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    Summary
    EudraCT Number:2025-000141-10
    Sponsor's Protocol Code Number:EBSI-CV-317-006
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2025-06-02
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2025-000141-10
    A.3Full title of the trial
    EBSI-CV-317-006: A Phase 3 Global, Randomized, Double-blind, Placebo-controlled, Safety and Immunogenicity Study of CHIKV VLP Vaccine in Children 2 to <12 Years of Age
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multi-country study to test the safety and effectiveness of a chikungunya virus vaccine in children aged 2 to 11. The study is designed so that neither the participants nor the researchers know who is getting the vaccine and who is getting a placebo (an inactive substance).
    A.3.2Name or abbreviated title of the trial where available
    EBSI-CV-317-006
    A.4.1Sponsor's protocol code numberEBSI-CV-317-006
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT07003984
    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 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
    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 AuthorisationDenmark
    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
    Healthy Volunteers (Chikungunya disease. Prevention of Chikungunya disease by use of a vaccine.)
    E.1.1.1Medical condition in easily understood language
    Healthy Volunteers (Prevention of Chikungunya disease)
    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 compare the anti-CHIKV serum neutralizing antibody (SNA) seroresponse rate to CHIKV VLP vaccine and placebo at Day 22 among baseline seronegative participants, as measured by clinically relevant difference in seroresponse rates (CHIKV VLP vaccine minus placebo) in children 2 to <12 years of age.
    2. To evaluate the safety of CHIKV VLP vaccine in children 2 to <12 years of age.
    E.2.2Secondary objectives of the trial
    1. To compare anti-CHIKV SNA response to CHIKV VLP vaccine and placebo at Days 15, 22, 183, and 366 using seroresponse rates, GMT, GMFI, and counts/percentages of participants with titer ≥15 and 4-fold rise over baseline. Describe anti-CHIKV SNA response to CHIKV VLP vaccine at Day 732 using the same metrics.
    2. To compare anti-CHIKV SNA response to CHIKV VLP vaccine and placebo in participants aged 2 to <6 and 6 to <12 years at Days 15, 22, 183, and 366 using seroresponse rates, GMT, GMFI, and counts/percentages of participants with titer ≥15 and 4-fold rise over baseline. Describe anti-CHIKV SNA response by age stratum at Day 732 using the same metrics.
    3. To compare anti-CHIKV SNA seroresponse rate to CHIKV VLP vaccine at Day 22 between baseline seronegative children aged 2 to <12 years and adolescents/adults aged 12 to <65 years in study EBSI-CV-317-004.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Males or females between 2 and <12 years of age at Day 1.
    2.In general good health, in the opinion of the investigator, based on medical history and physical examination.
    3.Able and willing to provide informed assent for study participation. Primary caregiver is able and willing to provide informed consent for study participation, in accordance with the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) determination and applicable federal and local regulations and guidelines.
    4.Able and willing to complete all scheduled visits and comply with all study procedures.
    E.4Principal exclusion criteria
    1.Participation or planned participation in an investigational clinical study (eg, vaccine, drug) within 30 days before Day 1 and for the duration of the study. Note: Participation in an observational study or follow-up phase of a study may be allowed; however, these instances should be discussed with the sponsor’s MM and written agreement obtained prior to enrollment.
    2.Current acute illness, with or without fever.
    3.Current or recent CHIKV infection indicated by positive immunoglobulin M (IgM) and negative immunoglobulin G (IgG) rapid diagnostic test (RDT) results at screening in the Philippines only; participants in the US will not be tested using the RDT.
    4.History of any known or suspected allergy or history of anaphylaxis to any component of the investigational product.
    5.History of any known congenital or acquired immunodeficiency or immunosuppressive condition that could impact response to vaccination.
    6.Prior receipt or anticipated use of systemic immunomodulatory or immunosuppressive medications from 6 months prior to screening through Day 22. Note: Systemic corticosteroid use at a dose or equivalent dose of 20 mg or greater (≥0.5 mg/kg for children <40 kg) of prednisone for 14 consecutive days or more within 90 days of screening through Day 22 is exclusionary. The use of inhaled, intranasal, topical, or ocular steroids is allowed.
    7.Receipt or anticipated receipt of immunoglobulin from 180 days prior to screening through the duration of the study.
    8.Any administration or planned administration of:
    •A licensed live attenuated vaccine within 28 days before administration of investigational product and until Visit 2 (Day 15 or 22, as applicable) has occurred.
    •Other licensed (not live) vaccine within 14 days before administration of investigational product and until Visit 2 (Day 15 or 22, as applicable) has occurred.
    •Another licensed or investigational CHIKV vaccine.
    9.Known infection with HIV, HCV, or HBV. Note: Positive anti HCV antibodies and negative HCV PCR would NOT be exclusionary. Polymerase chain reaction testing will not be performed as part of this protocol.
    10.Bleeding disorder or receipt of anticoagulants in the 21 days before Day 1, contraindicating IM vaccination, as judged by the investigator.
    11.Receipt or anticipated receipt of blood products from 90 days before Day 1 through the duration of the study.
    12.Onset of menarche prior to study vaccination.
    13.Planned medical or surgical procedure that could adversely impact the participant’s participation or the conduct of the study.
    14.Identified as an immediate family member of the investigator or employee with direct involvement in the study. Bavarian Nordic staff members and their families, contractors, agents, business partners, and anyone with a financial interest in the outcome of the study.
    15.Any other medical condition, including severe malnutrition, that, in the opinion of the investigator, could adversely impact the participant’s participation or conduct of the study.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Outcome Measure:
    1.Day 22 anti-CHIKV serum neutralizing antibody (SNA) seroresponse rate in baseline seronegative children 2 to <12
    years of age in the immunogenicity evaluable population.
    2.Incidence of solicited adverse events through Day 8.
    3.Incidence of unsolicited AEs through Day 29.
    4.Incidence of adverse events of special interest (defined as new onset or worsening arthralgia that is medically
    attended), medically attended adverse events, and serious adverse events through end of the trial.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Days 8, 22, 29, and 732
    E.5.2Secondary end point(s)
    1.Day 15 anti-CHIKV serum neutralizing antibody seroresponse rate in baseline seronegative children 2 to <12 years of age in the immunogenicity evaluable population.
    2.Day 22 anti-CHIKV serum neutralizing antibody seroresponse rate in both baseline seronegative and seropositive children 2 to <12 years of age in the immunogenicity evaluable population.
    3.Day 15 anti-CHIKV serum neutralizing antibody seroresponse rate in both baseline seronegative and seropositive children 2 to <12 years of age in the immunogenicity evaluable population.
    4.Day 183 and Day 366 anti-CHIKV serum neutralizing antibody seroresponse rate in both baseline seronegative and seropositive children 2 to <12 years of age in the immunogenicity evaluable population.
    5.Day 15, Day 22, Day 183, and Day 366 anti-CHIKV serum neutralizing antibody seroresponse rate in both baseline seronegative and seropositive children 2 to <12 years of age in the immunogenicity evaluable population, stratified by age stratum (2 to <6 and 6 to <12 years); analyzed by baseline serostatus separately and combined.
    6.Geometric mean titers of anti-CHIKV serum neutralizing antibodies at Day 15, Day 22, Day 183, and Day 366 for the CHIKV VLP vaccine and placebo groups, and Day 732 for CHIKV VLP vaccine group only, in children 2 to <12 years of age in the immunogenicity evaluable population by age stratum (2 to <6 and 6 to <12 years); analyzed by baseline serostatus separately and combined.
    7.Geometric mean fold increases from Day 1 (prevaccination) to Day 15, Day 22, Day 183, and Day 366 for the CHIKV VLP vaccine and placebo groups, and Day 732 for CHIKV VLP vaccine group only in children 2 to <12 years of age in the IEP and by age stratum (2 to <6 and 6 to <12 years); analyzed by baseline serostatus separately and combined.
    8.Frequency of participants with titer ≥15 and 4-fold rise over baseline at Day 15, Day 22, Day 183, and Day 366 for the CHIKV VLP vaccine and placebo groups, and Day 732 for the CHIKV VLP vaccine group only in children 2 to <12 years of age in the IEP and by age stratum (2 to <6 and 6 to <12 years); analyzed by baseline serostatus separately and combined.
    9.For the CHIKV VLP vaccine group only, anti-CHIKV SNA seroresponse rates at Day 732 in both baseline seronegative and seropositive children 2 to <12 years of age and by age stratum (2 to <6 and 6 to <12 years); analyzed by baseline serostatus separately and combined.
    10.Day 22 anti-CHIKV SNA seroresponse rate between baseline seronegative children 2 to <12 years of age in the IEP
    versus adolescents and adults from 12 to <65 years of age in study EBSI-CV-317-004.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Days 15, 22, 183, 366, and 732
    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 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
    1. 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 Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Philippines
    United States
    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.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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: 720
    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: 720
    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 No
    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 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 720
    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 Velocity Clinical Research - Salt Lake City
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Velocity Clinical Research - Omaha
    G.4.3.4Network Country United States
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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    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
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