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    The EU Clinical Trials Register currently displays   44235   clinical trials with a EudraCT protocol, of which   7336   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).

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    Summary
    EudraCT Number:2021-001735-10
    Sponsor's Protocol Code Number:21816
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-06-04
    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
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2021-001735-10
    A.3Full title of the trial
    COVID-19: A Phase 3, open-label, parallel group, multicenter clinical study to evaluate the safety, reactogenicity, and immunogenicity of the investigational SARS-CoV-2 mRNA vaccine CVnCoV in participants 45 years or older with either a solid tumor or hematologic malignant disease who are receiving or scheduled to receive systemic anticancer therapy (independent of intent)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    COVID-19: A study to learn about the safety, local and systemic reactions, and the immune responses to the SARS-CoV-2 mRNA Vaccine (CVnCoV) when given to participants 45 years or older who have either a solid tumor or blood cancer and are already taking or about to start systemic anticancer therapy
    A.4.1Sponsor's protocol code number21816
    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 SponsorBayer AG
    B.1.3.4CountryGermany
    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 supportBayer AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer AG
    B.5.2Functional name of contact pointBayer Clinical Trial Contacts
    B.5.3 Address:
    B.5.3.1Street AddressNot applicable
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.4Telephone number4930300139003
    B.5.6E-mailclinical-trials-contact@bayer.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 nameCVnCoV
    D.3.2Product code CV07050101
    D.3.4Pharmaceutical form Solution 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 INNZorecimeran
    D.3.9.2Current sponsor codeR9515
    D.3.9.4EV Substance CodeSUB214710
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Vaccination for prophylaxis of coronavirus disease 2019 (COVID-19)
    E.1.1.1Medical condition in easily understood language
    Vaccination for prevention of coronavirus disease 2019 (COVID-19)
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084464
    E.1.2Term COVID-19 immunization
    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
    To evaluate the safety and reactogenicity
    profile of the 2-dose administration of
    CVnCoV vaccine
    E.2.2Secondary objectives of the trial
    Secondary immunogenicity
    To evaluate the humoral immune response to the CVnCoV vaccine throughout the observation period

    Secondary safety
    To further evaluate the safety profile of the 2-dose administration of CVnCoV vaccine
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Participant of 45 years of age or older, at the time of signing the informed consent.
    2.For participants:
    For participants with malignancies (Path A, B or C):
    a.Path A: Participants with a solid tumor (i.e., NSCLC, CRC, breast cancer, prostate cancer) who have not received prior systemic anticancer therapy and are scheduled for treatment with either chemotherapy alone or chemotherapy in combination with another drug class (independent of intent).
    b.Path B: Participants with either a solid tumor (i.e., NSCLC, CRC, breast cancer, prostate cancer, RCC, melanoma) or hematologic malignant disease (lymphoma) who are scheduled to receive systemic anticancer therapy (independent of intent). NOTE: Participants who have received prior lines of systemic anticancer therapy are eligible provided exclusion criterion #5 is not violated.
    c.Path C: Participants with NSCLC on ongoing chemotherapy containing regimen.
    For healthy participants (Path D):
    d.Path D: participants who are generally healthy and have not had any malignant disease that required active treatment in the past 5 years.
    Note: healthy participant is defined as an individual who is in good general health. Participants with co-morbidities which are well controlled and clinically stable (on ongoing treatment) can be enrolled.
    For all participants:
    3.Participants with estimated life expectancy > 13 months as per the judgement of the investigator.
    4.Participants with ECOG performance status of 0 or 1 (See Section 10.5).
    5.Participants who have adequate bone marrow and organ function as assessed by the following laboratory tests:
    a.Hemoglobin ≥ 9 g/dL
    b.Absolute neutrophil count (ANC) > 1000/mm3
    c.Platelet count > 100000/µl
    d.Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x upper limit of normal (ULN) (≤ 5 x ULN in case of liver metastases)
    e.Total bilirubin ≤ 1.5 x ULN
    f.Estimated GFR ≥ 30 ml/min/1.73m2 (according to local laboratory standards)
    6.Participants expected to be compliant with protocol procedures and available for clinical follow-up to the last planned visit.
    Sex and Contraceptive/Barrier Requirements
    7.Male or female.
    Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    a.Male participants: no contraceptive requirement.
    b.Female participants: females of childbearing potential can only be included in the study if a pregnancy test is negative at the screening visit and if they agree to use highly effective methods of contraception from the screening visit until 3 months following the last administration of study vaccine (see Section 10.4 for details).
    Informed Consent
    8.Capable of giving signed informed consent as described in Section 10.1.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    Prior/Concomitant Therapy
    1.Use of any investigational or non-registered product (vaccine or drug other than anticancer therapy) within 28 days or 5 times half-life of the investigational product preceding the administration of the study vaccine, or planned use during the study period.
    2.Receipt of any other approved vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or planned receipt of any vaccine within 28 days of study vaccine administration.
    3.Receipt of any investigational, authorized or licensed, SARS-CoV-2 or other coronavirus vaccine prior to the administration of the CVnCoV study vaccine or planned receipt during the study.
    4.Receipt of any investigational or licensed lipid nanoparticles (LNP)-formulated mRNA vaccine prior to the administration of the study vaccine.
    5.Prior systemic anticancer therapy (applicable to Path A and Path B only)
    a.Path A: Any prior systemic anticancer therapy
    b.Path B: Systemic anticancer therapy within the last 30 days (4 months for immune check point inhibitors and 6 months for anti B cell antibodies)
    6.Planned start of investigational anticancer therapy during the vaccination period or within 28 days after the second dose of the study vaccine.
    7.Systemic corticosteroid therapy at doses exceeding 0.5 mg/kg/day prednisone equivalent for 14 consecutive days or more within the last 30 days before the scheduled start of study vaccine.
    8.Receipt of biologics - most importantly but not limited to recombinant proteins/anti-inflammatory monoclonal antibodies (e.g. anti-TNF, anti-IL6, anti-17 monoclonal antibodies) - within the last 6 months before the scheduled start of study vaccine, with the exception of biologics to treat the underlying cancer or cancer related conditions.
    9.Administration of immunoglobulins (Igs) within 3 months preceding the administration of any dose of the study vaccine.
    Medical Conditions
    10.Prior transplantation of human cells, tissues and major organs (e.g. liver transplant) or candidates for any type of transplantation.
    11.Participants not recovered from any surgery related acute toxicities.
    12.History of immune-deficiency disorders.
    13.History of angioedema (known C1 inhibitor deficiency).
    14.History of any anaphylactic reactions.
    15.Any known hypersensitivity reaction to any component of CVnCoV or aminoglycoside antibiotics.
    16.Acute or currently active and serologically confirmed SARS-CoV-2 infection.
    17.History of confirmed SARS, MERS or COVID-19 disease or known exposure to an individual with confirmed COVID-19 disease or SARS-CoV-2 infection within 2 weeks prior to enrollment.
    18.Evidence or history of any bleeding diathesis, irrespective of severity.
    19.Participants with a significant acute or chronic medical or psychiatric illness (other than the underlying cancer for participants in Path A, B and C) that, in the opinion of the investigator, precludes study participation (e.g., participation poses a major health risk for the participant, renders the participant unable to meet the logistic requirements of the study, or may interfere with the reliability of the participant’s study results). These conditions may include severe and/or uncontrolled cardiovascular disease, gastrointestinal disease, liver disease, renal disease, respiratory disease, endocrine disorder, and neurological or psychiatric illnesses. However, participants whose aforementioned co-morbidities are well-controlled and stable on ongoing treatments can be included in the study.
    20.Ongoing infection requiring systemic antimicrobial therapy.
    Other Exclusions
    21.Foreseeable non-compliance with protocol as judged by the investigator. This includes history of or current alcohol and/or drug abuse.
    22.Participants who are pregnant or breast-feeding.
    E.5 End points
    E.5.1Primary end point(s)
    For the primary objective (safety):
    •The occurrence of solicited local AEs on each vaccination day and the following 7 days
    •The occurrence of solicited systemic AEs on each vaccination day and the following 7 days
    •The occurrence of unsolicited AEs on each vaccination day and the following 28 days
    •The occurrence of SAEs from first injection up to 28 days after the second injection
    •The occurrence of SAEs related to study vaccine from first injection up to 28 days after the second injection
    •The occurrence of AESIs from first injection up to 28 days after the second injection
    •The occurrence of AESIs related to study vaccine from first injection up to 28 days after the second injection
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-2: On each vaccination day and the following 7 days
    3: On each vaccination day and the following 28 days
    4-7: From first injection up to 28 days after the second injection
    E.5.2Secondary end point(s)
    Secondary immunogenicity
    To evaluate the humoral immune response to the CVnCoV vaccine throughout the observation period
    At V4 (Day 43), V5 (Day 211) and V6 (Day 393)
    •Seroconversion for SARS-CoV-2 spike protein RBD antibodies, as measured by enzyme-linked immunosorbent assay (ELISA)
    •SARS-CoV-2 spike RBD protein-specific antibody levels in serum, as measured by ELISA
    •Seroconversion for SARS-CoV-2 neutralizing antibodies, as measured by an activity assay
    •SARS-CoV-2 neutralizing antibody levels in serum

    Secondary safety
    To further evaluate the safety profile of the 2-dose administration of CVnCoV vaccine
    From first injection to the end of study (Day 393)
    •The occurrence of SAEs related to study vaccine
    •The occurrence of AESIs
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-4: Day 43, Day 211 and Day 393
    5-6: From first injection to the end of study (Day 393)
    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
    Reactogenicity and 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Information not present in EudraCT
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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.8.4.1Number of sites anticipated in Member State concerned25
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    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: 310
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 310
    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.4.1In the member state61
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 620
    F.4.2.2In the whole clinical trial 620
    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 Decision2021-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-28
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-08-25
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