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    Summary
    EudraCT Number:2021-001512-28
    Sponsor's Protocol Code Number:COVIM
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-04-13
    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 ConcernedGermany - PEI
    A.2EudraCT number2021-001512-28
    A.3Full title of the trial
    Immunogenicity of COVID-19 vaccines in medical staff and special risk populations
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immune response of COVID-19 vaccines in medical staff and special risk populations
    A.4.1Sponsor's protocol code numberCOVIM
    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 SponsorCharité - Universitätsmedizin Berlin
    B.1.3.4CountryGermany
    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 supportBMBF
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportAlexion
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportRoche
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportHorizon
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportBfArM
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharité - Universitätsmedizin Berlin
    B.5.2Functional name of contact pointMed. Klinik m. S. Infektiologie
    B.5.3 Address:
    B.5.3.1Street AddressAugustenburger Platz 1
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13353
    B.5.3.4CountryGermany
    B.5.4Telephone number4930450653034
    B.5.6E-mailleif-erik.sander@charite.de
    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 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 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 INNTozinameran
    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) No
    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 Jans­sen
    D.2.1.1.2Name of the Marketing Authorisation holderJans­sen-Ci­lag In­ter­na­tio­nal NV
    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.3.9.3Other descriptive nameCOVID-19 Vaccine Janssen (Ad26.COV2.S)
    D.3.9.4EV Substance CodeSUB208328
    D.3.10 Strength
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number8,92
    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) No
    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.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 Bio­tech Spain, S.L.
    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 Dispersion 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.3.9.3Other 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) No
    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 Vaxzevria (CO­VID-19 Vac­ci­ne Astra­Zene­ca)
    D.2.1.1.2Name of the Marketing Authorisation holderAstra­Zene­ca AB, Schwe­den
    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.3.9.3Other 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 number2,5 x 10^8
    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) No
    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
    SARS-CoV-2 immunogenicity
    E.1.1.1Medical condition in easily understood language
    SARS-CoV-2 immune response
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determination of immunogenicity of SARS-CoV-2 vaccines in healthy individuals compared to special risk populations
    E.2.2Secondary objectives of the trial
    Determination of differences in humoral and cellular immunity after different vaccine regimen (vaccine schedule, vaccine type, combination of vaccines), particularly between homologous and heterologous prime-boost regimen
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: SARS-CoV-2 longterm immunity after primary immunisation and booster vaccination of the elderly and health care workers (short title: COVIM-Boost)

    Primary substudy endpoint:
    Immunogenicity of COVID-19 vaccination 18 months after first vaccination as confirmed by the presence of anti-SARS-CoV-2-specific antibodies, i.e. positivity in serological assay system (S1-IgG ELISA above the predefined lower detection limit).

    Secondary substudy endpoints:
    • Immunogenicity of COVID-19 vaccination 12 and 18 months after first vaccination as confirmed by the presence of anti-SARS-CoV-2-specific antibodies, i.e. positivity in serological assay system (S1-IgG ELISA above the predefined lower detection limit)
    • Immunogenicity of COVID-19 vaccination 12 and 18 months after first vaccination as confirmed by the presence of SARS-CoV-2 -specific CD4+ T cells
    • Immunogenicity of COVID-19 vaccination 12 and 18 months after first vaccination as confirmed by the presence of neutralizing antibodies against SARS-CoV-2 wildtype
    • Immunogenicity of COVID-19 vaccination 12 and 18 months after first vaccination as confirmed by the presence of neutralizing antibodies against different PANGO lineages of SARS-CoV-2 (e.g., B.1.1.7, B1.351, P.1, B.1.617.2)
    • Proportion of participants with symptomatic SARS-CoV-2 infection
    • Differences in humoral and cellular immunogenicity at 12 and 18 months after first vaccination in HCWs and elderly
    • Differences in humoral and cellular immunogenicity after different vaccine regimen (vaccine schedule, vaccine type, combination of vaccines), particularly between homologous and heterologous prime-boost regimen at 12 and 18 months after first vaccination in HCWs and elderly
    • Change in acceptance and adherence to the use of non-pharmacological measures (nPM) after vaccination or booster vaccination against COVID-19
    • Safety and tolerability of booster vaccination
    • For participants having received booster vaccination:
    - Immunogenicity of booster vaccination 4 weeks (± 1 week) after boost as confirmed by the presence of anti-SARS-CoV-2-specific antibodies, i.e. positivity in serological assay system (S1-IgG ELISA above the predefined lower detection limit)
    - Immunogenicity of booster vaccination 4 weeks (± 1 week) after boost as confirmed by the presence of SARS-CoV-2 -specific CD4+ T cells
    - Immunogenicity of booster vaccination 4 weeks (± 1 week) after boost as confirmed by the presence of neutralizing antibodies against SARS-CoV-2 wildtype
    - Immunogenicity of booster vaccination 4 weeks (± 1 week) after boost as confirmed by the presence of neutralizing antibodies against different PANGO lineages of SARS-CoV-2 (e.g., B.1.1.7, B1.351, P.1, B.1.617.2)
    - Differences in humoral and cellular immunogenicity after different booster regimen (including neutralizing antibodies against different PANGO lineages of SARS-CoV-2 (e.g., B.1.1.7, B1.351, P.1, B.1.617.2)), particularly between homologous and heterologous boost vaccination, at 12 and 18 months after first vaccination in HCWs and elderly

    Explanatory statement: In the context of protocol version 1.6 (dated 09.12.2021), it was decided to conduct COVIM-Boost as a separate study (in accordance with § 4 (7a) MedBVSV) and thus to terminate the substudy COVIM-Boost together with the main study. An analysis of the endpoints is therefore mainly performed as part of the analysis of the separate study.
    E.3Principal inclusion criteria
    - Subject is willing, understanding and able to provide written informed consent (exception: for cohort 8 (Elderly) subjects unable to give informed consent may be included, provided that legal representative gives written informed consent)
    - Written informed consent prior to initiation of any study procedures
    - Subject understands and agrees to comply with planned study procedures.
    - Male or female adult ≥18 years of age at time of enrolment.
    - Participant belongs to only one of the following categories:
    - Healthy health care worker at one of the participating trial centers (HCW)
    - Participant with history of kidney transplantation (NTx)
    - haemato-oncological participant and participant with B-cell neoplasia (B-NPL)
    - Participant with neuroimmunological diseases such as multiple sclerosis (MS) and neuromyelitis optica spectrum disorders (NMOSD)
    - Participant with rheumatic and autoimmune diseases under immunosuppression (RAID)
    - Participant with primary immunodeficiency (PID)
    - Participant with chronic kidney failure undergoing a chemo dialysis (HD)
    - Participant ≥ 70 years-of age, with none of the medical conditions specified above (elderly)

    - One of the following vaccination scenarios apply:
    - Subject will be vaccinated with a COVID-19 vaccine for the first time
    - Subject already received the first COVID-19 vaccination no longer than 6 month prior to enrolment

    - Absence of any conditions that prohibit or impede supplemental blood-sampling or throat swab.
    E.4Principal exclusion criteria
    An individual who meets any of the following criteria will be excluded from participation in this study:

    - Any contraindications for SARS-CoV-2 vaccination (according to SmPCs)
    - Refusal to participate.
    - Participants unwilling or unable to consent to saving and propagation of pseudonymized medical data for study reasons.
    - Persons who are legally detained in an official institution
    - Persons who might be dependent on the sponsor, the investigator or the trial site. This exclusion criterion does not apply for cohort 1 (HCWs), as it is necessary for this population to participate. In order to assure that no pressure to participate is put on them, the recruitment procedure of HCWs must follow the respective SOP of the sponsor.
    E.5 End points
    E.5.1Primary end point(s)
    Immunogenicity of COVID-19 vaccination six (up to max. nine months) months after first vaccination as confirmed by the presence of anti-SARS-CoV-2-specific antibodies, i.e. positivity in serological assay system (S1-IgG ELISA above the predefined lower detection limit).
    E.5.1.1Timepoint(s) of evaluation of this end point
    after end of trial
    E.5.2Secondary end point(s)
    Secondary endpoints:

    - Immunogenicity of COVID-19 vaccination one and three months after first vaccination as confirmed by the presence of anti-SARS-CoV-2-specific antibodies, i.e. positivity in serological assay system (S1-IgG ELISA above the predefined lower detection limit).
    - Immunogenicity of COVID-19 vaccination one, three, six and nine months after first vaccination as confirmed by the presence of SARS-CoV-2 -specific CD4+ T cells.
    - Immunogenicity of COVID-19 vaccination one, three, six and nine months after first vaccination as confirmed by the presence neutralizing antibodies against SARS-CoV-2 wildtype
    - Immunogenicity of the COVID-19 vaccination one, three, six and nine months after first vaccination as confirmed by the presence of neutralizing antibodies against different PANGO lineages of SARS-CoV-2 (e.g., B.1.1.7, B1.351, P.1)
    - Proportion of participants with symptomatic SARS-CoV-2 infection in special risk populations and health care workers
    - Differences in humoral and cellular immunogenicity in special risk populations (HCW, NTx, B-NPL, MS, RAID, PID, HD, elderly)
    - Differences in humoral and cellular immunogenicity after different vaccine regimen (vaccine schedule, vaccine type, combination of vaccines), particularly between homologous and heterologous prime-boost regimen
    - Change in acceptance and adherence to the use of non-pharmacological measures (nPM) after vaccination against
    COVID-19
    - Safety and tolerability of vaccines in healthcare workers and special risk groups
    - For RAID and MS/NMOSD cohorts: Effects of vaccination on underlying chronic disease measured by disease activity scores (RAID: BASDAI, Funktionsfragebogen Hannover, Gelenkmännchen, VAS; MS/NMOSD: EDSS, PHQ-9, GEE-COVID)
    - For participants having received booster vaccination:
    - Immunogenicity of booster vaccination 4 weeks (± 1 week) after boost as confirmed by the presence of anti-SARS-CoV-2-specific antibodies, i.e. positivity in serological assay system (S1-IgG ELISA above the predefined lower detection limit)
    - Immunogenicity of booster vaccination 4 weeks (± 1 week) after boost as confirmed by the presence of SARS-CoV-2 -specific CD4+ T cells
    - Immunogenicity of booster vaccination 4 weeks (± 1 week) after boost as confirmed by the presence of neutralizing antibodies against SARS-CoV-2 wildtype
    - Immunogenicity of booster vaccination 4 weeks (± 1 week) after boost as confirmed by the presence of neutralizing antibodies against different PANGO lineages of SARS-CoV-2 (e.g., B.1.1.7, B1.351, P.1, B.1.617.2)

    Explorative endpoints:

    - Differences in humoral and cellular immunogenicity in participants with and without SARS-CoV-2 infection after vaccination (= immunological Correlate of protection)
    - Diversity of the T-cell receptor (TCR) and B-cell receptor (BCR) repertoire, immunoglobulin levels, cytokine profiles, plasma proteome and RNA expression profiles in special risk populations
    - Influence of HLA subtypes on immunogenicity of COVID-19 vaccines
    - Presence of SARS-CoV-2 -specific CD8 T cells
    - For MS/NMOSD cohort:
    - secretory humoral immunity to vaccination in saliva samples
    - microbiome diversity and alterations in response to vaccination in stool samples
    - influence of affective state and expectancy as measured by PHQ9 (Korenke 2001) and the credibility and expectancy scale (Devilly & Borkovec 2000) on immunogenicity
    E.5.2.1Timepoint(s) of evaluation of this end point
    one, three, six and nine months after first vaccination
    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 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 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 concerned24
    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 months8
    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: 1375
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1675
    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 Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-04-13. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Persons above the age of 70 suffering from dementia or related illnesses, particularly elderly persons living in long-term care facilities
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3050
    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 Decision2021-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-12-30
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