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    Summary
    EudraCT Number:2021-001459-15
    Sponsor's Protocol Code Number:HS-2021-02
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-03-22
    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 ConcernedAustria - BASG
    A.2EudraCT number2021-001459-15
    A.3Full title of the trial
    Immune response to COVID-19 Vaccination in people with Diabetes Mellitus - COVAC-DM study
    Immunantwort auf COVID-19 Impfung bei Personen mit Diabetes-Mellitus - COVAC-DM-Studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immune response to COVID-19 Vaccination in people with Diabetes Mellitus
    Immunantwort auf COVID-19 Impfung bei Personen mit Diabetes Mellitus
    A.3.2Name or abbreviated title of the trial where available
    COVAC-DM
    A.4.1Sponsor's protocol code numberHS-2021-02
    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 SponsorMedical University of Graz
    B.1.3.4CountryAustria
    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 supportMedical University of Graz
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Graz
    B.5.2Functional name of contact pointTrial Manager
    B.5.3 Address:
    B.5.3.1Street AddressAuenbruggerplatz 15
    B.5.3.2Town/ cityGraz
    B.5.3.3Post code8036
    B.5.3.4CountryAustria
    B.5.4Telephone number43316385 78038
    B.5.6E-mailnorbert.tripolt@medunigraz.at
    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 AstraZeneca
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameCOVID-19 Vaccine AstraZeneca
    D.3.2Product code EMEA/H/C/005675
    D.3.4Pharmaceutical form 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 INNCOVID-19 Vaccine (ChAdOx1-S [recombinant])
    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 million IU million international units
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number250
    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.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 AuthorisationEuropean Union
    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 nameComirnaty
    D.3.2Product code EMEA/H/C/005735
    D.3.4Pharmaceutical form 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 INNCOVID-19 mRNA vaccine (nucleoside-modified)
    D.3.9.3Other descriptive nameCOVID-19 mRNA vaccine (nucleoside-modified)
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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.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 Moderna
    D.2.1.1.2Name of the Marketing Authorisation holderModerna
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameCOVID-19 Vaccine Moderna
    D.3.2Product code EMEA/H/C/005791
    D.3.4Pharmaceutical form 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 INN COVID-19 mRNA Vaccine (nucleoside modified)
    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 µg microgram(s)
    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 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: 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
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameCOVID-19 Vaccine Janssen
    D.3.2Product code EMEA/H/C/005737
    D.3.4Pharmaceutical form 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 INNCOVID-19 vaccine (Ad26.COV2-S [recombinant])
    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 million IU million international units
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number89200
    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
    Type 1 Diabetes Mellitus
    Type 2 Diabetes Mellitus
    Diabetes Mellitus Typ 1
    Diabetes Mellitus Typ 2
    E.1.1.1Medical condition in easily understood language
    Type 1 Diabetes Mellitus
    Type 2 Diabetes Mellitus
    Diabetes Mellitus Typ 1
    Diabetes Mellitus Typ 2
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    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 primary objective is to investigate the short and mid-term humoral immune response to COVID-19 vaccines as assessed by anti-spike protein antibodies in people with diabetes as compared to healthy controls.
    Das Hauptziel besteht darin, die kurz- und mittelfristige humorale Immunantwort auf COVID-19-Impfstoffe zu untersuchen, die durch Anti-Spike-Protein-Antikörper bei Menschen mit Diabetes im Vergleich zu gesunden Kontrollen bewertet wird.
    E.2.2Secondary objectives of the trial
    Secondary objective
    - to investigate the difference in the short and mid-term humoral immune response to COVID-19 vaccines in people with type 1 and type 2 diabetes, either with good or unsatisfactory glycaemic control.
    - to investigate glycaemic excursions and required changes to antihyperglycaemic doses or treatment regimens following COVID-19 vaccination in people with diabetes.
    - to investigate changes to the coagulatory system in people with diabetes as compared to healthy controls following COVID-19 vaccination.
    - to investigate the safety profile of COVID-19 vaccines in people with diabetes.
    Sekundäres Ziel
    - Untersuchung des Unterschieds in der kurz- und mittelfristigen humoralen Immunantwort auf COVID-19-Impfstoffe bei Menschen mit Typ-1- und Typ-2-Diabetes, entweder mit guter oder unbefriedigender Blutzuckerkontrolle.
    - Untersuchung von glykämischen Exkursionen und erforderlichen Änderungen der antihyperglykämischen Dosen oder Behandlungsschemata nach der COVID-19-Impfung bei Menschen mit Diabetes.
    - Untersuchung von Veränderungen des Gerinnungssystems bei Menschen mit Diabetes im Vergleich zu gesunden Kontrollen nach COVID-19-Impfung.
    - Untersuchung des Sicherheitsprofils von COVID-19-Impfstoffen bei Menschen mit Diabetes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria for Diabetes Mellitus Cohort
    -Age between 18 and 80 years, both inclusive
    -Planned COVID-19 vaccination

    Cohort I (Diabetes mellitus Type 1, well controlled)
    Glycated haemoglobin levels HbA1c ≤7.5 %

    Cohort II (Diabetes mellitus Type 1, uncontrolled)
    Glycated haemoglobin levels HbA1c >7.5 %

    Cohort III (Diabetes mellitus Type 2, well controlled)
    Glycated haemoglobin levels HbA1c ≤7.5 %

    Cohort IV (Diabetes mellitus Type 2, uncontrolled)
    Glycated haemoglobin levels HbA1c >7.5 %
    Einschlusskriterien für Diabetes Mellitus Kohorte

    -Alter zwischen 18 und 80 Jahren, beide inklusive
    -Geplante COVID-19-Impfung

    Kohorte I (Diabetes mellitus Typ 1, gut kontrolliert)
    Glykierte Hämoglobinspiegel HbA1c ≤ 7,5%

    Kohorte II (Diabetes mellitus Typ 1, unkontrolliert)
    Glykierte Hämoglobinwerte HbA1c> 7,5%

    Kohorte III (Diabetes mellitus Typ 2, gut kontrolliert)
    Glykierte Hämoglobinspiegel HbA1c ≤ 7,5%

    Kohorte IV (Diabetes mellitus Typ 2, unkontrolliert)
    Glykierte Hämoglobinwerte HbA1c> 7,5%
    E.4Principal exclusion criteria
    Exlcusion criteria for Diabetes Mellitus Cohort
    -Active known malignancy within the last year excluding intraepithelial neoplasia of prostate, gastrointestinal tract and basalioma
    -Pregnancy or intention of becoming pregnant; breastfeeding
    -Immunosuppressive therapy
    -Acute or chronic inflammatory disorder
    -Alcohol abuse (more than 15 drinks / week)
    -Any contraindication to the vaccine planned to receive as listed in the product characteristics
    -Previous COVID-19 vaccine or episode of COVID-19
    Ausschlusskriterien für die Diabetes-Mellitus-Kohorte
    -Aktive bekannte maligne Erkrankung innerhalb des letzten Jahres außer intraepitheliale Neoplasie der Prostata, des Magen-Darm-Trakts und des Basalioms
    - Schwangerschaft oder Absicht, schwanger zu werden; Stillende Frauen
    - Immunsuppressive Therapie
    - Akute oder chronisch entzündliche Störung
    - Alkoholmissbrauch (mehr als 15 Getränke / Woche)
    - Jede Kontraindikation für den Impfstoff, gemäß der Fachinformation
    - Vorherige COVID-19-Impfung oder vorhergehende COVID-19 Infektion
    E.5 End points
    E.5.1Primary end point(s)
    Difference in the change of anti-SARS-CoV-2 spike protein immune response measured by antigen-binding Ig assay from baseline to Visit 3 (2-3 weeks after the second vaccination) between people with diabetes (all 4 groups pooled) and healthy controls.
    Unterschied in der Veränderung der Anti-SARS-CoV-2-Spike-Protein-Immunantwort, gemessen durch Antigen-bindenden Ig-Assay vom Ausgangswert bis zu Visite 3 (2-3 Wochen nach der zweiten Impfung) zwischen Menschen mit Diabetes (alle 4 Gruppen zusammengefasst) und gesunden Kontrollen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and Visit 3 (2-3 weeks after second vaccination)
    Baseline und Visite 3 (2-3 Wochen nach der zweiten Impfung)
    E.5.2Secondary end point(s)
    -Difference in the change of anti-SARS-CoV-2 spike protein immune response measured by antigen-binding Ig assay from baseline to Visit 2 (1-2 weeks after the second vaccination) between people with diabetes (all 4 groups pooled) and healthy controls.
    -Difference in the change of anti-SARS-CoV-2 spike protein immune response measured by antigen-binding Ig assay from baseline to Visit 4 (12 months) between people with diabetes (all 4 groups pooled) and healthy controls.
    -Difference in the change of anti-SARS-CoV-2 spike protein immune response measured by antigen-binding Ig assay from baseline to Visit 3 (2-3 weeks after the second vaccination) the 4 groups of people with diabetes
    -Difference in the change of anti-SARS-CoV-2 spike protein immune response measured by antigen-binding Ig assay from baseline to Visit 4 (12 months) the 4 groups of people with diabetes
    -Differences in the immune phenotype (B cell and T cell subsets) between the 5 cohorts before the vaccination
    Immune phenotype predictors (B cell subsets, T cell subsets) at baseline for the anti-SARS-CoV-2 spike protein humoral immune response at Visit 3 based on immune-phenotyping patterns at baseline (B cell subsets, T cell subsets)
    -Glycaemic profiles (time in range, time below range and time above range), number of hypoglycaemia (<70 mg/dL and 54 mg/dL with a duration >15 min via isCGM/CGM) and hyperglycaemia (>180 mg/dL and >250 mg/dL), glycaemic variability (%CV, SD), post-prandial glucose excursion, and therapy (total daily insulin dose [basal rate/basal insulin and bolus insulin], carbohydrate to insulin ratio, number and amount of insulin corrections) the week following the vaccination as compared to the week before the first vaccination
    -Difference in the change of coagulation parameters from baseline to Visit 2 in people with diabetes and healthy controls.
    -Adverse events following the vaccinations
    -Differenz in der Veränderung der Anti-SARS-CoV-2-Spike-Protein-Immunantwort, gemessen durch Antigen-bindenden Ig-Assay vom Ausgangswert bis Besuch 2 (1-2 Wochen nach der zweiten Impfung) zwischen Menschen mit Diabetes (alle 4 Gruppen zusammengefasst) und gesunde Kontrollen.
    -Differenz in der Veränderung der Anti-SARS-CoV-2-Spike-Protein-Immunantwort, gemessen durch Antigen-bindenden Ig-Assay vom Ausgangswert bis Besuch 4 (12 Monate) zwischen Menschen mit Diabetes (alle 4 Gruppen zusammengefasst) und gesunden Kontrollpersonen.
    -Differenz in der Veränderung der Anti-SARS-CoV-2-Spike-Protein-Immunantwort, gemessen durch Antigen-bindenden Ig-Assay vom Ausgangswert bis zu Besuch 3 (2-3 Wochen nach der zweiten Impfung) der 4 Gruppen von Menschen mit Diabetes
    -Differenz in der Veränderung der Anti-SARS-CoV-2-Spike-Protein-Immunantwort, gemessen durch Antigen-bindenden Ig-Assay vom Ausgangswert bis Besuch 4 (12 Monate) der 4 Gruppen von Menschen mit Diabetes
    -Differenzen im Immunphänotyp (B-Zell- und T-Zell-Untergruppen) zwischen den 5 Kohorten vor der Impfung
    Immunphänotyp-Prädiktoren (B-Zell-Untergruppen, T-Zell-Untergruppen) zu Studienbeginn für die humorale Immunantwort des Anti-SARS-CoV-2-Spike-Proteins bei Visit 3 basierend auf Immunphänotypisierungsmustern zu Studienbeginn (B-Zell-Untergruppen, T-Zell-Untergruppen)
    -Glykämische Profile (Zeit im Bereich, Zeit unter dem Bereich und Zeit über dem Bereich), Anzahl der Hypoglykämien (<70 mg / dl und 54 mg / dl mit einer Dauer> 15 min über isCGM / CGM) und Hyperglykämie (> 180 mg / dl) und> 250 mg / dl), glykämische Variabilität (% CV, SD), postprandiale Glukoseexkursion und Therapie (tägliche Gesamtinsulindosis [Basalrate / Basalinsulin und Bolusinsulin], Verhältnis von Kohlenhydraten zu Insulin, Anzahl und Menge von Insulinkorrekturen) in der Woche nach der Impfung im Vergleich zur Woche vor der ersten Impfung
    - Differenz in der Änderung der Gerinnungsparameter vom Ausgangswert zu Besuch 2 bei Menschen mit Diabetes und gesunden Kontrollpersonen.
    - Nebenwirkungen nach den Impfungen
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, Visit 2, Visit 3 and Visit 4
    Baseline, Visite 2, Visite 3 und Visite 4
    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 Yes
    E.6.13.1Other scope of the trial description
    Measurement of seroconversion leading to humoral immune response following COVID-19 vaccines in people with type 1 and type 2 diabetes mellitus (well controlled and uncontrolled) and compare the response to healthy controls.
    Messung der Serokonversion, die nach COVID-19-Impfstoffen bei Menschen mit Typ-1- und Typ-2-Diabetes mellitus (gut kontrolliert und unkontrolliert) zu einer humoralen Immunantwort führt, und Vergleich der Reaktion mit gesunden Kontrollen.
    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 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 concerned2
    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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned days0
    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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state160
    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)
    there is no difference from the expected normal treatment
    es gibt keinen Unterschied zur Behandlung vor der der Teilnahme an der Studie
    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 Decision2021-04-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-08-30
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