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    Summary
    EudraCT Number:2021-000633-14
    Sponsor's Protocol Code Number:SZÚ/01591/2021
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-02-18
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2021-000633-14
    A.3Full title of the trial
    DYNAMICS OF POSTVACCINATION ANTI- SARS-COV-2 ANTIBODY RESPONSE IN EMPLOYES OF THE NATIONAL INSTITUTE OF PUBLIC HEALTH AND VOLUNTARIES 1-2021
    STUDIE DYNAMIKY POSTVAKCINAČNÍCH PROTILÁTEK ANTI- SARS-CoV-2 U ZAMĚSTNANCŮ SZÚ A DOBROVOLNÍKŮ 1-2021
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Observation of antibody response in vacinated empoleyes after COVID-19 vaccine.
    Sledování protilátkové odpovědi u očkovaných zaměstnanců po vakcíně proti covid-19.
    A.4.1Sponsor's protocol code numberSZÚ/01591/2021
    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 SponsorStátní zdravotní ústav
    B.1.3.4CountryCzechia
    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 supportStátní zdravotní ústav
    B.4.2CountryCzechia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationStátní zdravotní ústav
    B.5.2Functional name of contact pointRadomíra Limberková
    B.5.3 Address:
    B.5.3.1Street AddressŠrobárova49/48
    B.5.3.2Town/ cityPraha
    B.5.3.3Post code10000
    B.5.3.4CountryCzechia
    B.5.4Telephone number420267082412
    B.5.6E-mailradomira.limberkova@szu.cz
    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 holderBioNTech Manufacturing GmbH
    D.2.1.2Country which granted the Marketing AuthorisationCzechia
    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.3.4Pharmaceutical form Powder for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    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
    antibody response following vaccine application
    protilátková odpověď po aplikaci vakcíny
    E.1.1.1Medical condition in easily understood language
    antibody response following vaccine application
    protilátková odpověď po aplikaci vakcíny
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10060979
    E.1.2Term Antibody test
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the proportion of vaccinees who seroconverted at least 28 days after the administration of the 2nd dose of the vaccine according to the approved application schedule, quantitative determination of the level of anti-SARS-CoV-2 antibodies
    To determine the proportion of vaccinated in whom anti-SARS-CoV-2 antibodies are detectable 6 months after the administration of the 2nd dose of the vaccine according to the approved application schedule, quantitative determination of the level of anti-SARS-CoV-2 antibodies
    Determine the proportion of vaccinees in whom failed the vaccine within 6 months of the 2nd dose of the vaccine according to the approved dosing schedule
    Stanovit podíl očkovaných, u kterých proběhla sérokonverze minimálně do 28 dní po aplikaci 2. dávky vakcíny dle schváleného aplikačního schématu, kvantitativní stanovení hladiny anti SARS-CoV-2 protilátek
    Stanovit podíl očkovaných, u kterých jsou detekovatelné anti SARS-CoV-2 protilátky 6 měsíců po aplikaci 2. dávky vakcíny dle schváleného aplikačního schématu, kvantitativní stanovení hladiny anti SARS-CoV-2 protilátek
    Stanovit podíl očkovaných, u kterých došlo k selhání vakcíny do 6 měsíců od aplikace 2. dávky vakcíny dle schváleného aplikačního schématu
    E.2.2Secondary objectives of the trial
    To determine the proportion of vaccinees who seroconverted in an interval close to 21 days after the administration of the 1st dose of the vaccine, which will precede the administration of the 2nd dose, quantitative determination of the level of anti SARS-CoV-2 antibodies
    If vaccination fails and SARS-CoV-2 RNA is captured in the nasopharyngeal swab or other relevant biological material of the vaccinated, whole genome sequencing (WGS) sequencing will be performed if there is sufficient nucleic acid in the primary sample.
    Stanovit podíl očkovaných, u kterých proběhla sérokonverze v intervalu blízkém 21 dní po aplikaci 1. dávky vakcíny, který bude předcházet aplikaci 2. dávky, kvantitativní stanovení hladiny anti SARS-CoV-2 protilátek
    Při možném selhání vakcinace a zachycení RNA viru SARS-CoV-2 v nasopharyngeálním stěru nebo jiném relevantním biologickém materiálu u očkovaného bude v případě dostatečného množství nukleové kyseliny v primárním vzorku provedena sekvenační analýza metodami celogenomové sekvenace (WGS).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    those who were vaccinated in the vaccination centre of Státní zdravotní ústav and singed informed consent with participation in the study
    ti, kteří byli očkováni v očkovacím středisku Státního zdravotního ústavu a informovaným souhlasem potvrdili účast ve studii
    E.4Principal exclusion criteria
    contraindications of vaccine application according to Summary of product characteristics
    application of the first dose of the vaccine after the 1st of February 2021
    kontraindikace očkování, tak jak jsou uvedeny v Souhrnu údajů o přípravku
    aplikace 1.dávky vakcíny po 1.únoru 2021
    E.5 End points
    E.5.1Primary end point(s)
    Discontinuation of the treatment for adverse events
    individual decision not to continue in the study anytime
    Vysazení léčby z bezpečnostních důvodů
    Individuální rozhodnutí nepokračovat ve studii kdykoliv v průběhu studie
    E.5.1.1Timepoint(s) of evaluation of this end point
    Discontinuation of the treatment for adverse events
    Vysazení léčby z bezpečnostních důvodů
    E.5.2Secondary end point(s)
    not applicable for design of this study
    nelze aplikovat na tuto studii
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable for design of this study
    nelze aplikovat na tuto studii
    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 No
    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 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
    LVLS
    poslední návštěva posledního pacienta
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days21
    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: 200
    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 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 state300
    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
    žádné
    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 Decision2021-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-17
    P. End of Trial
    P.End of Trial StatusOngoing
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