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    The EU Clinical Trials Register currently displays   43890   clinical trials with a EudraCT protocol, of which   7298   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:2021-004608-17
    Sponsor's Protocol Code Number:SJ2021100
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-08-24
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2021-004608-17
    A.3Full title of the trial
    Effectivity of a mRNA-1273 booster vaccine against Covid-19 breakthrough infections in hemodialysis patients: a multicenter interventional study
    Effectiviteit van een mRNA-1273 booster vaccin tegen Covid-19 doorbraakinfecties bij hemodialyse patiënten: een multicentrische interventionele studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effectivity of a mRNA-1273 booster vaccine against Covid-19 breakthrough infections in hemodialysis patients: a multicenter interventional study
    Effectiviteit van een mRNA-1273 booster vaccin tegen Covid-19 doorbraakinfecties bij hemodialyse patiënten: een multicentrische interventionele studie
    A.3.2Name or abbreviated title of the trial where available
    Effectivity of a mRNA-1273 booster vaccine against Covid-19 breakthrough infections in hemodialysis
    Effectiviteit van een mRNA-1273 booster vaccin tegen Covid-19 doorbraakinfecties bij hemodialyse pat
    A.4.1Sponsor's protocol code numberSJ2021100
    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 SponsorAZ Sint-Jan Brugge-Oostende AV
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportVZW Nierziekten en infectieziekten AZ Sint-Jan Brugge Oostende
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Trial Center
    B.5.2Functional name of contact pointCTC
    B.5.3 Address:
    B.5.3.1Street AddressRuddershove 10
    B.5.3.2Town/ cityBrugge
    B.5.3.3Post code8000
    B.5.3.4CountryBelgium
    B.5.4Telephone number003250453289
    B.5.6E-mailctc@azsintjan.be
    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 Spikevax (Moderna)
    D.2.1.1.2Name of the Marketing Authorisation holderMODERNA BIOTECH SPAIN, S.L.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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.3.2Product code J07BX03
    D.3.4Pharmaceutical form Concentrate and solvent for 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 INNNAP
    D.3.9.1CAS number 2430046-03-8
    D.3.9.2Current sponsor codemRNA-1273
    D.3.9.3Other descriptive nameCOVID-19 mRNA vaccine Moderna (CX-024414)
    D.3.9.4EV Substance CodeSUB207171
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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
    hemodialysis patients
    hemodialyse patiënten
    E.1.1.1Medical condition in easily understood language
    patients with renal failure requiring renal function replacement therapy (i.e. hemodialysis)
    patiënten met nierfalen die niervervangende therapie nodig hebben
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The study aims to determine the rate of breakthrough infections in a population of hemodialysis patients which will receive a third vaccination against Covid-19 with the mRNA-1273 Covid-19 vaccine 6 months after the first vaccine and compare this with a control population. To this end, the figures of the ‘Nederlandstalige Belgische Vereniging voor Nefrologie’ (NBVN) registration will be used, which monitors the Covid-19 infections of all hemodialysis patients in the Flemish region.
    E.2.2Secondary objectives of the trial
    Analysis of side effects and predictive factors for breakthrough infections
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A consecutive series of hemodialysis patients which received 2 doses of a mRNA vaccine against Covid-19 and are willing to participate to the trial. Patients are eligible for inclusion 6 months after receiving the first dose. A target of around 800 patients is envisioned. Participants will be recruited in 5 participating centers (AZ Sint-Jan, AZ Damiaan, ZOL, OLV Aalst and AZ Groeninghe).
    E.4Principal exclusion criteria
    i. Younger than 18 years old
    ii. No informed consent
    iii. No previous vaccination with two mRNA Covid-19 vaccines, according to the scheme mentioned in the SmPC.
    iv. Individuals who are suffering from acute severe febrile illness or acute infection. People with a minor infection and/or low-grade fever should not be excluded. (This exclusion criteria is based on the SmPC of Comirnaty and COVID-19 vaccine Moderna, however, vaccination will be performed according to standard medical practice and at the discretion of the treating physician).
    v. Subjects with a history of severe adverse reactions associated with a vaccine and/or severe allergic reaction to any component of the study intervention (This exclusion criteria is based on the SmPC of COVID-19 vaccine Moderna, however, vaccination will be performed according to standard medical practice and at the discretion of the treating physician).
    vi. Unable to provide informed consent or not competent to understand the informed consent procedure and no legal representative
    vii. Not eligible to abovementioned inclusion criteria
    E.5 End points
    E.5.1Primary end point(s)
    Incidence rate and severity of breakthrough infections
    E.5.1.1Timepoint(s) of evaluation of this end point
    From day of vaccination until 24 weeks after.
    E.5.2Secondary end point(s)
    1. Analysis of baseline clinical predictive factors for breakthrough infections in hemodialysis patients
    2. Analysis of adverse events
    3. Analysis of variants of concern
    E.5.2.1Timepoint(s) of evaluation of this end point
    From day of vaccination until 24 weeks after.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 No
    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 Yes
    E.8.2.3.1Comparator description
    Hemodialysis patients who did no receive a booster vaccine (data from NBVN)
    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 concerned5
    E.8.5The trial involves multiple Member States No
    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 No
    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 months6
    E.8.9.1In the Member State concerned days
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    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 state800
    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 Decision2021-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-18
    P. End of Trial
    P.End of Trial StatusOngoing
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