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    Summary
    EudraCT Number:2020-005915-39
    Sponsor's Protocol Code Number:RT-CoV-2_01
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-03-01
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-005915-39
    A.3Full title of the trial
    COVID-19 A Phase II/III, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of GRAd-COV2 Vaccine in Adults Aged 18 Years and Older
    COVID-19 Studio di fase II/III, randomizzato, stratificato, cieco all’osservatore e controllato con placebo per valutare l'efficacia, la sicurezza e l'immunogenicità del vaccino GRAd-COV2 negli adulti di età pari o superiore a 18 anni.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study with GRAd-COV2 Vaccine for the Prevention of COVID-19 in Adults
    Studio clinico con vaccino GRAd-COV2 per la prevenzione di COVID-19 negli adulti
    A.3.2Name or abbreviated title of the trial where available
    COVITAR
    COVITAR
    A.4.1Sponsor's protocol code numberRT-CoV-2_01
    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 SponsorREITHERA SRL
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportReiThera Srl
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto Nazionale Malattie Infettive L. Spallanzani
    B.5.2Functional name of contact pointUnità di sperimentazioni COVID
    B.5.3 Address:
    B.5.3.1Street AddressVia Portuense 292
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00149
    B.5.3.4CountryItaly
    B.5.4Telephone number0655170923
    B.5.5Fax number065582825
    B.5.6E-mailsimone.lanini@inmi.it
    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 No
    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 nameGRAd-COV2
    D.3.2Product code [GRAd-COV2]
    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.3.9.2Current sponsor codeGRAd-COV2
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subjects exposed to SARS-COV-2 risk of infectious
    Soggetti a rischio di contagio da SARS-COV-2
    E.1.1.1Medical condition in easily understood language
    vaccine against SARS-COV-2 infection
    Vaccino contro l'infezione da SARS-COV-2
    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
    Primary for Phase II Part of the study:
    1) To assess the reactogenicity of a single or repeated (21 day apart) IM dose of GRAd-COV2 compared to placebo in adults of 18 years or more of age
    Phase III Part of the study:
    2) To identify the schedule to be further studied in phase III by assessing antibody responses to S antigen following a single or repeated (21 days apart) IM dose of GRAd-COV2 or placebo (first 450 participants)
    Primary for Phase III Part of the study:
    1) To estimate the efficacy of a single or repeated (21 days apart) IM dose of GRAd-COV2 compared to placebo for the prevention of COVID-19 in adults of 18 years or more of age
    Primario per la Fase II dello studio
    1) Valutare la reattogenicità di una dose intramuscolare singola o ripetuta (a distanza di 21 giorni) di GRAd-COV2 rispetto al placebo in soggetti adulti di età maggiore o uguale a 18 anni
    2) Identificare la posologia da applicare in Fase III dello studio, mediante valutazione delle risposte anticorpali all'antigene S dopo una dose intramuscolare singola o ripetuta (a 21 giorni di distanza) di GRAd-COV2 o placebo (primi 450 partecipanti)

    Primario per la Fase III dello studio
    1) Stimare l'efficacia di una dose intramuscolare singola o ripetuta (a 21 giorni di distanza) di GRAd-COV2 rispetto al placebo per la prevenzione di COVID-19 negli adulti di età maggiore o uguale a 18 anni
    E.2.2Secondary objectives of the trial
    Secondary (study phase indicated in parenthesis)
    To estimate the efficacy of 1 single or repeated (21 days apart) IM dose of GRAd-COV2 compared to placebo for the prevention of severe or critical symptomatic COVID-19 (Phase III)
    Refer to the Study Protocol for the other secondary objectives section
    Obiettivo secondario (fase di studio indicata tra parentesi)
    Stimare l'efficacia di una dose intramuscolare singola o ripetuta (a distanza di 21 giorni) di GRAd-COV2 rispetto al placebo per la prevenzione del COVID-19 con sintomatologia severa o critica. (Fase III)
    Per la sezione altri obiettivi secondari fare riferimento al protocollo di Studio
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Only at INMI Spallanzani- Rome
    The substudy in question, named "PBMC-Based System", consists in the evaluation of T lymphocyte cell responses to the candidate vaccine, in an in vitro system consisting of short-term antigenic stimulation of peripheral blood mononuclear cells (PBMC).

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Solo per INMI Spallanzani di Roma.
    Il sottostudio in questione, denominato “PBMC-Based System”, consiste nella valuazione delle risposte delle cellule linfociti T al candidato vaccino, in un sistema in vitro costituito da stimolazione antigenica a breve termine di cellule mononucleate di sangue periferico (PBMC).
    E.3Principal inclusion criteria
    1. Adult female and male, 18 years of age or older at the time of consent
    2. Medically stable such that, according to the judgment of the investigator, hospitalization within the study period is not anticipated and the participant appears likely to be able to remain on study through the end of protocol-specified follow-up. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months prior to enrollment
    3. Able to understand and comply with study requirements/procedures based on the assessment of the investigator
    4. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
    5. Female participants, (a) Women of childbearing potential must: Have a negative pregnancy test on the day of screening and on Day 1; use one highly effective form of birth control for at least 28 days prior to Day 1 and agree to continue using one highly effective form of birth control through 60 days following administration of study intervention.
    6. Capable of giving signed informed consent.
    1. Donne e uomini adulti, di età maggiore o uguale a 18 anni al momento del consenso
    2. Soggetti stabili dal punto di vista medico, secondo il giudizio dello sperimentatore, che non necessitino di ricovero ospedaliero durante il periodo di studio e che siano in grado di rimanere nello studio per l’intera durata prevista. Si definisce condizione medica stabile una patologia che non abbia richiesto un cambiamento significativo della terapia o un ricovero in ospedale dovuto a peggioramento nei 3 mesi precedenti allo screening
    3. Soggetti in grado di comprendere e rispettare i requisiti/procedure dello studio, secondo il giudizio dello sperimentatore
    4. L'uso di contraccettivi da parte delle donne deve essere conforme alle normative locali relative ai metodi di contraccezione per coloro che partecipano a studi clinici
    5. Partecipanti di sesso femminile, (a) le donne in età fertile devono: risultare negative a un test di gravidanza il giorno dello screening e il giorno 1; utilizzare una forma altamente efficace di controllo delle nascite da almeno 28 giorni prima del giorno 1 e accettare di continuare a utilizzare una forma altamente efficace di controllo delle nascite fino a 60 giorni dopo la somministrazione dell'intervento in studio.
    6. Soggetti in grado di firmare il consenso informato.
    E.4Principal exclusion criteria
    1. History of allergy to any component of the vaccine
    2. History of Guillain-Barré syndrome or any other demyelinating condition
    3. Significant infection or other acute illness, including fever > 37.3 °C on the day prior to or day of randomization
    4. History of laboratory-confirmed SARS-CoV-2 infection
    5. Any confirmed or suspected immunosuppressive or immunodeficient state, including asplenia (only for phase II)
    6. Recurrent severe infections and use of immunosuppressant medication within the past 6 months
    7. History of primary malignancy except for: (a) Malignancy with low potential risk for recurrence after curative treatment (for example, history of childhood leukaemia) or metastasis (for example, indolent prostate cancer) in the opinion of the site investigator. (b) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease (c) Adequately treated uterine cervical carcinoma in situ without evidence of disease (d) Localized prostate cancer (only for phase II)
    8. Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or vene puncture
    9. Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness, as judged by the Investigator (mild/moderate well-controlled comorbidities are allowed) (only for phase II)
    10. Any other significant disease, disorder, or finding that may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study, or impair interpretation of the study data
    11. Receipt of, or planned receipt of investigational or licensed products indicated for the treatment or prevention of SARS-CoV-2 or COVID-19
    12. Receipt of any vaccine (licensed or investigational) other than licensed influenza vaccines within 30 days prior to and after administration of study intervention
    13. Receipt of immunoglobulins and/or any blood products within 3 months prior to administration of study intervention or expected receipt during the period of study follow-up
    14. Involvement in the planning and/or conduct of this study (applies to both Sponsor staff and/or staff at the study site)
    15. For women only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding
    16. Has donated 450 ml or more of blood products within 30 days prior to randomization or expects to donate blood within 90 days of administration of study intervention.
    1. Storia di allergia a qualsiasi componente del vaccino
    2. Storia di sindrome di Guillain-Barré o di qualsiasi altra condizione demielinizzante
    3. Infezione significativa o altra malattia acuta, inclusa febbre > 37,3 °C il giorno precedente o il giorno della randomizzazione
    4. Storia di infezione da SARS-CoV-2 confermata da test di laboratorio
    5. Qualsiasi stato immunosoppressivo o immunodeficiente confermato o sospetto, inclusa l'asplenia (solo per la fase II)
    6. Infezioni gravi ricorrenti e uso di farmaci immunosoppressori negli ultimi 6 mesi
    7. Storia di tumore maligno primario ad eccezione di: (a) tumore maligno con basso rischio potenziale di recidiva dopo trattamento curativo (ad esempio, storia di leucemia infantile) o metastasi (ad esempio, cancro alla prostata indolente) secondo il parere dello sperimentatore del centro; (b) cancro della pelle non melanoma o lentigo maligna adeguatamente trattato senza evidenza di malattia; (c) carcinoma della cervice uterina adeguatamente trattato in situ senza evidenza di malattia; (d) cancro della prostata localizzato (solo per la fase II)
    8. Disturbo emorragico clinicamente significativo (ad es. deficit di fattore, coagulopatia o disturbo piastrinico) o storia precedente di sanguinamento o lividi significativi a seguito di iniezioni intramuscolari o puntura venosa
    9. Malattie cardiovascolari gravi e/o incontrollate, malattie respiratorie, malattie gastrointestinali, malattie epatiche, malattie renali, disturbi endocrini e malattie neurologiche, come giudicato dallo sperimentatore (sono consentite comorbidità lievi/moderate ben controllate) (solo per la fase II)
    10. Qualsiasi altra malattia, disturbo o riscontro rilevante che possa aumentare significativamente il rischio per il partecipante a causa della permanenza nello studio, influenzare la capacità del partecipante di partecipare allo studio o compromettere l'interpretazione dei dati dello studio
    11. Assunzione di prodotti sperimentali o autorizzati, anche programmata, indicati per il trattamento o la prevenzione di SARS-CoV-2 o COVID-19
    12. Assunzione di qualsiasi vaccino (autorizzato o sperimentale) diverso dai vaccini antinfluenzali autorizzati nei 30 giorni precedenti e successivi alla somministrazione del vaccino in studio
    13. Assunzione di immunoglobuline e/o prodotti derivati dal sangue nei 3 mesi precedenti alla somministrazione del vaccino in studio o assunzione prevista durante il periodo di follow-up dello studio
    14. Coinvolgimento nella pianificazione e/o conduzione del presente studio (si applica sia al personale dello Sponsor che/o al personale del centro dove si svolge lo studio)
    15. Donne attualmente in gravidanza (confermata con test positivo) o in allattamento
    16. Soggetti che hanno donato 450 ml o più di prodotti derivati dal sangue nei 30 giorni precedenti alla randomizzazione o prevedono di donare il sangue entro 90 giorni dalla somministrazione dell'intervento di studio
    E.5 End points
    E.5.1Primary end point(s)
    Phase II Part of the study
    Incidence of local and systemic solicited AEs for 7 days post each dose of study intervention
    a) Post-treatment GMTs and GMFRs from day of dosing baseline value to 35 days post first dose in SARS-CoV-2 S and/or RBD antibodies
    b) Proportion of participants who have a post-treatment seroresponse (at least 4-fold rise in titers from day of dosing baseline value to 35 days post first dose) to the S and/or RBD antigens of GRAd-COV2.

    Phase III Part of the study
    A binary response, whereby a participant is defined as a COVID-19 case if their first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurs at least 28 days post first dose or or at least 7 days after the second dose of study intervention (depending on the selected regimen). Otherwise, a participant is not defined as a COVID-19 case. The endpoint will be treated as time to event
    Intercurrent events: The intercurrent events (ie, withdrawals before having met the primary efficacy endpoint, deaths for reasons that are unrelated to COVID-19 and COVID-19 infections that occur before 28 days post single dose or before 7 days post second dose) will be handled using a “while on treatment” strategy, where the time to COVID-19 is censored at the date of withdrawal or death or early COVID-19 infection. In case the double-dose schedule is selected for phase III, subjects missing the second dose will be excluded from the primary analysis.
    a) Incidence of AEs for 28 days post each dose of study intervention
    b) Incidence of SAEs, MAAEs, and AESIs from Day 1 post treatment through Day 730.
    Fase II dello Studio
    Incidenza di eventi avversi locali e sistemici nei 7 giorni successivi ad ogni dose ricevuta
    a) Valutazione degli anticorpi SARS-CoV-2 S e/o RBD mediante analisi dei valori di GMTs e GMFRs, post trattamento, dal basale fino a 35 giorni dopo la prima dose.
    b) Percentuale di partecipanti che presentano una sierorisposta agli antigeni S e/o RBD di GRAd-COV2 post-trattamento, considerata come un aumento di almeno 4 volte il valore basale a 35 giorni dopo la prima dose
    Fase III dello Studio
    L’endpoint primario si basa sulla valutazione dei casi COVID-19. In particolare, un soggetto viene identificato come caso COVID-19 se il primo evento di positività al test RT-PCR per SARS-CoV-2 accompagnato da sintomi della malattia si verifica almeno 28 giorni dopo la prima dose o almeno 7 giorni dopo la seconda (a seconda dello schema di dosi selezionato). In caso contrario, il partecipante non verrà definito come caso COVID-19. L’endpoint verrà valutato come time to event.
    Eventi intercorrenti: gli eventi intercorrenti (ovverosia: interruzioni prima di aver raggiunto l'endpoint primario di efficacia, decessi per motivi non correlati al COVID-19 e infezioni da COVID-19 che si verificano nei 28 giorni successivi alla prima dose o nei 7 giorni successivi alla seconda dose) saranno gestiti usando una strategia “while on treatment (durante il trattamento)”, in cui la distribuzione nel tempo termina nella data di ritiro o morte o infezione precoce da COVID-19. Nel caso in cui nella Fase III verrà selezionata la modalità a due dosi, i soggetti che non abbiano ricevuto la seconda dose saranno esclusi dall'analisi primaria.
    a) Incidenza di eventi avversi nei 28 giorni successivi ad ogni dose ricevuta.
    b) Incidenza di SAE, MAAE e AESI dal primo giorno successivo al trattamento fino al giorno 730
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoint are reported within the endpoint list
    Tempi di rilevazione indicati all'interno dei punti finali
    E.5.2Secondary end point(s)
    For relevant study phase please see section E.2 objective:
    Time to first SARS-CoV-2 RT-PCR-positive severe or critical symptomatic illness occurring from 28 days post first dose or from 7 days after second dose of study intervention.
    1. Proportion of participants who have a post-treatment response (negative at baseline to positive post treatment with study intervention) for SARS-CoV-2 Nucleocapsid antibodies over time.
    2. Time to first case of SARS-CoV-2 RT-PCR- positive symptomatic illness occurring from 28 days post first dose or from 7 days after second dose of study intervention using CDC criteria.
    3. Time to first COVID-19-related Emergency Department admission occurring from 28 days post single dose or from 7 days post second dose of study intervention.
    4. Time to COVID-19 related death occurring from 28 days post single dose or from 7 days post second dose of study intervention.
    5a. Post-treatment GMTs and GMFRs from day of dosing baseline value to 35 days post first dose (14 days post second dose) in SARS-CoV-2 S and/or RBD antibodies
    5b. The proportion of participants who have a post-treatment seroresponse (at least 4-fold rise in titers from day of dosing baseline value to 35 days post first dose) to the S and/or RBD antigens of GRAd-COV2
    6a. Post-treatment GMTs and GMFRs from day of dosing baseline value to 35 days post first dose (14 days post second dose) in SARS-CoV-2 neutralizing antibodies.
    6b. Proportion of participants who have a post-treatment seroresponse (at least 4-fold rise in titers from day of dosing baseline value to 35 days post first dose) to GRAd-COV2 as measured by SARS-CoV-2 neutralizing antibodies.
    Per la fase di studio pertinente si prega di vedere la sezione E.2 obiettivo
    Tempo che intercorre al primo evento di positività al test RT-PCR per SARS-CoV-2, accompagnato da sintomatologia severa o critica, a partire da 28 giorni dopo la prima dose o 7 giorni dalla seconda.
    1. Percentuale di partecipanti che hanno una risposta post-trattamento (da negativa al basale a positiva nel post-trattamento) per gli anticorpi SARS-CoV-2 Nucleocapside nel corso del tempo.
    2. Tempo che intercorre al primo evento di positività al test RT-PCR per SARS-CoV-2, accompagnato da sintomatologia severa o critica secondo i criteri CDC, a partire da 28 giorni dopo la prima dose o 7 giorni dalla seconda.
    3. Tempo che intercorre al primo ricovero in Pronto Soccorso per COVID-19, a partire da 28 giorni dopo la prima dose o 7 giorni dalla seconda.
    4. Quanto tempo dopo si verifica il primo decesso per COVID-19 a partire da 28 giorni dopo la prima dose o 7 giorni dalla seconda.
    5a. Analisi dei valori degli anticorpi SARS-CoV-2 S e/o RBD misurati come GMTs e GMFRs dal basale fino a 35 giorni dopo la prima dose (14 giorni dopo la seconda)
    5b. b) La proporzione di partecipanti che hanno una sierorisposta agli antigeni S e/o RBD di GRAd-COV2 post-trattamento (aumento della titolazione di almeno 4 volte dal giorno del valore al basale della somministrazione ai 35 giorni successivi alla prima dose)
    6a. Analisi dei valori degli anticorpi neutralizzanti SARS-CoV-2 misurati come GMTs e GMFRs dal giorno del valore basale fino a 35 giorni dopo la prima dose (14 giorni dopo la seconda)
    6b. b) Percentuale di partecipanti che hanno una sierorisposta agli anticorpi neutralizzanti SARS-CoV-2 post-trattamento, considerata come un aumento di almeno 4 volte il valore basale a 35 giorni dopo la prima dose
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoint are reported within the endpoint list
    tempi di rilevazione indicati all'interno degli endpoint
    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 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 Yes
    E.6.13.1Other scope of the trial description
    immunogenicity
    immunogenicità
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Stratificato: 3 strati maggiore o uguale 65 anni, < 65 anni a rischio maggiore COVID-19 e < 65 anni
    Stratified: 3 strata 65 years or more, < 65 years at COVID-19 increased risk and < 65 years not at r
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    placebo o vaccino alternativo, solo fase III
    placebo or alternative vaccine, only during Phase III
    E.8.2.4Number of treatment arms in the trial3
    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 concerned23
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Belgium
    Brazil
    Chile
    Czechia
    France
    Germany
    Indonesia
    Italy
    Malaysia
    Poland
    South Africa
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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: 7500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2500
    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 state2500
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 6500
    F.4.2.2In the whole clinical trial 10000
    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)
    not expected
    non previsto
    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 Decision2021-02-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-19
    P. End of Trial
    P.End of Trial StatusOngoing
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