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    Summary
    EudraCT Number:2020-000753-28
    Sponsor's Protocol Code Number:212494
    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:2021-04-26
    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 number2020-000753-28
    A.3Full title of the trial
    A Phase 3, randomized, placebo-controlled, observer-blind, multi-country study to demonstrate the efficacy of a single dose of GSK’s RSVPreF3 OA investigational vaccine in adults aged 60 years and above.
    Studio di Fase III, randomizzato, controllato verso placebo, con osservatore in cieco, condotto in diversi paesi, per dimostrare l’efficacia di una singola dose di vaccino sperimentale GSK RSVPreF3 OA negli adulti con età pari o superiore a 60 anni.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy study of GSK’s investigational respiratory syncytial virus (RSV) vaccine in adults aged 60 years and above
    Studio di efficacia del vaccino sperimentale del virus respiratorio sinciziale (RSV) di GSK negli adulti con età pari o superiore a 60 anni
    A.3.2Name or abbreviated title of the trial where available
    RSV OA=ADJ-006
    RSV OA=ADJ-006
    A.4.1Sponsor's protocol code number212494
    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 SponsorGLAXOSMITHKLINE BIOLOGICALS
    B.1.3.4CountryBelgium
    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 supportGlaxoSmithKline Biologicals
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Biologicals
    B.5.2Functional name of contact pointClinical Disclosure Advisor
    B.5.3 Address:
    B.5.3.1Street AddressRue de l’Institut, 89
    B.5.3.2Town/ cityRixensart
    B.5.3.3Post code1330
    B.5.3.4CountryBelgium
    B.5.4Telephone number00442089904466
    B.5.5Fax number00442089904466
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 nameHigh dose RSVPreF3/adjuvanted
    D.3.2Product code [GSK3844766A]
    D.3.4Pharmaceutical form Powder and suspension for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeGSK3844766A
    D.3.9.3Other descriptive nameRespiratory Syncytial Virus (RSV) PreF3 investigational vaccine with Adjuvant System 01 (AS01)
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion
    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
    Respiratory Syncytial Virus Infection
    Infezione da virus respiratorio sinciziale
    E.1.1.1Medical condition in easily understood language
    Respiratory syncytial virus infection is caused by RSV, which causes respiratory tract infections in people of all ages.
    Infezione da virus respiratorio sinciziale è causata da RSV, che causa infezioni del tratto respiratorio in persone di tutte le età.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10035732
    E.1.2Term Pneumonia respiratory syncytial viral
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10038718
    E.1.2Term Respiratory syncytial virus bronchiolitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10069811
    E.1.2Term Respiratory syncytial virus bronchitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061603
    E.1.2Term Respiratory syncytial virus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10035692
    E.1.2Term Pneumonia due to respiratory syncytial virus
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10067384
    E.1.2Term Respiratory syncytial virus pneumonitis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10052200
    E.1.2Term Respiratory syncytial virus infection NOS
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10066741
    E.1.2Term Respiratory syncytial virus infection recurrent
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •Demonstrate the efficacy of the RSVPreF3 OA vaccine in preventing RSV-confirmed LRTD after at least 1 season in adults >/=60 YOA.
    •Demonstrate lot-to-lot consistency of 3 lots of RSVPreF3 OA vaccine in terms of immunogenicity at 30 days post-vaccination.
    • Dimostrare l'efficacia del vaccino RSVPreF3 OA nella prevenzione di malattie del tratto respiratorio inferiore (LRTD) di origine confermata da RSV, dopo almeno una stagione di osservazione, negli adulti di età >/= 60 anni.
    • Dimostrare la consistenza fra lotti dei 3 lotti di vaccino RSVPreF3 OA in termini di immunogenicità a 30 giorni dalla vaccinazione.
    E.2.2Secondary objectives of the trial
    •Demonstrate efficacy of RSVPreF3 OA vaccine in preventing RSV-confirmed LRTD in adults=60 YOA over several seasons.
    •In adults=60 YOA, evaluate efficacy of RSVPreF3 OA vaccine in preventing:
    -RSV-confirmed LRTD by age category, by season, by year, by baseline comorbidities, by baseline frailty status & for each RSV subtype (A & B) separately; severe RSV-confirmed LRTD & RSV-confirmed ARI; LRTD caused by other respiratory pathogens; hospitalization due to respiratory diseases; complications related to RSV-confirmed ARI & any ARI during RSV seasons
    •Evolution of efficacy of RSVPreF3 OA vaccine in preventing RSV-confirmed LRTD
    •Impact of RSVPreF3 OA vaccine on lower respiratory tract symptoms,ARI total symptoms,health utility score, physical functioning in RSVPreF3 group compared to placebo
    •Describe RSV-confirmed ARI cases & RSV-confirmed LRTD cases in RSVPreF3 & placebo groups
    •Humoral immune response to RSVPreF3 OA vaccine
    •Reactogenicity & safety of RSVPreF3 OA vaccine
    • Efficacia RSVPreF3 OA nel prevenire LRTD causate da RSV in adulti di età >/=60 anni nelle diverse stagioni osservate.
    • Efficacia RSVPreF3 OA in adulti di età >/= 60 anni nel prevenire: LRTD causate da RSV per fascia di età, stagione, anno, co-morbidità al basale, stato di fragilità al basale e per sottotipo RSV (A&B); LRTD gravi & infezioni respiratorie acute (ARI) causate da RSV; LRTD causate da altri patogeni respiratori; ospedalizzazione per patologie respiratorie; complicanze correlate ad ARI causate da RSV; qualsiasi ARI durante le stagioni RSV.
    • Evoluzione efficacia di RSVPreF3 OA nel prevenire LRTD causate da RSV
    • Impatto vaccino RSVPreF3 OA sui sintomi del tratto respiratorio inferiore, sintomi globali ARI, indice utilizzo risorse sanitarie, confronto funzionalità fisica nel gruppo vaccino vs placebo
    • Descrivere episodi ARI & LRTD causati da RSV nel gruppo vaccino vs placebo.
    • Risposta immunitaria umorale verso RSVPreF3 OA.
    • Reattogenicità e sicurezza di RSVPreF3 OA.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •A male or female = 60 YOA at the time of the first vaccination, who live in the general community (CD participants) or in a LTCF (LTCF participants).
    •Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards and questionnaires, attend regular phone calls/study site visits, perform self-swabbing, ability to access and utilize a phone or other electronic communications).
    Note: In case of physical incapacity that would preclude the self-completion of the diary cards and/or questionnaires, either site staff can assist the participant (for activities performed during site visits) or the participant may assign a caregiver to assist him/her with this activity (for activities performed at home or in the LTCF). However, at no time, the site staff or caregiver will evaluate the participant’s health status while answering diaries and/or questionnaires or make decisions on behalf of the participant
    •Written or witnessed informed consent obtained from the participant prior to performance of any study specific procedure.
    •Participants who are medically stable in the opinion of the investigator at the time of first vaccination. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable
    •Uomini o donne di età = 60 anni al momento della vaccinazione, che vivono nella comunità (partecipanti CD) o in case di riposo (partecipanti LTCF).
    •Soggetti che, secondo il giudizio dello Sperimentatore, siano in grado di rispettare le richieste del protocollo studio (ad esempio: completare le schede diario e i questionari, presentarsi alle visite presso il centro, avere contatti regolari con lo staff di studio, eseguire in autonomia il tampone nasale, essere contattabili telefonicamente o per altre vie di comunicazione elettronica).
    Nota: In caso di incapacità fisica che possa precludere al completamento in autonomia delle schede diario e/o dei questionari, lo staff del centro potrà assistere i soggetti (per le attività da eseguire durante le visite di studio) o potrà essere assegnato un “caregiver” per assisterli in questa attività (per le attività da eseguire a casa o presso la casa di riposo). Tuttavia, in nessuna occasione, lo staff del centro o il “caregiver” dovrà dare valutazioni proprie sullo stato di salute del soggetto in occasione della compilazione dei diari/questionari né prendere alcuna decisione al posto del soggetto stesso.
    •Consenso informato scritto fornito dal soggetto prima dell'esecuzione di qualsiasi procedura studio specifica.
    •Soggetti con condizioni mediche stabili secondo il giudizio dello Sperimentatore al momento della vaccinazione. I soggetti con condizioni mediche croniche stabili, con/senza trattamento medico, come ad es. diabete, ipertensione o patologie cardiache, potranno partecipare allo studio se considerati stabili dal punto di vista medico da parte dello Sperimentatore.
    E.4Principal exclusion criteria
    Medical conditions
    •Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy.
    •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine, incl. latex hypersensitivity
    •Serious or unstable chronic illness.
    •Any history of dementia or any medical condition that moderately or severely impairs cognition.
    •Recurrent or un-controlled neurological disorders or seizures. Participants with medically-controlled active neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol (e.g. completion of the diary cards and questionnaires, attend regular phone calls/study site visits, perform self-swabbing).
    •Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 3 years).
    •Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
    Prior/Concomitant therapy
    •Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccine during the period beginning 30 days before the first dose of study vaccine (Day -29 to Day 1), or planned use during the study period.
    •Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the study vaccine administration, with the exception of inactivated and subunit influenza vaccines which can be administered up to 14 days before or from 14 days after the study vaccination.
    •Previous vaccination with an RSV vaccine.
    •Administration of long-acting immune-modifying drugs or planned administration at any time during the study period (e.g. infliximab).
    •Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the study vaccine or planned administration during the study period.
    •Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the study vaccine administration or planned administration during the study period. For corticosteroids, this will mean prednisone ¿20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
    Prior/Concurrent clinical study experience
    •Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product (drug or medical device).
    Other exclusions
    •History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
    •Bedridden participants.
    •Planned move during the study period that will prohibit participating in the trial until study end. This includes:
    •Planned move during the study period to another LTCF that will prohibit participation in the trial until study end.
    •Planned move from the community to a LTCF that will prohibit participation in the trial until study end.
    •Participation of any study personnel or their immediate dependants, family, or household members.
    •Planned leave or holiday of 4 consecutive weeks or more during the RSV seasons* covered by the study, that would prohibit the reporting of ARI cases and attendance to ARI visit.
    *RSV seasons are from October to April in NH and from March to September in SH
    CONDIZIONI MEDICHE
    • Qualsiasi condizione di immunosoppressione o immunodeficienza confermata o sospetta risultante da una patologia o terapia immunosoppressiva/citotossica
    • Storia di qualsiasi reazione o ipersensibilità che possa essere esacerbata da un qualsiasi componente del vaccino, inclusa ipersensibiltà al lattice
    • Malattia cronica grave o instabile.
    • Qualsiasi storia di demenza o qualsiasi condizione medica che comprometta moderatamente o gravemente la cognizione
    • Disturbi neurologici ricorrenti o non controllati o convulsioni. Soggetti con malattie neurologiche attive o croniche, sotto controllo medico, possono essere arruolati nello studio secondo la valutazione dello Sperimentatore, a patto che le loro condizioni consentano loro di rispettare i requisiti del protocollo.
    • Malattia significativa di fondo che, a parere dello sperimentatore, potrebbe impedire il completamento dello studio
    • Qualsiasi condizione medica che, a giudizio dello sperimentatore, renderebbe insicura l'iniezione intramuscolare.
    TERAPIA PRECEDENTE/CONCOMITANTE
    • Uso di qualsiasi prodotto sperimentale o non registrato (farmaco, vaccino o dispositivo medicale) diverso dal vaccino dello studio, nei 30 giorni che precedono la somministrazione del vaccino sperimentale, o previsione di utilizzo durante lo studio.
    • Somministrazione pianificata o effettiva di un vaccino non previsto dal protocollo di studio nel periodo che inizia 30 gg. prima e finisce 30 gg. dopo la somministrazione del vaccino sperimentale, ad eccezione di vaccini influenzali inattivati o a subunità che possono essere somministrati fino 14 gg prima o a partire da 14 gg dopo la vaccinazione di studio.
    • Vaccinazione precedente con un vaccino contro RSV.
    • Somministrazione di farmaci immunomodulanti ad azione prolungata o somministrazione pianificata in qualsiasi momento dello studio (es. infliximab).
    • Somministrazione di immunoglobuline e/o di eventuali emoderivati o derivati plasmatici durante il periodo che inizia 90 giorni prima della somministrazione del vaccino di studio o somministrazione pianificata durante il periodo di studio.
    • Somministrazione cronica (definita come più di 14 giorni consecutivi in totale) di immunosoppressori o altri farmaci immunomodulanti durante il periodo che inizia 90 giorni prima della somministrazione del vaccino di studio o somministrazione pianificata durante il periodo dello studio. Per i corticosteroidi, ciò significherà prednisone ¿ 20 mg/giorno o equivalente. Sono ammessi steroidi inalatori e topici.
    ESPERIENZA PRECEDENTE/CONCOMITANTE IN STUDI CLINICI
    • Partecipazione contemporanea ad un altro studio clinico, in qualsiasi momento durante il periodo di studio, in cui il partecipante è stato o sarà esposto ad un vaccino/prodotto sperimentale o non sperimentale (farmaco o dispositivo medico).
    ALTRE ESCLUSIONI
    toria di consumo cronico di alcol e/o abuso di droghe che, a giudizio dello Sperimentatore, rendano il potenziale partecipante incapace/potenzialmente non in grado di fornire informazioni accurate di sicurezza o aderire alle procedure di studio.
    • Soggetti allettati.
    • Spostamento pianificato durante il periodo di studio che impedisca la partecipazione allo studio fino al suo completamento. Ciò include:
    - Spostamento pianificato durante il periodo di studio in un’altra LTCF che non permetta la partecipazione allo studio fino al suo completamento.
    - Spostamento pianificato dalla vita di comunità a LTCF che non permetta la partecipazione allo studio fino al suo completamento.
    • Personale del centro o alle sue immediate dipendenze, familiari o parenti più prossimi.
    • Assenza prevista o vacanza di 4 o più settimane consecutive durante le stagioni RSV* coperte dallo studio, che impediscano la segnalazione dei casi ARI e la partecipazione alle visite ARI.
    E.5 End points
    E.5.1Primary end point(s)
    1. First episode of RT-PCR confirmed RSV A and/or B associated LRTD after at least one season in adults >/ = 60 YOA
    2. RSVPreF3 specific immunoglobulin G (IgG) antibody concentrations for lot to lot consistency evaluation
    1. Primo episodio di LRTD di origine confermata da RSV (mediante RT-PCR) sottotipo A e/o B, dopo almeno una stagione di osservazione in adulti di età >/= 60 aa.
    2. Concentrazione anticorpi IgG RSVPreF3-specifici per la valutazione della consistenza fra lotti.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. From 1-month post-vaccination until at least end of 1st RSV season in NH and at least until 56 cases have been accrued.
    2. At 30 days post vaccination (Day 31)
    1.Da 1 mese dopo la vaccinazione fino almeno alla fine della prima stagione di RSV nell'emisfero Nord e almeno fino a quando non si sono accumulati 56 casi.
    2. 30 giorni dopo la vaccinazione (giorno 31)
    E.5.2Secondary end point(s)
    • 1st episode of RT-PCR confirmed RSV A and/or B associated LRTD over several seasons [From 1-month post vaccination]
    • 1st episode of RT-PCR confirmed RSV subtype A & B LRTD (1-month post vaccination to 1st occurrence of episode)
    • 1st episode of RT-PCR confirmed RSV A and /or B associated LRTD, by age categories (1-month post vaccination to 1st occurrence of episode)
    • 1st episode of RT-PCR confirmed RSV A and/or B associated LRTD by RSV season [1-month post vaccination to 1st occurrence episode]
    • 1st episode of RT-PCR confirmed RSV A and/or B associated LRTD by year (1-month post vaccination until end of year 1, 2 and 3)
    • 1st episode of RT-PCR confirmed RSV A and/or B associated LRTD (1-month post vaccination to 1st occurrence of episode over time)
    • 1st episode of RT-PCR confirmed RSV A and/or B associated LRTD by baseline comorbidities (1-month post vaccination to 1st occurrence of episode)
    • 1st episode of RT-PCR confirmed RSV A and/or B associated LRTD by baseline frailty status (1-month post vaccination to 1st occurrence of episode)
    • 1st episode of RT-PCR confirmed RSV A and/or B associated severe LRTD (1-month post vaccination to 1st occurrence of episode)
    • 1st episode of RT-PCR confirmed RSV A and/or B associated Acute Respiratory Infection (ARI) (1-month post vaccination to 1st occurrence of episode)
    • 1st episode of LRTD caused by other respiratory pathogens as confirmed by RT-PCR (1-month post vaccination to 1st occurrence of episode)
    • N. of hospitalizations due to respiratory diseases or due to a complication related to respiratory diseases, during the RSV seasons (3 consecutive seasons in NH & at least 2 consecutive seasons in SH)
    • N. of hospitalizations due to RSV-confirmed respiratory diseases or due to complication related to RSV-confirmed respiratory diseases, during the RSV seasons (3 consecutive seasons in NH & At least 2 consecutive seasons in SH)
    • Complications related to ARI and RSV-confirmed ARI during the RSV seasons (3 consecutive seasons in NH & At least 2 consecutive seasons in SH)
    • Maximum Flu-PRO Reported Outcome Chest score for participants with RT-PCR-confirmed RSV A and/or B-associated ARI (During first 7 days from onset of ARI symptoms)
    • Least Square Mean Flu-PRO total score for participants with RT-PCR-confirmed RSV A and/or B-associated ARI (During first 7 days from onset of ARI symptoms)
    • EQ-5D utility score for participants with RT-PCR-confirmed RSV A and/or B-associated ARI [At ARI visit (assessed from 1-month post vaccination until study end)]
    • SF-12 physical functioning score for participants with RT-PCR confirmed RSV A and/or B-associated ARI [At ARI visit(assessed from 1-month post vaccination until study end)]
    • Duration of RT-PCR confirmed RSV A and/or B ARI and LRTD episodes during study period
    • Number of each reported symptoms/signs of RT-PCR confirmed RSV A and/or B ARI and LRTD episodes during study period
    • Number of RT-PCR confirmed RSV A and/or B ARI and LRTD episodes according to severity during study period
    • RSVPreF3 specific IgG antibody concentrations at Day 1, Day 31, pre-season 2 & pre-season 3
    • RSV A neutralizing antibodies given as Geometric Mean Titers (GMTs) at Day 1, Day 31, pre-season 2 & pre-season 3
    • N. of participants with any grade 3 solicited administration site events (4-day follow up period after vaccination)
    • N. of participants with any grade 3 solicited systemic events (4-day follow up period after vaccination)
    • N. of days with solicited administration site and systemic events (4-day follow up period after vaccination)
    • N. of participants with any unsolicited AE (30-day follow up period after vaccination)
    • N. of participants with SAE (From Day 1 up to 6 months after vaccination)
    • N. of participants with potential Immune Mediated Diseases (From Day 1 up to 6 months after vaccination)
    • N. of participants with related SAEs and fatal SAEs [From Day 1 up to study end]
    • N.of participants with related pIMDs [From Day 1 up to study end]
    • 1° episodio LRTD associato a RSV A e/o B confermato con RT-PCR nelle diverse stagioni osservate (dal mese successivo alla vaccinazione)
    • 1° episodio LRTD associato a RSV sottotipo A & B (dal mese successivo alla vaccinazione alla comparsa del 1° episodio)
    • 1° episodio LRTD associato a RSV A e/o B confermato con RT-PCR per categoria di età (1 mese post-vaccinazione fino alla prima comparsa dell'episodio)
    • 1° episodio LRTD associato a RSV A e/o B confermato con RT-PCR per stagione RSV (1 mese post-vaccinazione fino alla prima comparsa dell'episodio)
    • 1° episodio LRTD associato a RSV A e/o B confermato con RT-PCR per anno (1 mese dopo la vaccinazione fino a fine anno 1, 2 e 3)
    • 1° episodio LRTD associato a RSV A e/o B confermato con RT-PCR (1 mese post-vaccinazione fino alla prima comparsa episodio nel tempo)
    • 1° episodio LRTD associato a RSV A e/o B confermato con RT-PCR per comorbidità al basale (1 mese post-vaccinazione fino alla prima comparsa dell'episodio)
    • 1° episodio LRTD associato a RSV A e/o B confermato con RT-PCR per stato di fragilità basale (1 mese post-vaccinazione fino alla prima comparsa dell'episodio)
    • 1° episodio LRTD grave associato a RSV A e/o B confermato con RT-PCR (1 mese post-vaccinazione fino alla prima comparsa dell'episodio)
    • 1° episodio ARI associato a RSV A e/o B confermato con RT-PCR (1 mese post-vaccinazione fino alla prima comparsa dell'episodio)
    • 1° episodio LRTD causato da altri patogeni respiratori confermati con RT-PCR (1 mese post-vaccinazione fino alla prima comparsa dell'episodio)
    • Numero ospedalizzazioni per patologie respiratorie o complicanze correlate a queste patologie, durante le stagioni RSV (3 stagioni consecutive emisfero nord)
    • Numero ospedalizzazioni per patologie respiratorie da RSV o complicanze correlate a queste patologie, durante le stagioni RSV (3 stagioni consecutive emisf. nord)
    • Complicanze correlate ad ARI o ARI causati da RSV durante le stagioni RSV (3 stagioni consecutive emisf. nord))
    • Valore max Flu-PRO Reported Outcome Chest per partecipanti con ARI associato a RSV A e/o B confermato con RT-PCR (durante i 7 gg dall'esordio dei sintomi ARI)
    • Media quadratica minima del punteggio totale Flu-PRO per soggetti con ARI associata a RSV A e/o B confermata con RT-PCR (nei 7 gg successivi all'esordio sintomi)
    • EQ-5D Utility Score per soggetti con ARI associata a RSV A e/o B confermata con RT-PCR [alla visita ARI (dal mese successivo alla vaccinazione alla fine dello studio)]
    • SF-12 physical functioning score per soggetti con ARI associata a RSV A e/o B confermata con RT-PCR [alla visita ARI (dal mese successivo alla vaccinazione alla fine dello studio)]
    • Durata dell'episodio ARI & LRTD associati a RSV A e/o B confermati con RT-PCR durante lo studio
    • Numero di segnalazioni per ciascun segno/sintomo ARI & LRTD associati a RSV A e/o B confermati con RT-PCR durante lo studio
    • Numero di episodi ARI & LRTD associati a RSV A e/o B confermati con RT-PCR, in base alla gravità, durante lo studio
    • Concentrazione anticorpi IgG RSVPreF3 specifici al Giorno 1, Giorno 31, pre-stagione 2 & pre-stagione 3
    • Media geometrica del titolo anticorpale RSV A al Giorno 1, Giorno 31, pre-stagione 2 & pre-stagione 3
    • N. soggetti con eventi attesi di grado 3 al sito di somministrazione (4-gg follow up post-vaccinazione)
    • N. soggetti con qualsiasi evento atteso sistemico di grado 3 (4-gg follow up post-vaccinazione)
    • N. di giorni con eventi attesi al sito di somministrazione o sistemici (4-gg follow up post-vaccinazione)
    • N. di soggetti con AE non attesi (30-gg follow up post-vaccinazione)
    • N. di soggetti con SAE (dal Giorno 1 fino a 6 mesi post-vaccinazione)
    • N. di soggetti con malattie potenzialmente immune-mediate (dal Giorno 1 fino a 6 mesi post-vaccinazione)
    • N. di soggetti con SAE correlati o fatali (dal Giorno 1 fino a fine studio)
    • N.di soggetti con o malattie potenzialmente immune-mediate correlate [dal Giorno 1 a fine studio]
    E.5.2.1Timepoint(s) of evaluation of this end point
    Due to the character limitation, timeframes for secondary endpoints are added in paranthesis along with the respective endpoints in section E.5.2
    A causa della limitazione dei caratteri, i tempi per gli endpoint secondari vengono aggiunti tra parentesi insieme ai rispettivi endpoint nella sezione E.5.2
    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 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) No
    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
    Osservatore in cieco
    Observer-blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 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 concerned17
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA86
    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
    Australia
    Brazil
    Canada
    Japan
    Korea, Republic of
    Mexico
    Russian Federation
    South Africa
    United States
    Belgium
    Estonia
    Finland
    Germany
    Italy
    Poland
    Spain
    United Kingdom
    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 (EoS): Release of the last testing results of samples collected at the last ARI visit. In these cases, EoS must be achieved no later than 8 months after Last Participant Last Visit (Visit 5NH/Visit 4SH).
    Fine dello studio (EoS): pubblicazione degli ultimi risultati dei test dei campioni raccolti durante l'ultima visita ARI. In questi casi, l'EoS deve essere raggiunto entro 8 mesi dall'ultima visita dell'ultimo partecipante (visita 5NH / visita 4SH).
    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 months12
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months12
    E.8.9.2In all countries concerned by the trial days31
    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: 6408
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9612
    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 state450
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 6845
    F.4.2.2In the whole clinical trial 18000
    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 Decision2021-02-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-13
    P. End of Trial
    P.End of Trial StatusOngoing
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