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    Summary
    EudraCT Number:2021-001357-31
    Sponsor's Protocol Code Number:IIV-478
    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:2021-04-20
    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 number2021-001357-31
    A.3Full title of the trial
    Immune Responses Induced by Vaccination Against COVID-19 in Dutch healthy subjects
    Immuun responsen opgewekt door vaccinatie tegen COVID-19 in Nederlandse gezonde proefpersonen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the immune response after corona vaccination
    Onderzoek van de immuunrespons (de afweer) na coronavaccinatie
    A.3.2Name or abbreviated title of the trial where available
    IIVAC
    IIVAC
    A.4.1Sponsor's protocol code numberIIV-478
    A.5.4Other Identifiers
    Name:ABR numberNumber:NL76440.041.21
    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 SponsorNational Institute of Health and the Environment
    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 supportMinistry of Health and the Environment
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNational Institute of Health and the Environment
    B.5.2Functional name of contact pointIIVAC studyteam
    B.5.3 Address:
    B.5.3.1Street AddressAntonie van Leeuwenhoeklaan 9
    B.5.3.2Town/ cityBilthoven
    B.5.3.3Post code3720 MA
    B.5.3.4CountryNetherlands
    B.5.6E-mailIIVAC@rivm.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.2.1.2Country 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.3.11 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 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.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
    Immune Responses Induced by Vaccination Against COVID-19 in Dutch healthy subjects
    Immuun responsen opgewekt door vaccinatie tegen COVID-19 in Nederlandse gezonde proefpersonen
    E.1.1.1Medical condition in easily understood language
    corona vaccination
    corona vaccinatie
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    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
    Monitoring & evaluation of immune responses induced by COVID-19 vaccines in the general population in the Netherlands, specifically vaccine (e.g. Spike protein)-specific serum IgG GMC at day 28 after completion of COVID-19 vaccination by multiplex immune assay (MIA).
    Monitoren en evalueren van de immuunrespons geïnduceerd door vaccinatie tegen COVID-19 in de algemene Nederlandse bevolking, specifiek vaccin (b.v. Spike eiwit)-specifiek serum IgG (GMC) op dag 28 na de laatste COVID-19 vaccinatie, gemeten via de multiplex immuun test (MIA).
    E.2.2Secondary objectives of the trial
    a. Measuring humoral, cellular and innate COVID-19 vaccine-induced immune responses
    b. Measuring virus neutralizing capacity of antibodies induced by COVID-19 vaccination
    c. Measuring Fc functionality of antibodies (e.g. complement deposition) and antibody glycosylation status induced by COVID-19 vaccination
    d. Measuring COVID-19 vaccine-induced antibodies in nasal mucosal lining fluid
    e. Measuring reactogenicity self-reported in questionnaires shortly after vaccination
    a. Het meten van humorale, cellulaire en aangeboren (aspecifieke) vaccin-geïnduceerde immuunresponsen
    b. Het meten van de capaciteit van antilichamen voor virusneutralisatie
    c. Het meten van Fc functionaliteit van antistoffen (b.v. complementdepositie) en glycosylatie van antistoffen na vaccinatie
    d. Het meten van vaccin-geïnduceerde antistoffen in neusvocht
    e. Het meten van reactogeniciteit na vaccinatie zoals gerapporteerd in vragenlijsten
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Be 0 – 60 years at the time of inclusion
    • Be capacitated mentally and physically
    • Be willing to receive SARS-CoV-2 vaccine
    • Having signed the Informed Consent
    • 0 - 60 jaar zijn op het moment van inclusie
    • Is bekwaam (geestelijk en lichamelijk)
    • Is bereid om het SARS-CoV-2-vaccin te krijgen
    • Heeft toestemming formulier ondertekend
    E.4Principal exclusion criteria
    •Participation in a phase I/II/III vaccination trial where the subject will be vaccinated with a pre-registration (COVID-19) vaccine
    •Participation in a phase I/II/III medicine (pre-registration) trial
    •Belonging to a risk group for COVID-19 that is studied in one of the ZonMw-funded risk group vaccination studies (details of risk group studies provided in protocol ref. [9,10,11]) that this study provides a comparison for:
    oPrimary (inherited) immune deficiency (VACOPID study)
    oSeverely decreased kidney function (defined as Chronic Kidney Disease stage 4 or 5 (eGFR<30)), treatment by dialysis or recipient of a kidney transplant (RECOVAC study)
    oPulmonary disease for which the patient will receive or has received a lung transplant (COVALENT study)
    oAutoimmune disease (e.g. MS, rheumatoid arthritis, IBD, SLE etc) (Target to B! (sub)study)
    oDown syndrome (PRIDE study)
    o(Known) infection with Human Immunodeficiency Virus (HIV) (COVIH study)
    oCancer patients and patients with active cancer treatment (including hormone therapy), receipt of chemotherapy in the last 3 years and/or any history of cancer immune therapy (VOICE study)
    oHaematological patients, such as haematological malignancies (leukemia and lymphomas), myelodysplastic and -proliferative syndromes, hemoglobinopathies (sickle cell disease and thalassemia), receipt of stem cell transplantation or cell therapy such as CAR T-cell therapy (COBRA-KAI study)
    •Any other immune deficiency through disease
    •Active or past immunosuppressive or immune modulating medication.
    However, for steroid treatment the exclusion criteria are: receipt of any high-dose (≥ 20 mg of prednisone daily or equivalent) steroid treatment; daily corticosteroids (locally, incl. inhaled steroids, are acceptable) within 2 weeks of study entry; or repeated use of any high dose of corticosteroids (a dose of > 30 mg of prednisone or equivalent per day for multiple days) in the recent past.
    •Women who are pregnant or breastfeeding
    •Having a (functional) asplenia
    •Receipt of blood products or immunoglobulin, within 3 months of study entry
    •Receipt of an organ transplant not mentioned above
    •For the subgroup: Known or suspected coagulation disorder, also by treatment, that would contraindicate undergoing frequent blood sampling
    •Deelname aan een experimenteel (corona)vaccin onderzoek (fase I/II/III)
    •Deelname aan een experimenteel geneesmiddelen onderzoek (fase I/II/III)
    •Onderdeel zijn van een risicogroep voor COVID-19 die bestudeerd wordt in een van de ZonMw-gesubsidieerde risicogroep vaccinatiestudies, waarvoor deze studie een vergelijking vormt:
    oPrimaire immuundeficiëntie (VACOPID studie)
    oErnstig nierfalen (gedefinieerd als Chronic Kidney Disease stage 4 or 5 (eGFR<30)), dialyse en/of niertransplantatiepatiënt (RECOVAC studie)
    oLongziekte waarvoor de patient een longtransplantatie heeft ondergaan of waarvoor deze op de wachtlijst staat (COVALENT studie)
    oEen auto-immuunziekte (bijvoorbeeld MS, reumatoide artritis, IBD, SLE etc) (Target to B! (sub)studie)
    oDown syndroom (PRIDE studie)
    o(Bekende) HIV infectie (COVIH studie)
    oKanker patiënten en patiënten die een behandeling tegen kanker ondergaan (inclusief hormoon therapie), een chemokuur ontvangen hebben in de laatste 3 jaar; en/of ooit immuuntherapie voor kanker ontvangen hebben (VOICE studie)
    oPatiënten met een hematologische aandoening (bijvoorbeeld hematologische malignitieiten, myelodysplastische en -proliferatieve syndromen, hemoglobinopathieën zoals sikkelcelziekte en thalassemieën, etc), ontvangst van stamceltransplantatie, of ontvangst van celtherapie zoals CAR T-cel therapie (COBRA-KAI studie)
    •Enig andere immuundeficiëntie of ziekte leidend tot een immuundeficiëntie
    •Gebruik van immuunsuppressiva of immuunmodulerende therapie, op dit moment danwel in het verleden
    Alleen voor corticosteroïden gelden de volgende exclusiecriteria: hoge doses (≥ 20 mg prednison of equivalent per dag) corticosteroïden; dagelijkse corticosteroïden (locaal gebruik zoals inhalatietherapie is toegestaan) in de laatste 2 weken voor deelname aan de studie; of herhaaldelijk gebruik van enige hoge dosis corticosteroïden (> 30 mg prednison of equivalent per dag gedurende meerdere dagen) in het recente verleden.
    •Zwangerschap en borstvoeding
    •Een (functionele) asplenie
    •Bloedproducten of immuunglobuline in de laatste 3 maanden voor deelname aan deze studie
    •Een orgaantransplantatie, indien nog niet genoemd hierboven
    •Voor de subgroep: Klinische (verdenking op) stollingsstoornis of gebruik van bloedverdunners/anti-stolling, waardoor frequente venapunctie gecontraïndiceerd is.
    E.5 End points
    E.5.1Primary end point(s)
    COVID-19 vaccine (e.g. Spike protein)-specific serum IgG (GMC) in Dutch healthy subjects, at day 28 after completion of COVID-19 vaccination, by bead-based multiplex immune assay (MIA).
    Meten van COVID-19 vaccin (b.v. Spike eiwit) specifieke serum IgG (GMC) in Nederlandse gezonde personen, op dag 28 na de laatste COVID-19 vaccinatie, gemeten via de bead gebaseerde multiplex immuun test (MIA).
    E.5.1.1Timepoint(s) of evaluation of this end point
    day 28 after completion of vaccination(s)
    dag 28 na voltooien vaccinatie(s)
    E.5.2Secondary end point(s)
    Humoral, cellular and innate COVID-19 vaccine induced immune responses
    Virus neutralizing capacity and Fc functionality of antibodies (e.g. complement deposition) induced by COVID-19 vaccination
    COVID-19 vaccine-induced antibodies in nasal mucosal lining fluid
    Local reactogenicity as reported in questionnaire shortly after vaccination
    Humorale, cellulaire en aangeboren COVID-19 vaccin geïnduceerde immuun reacties
    Virus neutraliserende kracht en Fc functionaliteit van antistoffen (b.v. complement deposition) geïnduceerd door COVID-19 vaccinatie
    COVID-19 vaccin geïnduceerde antistoffen in neusvocht
    Lokale reacties na vaccinatie zoals gerapporteerd in een vragenlijst
    E.5.2.1Timepoint(s) of evaluation of this end point
    pre vaccination, day 2/3, 28 post vaccination 1, (day 28 post vaccination 2), 6 and 12 months post vaccination(s)
    for subjects participating in the booster follow up; a selection of endpoints will be measured at pre booster, 28 days post booster, 6 and 12 months post booster.
    voor vaccinatie, dag 2/3, dag 28 na vaccinatie 1, (dag 28 na vaccinatie 2), 6 en 12 maanden na vacinatie(s)
    deelnemers aan de booster follow up; een selectie van eindpunten wordt gemeten voor booster, 28 dagen na boost, 6 en 12 maanden na booster.
    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 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
    immune responses after COVID-19 vaccination
    immuun respons na COVID-19 vaccination
    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 Yes
    E.8.1.7.1Other trial design description
    de studie volgt de verschillende SARS-CoV-2 vaccinaties gegeven door de overheid.
    the trial follows the different SARS-CoV-2 immunizations given by the Government.
    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.8.2.4Number of treatment arms in the trial4
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    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 Yes
    F.1.1Number of subjects for this age range: 300
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 20
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 130
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 150
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1800
    F.1.3Elderly (>=65 years) No
    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 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 2021-04-20. Yes
    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 state2100
    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 Decision2021-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-03
    P. End of Trial
    P.End of Trial StatusOngoing
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