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   44358   clinical trials with a EudraCT protocol, of which   7384   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:2024-000481-17
    Sponsor's Protocol Code Number:EBSI-CV-317-008
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2025-08-28
    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 number2024-000481-17
    A.3Full title of the trial
    A Long-term Follow-up Study to Evaluate Safety and Immunogenicity of a Chikungunya Virus Virus-like Particle Vaccine (PXVX0317) in Healthy Adults and Adolescents After Either a Single or a Booster Vaccination Dosing Regimen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A long-term (5 year) follow-up study to evaluate the safety and immune response of healthy participants 12 years of age and older who were vaccinated with a single dose of Vimkunya, and to evaluate the safety and immune response of a booster dose at 3, 4, or 5 years after the initial vaccination.
    A.3.2Name or abbreviated title of the trial where available
    Long-term follow-up and booster study of Vimkunya in participants 12 years of age and older
    A.4.1Sponsor's protocol code numberEBSI-CV-317-008
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT06007183
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/159/2021
    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 A/S
    B.5.2Functional name of contact pointSufia Muhammad, MD
    B.5.3 Address:
    B.5.3.1Street Address1005 Slater Road
    B.5.3.2Town/ cityDurham
    B.5.3.3Post code27703
    B.5.3.4CountryUnited States
    B.5.6E-mailsumu@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 nameVimkunya
    D.3.2Product code PXVX0317
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCHIKV VLP
    D.3.9.1CAS number 2986379-37-5
    D.3.9.2Current sponsor codeCHIKV VLP
    D.3.9.3Other descriptive nameChikungunya virus virus-like particle
    D.3.9.4EV Substance CodeSUB201355
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 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. The study evaluates safety and immunogenicity)
    E.1.1.1Medical condition in easily understood language
    Healthy Volunteers (Chikungunya disease. The study evaluates safety and immunogenicity).
    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
    - To evaluate the long-term immunogenicity of CHIKV VLP (PXVX0317) vaccine in healthy adult and adolescent participants as measured by proportion of participants maintaining an anti-CHIKV serum neutralizing antibody (SNA) titer ≥100 (seroresponse rate, also considered the presumptive seroprotection rate) at yearly intervals up to 5 years postvaccination in feeder studies EBSI-CV-317-004 and EBSI-CV-317-005.
    - To assess the vaccine-induced SNA titers by a booster dose of CHIKV VLP (PXVX0317) vaccine at 3, 4, or 5 years post-initial vaccination in feeder studies EBSI-CV-317-004 and EBSI-CV-317-005.
    - To evaluate the safety and tolerability of CHIKV VLP vaccine in all participants.
    - To evaluate the safety and tolerability of a booster vaccination and compare with safety and tolerability reported post-initial vaccination of CHIKV VLP vaccine under feeder studies EBSI-CV-317-004 and EBSI-CV-317-005 in healthy adults and adolescents.
    E.2.2Secondary objectives of the trial
    - To evaluate the long-term immunogenicity of CHIKV VLP (PXVX0317) vaccine in healthy adult and adolescent participants as measured by anti-CHIKV SNA geometric mean titers (GMTs) at yearly intervals up to 5 years post-initial vaccination in feeder studies EBSI-CV-317-004 and EBSI-CV-317-005.
    - To evaluate the immune response to a booster vaccination and compare this response to that reported post-initial vaccination of CHIKV VLP (PXVX0317) under feeder studies EBSI-CV-317-004 and EBSI-CV-317-005 in healthy adults and adolescents.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants must meet all the following criteria to be enrolled:
    1. Only within the EBSI-CV-317-004 feeder study informed consent form (ICF) (and/or assent form, as applicable), the participant voluntarily signed and agreed to be contacted or did not indicate they were not to be contacted for potential screening and enrollment in a future study (ie, EBSI-CV-317-008).
    2. Able and willing to provide informed consent (and assent, as applicable) voluntarily signed by participant (and guardian, as applicable) for participation in this rollover study EBSI-CV-317-008, including possible receipt of a booster dose of CHIKV VLP (PXVX0317) vaccine.
    3. Males or females, 12 years of age or older at the time of enrollment in the feeder studies.
    4. Received a single dose of CHIKV VLP (PXVX0317) vaccine in one of the feeder studies, EBSI-CV-317-004 or EBSI-CV-317-005.
    5. Demonstrated compliance to the feeder study conduct (ie, rollover participant was without protocol deviations that excluded them from immunogenicity analysis in feeder study EBSI-CV-317-004 or EBSI-CV-317-005) without discontinuation or early withdrawal.
    6. Generally healthy, in the opinion of the investigator, based on medical history and physical examination.
    Additional inclusion criteria to be assessed at Prerandomization Visit (Visit 5), before Randomization A (Visit 6), and before Randomization B (Visit 8 for Group 2 and Visit 10 for Group 3) to determine eligibility for a booster dose of CHIKV VLP (PXVX0317) vaccine or placebo:
    7. Women who are either:
    i. Not of childbearing potential (CBP): premenarche, surgically sterile (at least six weeks postbilateral tubal ligation or bilateral total 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). For women who are postmenopausal, documented follicle stimulating hormone (FSH) level of ≥40 mIU/mL must be obtained. If the FSH is <40 mIU/mL, the participant must agree to use an acceptable form of contraception.
    or:
    ii. Meet all the below criteria:
    • Negative serum pregnancy test at Prerandomization and Prebooster Visits
    • Negative urine pregnancy test immediately prior to booster dose administration
    • Use one of these acceptable methods of contraception (if women of CBP) for at least 6 months after booster:
    • Hormonal contraceptives (eg, implants, pills, patches) initiated ≥30 days prior to booster dose administration
    • Intrauterine device (IUD) inserted ≥30 days prior to booster dose administration
    • Double barrier type of birth control (male condom with female diaphragm, male condom with cervical cap)
    • Abstinence is acceptable only for adolescents (12 to <18 years of age) who are not sexually active.
    Women participants of CBP must use an acceptable method of contraception from ≥30 days prior to Randomization A or assignment to Group 1; those who are randomized to Groups 2 or 3 at Year 3 can discontinue contraception until 30 days prior to booster dose administration, if desired. Women of CBP must use an acceptable method of contraception from ≥30 days prior to Randomization B through 6 months postbooster vaccination dose (if applicable).
    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 during the same time period as women of CBP are required to use contraception. Contraception requirements do not apply to Group 4 participants (unrandomized or unboosted).
    E.4Principal exclusion criteria
    Participants who meet any of the following criteria cannot be enrolled:
    1. Received placebo treatment in the feeder study.
    2. Measurable anti-CHIKV SNA at Day 1 in the feeder study.
    3. History of severe allergic reaction or anaphylaxis to any component of the investigational product (IP).
    4. Receipt of either an investigational or licensed CHIKV vaccine (excluding prior receipt of CHIKV VLP [PXVX0317] vaccine).
    5. New onset/diagnosis of any disease falling within the feeder study exclusion criteria including:
    i. History of any known congenital or acquired immunodeficiency that could impact response to vaccination (eg, leukemia, lymphoma, generalized malignancy, functional or anatomic asplenia, alcoholic cirrhosis).
    ii. Clinically significant cardiac, pulmonary, rheumatologic, or other chronic disease, in the opinion of the investigator. This may include chronic illness requiring hospitalization during the feeder study.
    6. Evidence of substance abuse that, in the opinion of the investigator, could adversely impact the individual’s participation or the conduct of the study.
    7. Any other medical condition or general reason that, in the opinion of the investigator, could adversely impact the individual’s participation or the conduct of the study.
    8. Experienced a related safety event in the feeder study that, in the investigator’s judgement, precludes receipt of booster.
    9. Bavarian Nordic staff members and their families, contractors, agents, business partners, and anyone with a financial interest in the outcome of the study.
    Additional exclusion criteria to be assessed at Prerandomization Visit (Visit 5), before Randomization A (Visit 6), and before Randomization B (Visit 8 for Group 2 and Visit 10 for Group 3) to determine eligibility for a booster dose of CHIKV VLP (PXVX0317) vaccine or placebo:
    10. Participation or planned participation in an investigational clinical trial, excluding feeder studies EBSI-CV-317-004 and EBSI-CV-317-005 (eg, vaccine, drug, medical device, or medical procedure) for the following time periods:
    Group 1: 30 days prior to Randomization A or assignment to Group 1 at Visit 6 through Visit 7
    Group 2: 30 days prior to Randomization A at Visit 6 until the Randomization A visit and 30 days prior to booster dose at Visit 8 through Visit 9
    Group 3: 30 days prior to Randomization A at Visit 6 until the Randomization A visit and 30 days prior to booster dose at Visit 10 through EOS Visit
    Group 4: 30 days prior to Randomization A at Visit 6 until the Randomization A visit
    Note: Participation in an observational trial or follow-up phase of a trial may be allowed; however, these instances should be discussed with this study’s medical monitor (MM).
    11. Currently breastfeeding.
    12. Positive laboratory evidence of current infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV).
    13. Prior receipt or anticipated use of systemic immunomodulatory or immunosuppressive medications from 6 months prior to Prebooster Visit through 21 days after booster dose. Note: For systemic corticosteroids, use at a dose or equivalent dose of 20 mg of prednisone daily for 14 days or more within 3 months of Prebooster Visit through 21 days postbooster dose is exclusionary. The use of inhaled, intranasal, topical, ocular, or intraocular steroids is allowed.
    14. Receipt or anticipated receipt of blood or blood-derived products from 90 days prior to Prebooster Visit through 21 days postbooster dose.
    15. Acute disease within the last 14 days prior to booster dose (participants with an acute mild febrile illness can be considered for a deferral of vaccination 2 weeks after the illness has resolved and treatment has been completed).
    16. Receipt or anticipated receipt of any vaccine from 30 days prior to booster dose through 21 days postbooster.

    Note: Participants that are ineligible or decline booster will be included in Group 4 (unrandomized or unboosted) for follow-up unless consent/assent for follow-up is withdrawn.
    E.5 End points
    E.5.1Primary end point(s)
    - For all groups using the immunogenicity evaluable population (IEP), the proportion of participants maintaining a preboost anti-CHIKV SNA titer ≥100 (seroresponse rate, also considered the presumptive seroprotection rate) at yearly intervals up to 5 years post-initial vaccination in one of the feeder studies; only prebooster data will be summarized.
    - For IEP participants who receive a CHIKV VLP (PXVX0317) vaccine booster (Groups 1a, 2a, and 3a), proportion of participants with a boost response is defined as a composite of:

    - ≥4-fold rise in anti-CHIKV SNA titer from prebooster to postbooster measured at 21 days after booster for participants with a prebooster titer ≥100.

    OR

    - Anti-CHIKV SNA titer ≥100 and ≥4-fold increase in anti-CHIKV SNA titer from prebooster to postbooster measured at 21 days after booster vaccination for participants with a prebooster titer <100.

    Note: Prebooster is the last SNA sample prior to booster dose, ideally the sample on boost day prior to booster dose administration but can be the time point prior if the boost day sample is missed or incorrectly processed.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Years 2, 3, 4, and 5
    E.5.2Secondary end point(s)
    - For all groups using the IEP, anti-CHIKV SNA GMTs preboost at yearly intervals up to 5 years post-initial CHIKV VLP (PXVX0317) vaccination in feeder study EBSI-CV-317-004 or EBSI-CV-317-005 (only prebooster data will be summarized) and, in Groups 1a, 2a, and 3a, at Postboost Visit B.
    - For IEP participants who receive a CHIKV VLP (PXVX0317) vaccine booster (Groups 1a, 2a, and 3a) and have a 21-day postbooster SNA titer, geometric mean fold increase (GMFI) from prebooster anti-CHIKV SNA titer to 21 days postbooster anti-CHIKV SNA titer and at yearly intervals up to 5 years post-initial vaccination in feeder study EBSI-CV-317-004 or EBSI-CV-317-005.
    - For IEP participants who receive a CHIKV VLP (PXVX0317) vaccine booster (Groups 1a, 2a, and 3a), and have a 21-day postbooster SNA titer, GMFI from feeder study EBSI-CV-317-004 or EBSI-CV-317-005 Day 22 SNA titer to 21-day postbooster SNA titer in the rollover study.
    E.5.2.1Timepoint(s) of evaluation of this end point
    21 days after booster
    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 No
    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 trial7
    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
    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 years6
    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: 100
    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: 50
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 50
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 650
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2025-08-28. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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
    Adolescents must have parental/ guardian consent provided.
    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 800
    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 Alliance for Multispecialty Research, LLC
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Optimal Research, LLC
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation Suncoast Research Associates, LLC
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation Synexus Clinical Research US, Inc
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 5
    G.4.1Name of Organisation Wr-Crcn, LLC
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 6
    G.4.1Name of Organisation Rochester Clinical Research, LLC
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 7
    G.4.1Name of Organisation M3 Wake Research, Inc
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 8
    G.4.1Name of Organisation Velocity Clinical Research
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 9
    G.4.1Name of Organisation Lynn Institute of Norman
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 10
    G.4.1Name of Organisation DM Clinical Research
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 11
    G.4.1Name of Organisation BFHC Research, LLC
    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
    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-Mon Sep 01 17:56:36 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA