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    Summary
    EudraCT Number:2021-004558-44
    Sponsor's Protocol Code Number:2021-00604
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-09-13
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-004558-44
    A.3Full title of the trial
    Optimal Booster Strategy for SARS-CoV-2 Vaccination in Kidney Transplant patients
    Optimale booster strategie voor SARS-CoV-2 vaccinatie in niertransplantatie patiënten.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Optimal Booster Strategy for SARS-CoV-2 Vaccination in Kidney Transplant patients
    Optimale booster strategie voor SARS-CoV-2 vaccinatie in niertransplantatie patiënten.
    A.3.2Name or abbreviated title of the trial where available
    Recovac booster study
    Recovac booster studie
    A.4.1Sponsor's protocol code number2021-00604
    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 SponsorUMCG
    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 supportZonMW
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUMCG
    B.5.2Functional name of contact pointJSF Sanders
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713GZ
    B.5.3.4CountryNetherlands
    B.5.6E-mailj.sanders@umcg.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.2.1.1.1Trade name Spikevax
    D.2.1.1.2Name of the Marketing Authorisation holderModerna
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 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 INNINN-COVID-19 mRNA Vaccine
    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 mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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 Spikevax
    D.2.1.1.2Name of the Marketing Authorisation holderModerna
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 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 INNINN-COVID-19 mRNA Vaccine
    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 mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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 Janssen
    D.2.1.1.2Name of the Marketing Authorisation holderCOVID-19 Vaccine Janssen
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 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 INNAd26.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 Infectious unit
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number831763771
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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 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
    COVID-19 is associated with severely increased morbidity and mortality in kidney transplant patients. Available data show that the immune response after a standard regimen of two mRNA vaccinations is severely attenuated in kidney transplant patients compared to controls, especially when their immunosuppressive regimen contains mycophenolate mofetil (MMF) / mycophenolic acid (MPA).
    COVID-19 is geassocieerd met ernstig vergroot risico op ziekte en mortaliteit in niertransplantatie patiënten. Beschikbare data laat zien dat de immuunrespons na een standaard programma van 2 mRNA vaccinaties ernstig lager is in niertransplantatie patienten dan in een controle groep, zeker wanneer hun immuunsuppressie therapie MMF/MPA bevat.
    E.1.1.1Medical condition in easily understood language
    Many kidneytransplant patients are none responsive to the current Covid-19 vaccination regime. Therefore it is important to know whether a booster vaccine will increase the efficacy of vaccination.
    Veel niertransplantatie patienten hebben geen respons op het huidige Covid-19 vaccinatie beleid. Het is daarom van belang om te weten of een booster vaccin de effectiviteit van vaccinatie vergroot.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084401
    E.1.2Term COVID-19 respiratory infection
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084464
    E.1.2Term COVID-19 immunization
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084465
    E.1.2Term COVID-19 vaccination
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084508
    E.1.2Term COVID-19 antibody test
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10023439
    E.1.2Term Kidney transplant rejection
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10023438
    E.1.2Term Kidney transplant
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084270
    E.1.2Term SARS-CoV-2 acute respiratory disease
    E.1.2System Organ Class 100000004862
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084462
    E.1.2Term SARS-CoV-2 vaccination
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084463
    E.1.2Term SARS-CoV-2 immunisation
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10084466
    E.1.2Term SARS-CoV-2 immunization
    E.1.2System Organ Class 100000004865
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10084501
    E.1.2Term SARS-CoV-2 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 assess the immunogenicity (expressed as percentage of responders) of various COVID-19 booster vaccination strategies in kidney transplant patients that failed to mount a sufficient antibody response after two primary doses of the mRNA-1273 vaccine.
    Om de immunogeniciteit (uitgedrukt als percentage van de responders) te beoordelen van verschillende COVID-19-boostervaccinatiestrategieën bij niertransplantatiepatiënten die geen voldoende antilichaamrespons opriepen na twee primaire doses van het mRNA-1273-vaccin.
    E.2.2Secondary objectives of the trial
    - To measure the concentration of SARS-CoV-2 spike S1-specific IgG antibodies in serum at 28 days after the 3rd vaccine administration
    - To assess the durability of the SARS-CoV-2 spike S1-specific IgG antibody response at 6 and 12 months after the 3rd vaccine administration
    - To measure the presence and titer of neutralizing anti-SARS-CoV-2 antibodies after booster vaccination
    - To evaluate SARS-CoV-2 specific T cell responses
    - To measure anti-S1 antibody (IgG and IgA) responses and neutralizing capacity of these antibodies in nasal mucosal fluid
    - To evaluate vaccine safety in terms of incidence of solicited local and systemic adverse events (AEs) graded according to severity, including the incidence of acute rejections within 6 months after the third vaccination .
    - Om de concentratie van SARS-CoV-2 spike S1-specifieke IgG-antilichamen in serum te meten 28 dagen na de 3e vaccintoediening
    - Om de duurzaamheid van de SARS-CoV-2 spike S1-specifieke IgG-antilichaamrespons te beoordelen op 6 en 12 maanden na de 3e vaccintoediening
    - Om de aanwezigheid en titer van neutraliserende anti-SARS-CoV-2-antilichamen te meten na boostervaccinatie
    - Om SARS-CoV-2-specifieke T-celreacties te evalueren
    - Om anti-S1 antilichaam (IgG en IgA) responsen en neutraliserend vermogen van deze antilichamen in neusslijmvliesvloeistof te meten
    - Om de veiligheid van het vaccin te evalueren in termen van incidentie van gevraagde lokale en systemische bijwerkingen (AE's) gerangschikt naar ernst, inclusief de incidentie van acute afstoting binnen 6 maanden na de derde vaccinatie.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18 years or older
    2. Received 2 doses of mRNA-1273 according to the recommended vaccination schedule, with the last administration within the last nine months
    3. Insufficient response to vaccination, defined as anti-spike IgG in serum < 10 BAU/mL measured between 25 and 56 days after the second dose of the mRNA-1273 vaccine with a validated test
    4. Eligible for COVID-19 vaccination as described by the instructions of the manufacturers of the vaccine (Moderna and Janssen)
    5. Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed informed consent form has been obtained)
    6. Willing to adhere to the protocol and be available during the study period

    Additional inclusion criteria to be eligible for stratum A:
    7. Maintenance immunosuppressive therapy consisting of a calcineurin inhibitor (tacrolimus or cyclosporine), MMF/MPA, and prednisone
    8. In case of tacrolimus treatment: last tacrolimus pre-dose level while on current dosage above 4 μg/l
    9. In case of cyclosporine treatment: last cyclosporine pre-dose level while on current dosage above 75 μg/l
    10. Prednisone dose at least 5 mg/day
    11. First or second transplantation
    12. Calculated level of panel reactive antibodies prior to last transplantation below 85%
    13. No signs of acute rejection during the preceding year
    1. Leeftijd 18 jaar of ouder
    2. 2 Doses mRNA-1273 vaccin volgens het aanbevolen vaccinatie schema hebben ontvangen, met de laatste registratie binnen de afgelopen negen maanden
    3. Onvoldoende respons op de vaccinatie, gedefinieerd als anti-spike IgG in serum < 10 BAU/mL, gemeten tussen 25 en 56 dagen na de tweede dosis mRNA-1273 vaccin met een gevalideerde test.
    4. In aanmerking komend voor Covid-19 vaccinatie zoals beschreven in de instructies van de fabrikant (Moderna en Janssen)
    5. In staat om het doel en de risico's van de studie te begrijpen, volledig geïnformeerd en schriftelijke geïnformeerde toestemming te geven (ondertekend formulier voor geïnformeerde toestemming is verkregen)
    6. Bereid zijn het protocol te volgen en gedurende de periode van de studie beschikbaar te zijn

    Bijkomende inclusie criteria om in aanmerking te komen voor arm A:
    7. Onderhouds immuunsuppressie therapie bestaande uit een calcineurine remmer (tacrolimus of cyclosporine), MMF/MPA en Prednison
    8. In het geval van tacrolimus gebruik: laatste tacrolimus dalspiegel tijdens de huidige dosering boven de 4 μg/l
    9. In het geval van cyclosporine gebruik: laatste cyclosporine dalspiegel tijdens de huidige dosering boven de 75 μg/l
    10. Prednison dosering minimaal 5mg/dag
    11. Eerste of tweede transplantatie
    12. Berekende hoeveelheid panel reactieve antilichamen voorafgaand aan de laatste transplantatie lager dan 85%
    13. Geen tekenen van acute afstoting in het voorafgaande jaar.
    E.4Principal exclusion criteria
    1. Multi-organ transplant recipient
    2. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s).
    3. Previous or active COVID-19 disease
    4. Active malignancy, except non-melanoma skin cancer
    5. Inherited immune deficiency
    6. Infection with Human Immunodeficiency Virus (HIV)
    7. Administration of T cell, B cell, or plasma cell depleting antibodies during the last 6 months
    8. Any vaccination within a month before enrolment
    9. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
    1. Multi orgaan transplantatie ontvanger
    2. Geschiedenis van ernstige bijwerkingen na vaccinatie en/of een ernstige allergische reactie (bv anafylactie) op een onderdeel van de studie interventies.
    3. Eerdere of actieve Covid-19 besmetting
    4. Actieve maligne aandoening, behalve non-melanoom huidkanker
    5. Aangeboren immuun deficiëntie
    6. HIV infectie
    7. Toediening van T cellen, B cellen of plasma cellen gedurende de afgelopen 6 maanden
    8. geen enkele vaccinatie gehad in de maand voor deelname
    9. verhoogde bloedingsneiging of een aandoening met een verlengde bloedingstijd die, naar inzicht van de onderzoeker, een contra-indicatie is voor een intramusculaire injectie
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the percentage of subjects with a serum anti-S1 IgG concentration ≥10 BAU/mL at 28 days after the third vaccine administration.
    Het primaire eindpunt is het percentage deelnemers met een serum anti-S1 IgG concentratie ≥10 BAU/mL op dag 28 na de derde vaccinatie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days after the third (and possibly a fourth) vaccination
    28 dagen na de derde (en eventueel de vierde) vaccinatie
    E.5.2Secondary end point(s)
    o SARS-CoV-2 specific antibody concentrations in serum at 28 days after the 3rd vaccine administration
    o SARS-CoV-2 specific antibody concentrations in serum at 6 and 12 months after the 3rd vaccine administration
    o The titer of neutralizing anti-SARS-CoV-2 antibodies at 28 days after the 3rd vaccine administration
    o SARS-CoV-2 specific antibody concentrations in nasal mucosal fluid at 28 days and 6 months after the 3rd vaccine administration
    o SARS-CoV-2 specific T cell responses at 28 days after the third vaccine administration by:
     Measuring interferon-gamma concentration in whole blood after ex vivo stimulation with SARS-CoV-2 specific peptides
     Measuring ex vivo production of T cell related cytokines by peripheral blood mononuclear cells (PBMC) in ELISpot assays
    o Incidence of acute rejection within 6 months after the third vaccine administration
    o Safety in terms of incidence of solicited local and systemic adverse events (AEs) within one week after vaccine administration graded according to severity. The following items will be specifically addressed:
     Percentage of participants reporting local reactions (pain at the injection site, redness and swelling) within 7 days after vaccine administration
     Percentage of participants reporting systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, new of worsened muscle pain, and new or worsened joint pain) within 7 days after vaccine administration
     Percentage of participants with serious adverse events within 6 months after the third vaccine administration
    - SARS-CoV-2 specifieke antilichamen concentraties in serum op 28 dagen na de derde vaccinatie
    - SARS-CoV-2 specifieke antilichamen concentraties in serum op 6 en 12 maanden na de derde vaccinatie
    - De titer van neutraliserende antilichamen op 28 dagen na de derde vaccinatie
    - SARS-CoV-2 specifieke antilichamen concentraties in neusslijm op 28 dagen en 6 maanden na de derde vaccinatie
    - SARS-CoV-2 specifieke T cel respons op- 28 dagen na de derde vaccinatie door:
    *het meten van de interferon gamma concentratie in volbloed na ex vivo stimulatie met SARS-CoV-2 specifieke peptiden
    * het meten van de ex-vivo productie van T cel gerelateerde cytokines door perifeer bloed mononucleaire cellen (PBMC) in ELIspot assays
    - Het voorkomen van acute afstoting binnen 6 maanden na de derde vaccinatie
    - Veiligheid in termen van het voorkomen van lokale en systemische bijwerkingen (AE's) binnen ene week na de vaccinatie, ingedeeld naar ernst. De volgende items worden specifiek benoemd:
    * percentage deelnemers dat lokale reacties benoemd (pijn op de injectieplek, roodheid, zwelling) binnen 7 dagen na vaccinatie
    * percentage deelnemers dat systemische reacties benoemd (koorts, moeheid, hoofdpijn, koude rillingen, braken, diarree, spierpijn (nieuw of verergerd), en gewrichtspijn (nieuw of verergerd) binnen 7 dagen na vaccinatie.
    * percentage deelnemers met ernstige bijwerkingen binnen 6 maanden na de derde vaccinatie
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 and 12 months after the third vaccination
    6 en 12 maanden na de derde vaccinatie
    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 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 Yes
    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.8.2.4Number of treatment arms in the trial5
    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 concerned4
    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 Yes
    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
    End of study will be 12 months after the last subjecthas had his/her third vaccination
    12 maanden nadat de laatste deelnemer zijn derde vaccinatie heeft gehad
    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 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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 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 state460
    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
    geen
    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 Decision2021-09-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-03-12
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