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    Summary
    EudraCT Number:2021-000206-17
    Sponsor's Protocol Code Number:COVID19_7
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-02-10
    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 ConcernedSweden - MPA
    A.2EudraCT number2021-000206-17
    A.3Full title of the trial
    Studies of ongoing and completed SARS-CoV-2 infection (which causes COVID-19) within the healthcare in Stockholm County, with regard to vaccinations.
    Studier av pågående och genomgången SARS-CoV-2 infektion (som orsakar COVID-19) inom vård och omsorg i Stockholms län, med avseende på vaccinationer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Studies of ongoing and completed SARS-CoV-2 infection (which causes COVID-19) within the healthcare in Stockholm County, with regard to vaccinations.
    Studier av pågående och genomgången SARS-CoV-2 infektion (som orsakar COVID-19) inom vård och omsorg i Stockholms län, med avseende på vaccinationer.
    A.4.1Sponsor's protocol code numberCOVID19_7
    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 SponsorKarolinska University Hospital
    B.1.3.4CountrySweden
    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 supportKarolinska University Hospital
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKarolinska University Hospital
    B.5.2Functional name of contact pointJoakim Dillner
    B.5.3 Address:
    B.5.3.1Street AddressDept of LabMed, Div Pat, F46, Karolinska University Hospital
    B.5.3.2Town/ cityStockholm
    B.5.3.3Post code14186
    B.5.3.4CountrySweden
    B.5.4Telephone number+4672468 2460
    B.5.6E-mailjoakim.dillner@sll.se
    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 Comirnaty
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer/BioNTech
    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.3.4Pharmaceutical form Concentrate 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 INNmodified mRNA, encoding full length SARS-CoV-2 spike protein
    D.3.9.1CAS number 2417899-77-3
    D.3.9.3Other descriptive nameTozinameran
    D.3.9.4EV Substance CodeSUB210693
    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: 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 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.3.4Pharmaceutical 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 INNCOVID-19 Vaccine Moderna
    D.3.9.1CAS number 2430046-03-8
    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: 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
    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.3.4Pharmaceutical 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 INNchimpanzee adenovirus vector, encoding SARS-CoV-2 spike protein, recombinant
    D.3.9.1CAS number 2499737-08-3
    D.3.9.3Other descriptive nameCOVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19)
    D.3.9.4EV Substance CodeSUB207764
    D.3.10 Strength
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number250000000 inf. U
    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 against COVID-19.
    Vaccination mot COVID-19.
    E.1.1.1Medical condition in easily understood language
    Vaccination against COVID-19.
    Vaccination mot COVID-19.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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
    To investigate the incidence of SARS-CoV-2 infections after vaccination, to monitor the development of SARS-CoV-2 antibody levels after vaccination and to compare this in relation to both previous health & disease, previous antibody responses and in relation to future disease occurring after vaccination.



    Att undersöka förekomsten av SARS-CoV-2-infektioner efter vaccination, att följa utvecklingen av SARS-CoV-2-antikroppsnivåer efter vaccination och jämföra detta i förhållande till både tidigare hälsa & sjukdom, tidigare antikroppssvar och i förhållande till framtida sjukdom som inträffar efter vaccination.
    E.2.2Secondary objectives of the trial
    Not applicable.
    Inte tillämpbart.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Study participant who agreed to be included in the study "Studies of ongoing and completed SARS-CoV-2 infection (which causes COVID-19) within the healthcare in Stockholm County".
    • Study participant who has received or will receive vaccine against Covid-19 and who gives new written consent to the study “Studies of ongoing and completed SARS-CoV-2 infection (which causes COVID-19) within the healthcare in Stockholm County, with regard to on vaccinations”.

    • Forskningsperson som samtyckt till att ingå i studien ”Studier av pågående och genomgången SARS-CoV-2 infektion (som orsakar COVID-19) inom vård och omsorg i Stockholms län”.
    • Forskningsperson som fått eller kommer att få vaccin mot Covid-19 och som ger nytt skriftligt samtycke till studien” Studier av pågående och genomgången SARS-CoV-2 infektion (som orsakar COVID-19) inom vård och omsorg i Stockholms län, med avseende på vaccinationer”.

    E.4Principal exclusion criteria
    • those who have not given informed consent to participate in the study

    In this study, no initiative is taken for vaccination. The vaccinations are carried out by the healthcare system and of course follow the established exclusion and inclusion criteria for the approved vaccines, the package leaflets of which are attached. All persons who have received the vaccine and who give written consent are eligible to be included in the study.

    • De som inte lämnat informerat samtycke till att delta i studien

    I denna studie tas inget initiativ till vaccination. Vaccinationerna utförs av vården och följer självfallet de etablerade exklusions- och inklusionskriterierna för de godkända vaccinerna, vars bipacksedlar bifogas. Alla personer som fått vaccin och som ger skriftligt samtycke är valbara att ingå i studien.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the detection of SARS-CoV-2 infection, relative to whether vaccination has been given. SARS-CoV-2 infections will be characterized by whether they are asymptomatic infections or sick leave-requiring infections. Regarding possible side effects, the primary outcome measure is sick leave, which will be characterized regarding every known case of illness within the cohort.

    Primärt effektmått är påvisning av SARS-CoV-2 infektion, i förhållande till om vaccination givits. SARS-CoV-2 infektioner kommer att karakteriseras med avseende på om det är asymtomatiska infektioner eller sjukskrivningskrävande infektioner. Beträffande eventuella biverkningar så är det primära utfallsmåttet sjukskrivning, som kommer att karakteriseras beträffande varje i kohorten känt fall av sjukdom.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months post primary vaccination.
    24 månader efter första vaccinationstillfället.
    E.5.2Secondary end point(s)
    Secondary endpoint is induction of antibodies to SARS-CoV-2. These will be characterized in terms of antibody levels, which SARS-CoV-2 antigen to which the response is directed and whether the antibodies are protective or not.
    Sekundärt effektmått är induktion av antikroppar mot SARS-CoV-2. Dessa kommer att karakteriseras beträffande antikroppsnivåer, vilket SARS-CoV-2 antigen som svaret riktas mot samt om antikropparna är skyddande eller ej.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 months post primary vaccination.
    24 månader efter första vaccinationstillfället.
    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 No
    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
    The study stops enrolling when participants in the cohort are no longer offered vaccination. Follow-up is planned to continue as long as there are still cases of SARS-CoV-2 or SARS-CoV-2-related disease in the cohort, with a reporting frequency of once every two years. The decision that continued follow-up is no longer meaningful and the study is discontinued is made by the sponsor.

    Studien slutar enrollera när deltagarna i kohorten inte längre erbjuds vaccination. Uppföljning planeras fortgå så länge det fortfarande uppkommer fall av SARS-CoV-2 eller SARS-CoV-2-relaterad sjukdom i kohorten, med en rapporteringsfrekvens av en gång vartannat år. Beslutet om att fortsatt uppföljning inte längre är meningsfull och studien avbrytes görs av sponsorn.
    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 months24
    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: 9500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 500
    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 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 state10000
    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
    Inga
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Roo Hemtjänst & Vård
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Södersjukhuset
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation Capio S:t Görans sjukhus
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation Södertälje sjukhus
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 5
    G.4.1Name of Organisation Ersta sjukhus
    G.4.3.4Network Country Sweden
    G.4 Investigator Network to be involved in the Trial: 6
    G.4.1Name of Organisation S:t Eriks Ögonsjukhus
    G.4.3.4Network Country Sweden
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-10
    P. End of Trial
    P.End of Trial StatusOngoing
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