperatures ≥38.0 °C [100.4 °F]) within 14 days prior to investigational product administration.

    11. Medical or social condition (eg, substance abuse) that could have an impact on the participant’s ability to be compliant with study procedures/visits, as determined by the investigator.

    12. Plans to travel outside the study area or move away for more than 3 consecutive months and will not be available for follow up at the site.

    13. Identified as an investigator or employee of an investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse) of the investigator or employee with direct involvement in the proposed study, or identified as an employee of Bavarian Nordic, their families, contractors, agents, business partners, or anyone with a financial interest in the outcome of the study.

    14. Any other medical condition that, in the opinion of the investigator, could adversely impact the participant’s participation or the conduct of the study.
    E.5 End points
    E.5.1Primary end point(s)
    1. Incidence of laboratory-confirmed acute CHIKV disease: Laboratory-confirmed acute CHIKV disease is defined by the presence of fever, one or more of arthralgia, myalgia or rash, and reverse transcription-quantitative polymerase chain reaction (RT-qPCR) confirmation of CHIKV ribonucleic acid.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. From 14 days postvaccination through end of study follow-up, up to 1095 days postvaccination
    E.5.2Secondary end point(s)
    1. Incidence of laboratory-confirmed chronic CHIKV disease: Laboratory-confirmed chronic CHIKV disease is defined as the persistence of at least one of the articular manifestations (continuous or recurrent pain, rigidity, edema) for >12 weeks after the onset of laboratory confirmed acute CHIKV disease.

    2. Incidence of laboratory-confirmed severe CHIKV disease: Laboratory-confirmed severe CHIKV disease is defined as a laboratory confirmed acute CHIKV disease presenting with dysfunction of at least one organ or system that threatens life and requires hospitalization.

    3. Number of participants with Solicited or Local Adverse Events: In the Safety Subset, the number and percentage of participants with local and systemic reactogenicity events through 7 days postvaccination.

    4. Number of participants with Unsolicited Adverse Events: In the Safety Subset, the number and percentage of participants with unsolicited adverse events through 28 days postvaccination.

    5. Number of Participants with Serious Adverse Events: For all study participants who receive investigational product, number and percentage of participants with Serious Adverse Events (SAEs).
    Note: All participants will be followed for a minimum duration of 6 months following investigational product administration.

    6. Number of Participants with Adverse Events of Special Interest: Adverse events of special interest are defined as the occurrence of new onset or worsening arthralgia that is medically attended and are not associated with a febrile disease case. For all study participants who receive investigational product, number and percentage of participants with AESI for the duration of the study.
    Note: All participants will be followed for a minimum duration of 6 months following investigational product administration.

    7. Number of Participants with Medically Attended Adverse Events: Medically attended adverse events (MAAEs) are defined as adverse events requiring a visit to the hospital, emergency room, urgent care clinic, or other visits to or from medical personnel that are not part of routine scheduled study visits. For study participants in the Safety Subset, the number and percentage of participants with MAAEs for the duration of the study.
    Note: All participants will be followed for a minimum duration of 6 months following investigational product administration.

    8. Anti-CHIKV Serum Neutralizing antibody titers: Geometric Mean Titers (GMTs) of anti-CHIKV serum neutralizing antibodies based on a validated luciferase based anti-CHIKV neutralization assay.

    9. Anti-CHIKV Serum Neutralizing Antibody seroresponse rate: Seroresponse is defined as the presence of anti-CHIKV serum neutralizing antibody (SNA) titer meeting or exceeding 100. Seroresponse rate is defined as the percentage of participants with an Anti-CHIKV SNA titer meeting or exceeding a titer of 100 based on a validated luciferase based anti-CHIKV neutralization assay.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 98 days postvaccination through end of study follow-up, up to 1095 days postvaccination

    2. 14 days postvaccination through end of study follow-up, up to 1095 days postvaccination

    3. Within 7 days postvaccination

    4. Within 28 days postvaccination

    5. Through end of study follow-up, up to 1095 days postvaccination

    6. Through end of study follow-up, up to 1095 days postvaccination

    7. Through end of study follow-up, up to 1095 days postvaccination

    8. 3 weeks postvaccination

    9. 3 weeks postvaccination
    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 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
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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
    Philippines
    Thailand
    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
    Upon accumulation of the target number of protocol-defined, adjudicated acute CHIKV disease cases, including a minimum of 6 months of safety follow-up for all participants and at least 12 weeks of follow-up for participants with confirmed acute CHIKV disease.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years4
    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: 308
    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.1.1.6.1Number of subjects for this age range: 308
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 5530
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 308
    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 Yes
    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.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 6144
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Kamphaeng Phet Hospital - Kamphaeng Phet-AFRIMS Virology Research Unit (KPP/KAVRU)
    G.4.3.4Network Country Thailand
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Songklanagarind hospital, Prince of Songkla University (PSU)
    G.4.3.4Network Country Thailand
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation WRAIR-AFRIMS Philippines, Cebu (WRAIR-APC)
    G.4.3.4Network Country Philippines
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Philippines
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Mar 26 10:09:16 CET 2026 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA