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    Summary
    EudraCT Number:2019-000690-22
    Sponsor's Protocol Code Number:VAC52150EBL2002
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-04-25
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2019-000690-22
    A.3Full title of the trial
    A Randomized, Observer-blind, Placebo-controlled, Phase 2 Study to Evaluate the Safety, Tolerability and Immunogenicity of Different Prime-boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo in Healthy Adults, Including Elderly Subjects, HIV-infected Subjects, and Healthy Children in Two Age Strata in Africa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study to Evaluate the Safety, Tolerability and Immunogenicity of Different Prime-boost Regimens of the Candidate Prophylactic Vaccines for Ebola Ad26.ZEBOV and MVA-BN-Filo in Healthy Adults, Including Elderly Subjects, HIV-infected Subjects, and Healthy Children in Two Age Strata in Africa
    A.4.1Sponsor's protocol code numberVAC52150EBL2002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02564523
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/116/2019
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen Vaccines & Prevention B.V.
    B.1.3.4CountryNetherlands
    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 supportJanssen Vaccines & Prevention B.V.
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportLe Centre MURAZ
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportInstitut National de la Santé et de la Recherche Médicale
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 No
    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 nameAd26.ZEBOV
    D.3.2Product code JNJ-61210474
    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 INNNot available
    D.3.9.2Current sponsor codeJNJ-61210474
    D.3.9.3Other descriptive nameAd26.ZEBOV
    D.3.9.4EV Substance CodeSUB169588
    D.3.10 Strength
    D.3.10.1Concentration unit billion organisms/ml billion organisms/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Yes
    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 No
    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 nameMVA-BN-Filo
    D.3.2Product code JNJ-63839880
    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 INNNot available
    D.3.9.2Current sponsor codeMVA-mBN226B; JNJ-63839880
    D.3.9.3Other descriptive nameMVA-BN-FILO
    D.3.9.4EV Substance CodeSUB169589
    D.3.10 Strength
    D.3.10.1Concentration unit titre titre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200000000
    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 Yes
    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
    Prevention of Ebola virus disease
    E.1.1.1Medical condition in easily understood language
    Prevention of Ebola virus 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 20.0
    E.1.2Level PT
    E.1.2Classification code 10014071
    E.1.2Term Ebola disease
    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 assess the safety and tolerability of different vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as heterologous prime-boost regimens on Days 1 and 29, Days 1 and 57, or Days 1 and 85, in healthy adults, including elderly subjects, and on Days 1 and 29 and Days 1 and 57 in human immunodeficiency virus (HIV)-infected subjects and healthy children in 2 age strata.
    E.2.2Secondary objectives of the trial
    • To assess humoral immune responses, as measured by enzyme-linked immunosorbent assay (ELISA), to the Ebola virus glycoprotein (EBOV GP) at 21 days post boost of different vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered IM as heterologous prime-boost regimens on Days 1 and 29, Days 1 and 57, or Days 1 and 85, in healthy adults, including elderly subjects, and on Days 1 and 29 and Days 1 and 57 in HIV-infected subjects and healthy children in 2 age strata.
    • To assess the safety and tolerability of a third vaccination with Ad26.ZEBOV administered at least 1 year post prime in a subset of approximately 90 healthy adults, including elderly subjects, in Cohort 1 (Groups 1 and 2).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    At selected sites, approximately 90 healthy adult subjects in Cohort 1 (Groups 1 and 2) will receive a third vaccination with Ad26.ZEBOV or placebo at least 1 year post prime vaccination.
    E.3Principal inclusion criteria
    Inclusion Criteria for Healthy Adult and Elderly Subjects
    1. Each subject must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study. In case the subject cannot read or write, the procedures must be explained and informed consent must be witnessed by a literate third party not involved with the conduct of the study.
    2. Subject must be a man or woman aged 18 to 70 years of age, inclusive at randomization.
    3. Subject must be healthy in the investigator’s clinical judgment on the basis of medical history, ECG, physical examination and vital signs performed at screening.
    4. Subject must be healthy on the basis of clinical laboratory tests performed at screening.
    5. Before randomization, a sexually active woman must be either:
    - Of childbearing potential and practicing a highly effective method of birth control consistent with local regulations, beginning at least 28 days prior to vaccination, OR
    - Not of childbearing potential: postmenopausal; permanently sterilized; or otherwise be incapable of pregnancy.
    6. A woman of childbearing potential must have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test at screening and a negative urine β-hCG pregnancy test immediately prior to each study vaccine administration.
    7. A man who is sexually active with a woman of childbearing potential must be willing to use condoms for sexual intercourse beginning prior to enrollment, unless a vasectomy was performed more than 1 year prior to screening.
    8. Subject must be available and willing to participate for the duration of the study visits and follow-up.
    9. Subject must be willing and able to comply with the protocol requirements, including the Prohibitions and Restrictions specified in Section 4.3.
    10. Subject must be willing to provide verifiable identification.
    11. Subject must have a means to be contacted.
    12. Subject must pass the test of understanding (TOU)

    Additional Inclusion Criteria for HIV-infected Subjects
    13. Subject must be a man or woman aged 18 to 50 years of age, inclusive at randomization.
    14. Subject must have a documented HIV-infection for at least 6 months prior to screening.
    15. Subject must be on a stable regimen of Highly Active Antiretroviral Therapy (HAART).
    16. Subject must be in an otherwise reasonably good medical condition, diagnosed on the basis of physical examination, medical history and the investigator’s clinical judgment.

    Inclusion Criteria for Pediatric Subjects
    17. Parent(s)/legal guardian must have signed an ICF indicating that they understand the purpose of, and procedures required for, the study, are willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures, and are willing for their child to participate in the study. Informed assent must be obtained from adolescents and older children, depending on local regulations and practice.
    18. Subject must be male or female whose age on the day of randomization is within one of the 2 age strata in the study: 12-17 years or 4-11 years.
    19. Subject must be healthy in the investigator’s clinical judgment (and the parent(s)/legal guardian) on the basis of medical history, physical examination and vital signs performed at screening.
    20. Subject must be healthy on the basis of clinical laboratory tests performed at screening.
    21. Before randomization, a female subject must be either:
    - Of childbearing potential and practicing a highly effective method of birth control consistent with local regulations, beginning at least 28 days prior to vaccination; OR
    - Not of childbearing potential: premenarchal.
    22. A female subject of childbearing potential must have a negative serum β-hCG pregnancy test at screening and a negative urine β-hCG pregnancy test immediately prior to each study vaccine administration.
    23. A male subject who is sexually active with a female subject of childbearing potential must be willing to use condoms for sexual intercourse beginning prior to enrollment.
    24. Subject and parent(s)/legal guardian are available and willing to participate for the duration of the study visits and follow-up.
    25. Subject and parent(s)/legal guardian must be willing and able to comply with the protocol requirements, including the Prohibitions and Restrictions specified in Section 4.3.
    26. Subject and parent(s)/legal guardian must have a means to be contacted.
    27. The parent(s)/legal guardian must pass the TOU. Older children and adolescents, who provided assent according to local regulations and practice, must also pass the TOU.
    28. Subject has received all routine immunizations appropriate for his or her age as reported by the parent(s)/legal guardian, according to local routine vaccination schedules.


    E.4Principal exclusion criteria
    Healthy Adult and Elderly Subjects
    1. Has received any candidate Ebola vaccine.
    2. Diagnosed with Ebola virus disease, or prior exposure to Ebola virus.
    3. Has received any experimental candidate Ad26-or MVA-based vaccine in the past.
    4. Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products.
    5. Subject with acute illness or body temperature ≥38.0° C on Day 1.
    6. HIV type 1 or type 2 infection.
    7. A woman who is pregnant, breast-feeding or planning to become pregnant while enrolled in the study or within at least 3 months after the prime vaccination, up to 1 month after the boost vaccination, or within at least 3 months after the third vaccination.
    8. Presence of significant conditions or clinically significant findings during screening of medical history, ECG, physical examination, vital signs or laboratory testing for which participation would not be in the best interest of the subject.
    9. History of or underlying liver or renal insufficiency, or significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric or metabolic disturbances.
    10. History of malignancy other than squamous cell or basal cell skin cancer, unless there has been surgical excision that is considered cured.
    11. Major surgery within the 4 weeks prior to screening or planned major surgery through the course of the study.
    12. Post-organ and/or stem cell transplant whether or not with chronic immunosuppressive therapy.
    13. Receipt of any disallowed therapies before the planned administration of the prime vaccine on Day 1.
    14. Received an investigational drug/vaccine or used an invasive investigational medical device within 3 months prior to screening, or current or planned participation in another clinical study.
    15. Donation of a unit of blood within 8 weeks before Day 1 or plans to donate blood until 42 days post-last vaccination.
    16. Receipt of blood products or immunoglobulin within 3 months prior to screening and during the study.
    17. Current or past abuse of alcohol, recreational or narcotic drugs, which in the investigator’s opinion would compromise the subject’s safety and/or compliance with the study procedures.
    18. History of chronic urticaria.
    19. Subject cannot communicate reliably with the investigator.
    20. Subject who, in the opinion of the investigator, is unlikely to adhere to the requirements of the study.
    21. Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator.

    Additional Criteria for HIV-infected Subjects
    Must not meet any of the exclusion criteria for healthy adult and elderly subjects with the exception of #6.

    Pediatric Subjects
    22. Has received any candidate Ebola vaccine.
    23. Diagnosed with Ebola virus disease, or prior exposure to Ebola virus.
    24. Has received any experimental candidate Ad26-or MVA-based vaccine in the past.
    25. Known allergy or history of anaphylaxis or other serious adverse reactions to vaccines or vaccine products.
    26. Subject with acute illness or body temperature ≥38.0ºC on Day 1.
    27. HIV type 1 or type 2 infection.
    28. A female subject who is pregnant, breast-feeding or planning to become pregnant while enrolled in the study or within 3 months after the prime vaccination or up to 1 month after the boost vaccination.
    29. Weight-per-height below 10th percentile according to the CDC growth charts (4-11 year olds).
    30. Presence of significant conditions or clinically significant findings during screening of medical history, physical examination, laboratory testing or vital signs for which participation would not be in the best interest of the subject.
    31. History of or underlying liver or renal insufficiency, or significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric or metabolic disturbances.
    32. Major congenital anomalies or known cytogenetic disorders.
    33. Major surgery within the 4 weeks prior to screening or planned major surgery through the course of the study.
    34. Receipt of any disallowed therapies before the planned administration of the prime vaccine on Day 1.
    35. Received an investigational drug/vaccine or used an invasive investigational medical device within 3 months prior to screening, or current or planned participation in another clinical study.
    36. Receipt of blood products or immunoglobulin within 3 months prior to screening and during the study.
    37. History of chronic urticaria, eczema and/or atopic dermatitis.
    38. Subject lives in an orphanage.
    39. Subject’s parent(s)/legal guardian cannot communicate reliably with the investigator.
    40. Subject or parent(s)/legal guardian who, in the opinion of the investigator, is unlikely to adhere to the requirements of the study.
    E.5 End points
    E.5.1Primary end point(s)
    1. Adverse events, collected until the 42-day post-last vaccination (excluding third vaccination) visit.

    2. Serious adverse events and immediate reportable events (IREs), collected from signing of the ICF onwards until the end of the study.

    3. Solicited local and systemic adverse events (reactogenicity), collected until 7 days after each study vaccine administration.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Until the 42-day post-last vaccination (excluding third vaccination) visit
    2. From screening until the end of the study
    3. Until 7 days after each study vaccine administration
    E.5.2Secondary end point(s)
    1. Humoral immune response
    - Binding antibody levels elicited by vaccination using EBOV GP ELISA at 21 days post boost.

    2. Safety and tolerability (Cohort 1 substudy)
    - Adverse events, collected from the day of the third vaccination onwards until 28 days thereafter.
    - Serious adverse events and IREs, collected from signing of the original ICF onwards until the end of the study (including Cohort 1 substudy).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. At 21 days post boost vaccination
    2 a). From the day of the third vaccination onwards until 28 days thereafter
    2 b). From screening until the end of the study
    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 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
    Immunogenicity and tolerability
    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 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 trial3
    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
    Burkina Faso
    Côte d’Ivoire
    Kenya
    Uganda
    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 months4
    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: 264
    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: 132
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 132
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 802
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 1075
    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
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Côte d’Ivoire
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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