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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2022-000074-25
    Sponsor's Protocol Code Number:HIPRA-HH-5
    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:2022-03-02
    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 number2022-000074-25
    A.3Full title of the trial
    A PHASE III, OPEN LABEL, SINGLE ARM, MULTI-CENTER, TRIAL TO ASSESS THE SAFETY AND IMMUNOGENICITY OF A BOOSTER VACCINATION WITH A RECOMBINANT PROTEIN RBD FUSION HETERODIMER CANDIDATE (PHH-1V) AGAINST SARS-COV-2, IN ADULTS VACCINATED AGAINST COVID-19
    Uno studio di fase III, in aperto, a braccio singolo, multicentrico per la valutazione della sicurezza e dell'immunogenicità di una vaccinazione di richiamo con una proteina ricombinante candidata a base di eterodimero di fusione RBD (PHH-1V) contro il SARS-CoV-2, in adulti vaccinati contro il COVID-19
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase III study to evaluate safety and immunogenicity of recombinant protein candidate vaccine against SARS-CoV-2 in adults vaccinated against COVID-19
    Uno studio di fase III per valutare la sicurezza e l'immunogenicità del vaccino candidato proteico ricombinante contro SARS-CoV-2 negli adulti vaccinati contro COVID-19
    A.3.2Name or abbreviated title of the trial where available
    -
    -
    A.4.1Sponsor's protocol code numberHIPRA-HH-5
    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 SponsorHIPRA SCIENTIFIC S.L.U
    B.1.3.4CountrySpain
    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 supportHIPRA SCIENTIFIC S.L.U
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHIPRA SCIENTIFIC S.L.U.
    B.5.2Functional name of contact pointR&D and Regulatory Affairs Director
    B.5.3 Address:
    B.5.3.1Street AddressAvda. La Selva, 135
    B.5.3.2Town/ cityAmer
    B.5.3.3Post code17170
    B.5.3.4CountrySpain
    B.5.4Telephone number972430660
    B.5.5Fax number972430660
    B.5.6E-mailelia.torroella@hipra.com
    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 namePHH-1V
    D.3.2Product code [PHH-1V]
    D.3.4Pharmaceutical form Emulsion 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 INNPHH-1V
    D.3.9.2Current sponsor codePHH-1V
    D.3.9.4EV Substance CodeSUB223972
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 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 No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    SARS-CoV-2
    SARS-CoV-2
    E.1.1.1Medical condition in easily understood language
    COVID-19 infection
    Infezione Covid-19
    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
    To assess the safety and tolerability of PHH-1V as a booster dose in healthy adult subjects vaccinated against COVID-19 with the Comirnaty, Spikevax, Vaxevria or Janssen vaccine
    Valutare la sicurezza e la tollerabilità di PHH-1V come dose di richiamo in soggetti adulti sani già vaccinati contro il COVID-19 con i vaccini Comirnaty, Spikevax, Vaxzevria o Janssen.
    E.2.2Secondary objectives of the trial
    1. To determine and compare the changes of the immunogenicity measured by pseudovirus neutralisation against Wuhan strain (also known as L strain) and against Omicron, and any other relevant Variants of Concern (VOC) in the epidemiologic moment, at Baseline and at Days 14, 91, 182 and 365, after booster of HIPRA’s vaccine (PHH-1V) in a subset of participants.
    2. To evaluate the immunogenicity measured by means of total antibody against Receptor Binding Domain of the Spike protein of SARS-CoV-2 quantification, measured by an electrochemiluminescence immunoassay (ECLIA) at Baseline and at Days 14, 91, 182 and 365 after booster of HIPRA’s vaccine (PHH-1V) in a subset of participants.
    1. Determinare e confrontare le variazioni dell'immunogenicità misurata in termini di neutralizzazione dello pseudovirus contro il ceppo Wuhan (noto anche come ceppo L) e contro Omicron, e qualsiasi altra variante di preoccupazione (VOC) nel periodo epidemiologico, rispetto al basale ed ai giorni 14, 91, 182 e 365 dopo la somministrazione della dose di richiamo del vaccino HIPRA (PHH-1V) in un sottogruppo di partecipanti.
    2. Valutare l'immunogenicità misurata attraverso la quantificazione degli anticorpi totali contro il dominio di legame al recettore della proteina Spike del SARS-CoV-2, misurata mediante un test immunologico in elettrochemiluminescenza (ECLIA) al basale e ai giorni 14, 91, 182 e 365 dopo la somministrazione del vaccino di richiamo HIPRA (PHH-1V) in un sottogruppo di partecipanti.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female, =16 years old at Day 0.
    - Willing to provide consent indicating that she or he understands the purpose and potential risks and is willing and able to participate in the study and comply with all the study requirements and procedures.
    - Have a recognized primary vaccination scheme recognized by the authorities with Comirnaty, Spikevax, Vaxevria or Janssen at least 91 days and preferably a maximum of 240 days before Day 0.
    - Participants may have underlying illnesses if are stable and well-controlled according to the investigator judgment.
    - Participant is willing to avoid receiving live attenuated vaccines (licensed) within 4 weeks before screening or after receiving any study vaccine, or other not live vaccines (licensed) within 14 days before and after receiving any study vaccine.
    - Participant agrees not to donate blood, blood products and bone marrow at least 3 months before and after vaccination.
    - Female participants of childbearing potential must have a negative pregnancy test on the on Day 0 prior to vaccination.
    - Female participants of childbearing potential must use any acceptable contraceptive method that should be started on day 0 and until 8 weeks after vaccination (hormonal contraception: oral, injectable or transdermal patch, intrauterine device, vasectomized partner, sexual abstinence or condom).
    - Male participants must use any acceptable contraceptive method that should be started on day 0 and until 8 weeks after vaccination (vasectomized participants, condom, sexual abstinence).
    - Male participants must refrain from donating sperm for at least 28 days after day 0.
    - Maschio o femmina, = 16 anni al giorno 0.
    - Partecipante in grado di fornire il consenso nel quale indica che comprende lo scopo e i rischi potenziali ed è disposto e in grado di partecipare allo studio nel rispetto di tutti i requisiti e delle procedure dello studio.
    - Partecipante al quale è stato eseguito un programma di vaccinazione SARS-CoV-2 riconosciuto dalle autorità nazionali con uno dei seguenti vaccini: Comirnaty, Spikevax, Vaxzevria o Janssen almeno 91 giorni e preferibilmente un massimo di 240 giorni prima del giorno 0.
    - Possono partecipare soggetti affetti da patologie sottostanti se sono stabili e ben controllate a giudizio dello sperimentatore.
    - Il partecipante è disposto a evitare di ricevere vaccini vivi attenuati (autorizzati) entro 4 settimane prima dello screening o dopo aver ricevuto qualsiasi vaccino in studio, o altri vaccini inattivati (autorizzati) entro 14 giorni prima e dopo aver ricevuto qualsiasi vaccino in studio.
    - Il partecipante accetta di non donare sangue, componenti ematiche e midollo osseo almeno 3 mesi prima e dopo la vaccinazione.
    - Le partecipanti di sesso femminile in età fertile devono avere un test di gravidanza negativo il giorno 0 prima della vaccinazione.
    - Partecipanti di sesso femminile in età fertile devono utilizzare qualsiasi metodo contraccettivo accettabile dal giorno 0 e fino ad 8 settimane dopo la vaccinazione (contraccezione ormonale - orale, iniettabile o cerotto transdermico - dispositivo intrauterino, partner vasectomizzato, astinenza sessuale, uso di profilattico.
    - Partecipanti di sesso maschile devono utilizzare un metodo contraccettivo dal giorno 0 e fino a 8 settimane dopo la vaccinazione (partecipanti vasectomizzati, preservativo, astinenza sessuale).
    - Partecipanti di sesso maschile devono astenersi dalla donazione di sperma per almeno 28 giorni dopo il giorno 0.
    E.4Principal exclusion criteria
    - History of anaphylaxis to any prior vaccine.
    - Previous severe SARS-CoV-2 infections are not permitted (ote: Severity explained as any episode of COVID-19 requiring = 24hrs of hospitalization).
    - Participant received or plans to receive live attenuated vaccines within 4 weeks before and after day 0; or other not live vaccines within 14 days before and after day 0.
    - Pregnancy or breast-feeding at screening or Day 0 or willingness/intention to become pregnant during the study.
    - Participant has a clinically significant acute illness or fever (temperature =38º C (100.4ºF)) at screening or within 48 hours prior to Day 0.
    - Participant had a surgery requiring hospitalization before vaccination and he/she has not received the hospital discharge at day 0; or has a surgery requiring hospitalization planned within 12 weeks after study vaccine administration.
    - Participant has any active malignancy even if under treatment except for non-melanoma skin cancer, uterine cervical carcinoma, anal carcinoma, localized prostate cancer.
    - Participant has ongoing severe and non-stable psychiatric condition likely to affect participation in the study.
    - Participant has a problematic or risk use of substances including alcohol that can compromise the study follow-up.
    - Participant has a bleeding disorder or has any condition that in the opinion of the investigator contraindicates intramuscular injections.
    - Participant has abnormal function of the immune system, except stable clinical conditions like controlled HIV.
    - Participants have clinically significant and unstable cardiovascular, respiratory, hepatic, neurological, gastrointestinal, renal, or any other medical disorder judged by the investigator clinically significant and unstable within 3 months before screening.
    - Chronic or recurrent administration of systemic immunosuppressant medication.
    - Subject has received immunoglobulins and/or blood-derived products 12 weeks prior vaccination (Day 0) or expects to receive them during the study.
    - Participant received any immunotherapy (monoclonal antibodies, plasma) aimed to prevent or treat COVID-19 within 90 days before day 0.
    - Participation in any research involving an investigational product (drug, biologic, device) within 12 weeks prior to vaccination and during the study.
    - Participant has donated = 450ml of blood products within 12 weeks before screening.
    - Participant has any medical condition and/or finding that in the investigator opinion might increase participant risks, interfere with the study or impair interpretation of study data.
    - Storia di anafilassi dopo un qualsiasi vaccino precedente.
    - Infezione grave da SARS-CoV-2 ( la gravità si riferisce a qualsiasi episodio di COVID-19 che richiede = 24 ore di ricovero).
    - Al partecipante sono stati somministrati o si prevede che gli vengano somministrati vaccini vivi attenuati entro 4 settimane prima e dopo il giorno 0 o altri vaccini inattivati (autorizzati) entro 14 giorni prima e dopo il giorno 0.
    - Stato di gravidanza o allattamento allo screening o al giorno 0 o volontà/intenzione di rimanere incinta durante lo studio.
    - Partecipante affetto da una malattia acuta clinicamente significativa o febbre (temperatura =38 °C (100,4 °F) al momento dello screening o entro 48 ore prima del giorno 0.
    - Partecipante che ha subito un intervento chirurgico con necessità di ricovero (definito come permanenza in ospedale per > 24 ore) prima della vaccinazione e non è stato dimesso dall'ospedale al giorno 0; oppure che dovrà subire un intervento chirurgico pianificato con necessità di ricovero entro 12 settimane dalla somministrazione del vaccino dello studio.
    - Partecipante affetto da qualsiasi tumore maligno attivo anche se in trattamento, ad eccezione di cancro della pelle non melanoma, carcinoma cervicale uterino in situ, carcinoma anale in situ, cancro alla prostata localizzato.
    - Partecipante affetto da un disturbo psichiatrico grave e non stabile che potrebbe influenzare la sua partecipazione allo studio.
    - Partecipante affetto da uso problematico o a rischio di sostanze, compreso l’alcool, che può compromettere il follow-up dello studio.
    - Partecipante affetto da un disordine di sanguinamento o condizione che a giudizio dello sperimentatore controindica iniezioni intramuscolari frequenti.
    - Partecipante con funzione anormale del sistema immunitario ad eccezioni di condizioni cliniche stabili come l'HIV controllato.
    - Partecipanti affetti da disturbi cardiovascolari, respiratori, epatici, neurologici, gastrointestinali, renali o qualsiasi altro disturbo medico clinicamente significativo e instabile a giudizio dello sperimentatore entro 3 mesi prima dello screening.
    - Somministrazione cronica o ricorrente di farmaci immunosoppressori sistemici.
    - Partecipante che ha ricevuto immunoglobuline e/o prodotti emoderivati 12 settimane prima della vaccinazione (giorno 0) o prevede di riceverli durante lo studio.
    - Partecipante che ha ricevuto una qualsiasi immunoterapia (anticorpi monoclonali, plasma) volta a prevenire o trattare la COVID-19 nei 90 giorni che precedono la somministrazione prevista del vaccino in studio.
    - Partecipazione a qualsiasi studio che preveda l’uso di un prodotto sperimentale (farmaco, farmaco biologico, dispositivo) entro 12 settimane prima della vaccinazione e durante lo studio.
    - Partecipante che ha donato = 450 ml di componenti ematiche nelle 12 settimane che precedono lo screening.
    - Partecipante affetto da qualsiasi condizione medica e/o riscontro diagnostico che, secondo il parere dello sperimentatore, potrebbe aumentare i rischi, interferire con lo studio o compromettere l'interpretazione dei dati dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    Number, percentage, and characteristics of solicited local reactions through Day 7 after vaccination.
    Number, percentage, and characteristics of unsolicited local and systemic adverse events (AEs) through Day 28 after vaccination.
    Number and percentage of serious adverse events (SAEs) through the end of the study.
    Number and percentage of adverse event of special interest (AESI) through the end of the study.
    Number and percentage of medically attended adverse events (MAAE) related to study vaccine through the end of the study.
    Grade 3 and 4 change from baseline in safety laboratory parameters at Days 14, 91 and 182 after vaccination
    Numero, percentuale e caratteristiche delle reazioni locali e sistemiche sollecitate fino al giorno 7 dopo la vaccinazione.
    Numero, percentuale e caratteristiche degli eventi avversi locali e sistemici non sollecitati (AEs) fino al giorno 28 dopo la vaccinazione.
    Numero e percentuale di eventi avversi gravi (SAE) fino al termine dello studio.
    Numero e percentuale di eventi avversi di particolare interesse (AESI) fino al termine dello studio.
    Numero e percentuale di eventi avversi di interesse medico (MAAE) relativi al vaccino in studio fino al termine dello studio.
    Variazioni di grado 3 e 4 rispetto al basale rilevate nei parametri di laboratorio relativi alla sicurezza ai giorni 14, 91 e 182 dopo la vaccinazione.
    E.5.1.1Timepoint(s) of evaluation of this end point
    D0, D14, D91, D182.
    Giorno 0, giorno 14, giorno 91, giorno 182.
    E.5.2Secondary end point(s)
    Neutralisation titre against Wuhan and Omicron strains, and any other relevant VOC in the epidemiologic moment, measured as inhibitory concentration 50 (IC50) by a pseudovirion-based neutralisation assay (PBNA) and reported as reciprocal concentration for each individual sample and geometric mean titre (GMT) for descriptive analysis at Baseline and at Days 14, 91, 182 and 365.
    The geometric mean fold rise (GMFR) in neutralising antibody titre from baseline to Day 14.
    Binding antibodies titre measured for each individual sample and GMT for descriptive analysis at Baseline and Days 14, 91, 182 and 365.
    The geometric mean fold rise (GMFR) in binding antibody titre from baseline to Day 14.
    The percentage of subjects that after the booster dose have a =4-fold change in binding antibodies titre from Baseline to Day 14.
    Titolo di neutralizzazione contro i ceppi Wuhan e Omicron, e qualsiasi altro VOC rilevante nel periodo epidemiologico, misurato come concentrazione inibitoria 50 (IC50) mediante un saggio di neutralizzazione basato su pseudovirioni (PBNA) e riportato come concentrazione reciproca per ogni singolo campione e titolo geometrico medio (GMT) per l'analisi statistica descrittiva al basale e ai giorni 14, 91, 182 e 365.
    Variazione della media geometrica (GMFR) dei titoli anticorpali neutralizzanti dal basale al giorno 14.
    Titoli di anticorpi leganti misurati per ogni singolo campione e GMT per l'analisi statistica descrittiva al basale e ai giorni 14, 91, 182 e 365.
    Variazione della media geometrica (GMFR) dei titoli anticorpali leganti dal basale al giorno 14.
    La percentuale di soggetti che dopo la dose di richiamo hanno sperimentato un cambiamento =4 volte dei titoli anticorpali leganti dal basale al giorno 14.
    E.5.2.1Timepoint(s) of evaluation of this end point
    D0, D14, D91, D182, D365.
    Giorno 0, giorno 14, giorno 91, giorno 182, giorno 365
    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 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 trial1
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 Information not present in EudraCT
    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 years0
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    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 Yes
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 50
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2940
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 No
    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 state150
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3000
    F.4.2.2In the whole clinical trial 3000
    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
    Nessuno
    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 Decision2022-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-30
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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