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    Summary
    EudraCT Number:2021-001520-18
    Sponsor's Protocol Code Number:NL76839.042.21
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-03-25
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-001520-18
    A.3Full title of the trial
    Long term efficacy and safety of SARS-CoV-2 vaccination in Dutch patients with chronic kidney disease stage G4-G5, on dialysis or after kidney transplantation
    Lange termijn effectiviteit en veiligheid van SARS-CoV-2 vaccinatie in Nederlandse patiënten met chronische nierziekte stadium G4-G5, dialyse of na niertransplantatie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long term efficacy and safety of COVID-19 vaccination in patients with a kidney disease
    Lange termijn effectiviteit en veiligheid van COVID-19 vaccinatie in patiënten met een nierziekte
    A.3.2Name or abbreviated title of the trial where available
    The LESS CoV-2 study
    De LESS CoV-2 studie
    A.4.1Sponsor's protocol code numberNL76839.042.21
    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 SponsorRECOVAC consortium
    B.1.3.4CountryNetherlands
    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 supportZonMW
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRECOVAC consoritum
    B.5.2Functional name of contact pointstudy coordinator
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713 GZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310503616161
    B.5.6E-maila.l.messchendorp@umcg.nl
    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 COVID-19 vaccine Moderna
    D.2.1.1.2Name of the Marketing Authorisation holderModerna
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Solution for injection/infusion
    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 INNSingle-stranded, 5’-capped messenger RNA (mRNA) encoding the viral spike (S) protein of SARS-CoV-2
    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 milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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.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 Yes
    D.2.1.1.1Trade name Comirnaty
    D.2.1.1.2Name of the Marketing Authorisation holderBioNTech/Pfizer
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical 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 INNSingle-stranded, 5’-capped messenger RNA (mRNA) encoding the viral spike (S) protein of SARS-CoV-2
    D.3.9.3Other descriptive nameCOVID-19 mRNA vaccine (nucleoside-modified)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.03
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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.IMP: 3
    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 COVID-19 Vaccine AstraZeneca suspension for injection
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical 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 INNChimpanzee Adenovirus encoding the SARS-CoV-2 Spike glycoprotein (ChAdOx1-S)*
    D.3.9.3Other descriptive nameCOVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19)
    D.3.9.4EV Substance CodeSUB207764
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number2.5*10^8
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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: 4
    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 COVID-19 Vaccine Janssen
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical 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 INNAdenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein* (Ad26.COV2-S)
    D.3.9.3Other descriptive nameCOVID-19 Vaccine Janssen (Ad26.COV2.S)
    D.3.9.4EV Substance CodeSUB208328
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number8.92 log10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COVID-19 is associated with increased morbidity and mortality in kidney
    transplant recipients (KTR) and patients with chronic kidneydisease
    (CKD). Therefore, potential efficacious SARS-CoV-2 vaccination would be
    of great clinical importance in these patients.However, SARS-CoV-2
    vaccination studies have excluded KTR and patients with CKD so-far and it is unknown how long a possible antibody response will endure.
    This will be the subject of this trial.
    COVID-19 geeft een verhoogde morbiditeit en
    mortaliteit bij niertransplantatie patienten en patiënten met chronische
    nierziekte (CKD). Daarom zou een effectieve SARS-CoV-2-
    vaccinatie bij deze patiënten van groot klinisch belang zijn. SARS-CoV-2-vaccinatiestudies hebben tot dusver niertransplantatie ontvangers en
    patiënten met CKD echter uitgesloten, daarnaast is het onbekend of een eventuele antistof response voor langere tijd aan zal houden. Dit zal het onderwerp van deze
    studie worden.
    E.1.1.1Medical condition in easily understood language
    The course of corona disease 2019 (COVID-19) is worse in kidney
    disease patients. A safe and effective vaccin against COVID-19 is crucial
    in these patients.
    Corona ziekte 2019 (COVID-19) heeft een ernstiger beloop in patiënten
    met een nierziekte. Een veilig en goed werkend vaccin is van cruciaal
    belang in deze patiënten.
    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 10084401
    E.1.2Term COVID-19 respiratory infection
    E.1.2System Organ Class 100000004862
    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 10042613 - Surgical and medical procedures
    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 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084508
    E.1.2Term COVID-19 antibody test
    E.1.2System Organ Class 100000004848
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084270
    E.1.2Term SARS-CoV-2 acute respiratory disease
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084272
    E.1.2Term SARS-CoV-2 infection
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084462
    E.1.2Term SARS-CoV-2 vaccination
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084463
    E.1.2Term SARS-CoV-2 immunisation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10023439
    E.1.2Term Kidney transplant rejection
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10023438
    E.1.2Term Kidney transplant
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061105
    E.1.2Term Dialysis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10018875
    E.1.2Term Haemodialysis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10034660
    E.1.2Term Peritoneal dialysis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10076412
    E.1.2Term Chronic kidney disease stage 5
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10076411
    E.1.2Term Chronic kidney disease stage 4
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    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 efficacy of SARS-CoV vaccination by the incidence of COVID-19 in patients with chronic kidney disease stage G4-G5, on dialysis and patients after kidney transplantation who received SARS-CoV-2 vaccination
    Het bepalen van de effectiviteit van SARS-CoV-2 vaccinatie middels de incidentie van COVID-19 in patiënten met chronische nierziekte stadium G4-G5, dialyse of na transplantatie na SARS-CoV-2 vaccinatie
    E.2.2Secondary objectives of the trial
    - To assess the antibody response at 28 days after SARS-CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, on dialysis and in patients after kidney transplantation
    - To assess durability of the antibody response at 6 months after SARS-CoV 2 vaccination in patients with chronic kidney disease stage G4-G5, on dialysis and in patients after kidney transplantation
    - To assess the safety of vaccination
    - Om de antilichaam response te bepalen 28 dagen na SARS-CoV-2 vaccinatie in patiënten met chronische nierziekte stadium G4-G5, dialyse of na niertransplantatie
    - Om de duur van de antistofrespons te bepalen in patiënten met chronische nierziekte stadium G4-G5, dialyse of na niertransplantatie door het meten van antistoffen 6 maanden na vaccinatie.
    - Het bepalen van de veiligheid van vaccinatie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Eligible for COVID-19 vaccination as described by the instructions of the manufacturer.
    2. Age of 18 years or older
    3. Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed informed consent form has been obtained)
    4. Either
    - eGFR < 30 ml/min/1.73m2 but not on dialysis or with a kidney transplant
    - Hemodialysis, or peritoneal dialysis
    - Kidney Transplant recipient at least 6 weeks after transplantation
    1. Geschikt om COVID-19 vaccinatie te ontvangen volgens de instructies van de fabrikant
    2. Leeftijd van 18 jaar of ouder
    3. In staat om het doel en de risico's van de studie te begrijpen, volledig geïnformeerd te worden en in staat zijn om geschreven informed consent te geven.
    4. Een van de volgende:
    - eGFR <30 ml/min/1.73m2 maar niet met dialyse of na niertransplantatie
    - Hemodialyse of peritoneaal dialyse
    - Niertransplantatieontvanger tenminste 6 weken na transplantatie
    E.4Principal exclusion criteria
    • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s).
    • Patients who opted out for research in the Santeon, RENINE and NOTR registries.
    • Patients who participate in the RECOVAC-IR study.
    - Voorgeschiedenis met een ernstige reactie geassocieerd met een vaccin en/of een ernstige allergische reactie op enig component van de studie interventie(s)
    - Patienten die aangeven dat ze hun data, geregistreerd in bestaande registratie studies (Santeon, RENINE, NOTR), niet met dit onderzoek willen delen
    - Patiënten die meedoen aan de RECOVAC-IR studie
    E.5 End points
    E.5.1Primary end point(s)
    The incidence of COVID-19 in a two years period after SARS- CoV-2 vaccination in patients with chronic kidney disease stage G4-G5, on dialysis or after kidney transplantation.
    De incidentie van COVID-19 in een periode van twee jaar na SARS-CoV-2 vaccinatie in patiënten met chronische nierziekte stadium G4-G5, dialyse of na niertransplantatie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Two years after SARS-CoV-2 vaccination
    Twee jaar na SARS-CoV-2 vaccinatie
    E.5.2Secondary end point(s)
    • Efficacy:
    o The antibody based immune response to vaccination against COVID-19 at day 28 after the second vaccination.
    o The durability of the antibody response at 6 months after SARS-CoV 2 vaccination

    • Safety:
    • Incidence of mortality
    • Incidence of adverse events of specific interest as defined by (inter)national authorities
    • Incidence of a combined endpoint of acute rejection or graft failure in patients after kidney transplantation
    • Incidence of HLA antibodies defined as calculated Panel Reactivity Antibodies (cPRA) > 5% in dialysis patients on the waiting list for their first kidney transplantation
    Effectiviteit:
    - De antistof immuun respons 28 dagen na de tweede vaccinatie
    - De duur van de antistofrerspons op 6 maanden na SARS-CoV-2 vaccinatie

    Veiliigheid:
    - Incidentie van mortaliteit
    - Incidentie van bijwerkingen van specifieke interesse gedefinieerd door (inter)nationale autoriteiten.
    - Incidentie van een gecombineerd eindpunt van acute rejectie of transplantaatfalen in patiënten na niertransplantatie
    - Incidentie van HLA anstistoffen gedefineerd als een calculated Panel Reactivity Antibodies (cPRA) > 5% bij dialyse patiënten die op de wachtlijst staan voor een eerste niertransplantatie
    E.5.2.1Timepoint(s) of evaluation of this end point
    Antibody response:
    28 days and 6 months after vaccination
    Other endpoints over a period of 2 years
    Antilichaam response:
    28 dagen en 6 maanden na vaccinatie
    Andere eindpunten over een periode van 2 jaar
    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 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 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 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 No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    If the last subject is two years after SARS-CoV-2 vaccination
    Wanneer de laaste deelnemer twee jaar na SARS-CoV-2 vaccinatie is
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    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: 8000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4000
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state24300
    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 Decision2021-03-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-09
    P. End of Trial
    P.End of Trial StatusOngoing
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