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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   42869   clinical trials with a EudraCT protocol, of which   7063   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

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    Summary
    EudraCT Number:2020-005576-35
    Sponsor's Protocol Code Number:CP-PRO-CoVLP-021
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-04-07
    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
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2020-005576-35
    A.3Full title of the trial
    A Randomized, Observer-Blind, Placebo-Controlled, Phase 2/3 Study to Assess the Safety, Efficacy, and Immunogenicity of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults 18 Years of Age or Older
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    COVID-19 Vaccine in Adults 18 Years of Age or Older
    A.4.1Sponsor's protocol code numberCP-PRO-CoVLP-021
    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 SponsorMedicago R&D Inc.
    B.1.3.4CountryCanada
    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 supportMedicago R&D Inc.
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedicago R&D Inc.
    B.5.2Functional name of contact pointMedicago Trial Inquiries
    B.5.3 Address:
    B.5.3.1Street Address1020 route de l’Église, bureau 600
    B.5.3.2Town/ cityQuébec (Qc)
    B.5.3.3Post codeG1V 3V9
    B.5.3.4CountryCanada
    B.5.4Telephone number581700-19771111
    B.5.6E-mailclinicalTrialInquiries@medicago.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 nameCoronavirus-Like Particle COVID-19 Vaccine
    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 INNSARS-COV-2, VIRUS-LIKE-PARTICLES
    D.3.9.2Current sponsor codeCoVLP
    D.3.9.3Other descriptive nameSARS-CoV-2, virus-like-particles
    D.3.9.4EV Substance CodeSUB219105
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 Yes
    D.3.11.13.1Other medicinal product typeplant-based platform technology for production of virus-like particle (VLP) vaccine
    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 placeboSuspension 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
    Covid-19
    E.1.1.1Medical condition in easily understood language
    Covid-19
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084465
    E.1.2Term COVID-19 vaccination
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 3 portion
    The primary objective of the Phase 3 portion of the study is:
    Efficacy:
    • To evaluate the efficacy of the CoVLP formulation, compared to placebo, in the prevention of laboratory confirmed symptomatic SARS-CoV-2 infection (virologic method) starting 7 days after the second vaccination in Period 1 and prior to the cross-over.
    E.2.2Secondary objectives of the trial
    Phase 3 portion
    The secondary objectives of the Phase 3 portion of the study are:
    Efficacy:
    • To evaluate the efficacy of the CoVLP formulation, compared to placebo, in the prevention of laboratory confirmed asymptomatic SARS-CoV-2 infection (serologic method) starting 7 days after the second vaccination in Period 1 and prior to the cross-over;
    • To evaluate the efficacy of the CoVLP formulation, compared to placebo, in the prevention of severe COVID-19 disease starting 7 days after the second vaccination in Period 1 and prior to the cross-over;
    Please refer the protocol for further details.
    Immunogenicity:
    • To assess the immunogenicity of the CoVLP formulation, compared to placebo, in a subset of subjects, as determined by the protocol
    Safety:
    • To assess the safety and tolerability of the CoVLP formulation, compared to placebo, up to the end of the study.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria at the Screening (Visit 1) and/or Vaccination (Visit 2) visits to be eligible for participation in this study; no protocol waivers are allowed. All Investigator assessment-based judgements must be carefully and fully documented in the source documents:
    1. Subjects must have read, understood, and signed the informed consent form (ICF) prior to participating in the study; subjects must also complete study-related procedures and the subjects must communicate with the study staff at visits and by phone during the study;
    2. At the Screening visit (Visit 1), male and female subjects must be:
    • Study Populations #1: 18 to 64 (has not yet had his/her 65th birthday) years of age, inclusive;
    • Study Population #2: 65 years of age or older;
    • Study Population #3: 18 years of age or older;
    3. At Screening (Visit 1) and Vaccination (Visit 2), study populations #1 and #2 must have a body mass index (BMI) of ≥ 18.5 and < 30 kg/m2 for the Phase 2 portion of the study and a BMI of ≥ 18.5 and < 35 kg/m2 for the Phase 3 portion of the study;
    4. Subjects are considered by the Investigator to be reliable and likely to cooperate with the assessment procedures and be available for the duration of the study;
    5. Study Populations #1: Subjects must be in good general health prior to study participation, with no clinically relevant abnormalities that could jeopardize subject safety or interfere with study assessments, as determined by medical history, physical examination, and vital signs. Investigator discretion will be permitted with this inclusion criterion;
    6. Study Populations #1 and #3: Female subjects of childbearing potential must have a negative serum pregnancy test result at Screening (Visit 1 for the Phase 2 portion) and/or a negative urine pregnancy test result at Vaccination (Visit 2 for the Phase 2 portion; Visit 1 for the Phase 3 portion):
    Non-childbearing females are defined as:
    • Surgically-sterile (defined as bilateral tubal ligation, hysterectomy or bilateral oophorectomy performed more than one month prior to the first study vaccination); or
    • Post-menopausal (absence of menses for 12 consecutive months and age consistent with natural cessation of ovulation);
    7. Study Populations #1 and #3: Female subjects of childbearing potential must use an effective method of contraception for one month prior to vaccination (Visit 2) and agree to continue employing highly effective birth control measures for at least one month after the last study vaccination (or in the case of early termination, she must not plan to become pregnant for at least one month after her last study vaccination).
    The following relationship or methods of contraception are considered to be highly effective:
    • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal;
    • Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable;
    • Intra-uterine device with or without hormonal release;
    • Credible self-reported history of heterosexual vaginal intercourse abstinence prior to and for at least one month after the last study vaccination. Abstinent subjects who are ovulating should be asked what method(s) they would use should their circumstances change, and subjects without a well-defined plan should be excluded;
    • Female partner;
    • All regions except the US: Vasectomised partner, provided that this partner is the sole sexual partner of the study participant and that the vasectomised partner has received a medical assessment of the surgical success;
    • Bilateral tubal occlusion.
    8. Study Population #2: Subjects must be non-institutionalized and have no acute or evolving medical problems prior to study participation and no clinically relevant abnormalities that could jeopardize subject safety or interfere with study assessments, as assessed by the Principal Investigator or sub-Investigator and determined by medical history, physical examination, vital signs and, only for the Phase 2 portion, serology, clinical chemistry and haematology tests and urinalysis. Investigator discretion will be permitted with this inclusion criterion.
    9. Study Population #3: Subjects must have one or more co-morbid conditions that puts them at higher risk for severe COVID-19 disease
    Please, see protocol for further inclusion criteria details
    E.4Principal exclusion criteria
    Subjects who meet any of the following criteria at the Screening (Visit 1) and/or Vaccination (Visit 2) visits will not be eligible for participation in this study; no protocol waivers are allowed.
    All Investigator assessment-based judgements must be thoroughly documented in the source documents:
    1. Study Populations #1 and #2: According to the Investigator’s opinion, significant acute or chronic, uncontrolled medical or neuropsychiatric illness. Acute disease is defined as presence of any moderate or severe acute illness with or without a fever within 48 hours prior to the Screening (Visit 1) and/or Vaccination visit (Visit 2).
    ‘Uncontrolled’ is defined as:
    • Requiring a new medical or surgical treatment during the three months prior to study vaccine administration;
    Requiring any significant change in a chronic medication (i.e. drug, dose, frequency) during the three months prior to study vaccine administration due to uncontrolled symptoms or drug toxicity unless the innocuous nature of the medication change meets the criteria outlined in inclusion criterion no. 5(Study Population #1) or no. 8 (Study Population #2) and is appropriately justified and documented by the Investigator.
    Investigator discretion is permitted with this exclusion criterion and must be carefully and fully documented in the source documents;
    2. Study Populations #1 and #2: Any chronic medical condition associated with elevated risk of severe outcomes of COVID-19, including obesity, diabetes (type I/II), significant cardiovascular or respiratory disease including asthma, chronic renal failure, disorders of bleeding/coagulation, chronic inflammatory or autoimmune conditions, immunosuppressive conditions (including HIV), and hypertension;
    3. Study Populations #1 and #2: Any confirmed or suspected current immunosuppressive condition or immunodeficiency, including cancer, human immunodeficiency virus (HIV), hepatitis B or C infection (subjects with a history of cured hepatitis B or C infection without any signs of immunodeficiency at present time are allowed). Investigator discretion is permitted with this exclusion criterion;
    4. Study Populations #1 and #2: Current autoimmune disease (such as rheumatoid arthritis, systemic lupus erythematosus,
    multiple sclerosis or narcolepsy). Investigator discretion is permitted with this exclusion criterion, and subjects may be eligible to participate with appropriate written justification in the source document(i.e. subjects with a history of autoimmune disease who are diseasefree without treatment for three years or more, or on stable thyroid replacement therapy, mild psoriasis [i.e. a small number of minor plaques requiring no systemic treatment], etc.);
    5. Study Populations #1 and #2: Administration of any medication or treatment that may alter the vaccine immune responses, such as:
    • Systemic glucocorticoids at a dose exceeding 10 mg of prednisone (or equivalent) per day for more than seven consecutive days or for 10 or more days in total, within one month prior to the Vaccination visit (Visit 2). Inhaled, nasal, ophthalmic, dermatological, and other topical glucocorticoids are permitted;
    • Cytotoxic, antineoplastic, or immunosuppressant drugs - within 36 months prior to Vaccination (Visit 2);
    • Any immunoglobulin preparations or blood products, blood transfusion – within 6 months prior to Vaccination (Visit 2);
    6. Study Population #3: Acute disease defined as presence of any moderate or severe acute illness with or without a fever within 48 hours prior to the Screening (V1) and/or Vaccination visit (V2);
    7. Administration of any vaccine within 14 days prior to Vaccination (V2); planned administration of any vaccine during the study (up to Day 28 of the study). Immunization on an emergency basis during the study will be evaluated on case-by-case basis by the Investigator;
    8. Administration of any other SARS-CoV-2 / COVID-19, or other experimental coronavirus vaccine at any time prior to or during the study;
    9. History of virologically-confirmed COVID-19;
    10. Use of any investigational or non-registered product within 30 days or 5 half-lives, whichever is longer, prior to Vaccination (V2) or planned use during the study period.
    Subjects who are in a prolonged post-administration observation period of another investigational or marketed drug clinical study, for which there is no ongoing exposure to the investigational or marketed product and all scheduled on-site visits are completed, will be allowed to take part in this study, if all other eligibility criteria are met;
    11. Have a rash, dermatological condition, tattoos, muscle mass, or any other abnormalities at injection site that may interfere with injection site reaction rating. Investigator discretion will be permitted with this exclusion criterion;
    Please, refer to protocol for further exclusion criteria
    E.5 End points
    E.5.1Primary end point(s)
    Phase 2 portion
    In the Phase 2 portion, the primary endpoints are:
    Safety:
    • Occurrence, intensity, and relationship to vaccination of immediate AEs (30 minutes after each vaccination);
    • Occurrence and intensity of solicited local and systemic AEs (for seven days following each vaccine administration);
    • Occurrence, intensity, and relationship of unsolicited AEs for 21 days following each vaccine administration;
    • Number and percentage of subjects with normal and abnormal clinically significant urine, haematological and biochemical values prior to and three days following each vaccination;
    • Occurrences of SAEs, MAAEs, AEs leading to withdrawal, AESIs (including VED), and deaths up to 21 days following each vaccine administration;
    Immunogenicity:
    • Nab response induced in each Study Population against the SARS-CoV-2 virus on Days 0, 21, and 42 will be analyzed using the following parameter: geometric mean titers (GMT), seroconversion (SC) rate, and geometric mean fold rise (GMFR);
    • Specific Th1 CMI response induced in each Study Population against the SARS-CoV-2 virus on Days 0, 21, and 42, as measured by IFN-γ ELISpot.
    Phase 3 portion
    In the Phase 3 portion, the primary endpoint is:
    Efficacy:
    • First occurrence, in a subject, of laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection (≥ 7 days post-second vaccination) in Period 1 and prior to cross-over.
    E.5.1.1Timepoint(s) of evaluation of this end point
    As defined in endpoints
    E.5.2Secondary end point(s)
    Phase 2 portion
    In the Phase 2 portion, the secondary endpoints are:
    Immunogenicity:
    • Relative neutralizing antibody response between the healthy adults (Study Population #1) and the healthy elderly populations (Study Population #2; each age strata) induced at 21 days after the second vaccination will be analyzed using the following parameter: GMT;
    • Relative neutralizing antibody response for the combination of healthy adults (Study Population #1) and healthy elderly adults (Study Population #2) compared to adults and elderly adults with significant comorbidities (Study Population #3) induced at 21 days after the second vaccination will be analyzed using the following parameter: GMT;
    • Persistence of the Nab antibody response induced in each Study Population against the SARS-CoV-2 virus at Day 128, Day 201, and Day 386 will be analyzed using the following parameters: GMT, SC rate, and GMFR;
    • Specific antibody response induced in each Study Population against the SARS-CoV-2 virus will be measured by the total IgG levels on Days 0, 21, and 42, and the persistence of these antibodies at Days 128, 201, and 386 and analyzed using the following parameters: GMT, SC rate, and GMFR;
    • The ratio of neutralizing antibody titers: IgG (ELISA) antibody titers at Day 21, Day 42, Day 128, Day 201, and Day 386;
    • Specific Th1 CMI response induced in each Study Population against the SARS-CoV-2 virus on Day 201 and Day 386, as measured by IFN-γ ELISpot;
    • Specific T helper 2 (Th2) CMI response induced in each Study Population against the SARS-CoV-2 virus on Days 0, 21, 42, 201, and 386, as measured by IL-4 ELISpot;
    Safety:
    • Relative occurrence of solicited local and systemic AEs by intensity grades for seven days following each vaccine administration between the healthy adults (Study Population #1) and each healthy elderly population (Study Population #2);
    • Relative occurrence of solicited local and systemic AEs by intensity grades for seven days following each vaccine administration for the combination of healthy adults (Study Population #1) and the healthy elderly adults (Study Population #2) compared to adults and elderly adults with significant comorbidities (Study Population #3);
    • Occurrences of SAEs, MAAEs, AEs leading to withdrawal, AESIs (including VED), and deaths from Day 43 to Day 201;
    • Occurrences of SAEs, MAAEs, AEs leading to withdrawal, AESIs (including VED), and deaths from Day 202 to Day 386.
    Efficacy:
    • First occurrence, in a subject, of laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection (≥ 7 days post-second vaccination);
    • Occurrences of severe COVID-19 disease (≥ 7 days post-second vaccination). Refer to the definition of severe COVID-19 disease in the Secondary Objectives section above.

    Phase 3 portion
    In the Phase 3 portion, the secondary endpoints are:
    Efficacy:
    • Occurrences of laboratory-confirmed (confirmed by the ELISA method for the N protein) asymptomatic SARSCoV-2 infection starting 7 days after the second vaccination in Period 1 and prior to the cross-over;
    • Occurrences of severe COVID-19 disease (≥ 7 days post-second vaccination) in Period 1 and prior to crossover. Refer to the definition of severe COVID-19 disease in the Secondary Objectives section above;
    • Occurrence and intensity of COVID-19-related symptoms in virologically-confirmed cases up until resolution of the symptoms in Period 1 compared to subjects administered the placebo and compared to subjects administered CoVLP at the time of cross-over in Period 2;
    • First occurrence, in a subject, of laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection (≥ first vaccination) in Period 1 and prior to cross-over;
    • First occurrence, in a subject, of laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection (≥ first vaccination and < second vaccination) in Period 1 and prior to cross-over;
    • First occurrence, in a subject, of laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection (≥ second vaccination and < 7 days post-second vaccination) in Period 1 and prior to cross-over;
    • Occurrences of laboratory-confirmed (confirmed by the ELISA method for the N protein) asymptomatic SARSCoV-2 infection starting 7 days after the vaccination in Period 1 and prior to the cross-over in subjects who only received a single vaccination;
    • Duration and intensity of viral shedding after virologically-confirmed SARS-CoV-2 infection in Period 1 and prior to cross-over;
    • First occurrence, in a subject, of laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection (≥ 7 days post-second vaccination) in Period 1 by strain and prior to cross-over;
    Please, refer to protocol for further secondary endpoints (Immunogenicity and safety secondary endpoints in the Phase 3 portion).
    E.5.2.1Timepoint(s) of evaluation of this end point
    as defined in the endpoints
    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 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 & 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) 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 No
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    observer blind
    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 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Brazil
    Canada
    Colombia
    Hungary
    Mexico
    Peru
    Poland
    Spain
    United Kingdom
    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.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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: 23000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7000
    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 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.4.1In the member state2000
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3500
    F.4.2.2In the whole clinical trial 30000
    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 Decision2021-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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