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Uno studio di fase 1/2/3 per valutare la sicurezza, la tollerabilità e l'immunogenicità di un candidato vaccino a RNA contro il COVID-19 in bambini e giovani adulti sani

26 maggio 2026 aggiornato da: BioNTech SE

UNO STUDIO DI FASE 1, IN APERTO, PER VALUTARE LA SICUREZZA, LA TOLLERABILITÀ E L'IMMUNOGENICITÀ E LO STUDIO DI FASE 2/3 CONTROLLATO CON PLACEBO, IN CIECO DELL'OSSERVATORE SULLA SICUREZZA, LA TOLLERABILITÀ E L'IMMUNOGENICITÀ DI UN CANDIDATO VACCINO SARS-COV-2 RNA CONTRO IL COVID -19 NEI BAMBINI E NEI GIOVANI ADULTI SANI

Questo è uno studio di fase 1/2/3 su bambini sani e giovani adulti.

A seconda dei dati sulla sicurezza e/o sull'immunogenicità generati nel corso di questo studio e sulla conseguente valutazione del rapporto rischio-beneficio, la sicurezza, la tollerabilità e l'immunogenicità di BNT162b2 nei partecipanti di età inferiore ai 6 mesi possono essere successivamente valutate.

Panoramica dello studio

Stato

Completato

Condizioni

Infezione da SARS-CoV-2, COVID-19

Intervento / Trattamento

Descrizione dettagliata

Ricerca della dose di fase 1

È la porzione in aperto dello studio di determinazione della dose che valuterà la sicurezza, la tollerabilità e l'immunogenicità di BNT162b2 somministrato con una schedula a 2 dosi (separate da circa 21 giorni) in un massimo di 3 gruppi di età (partecipanti da ≥5 a <12 anni, da ≥2 a <5 anni e da ≥6 mesi a <2 anni di età).

La determinazione della dose è stata avviata in questo studio nei partecipanti di età compresa tra ≥5 e <12 anni sulla base della valutazione di sicurezza in cieco accettabile della dose di 30 µg nei soggetti di età compresa tra 12 e 15 anni nello studio C4591001.

Lo scopo della Fase 1 è identificare i livelli di dose preferiti di BNT162b2 da un massimo di 3 diversi livelli di dose in ciascun gruppo di età.

A seconda dei dati sulla sicurezza e/o sull'immunogenicità generati nel corso di questo studio, è possibile che i livelli di dose non vengano avviati, possano essere interrotti anticipatamente e/o possano essere aggiunti con livelli di dose inferiori alla dose più bassa dichiarata.

Aggiornamento come parte dell'emendamento 6 del protocollo: tutti i partecipanti riceveranno una terza dose di BNT162b2. Per i partecipanti da ≥6 mesi a <5 anni, la terza dose avverrà almeno 8 settimane dopo la seconda dose. Nei partecipanti da ≥5 a <12 anni, la terza dose avverrà almeno 6 mesi dopo la seconda dose. L'intervallo tra la seconda e la terza dose sarà basato sull'età del partecipante al momento dell'arruolamento. Il livello di dose della terza dose di BNT162b2 sarà basato sull'età al momento della vaccinazione: i partecipanti <5 anni di età al momento della terza dose riceveranno il livello di dose di 3 µg, i partecipanti da ≥5 a <12 anni di l'età al momento della terza dose riceverà il livello di dose di 10 µg e i partecipanti di età ≥12 anni al momento della terza dose riceveranno il livello di dose di 30 µg.

I partecipanti riceveranno un prelievo di sangue prima della Dose 1 e della Dose 2 e 7 giorni dopo la Dose 2 per valutare l'immunogenicità e determinare il livello di dose di BNT162b2 selezionato per la Fase 2/3. I partecipanti riceveranno anche un prelievo di sangue prima della Dose 3 e 1, 6 e 12 mesi dopo la Dose 3.

Fase 1 Valutazione a basso dosaggio

È la parte di valutazione a basso dosaggio in aperto dello studio che valuterà la sicurezza, la tollerabilità e l'immunogenicità di 10 µg di BNT162b2 da 2 programmi in 2 gruppi di età (partecipanti da 12 a <16 anni e da 16 a <18 anni di età) .

Lo scopo della valutazione della dose inferiore di fase 1 è valutare la sicurezza e l'immunogenicità di BNT162b2 da 2 diversi schemi di dosaggio in ciascun gruppo di età: (1) 2 dosi separate da circa 21 giorni e (2) 2 dosi separate da circa 8 settimane .

Ai partecipanti verrà prelevato il sangue prima della Dose 1, prima della Dose 2, 7 giorni dopo la Dose 2 e 1 mese dopo la Dose 2 per valutare l'immunogenicità per determinare il programma di dosaggio BNT162b2 selezionato per la parte di valutazione della dose inferiore di Fase 2/3 del studia. Inoltre, i partecipanti verranno prelevati dal sangue a 6 e 12 mesi dopo la Dose 2 per determinare la persistenza della risposta immunitaria.

Dose selezionata di fase 2/3

È la parte dello studio che valuterà la sicurezza, la tollerabilità e l'immunogenicità in ciascun gruppo di età al livello di dose selezionato dalla fase 1 della parte di determinazione della dose dello studio. L'efficacia sarà valutata all'interno o tra i gruppi di età in cui l'immunobridging ha successo, a seconda dell'accumulo di un numero sufficiente di casi in quei gruppi di età.

I partecipanti riceveranno un prelievo di sangue al basale prima della dose 1 e 6 mesi dopo la dose 2. L'immunobridging ai partecipanti di età compresa tra 16 e 25 anni nello studio C4591001 si baserà sui dati di immunogenicità raccolti al (1) basale e 1 mese dopo la dose 2 e (2) al basale e 1 mese dopo la dose 3. La persistenza della risposta immunitaria si baserà sui dati di immunogenicità raccolti nei partecipanti al (1) basale e 1 e 6 mesi dopo la dose 2 e (2) al basale e 1, 6, 12 e 18 mesi dopo la dose 3. Inoltre, l'efficacia contro il COVID-19 confermato e contro l'infezione asintomatica sarà valutata anche nei partecipanti di età compresa tra ≥5 e <12 anni.

Presso i siti statunitensi designati, verrà prelevato un ulteriore campione di sangue intero facoltativo di circa 10 ml prima della Dose 1 e 7 giorni e 6 mesi dopo la Dose 2 da un massimo di circa 60 partecipanti di età ≥10 anni. Ulteriori campioni saranno ottenuti prima della Dose 3 e 1 mese dopo la Dose 3 (solo gruppo BNT162b2 originale). Questi campioni saranno utilizzati su base esplorativa per studiare la risposta immunitaria cellulo-mediata post-vaccinazione in questi punti temporali.

Alla visita di follow-up di 6 mesi, tutti i partecipanti saranno aperti. Ai partecipanti che hanno originariamente ricevuto il placebo verrà offerta l'opportunità di ricevere BNT162b2 come parte dello studio. - Partecipanti che hanno originariamente ricevuto il placebo e diventano idonei a ricevere BNT162b2 o un altro vaccino COVID-19 secondo le raccomandazioni locali o nazionali prima della visita di follow-up di 6 mesi (Visita 5 o 405) (dettagliati separatamente e disponibili nel portale elettronico di riferimento dello studio ) avranno l'opportunità di ricevere BNT162b2 (10 µg o 3 µg) in base all'età al momento della vaccinazione.

Aggiornamento come parte dell'emendamento 6 del protocollo: tutti i partecipanti riceveranno una terza dose di BNT162b2. Per i partecipanti da ≥6 mesi a <5 anni, la terza dose avverrà almeno 8 settimane dopo la seconda dose. Nei partecipanti da ≥5 a <12 anni, la terza dose avverrà almeno 6 mesi dopo la seconda dose. L'intervallo tra la seconda e la terza dose sarà basato sull'età del partecipante al momento dell'arruolamento. Il livello di dose della seconda e terza dose di BNT162b2 sarà basato sull'età al momento della vaccinazione: i partecipanti <5 anni di età al momento della seconda/terza dose riceveranno il livello di dose di 3 µg, i partecipanti da ≥5 a <12 anni di età al momento della seconda/terza dose riceveranno il livello di dose di 10 µg e i partecipanti di età ≥12 anni al momento della seconda/terza dose riceveranno il livello di dose di 30 µg.

Valutazione della dose inferiore di fase 2/3

È la parte in aperto dello studio che valuterà la sicurezza, la tollerabilità e l'immunogenicità del programma di dosaggio selezionato in ciascun gruppo di età dalla valutazione della dose più bassa di Fase 1, con un totale di circa 600 partecipanti attivi.

Circa 300 partecipanti attivi in ogni fascia di età in questa fase contribuiranno all'analisi dell'immunobridging a 1 mese dopo la Dose 2 e all'analisi complessiva della persistenza della risposta immunitaria a 6 e 12 mesi dopo la Dose 2.

Fase 2/3 Raccolta di campioni di siero per il potenziale test della troponina I

Se il test dei livelli di troponina I in individui che non hanno ricevuto BNT162b2 indica che il livello di troponina I potrebbe essere un indicatore affidabile di una potenziale miocardite subclinica, l'ottenimento di campioni di siero per il potenziale test della troponina I durante il periodo di aumentato rischio di miocardite clinica può aiutare a caratterizzare l'assenza /presenza e frequenza di miocardite subclinica. Per valutare, sarà incluso un ulteriore gruppo di partecipanti: da ≥5 a <12 anni: randomizzati 2:1 per ricevere BNT162b2 10 µg o placebo, e da ≥12 a <16 anni: ricevimento in aperto di BNT162b2 30 µg.

Aggiornamento come parte dell'emendamento 7 del protocollo: tutti i partecipanti riceveranno una terza dose di BNT162b2. Per tutti i partecipanti (da ≥5 a <12 anni e da ≥12 a <16 anni), la terza dose avverrà almeno 5 mesi dopo la Dose 2.

Il livello di dose della seconda e della terza dose di BNT162b2 sarà basato sull'età al momento della vaccinazione: i partecipanti di età compresa tra ≥5 e <12 anni al momento della seconda/terza dose riceveranno il livello di dose di 10 µg e i partecipanti di età ≥12 anni al momento della seconda/terza dose riceveranno il livello di dose di 30 µg.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

11837

Fase

Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

Brasile
- - São Paulo, Brasile, 04266-010
    - CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda.
- Estado de Bahia
  - Salvador, Estado de Bahia, Brasile, 40415-006
    - Hospital Santo Antônio - Obras Sociais Irmã Dulce/ Centro de Pesquisa Clínica - CPEC
- Minas Gerais
  - Belo Horizonte, Minas Gerais, Brasile, 30150-221
    - Santa Casa de Misericordia de Belo Horizonte
- Paraná
  - Curitiba, Paraná, Brasile, 80810-050
    - Serviço de Infectologia e Controle de Infecção Hospitalar de Curitiba/ Centro Médico São Francisco
- Rio Grande do Norte
  - Natal, Rio Grande do Norte, Brasile, 59025-050
    - CePCLIN - Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda
Finlandia
- - Espoo, Finlandia, 02230
    - FVR, Espoo Clinic
  - Helsinki, Finlandia, 00100
    - FVR, Helsinki South Clinic
  - Helsinki, Finlandia, 00290
    - MeVac - Meilahti Vaccine Research Center
  - Helsinki, Finlandia, 00930
    - FVR, Helsinki East Clinic
  - Kokkola, Finlandia, 67100
    - FVR, Kokkola Clinic
  - Pori, Finlandia, 28100
    - FVR, Pori Clinic
  - Seinäjoki, Finlandia, 60100
    - FVR, Seinäjoki Clinic
  - Tampere, Finlandia, 33100
    - FVR, Tampere Clinic
  - Turku, Finlandia, 20520
    - FVR, Turku Clinic
- North Ostrobothnia
  - Oulu, North Ostrobothnia, Finlandia, 90220
    - FVR, Oulu Clinic
- Uusimaa
  - Jarvenpaa, Uusimaa, Finlandia, 04400
    - FVR, Järvenpää Clinic
Messico
- - Veracruz, Messico, C.P. 91900
    - Sociedad de Metabolismo y Corazón S.C.
- Nuevo León
  - Monterrey, Nuevo León, Messico, C.P. 64060
    - Christus - Latam Hub Center of Excellence and Innovation S.C.
- Yucatán
  - Mérida, Yucatán, Messico, 97070
    - Köhler & Milstein Research S.A. de C.V.
  - Mérida, Yucatán, Messico, 97130
    - Centro Multidisciplinario Para El Desarrollo Especializado De La Investigacion
Polonia
- - Bydgoszcz, Polonia, 85-048
    - IN-VIVO Bydgoszcz
  - Krakow, Polonia, 30-348
    - Centrum Badan Klinicznych JCI
  - Lodz, Polonia, 90-349
    - Osrodek Badan Klinicznych Appletreeclinics
  - Lodz, Polonia, 91-347
    - GRAVITA Diagnostyka i Leczenie nieplodnosci
  - Luboń, Polonia, 62-030
    - Rodzinne Centrum Medyczne LUBMED
  - Siemianowice Śląskie, Polonia, 41-103
    - Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Jarosz i Partnerzy Spolka Lekarska
  - Warsaw, Polonia, 02-647
    - Provita 001
- Kuyavian-Pomeranian Voivodeship
  - Torun, Kuyavian-Pomeranian Voivodeship, Polonia, 87-100
    - MICS Centrum Medyczne Torun
Spagna
- - Madrid, Spagna, 28041
    - Hospital Universitario 12 de Octubre
  - Seville, Spagna, 41012
    - Instituto Hispalense de Pediatria
- A Coruña
  - Santiago de Compostela, A Coruña, Spagna, 15706
    - Hospital Clínico Universitario Santiago de Compostela
- Barcelona
  - Centelles, Barcelona, Spagna, 08540
    - EBA Centelles
  - Esplugues de Llobregat, Barcelona, Spagna, 08950
    - Hospital Sant Joan de Deu
  - Sant Cugat del Vallès, Barcelona, Spagna, 08195
    - Hospital Universitari General de Catalunya
- Madrid
  - Boadilla del Monte, Madrid, Spagna, 28660
    - Hospital Universitario HM Monteprincipe
- Madrid, Comunidad de
  - Madrid, Madrid, Comunidad de, Spagna, 28938
    - Hospital Universitario HM Puerta del Sur
- Málaga
  - Antequera, Málaga, Spagna, 29200
    - Hospital de Antequera
  - Málaga, Málaga, Spagna, 29015
    - Grupo Pediatrico Uncibay
Stati Uniti
- Alabama
  - Birmingham, Alabama, Stati Uniti, 35233
    - University of Alabama at Birmingham - School of Medicine
- Arizona
  - Phoenix, Arizona, Stati Uniti, 85016
    - Phoenix Children's Hospital
- California
  - Los Angeles, California, Stati Uniti, 90057
    - Matrix Clinical Research
  - Los Angeles, California, Stati Uniti, 90027
    - SCPMG/Kaiser Permanente Los Angeles Medical Center
  - Madera, California, Stati Uniti, 93637
    - Madera Family Medical Group
  - Oakland, California, Stati Uniti, 94611
    - Kaiser Permanente Oakland
  - Palo Alto, California, Stati Uniti, 94304
    - Lucile Packard Children's Hospital Stanford
  - Palo Alto, California, Stati Uniti, 94304
    - Clinical & Translational Research Unit (CTRU) & Spectrum BioBank, Stanford University
  - Paramount, California, Stati Uniti, 90723
    - Center for Clinical Trials, LLC
  - Paramount, California, Stati Uniti, 90723
    - Center for Clinical Trials
  - Rolling Hills Estates, California, Stati Uniti, 90274
    - Peninsula Research Associates
  - Sacramento, California, Stati Uniti, 95815
    - Kaiser Permanente Sacramento
  - Santa Clara, California, Stati Uniti, 95051
    - Kaiser Permanente Santa Clara
  - Stanford, California, Stati Uniti, 94305
    - Stanford Health Care
  - Stanford, California, Stati Uniti, 94305
    - Stanford Health Care Investigational Drug Service
  - Valley Village, California, Stati Uniti, 91607
    - Bayview Research Group, LLC
- Colorado
  - Aurora, Colorado, Stati Uniti, 80045
    - Children's Hospital Colorado
- Connecticut
  - New Haven, Connecticut, Stati Uniti, 06519
    - Yale Center for Clinical Investigation
- District of Columbia
  - Washington D.C., District of Columbia, Stati Uniti, 20010
    - Children's National Medical Center
  - Washington D.C., District of Columbia, Stati Uniti, 20016
    - Velocity Clinical Research, Washington DC
  - Washington D.C., District of Columbia, Stati Uniti, 20009
    - Emerson Clinical Research Institute
- Florida
  - Jacksonville, Florida, Stati Uniti, 32256
    - Clinical Neuroscience Solutions, Inc.
  - Miami, Florida, Stati Uniti, 33142
    - Acevedo Clinical Research Associates
  - Orlando, Florida, Stati Uniti, 32801
    - Clinical Neuroscience Solutions
- Georgia
  - Atlanta, Georgia, Stati Uniti, 30331
    - Atlanta Center for Medical Research
  - Atlanta, Georgia, Stati Uniti, 30322
    - Emory University School of Medicine
  - Atlanta, Georgia, Stati Uniti, 30322
    - Emory Children's Center Illness POD
  - Macon, Georgia, Stati Uniti, 31210
    - Meridian Clinical Research, LLC
  - Union City, Georgia, Stati Uniti, 30291
    - Rophe Adult and Pediatric Medicine/SKYCRNG
- Idaho
  - Idaho Falls, Idaho, Stati Uniti, 83404
    - Clinical Research Prime
  - Meridian, Idaho, Stati Uniti, 83646
    - Solaris Clinical Research
- Kansas
  - Newton, Kansas, Stati Uniti, 67114
    - Alliance for Multispecialty Research, LLC
  - Wichita, Kansas, Stati Uniti, 67207
    - Alliance for Multispecialty Research, LLC
- Kentucky
  - Bardstown, Kentucky, Stati Uniti, 40004
    - Kentucky Pediatric/ Adult Research
  - Louisville, Kentucky, Stati Uniti, 40202
    - Novak Center for Children's Health
- Louisiana
  - New Orleans, Louisiana, Stati Uniti, 70121
    - Ochsner Clinic Foundation
  - Shreveport, Louisiana, Stati Uniti, 71101
    - Louisiana State University Health Sciences Shreveport
- Maryland
  - Baltimore, Maryland, Stati Uniti, 21224
    - Johns Hopkins Bayview Medical Center
- Massachusetts
  - Boston, Massachusetts, Stati Uniti, 02118
    - Boston Medical Center
- Michigan
  - Bingham Farms, Michigan, Stati Uniti, 48025
    - Michigan Center of Medical Research
- Mississippi
  - Ridgeland, Mississippi, Stati Uniti, 39157
    - SKY Integrative Medical Center/SKYCRNG
- Missouri
  - Chesterfield, Missouri, Stati Uniti, 63005
    - Clinical Research Professionals
  - Kansas City, Missouri, Stati Uniti, 64108
    - Children's Mercy Hospital
- Nebraska
  - Hastings, Nebraska, Stati Uniti, 68901
    - Meridian Clinical Research, LLC
  - Lincoln, Nebraska, Stati Uniti, 68510
    - Velocity Clinical Research, Lincoln
  - Omaha, Nebraska, Stati Uniti, 68114
    - Children's Hospital & Medical Center
  - Omaha, Nebraska, Stati Uniti, 68117
    - Children's Physician's Clinic, Spring Valley
- New Jersey
  - New Brunswick, New Jersey, Stati Uniti, 08901
    - Cancer Institute Of New Jersey
  - New Brunswick, New Jersey, Stati Uniti, 08901
    - Rutgers University
- New York
  - Binghamton, New York, Stati Uniti, 13905
    - Meridian Clinical Research LLC
  - Commack, New York, Stati Uniti, 11725
    - Advanced Specialty Care
  - Rochester, New York, Stati Uniti, 14642
    - University of Rochester Medical Center
  - Rochester, New York, Stati Uniti, 14609
    - Rochester Clinical Research, Inc.
  - Stony Brook, New York, Stati Uniti, 11794
    - Stony Brook University
  - Syracuse, New York, Stati Uniti, 13210
    - Suny Upstate Medical University
- North Carolina
  - Charlotte, North Carolina, Stati Uniti, 28207
    - Atrium Health-STRIVE Vaccine Research Clinic
  - Charlotte, North Carolina, Stati Uniti, 28211
    - Teen Health Connection (study visits)
  - Durham, North Carolina, Stati Uniti, 27703
    - Duke University - Main Hospital and Clinics
  - Matthews, North Carolina, Stati Uniti, 28105
    - Atrium Health-STRIVE Vaccine Research Clinic (study visits)
- Ohio
  - Cincinnati, Ohio, Stati Uniti, 45229
    - Cincinnati Children's Hospital Medical Center Vaccine Research Center
  - Columbus, Ohio, Stati Uniti, 43213
    - Centricity Research Columbus Ohio Multispecialty
  - Dayton, Ohio, Stati Uniti, 45429
    - Primed Clinical Research
  - South Euclid, Ohio, Stati Uniti, 44121
    - Senders Pediatrics
- Oregon
  - Gresham, Oregon, Stati Uniti, 97030
    - Cyn3rgy Research
- Pennsylvania
  - Erie, Pennsylvania, Stati Uniti, 16506
    - AHN Erie Health + Wellness Pavillion: West
- Rhode Island
  - East Greenwich, Rhode Island, Stati Uniti, 02818
    - Velocity Clinical Research-Providence
- South Carolina
  - Charleston, South Carolina, Stati Uniti, 29414
    - Coastal Pediatric Research
  - Greenville, South Carolina, Stati Uniti, 29607
    - Tribe Clinical Research, LLC
  - Summerville, South Carolina, Stati Uniti, 29486
    - Coastal Pediatric Research
- Tennessee
  - Memphis, Tennessee, Stati Uniti, 38105
    - St. Jude Children's Research Hospital
  - Nashville, Tennessee, Stati Uniti, 37203
    - Clinical Research Associates Inc
- Texas
  - Austin, Texas, Stati Uniti, 78726
    - Innovo Research - Austin Regional Clinic
  - Corpus Christi, Texas, Stati Uniti, 78411
    - Driscoll Children's Hospital
  - Dallas, Texas, Stati Uniti, 75251
    - Cedar Health Research
  - Dickinson, Texas, Stati Uniti, 77539
    - Bay Colony Pediatrics
  - Edinburg, Texas, Stati Uniti, 78539
    - Proactive Clinical Research, LLC
  - Frisco, Texas, Stati Uniti, 75033
    - Village Health Partners (Patient Seen Address)
  - Houston, Texas, Stati Uniti, 77055
    - West Houston Clinical Research Services
  - Houston, Texas, Stati Uniti, 77008
    - HG Pediatrics
  - Houston, Texas, Stati Uniti, 77008
    - Van Tran Family Practice
  - Houston, Texas, Stati Uniti, 77030
    - Texas Children's Hospital - Clinical Research Center
  - Houston, Texas, Stati Uniti, 77087
    - Pediatric Associates
  - Houston, Texas, Stati Uniti, 77008
    - Helios Clinical Research - HOU
  - Houston, Texas, Stati Uniti, 77008
    - Helios Clinical Research
  - Houston, Texas, Stati Uniti, 77065
    - DM Clinical Research - MDC
- Utah
  - Salt Lake City, Utah, Stati Uniti, 84109
    - J. Lewis Research, Inc. / Foothill Family Clinic
  - Salt Lake City, Utah, Stati Uniti, 84121
    - J. Lewis Research, Inc. / Foothill Family Clinic South
- Virginia
  - Charlottesville, Virginia, Stati Uniti, 22902
    - Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)
  - Midlothian, Virginia, Stati Uniti, 23114
    - Virginia Research Center
- Washington
  - Seattle, Washington, Stati Uniti, 98105
    - Seattle Children's Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 6 mesi a 18 anni (Bambino)

Accetta volontari sani

Sì

Descrizione

Criterio di inclusione

Partecipanti di sesso maschile o femminile di età compresa tra ≥6 mesi e <12 anni, al momento della randomizzazione, alla Visita 1 per la determinazione della dose/valutazione della dose selezionata e per i partecipanti di età compresa tra ≥12 e <18 anni, al momento della randomizzazione , alla Visita 1 per la valutazione della dose più bassa. Per la parte dello studio relativa all'ottenimento di campioni di siero per la potenziale troponina I: partecipanti di sesso maschile o femminile di età compresa tra ≥5 e <16 anni.
Genitori/tutori legali dei partecipanti e partecipanti, a seconda dell'età, che sono disposti e in grado di rispettare tutte le visite programmate, il piano di trattamento, i test di laboratorio, le considerazioni sullo stile di vita e altre procedure di studio.
- Partecipanti sani che sono determinati dall'anamnesi, dall'esame fisico e dal giudizio clinico dello sperimentatore per essere idonei all'inclusione nello studio.
Nota: possono essere inclusi partecipanti sani con malattia stabile preesistente, definita come malattia che non richiede un cambiamento significativo nella terapia o ricovero in ospedale per il peggioramento della malattia durante le 6 settimane precedenti l'arruolamento.
I partecipanti devono essere disponibili per tutta la durata dello studio e i cui genitori/tutori legali possono essere contattati telefonicamente durante la partecipazione allo studio.
Test di gravidanza sulle urine negativo per partecipanti di sesso femminile che sono biologicamente in grado di avere figli.
Partecipante di sesso femminile in età fertile o partecipante di sesso maschile in grado di generare figli che è disposto a utilizzare un metodo contraccettivo altamente efficace come delineato in questo protocollo per almeno 28 giorni dopo l'ultima dose dell'intervento dello studio se a rischio di gravidanza con il proprio partner ; o partecipante di sesso femminile non potenzialmente fertile o partecipante di sesso maschile non in grado di generare figli.
Il partecipante o il/i genitore/i/tutore legale del partecipante è in grado di fornire il consenso informato firmato, che include il rispetto dei requisiti e delle restrizioni elencate nell'ICD e nel presente protocollo. A seconda dell'età del partecipante e in base ai requisiti locali, ai partecipanti verrà inoltre chiesto di fornire il consenso appropriato (verbale o scritto).

Criteri di esclusione

Solo fase 1: passato clinico (basato solo sui sintomi/segni di COVID-19, se non era disponibile un risultato NAAT SARS-CoV-2) o microbiologico (basato sui sintomi/segni COVID-19 e un risultato NAAT SARS-CoV-2 positivo) diagnosi di COVID 19.
Solo fase 1: infezione nota da HIV, HCV o HBV.
Ricezione di farmaci destinati a prevenire il COVID-19.
Diagnosi precedente o attuale di MIS-C.
Altre condizioni mediche o psichiatriche tra cui ideazione/comportamento suicidario recente (nell'ultimo anno) o attivo o anomalie di laboratorio che possono aumentare il rischio di partecipazione allo studio o, a giudizio dello sperimentatore, rendere il partecipante inappropriato per lo studio. Nota: questo include entrambe le condizioni che possono aumentare il rischio associato alla somministrazione dell'intervento dello studio o una condizione che può interferire con l'interpretazione dei risultati dello studio
Anamnesi di grave reazione avversa associata a un vaccino e/o grave reazione allergica (ad es. anafilassi) a qualsiasi componente dell'intervento/i dello studio.
Soggetti immunocompromessi con immunodeficienza nota o sospetta, come determinato dall'anamnesi e/o dall'esame di laboratorio/fisico.
Individui con una storia di malattia autoimmune o una malattia autoimmune attiva che richiede un intervento terapeutico, incluso ma non limitato al lupus eritematoso sistemico. Nota: il diabete di tipo 1 stabile e l'ipotiroidismo sono consentiti.
Diatesi emorragica o condizione associata a sanguinamento prolungato che, a parere dello sperimentatore, controindicare l'iniezione intramuscolare.
Donna incinta o che allatta.
Precedente vaccinazione con qualsiasi vaccino contro il coronavirus.
- Individui che ricevono un trattamento con terapia immunosoppressiva, inclusi agenti citotossici o corticosteroidi sistemici, ad esempio, per cancro o una malattia autoimmune, o ricezione programmata durante lo studio. Se i corticosteroidi sistemici sono stati somministrati a breve termine (<14 giorni) per il trattamento di una malattia acuta, i partecipanti non devono essere arruolati nello studio fino a quando la terapia con corticosteroidi non è stata interrotta per almeno 28 giorni prima della somministrazione dell'intervento dello studio. Sono consentiti corticosteroidi per via inalatoria/nebulizzata, intra-articolare, intraborsale o topica (cutanea o oculare).
Ricezione di prodotti ematici/plasmatici, immunoglobuline o anticorpi monoclonali, da 60 giorni prima della somministrazione dell'intervento dello studio, o ricezione di qualsiasi terapia anticorpale passiva specifica per COVID-19 da 90 giorni prima della somministrazione dell'intervento dello studio, o ricezione programmata durante lo studio.
- Partecipazione ad altri studi che comportano l'intervento dello studio entro 28 giorni prima dell'ingresso nello studio e/o durante la partecipazione allo studio.
Precedente partecipazione ad altri studi che coinvolgono interventi di studio contenenti LNP.
- Partecipanti che sono discendenti diretti (figli o nipoti) di membri del personale del sito sperimentale o dipendenti Pfizer/BioNTech direttamente coinvolti nella conduzione dello studio, personale del sito altrimenti supervisionato dallo sperimentatore e rispettivi familiari.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Scopo principale: Prevenzione
Assegnazione: Non randomizzato
Modello interventistico: Assegnazione parallela
Mascheramento: Nessuno (etichetta aperta)

Numero di armi

Armi e interventi

Gruppo di partecipanti / Arm	Intervento / Trattamento
Sperimentale: Dose bassa/media, da ≥5 a <12 anni Dose bassa/media (10 mcg), 2 dosi a distanza di 21 giorni	Biologico: Biologico/Vaccino: BNT162b2 10mcg BNT162b2 Livello a dose bassa/media (10 mcg).
Sperimentale: Dose media, da ≥5 a <12 anni Mid-Dose, (20mcg), 2 dosi a distanza di 21 giorni	Biologico: BNT162b2 20mcg BNT162b2 Livello a dose media (20 mcg).
Sperimentale: Ad alto dosaggio, da ≥5 a <12 anni Dose elevata (30 mcg), 2 dosi a distanza di 21 giorni	Biologico: BNT162b2 30mcg BNT162b2 Livello ad alto dosaggio (30mcg).
Sperimentale: Basso/medio dosaggio, da ≥2 a <5 anni Dose bassa/media (10 mcg), 2 dosi a distanza di 21 giorni	Biologico: Biologico/Vaccino: BNT162b2 10mcg BNT162b2 Livello a dose bassa/media (10 mcg).
Sperimentale: Dose media, da ≥2 a <5 anni Mid-Dose, (20mcg), 2 dosi a distanza di 21 giorni	Biologico: BNT162b2 20mcg BNT162b2 Livello a dose media (20 mcg).
Sperimentale: Dose elevata, da ≥2 a <5 anni Dose elevata, (30 mcg), 2 dosi a distanza di 21 giorni	Biologico: BNT162b2 30mcg BNT162b2 Livello ad alto dosaggio (30mcg).
Sperimentale: Dose bassa/media, da ≥6 mesi a <2 anni Dose bassa/media (10 mcg), 2 dosi a distanza di 21 giorni	Biologico: Biologico/Vaccino: BNT162b2 10mcg BNT162b2 Livello a dose bassa/media (10 mcg).
Sperimentale: Dose media, da ≥6 mesi a <2 anni Mid-Dose, (20mcg), 2 dosi a distanza di 21 giorni	Biologico: BNT162b2 20mcg BNT162b2 Livello a dose media (20 mcg).
Sperimentale: Dose elevata, da ≥6 mesi a <2 anni Dose elevata, (30 mcg), 2 dosi a distanza di 21 giorni	Biologico: BNT162b2 30mcg BNT162b2 Livello ad alto dosaggio (30mcg).
Comparatore placebo: Placebo, da ≥6 mesi a <2 anni	Altro: Placebo Iniezione intramuscolare
Comparatore placebo: Placebo, da ≥2 a <5 anni	Altro: Placebo Iniezione intramuscolare
Comparatore placebo: Placebo, da ≥5 a <12 anni	Altro: Placebo Iniezione intramuscolare
Sperimentale: Basso dosaggio, da ≥6 mesi a <2 anni Basso dosaggio (3mcg), 2 dosi a distanza di 21 dosi	Biologico: Biologico/Vaccino: BNT162b2 3mcg BNT162b2 Livello a basso dosaggio (3mcg).
Sperimentale: Basso dosaggio, da ≥2 a <5 anni Basso dosaggio (3mcg), 2 dosi a distanza di 21 giorni	Biologico: Biologico/Vaccino: BNT162b2 3mcg BNT162b2 Livello a basso dosaggio (3mcg).
Sperimentale: Ad alto dosaggio, da 12 a <16 anni (test della troponina I) High-Dose (30mcg), 3 dosi	Biologico: BNT162b2 30mcg BNT162b2 Livello ad alto dosaggio (30mcg).
Sperimentale: Basso/medio dosaggio, da ≥5 a <12 anni (test della troponina I) Basso/medio dosaggio (10mcg), 3 dosi	Biologico: Biologico/Vaccino: BNT162b2 10mcg BNT162b2 Livello a dose bassa/media (10 mcg).
Sperimentale: Placebo, da ≥5 a <12 anni (test della troponina I)	Altro: Placebo Iniezione intramuscolare
Sperimentale: Basso dosaggio, da ≥6 mesi a <2 anni (regime a 3 dosi) Basso dosaggio (3mcg), 3 dosi	Biologico: Biologico/Vaccino: BNT162b2 3mcg BNT162b2 Livello a basso dosaggio (3mcg).
Sperimentale: Basso dosaggio, da ≥2 a <5 anni (regime a 3 dosi) Basso dosaggio (3mcg), 3 dosi	Biologico: Biologico/Vaccino: BNT162b2 3mcg BNT162b2 Livello a basso dosaggio (3mcg).
Comparatore placebo: Placebo, da ≥6 mesi a <2 anni (regime a 3 dosi)	Altro: Placebo Iniezione intramuscolare
Comparatore placebo: Placebo, da ≥2 a <5 anni (regime a 3 dosi)	Altro: Placebo Iniezione intramuscolare

Cosa sta misurando lo studio?

Misure di risultato primarie

Misure di risultato secondarie

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

BioNTech SE

Collaboratori

Pfizer

Investigatori

Direttore dello studio: Pfizer CT.gov Call Center, Pfizer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

To obtain contact information for a study center near you, click here.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

24 marzo 2021

Completamento primario (Effettivo)

4 ottobre 2023

Completamento dello studio (Effettivo)

8 dicembre 2023

Date di iscrizione allo studio

Primo inviato

19 marzo 2021

Primo inviato che soddisfa i criteri di controllo qualità

24 marzo 2021

Primo Inserito (Effettivo)

25 marzo 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

28 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

C4591007
2020-005442-42 (Numero EudraCT)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Infezione da SARS-CoV-2, COVID-19

Pfizer

Attivo, non reclutante

Uno studio per conoscere quanto bene gli aggiornamenti annuali al vaccino covid-19 lavorano per proteggere le persone da Covid-19 e quanti soldi le persone spendono per l'assistenza sanitaria per Covid-19

COVID-19 | Malattia da coronavirus 2019 (COVID-19) | Infezione da covid-19 | Vaccini contro il covid-19 | Infezione da SARS-CoV-2, COVID19 | Vaccinazione COVID-19 | Infezione da SARS-CoV-2, COVID-19 | COVID-19 (Coronavirus 2019) | Infezione da COVID-19 SARS-CoV-2

Stati Uniti
AstraZeneca

Completato

Studio dell'iniezione intramuscolare AZD3152 o dell'infusione endovenosa in partecipanti adulti giapponesi sani

COVID-19, SARS-CoV-2

Giappone
Institute of Tropical Medicine, Belgium
Jessa Hospital; University Hospital, Antwerp; Universiteit Antwerpen; Sciensano; Me...

Completato

Gli anticorpi specifici SARS-CoV-2 sono un correlato per la protezione? (ImmCoV)

COVID-19 | SARS-CoV-2

Belgio
SAb Biotherapeutics, Inc.
Department of Health and Human Services; JPEO, Chemical, Biological, Radiological...

Completato

Sicurezza, tollerabilità e farmacocinetica di SAB-185 in partecipanti sani

COVID-19 | SARS-CoV-2

Stati Uniti
University of Wisconsin, Madison
National Institutes of Health (NIH)

Completato

Ripetere il test per SARS-CoV-2

COVID-19 | SARS-CoV-2

Stati Uniti
The Institute of Molecular and Translational Medicine...
University Hospital Olomouc; Palacky University

Completato

Studio SARS-CoV-2-CZ-PREVAL-II - Braccio della Regione di Olomouc

SARS-CoV-2 | Infezione da SARS-CoV-2 (COVID-19).

Cechia
Syneos Health
US Specialty Formulations, LLC

Completato

Primo studio sull'uomo di CoV2-OGEN1 somministrato per via orale in soggetti sani

SARS-CoV-2 (COVID-19)

Nuova Zelanda
Mayo Clinic

Completato

Seroprevalence of SARS CoV 2 Antibodies in Previously Undiagnosed Healthcare Workers

COVID-19 | SARS-CoV-2

Stati Uniti
Interna Therapeutics Ltd.

Attivo, non reclutante

Sicurezza, tollerabilità ed esposizione sistemica di APO-SI-K170A-C76 in volontari sani (BID)

Infezione da SARS-CoV-2 (COVID-19).

Israele
University of Valladolid

Completato

Impatto della maschera di allenamento di elevazione nell'infezione da CrossFit® Post-SARS-CoV-2. (ETMEXCOVID)

Infezione da SARS-CoV-2 (sintomatica) | Complicanze polmonari COVID-19 | Pazienti positivi al SARS-CoV-2 | Covid19- Infezione con virus SARS-CoV-2

Spagna

Misura del risultato	Misura Descrizione	Lasso di tempo
Phase 1: Geometric Mean Titer (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Titer at 7 Days After Dose 2: >=6 Months to <2 Years of Age: Participants Without Evidence of Infection Lasso di tempo: Phase 1: 7 days post Dose 2	GMT of SARS-CoV-2 neutralizing titer after the study vaccination was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titer and the corresponding CIs(based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. Evaluable Immunogenicity Population consisted of all eligible randomized participants who received 2 doses with the same dose level to which they were randomized, with Dose 2 received within the predefined window, had at least 1 valid and determinate immunogenicity result after Dose 2 from the blood sample collected within an appropriate window after Dose 2(within 6-8 days after Dose 2 for Phase 1), and had no other important protocol deviations as determined by the clinician.	Phase 1: 7 days post Dose 2
Phase 1: GMT of Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Titer at 7 Days After Dose 2: >=2 to <5 Years of Age: Participants Without Evidence of Infection Lasso di tempo: Phase 1: 7 days post Dose 2	GMT of SARS-CoV-2 neutralizing titers after the study vaccination was reported in this outcome measure. GMT and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titer and the corresponding CIs(based on Student's t distribution).Assay results below the LLOQ were set to 0.5*LLOQ. Evaluable Immunogenicity Population consisted of all eligible randomized participants who received 2 doses with the same dose level to which they were randomized, with Dose 2 received within the predefined window, had at least 1 valid and determinate immunogenicity result after Dose 2 from the blood sample collected within an appropriate window after Dose 2(within 6-8 days after Dose 2 for Phase 1), and had no other important protocol deviations as determined by the clinician.	Phase 1: 7 days post Dose 2
Phase 1: GMT of Severe Acute Respiratory Syndrome Coronavirus 2 Neutralizing Titer at 7 Days After Dose 2: >=5 to <12 Years of Age: Participants Without Evidence of Infection Lasso di tempo: Phase 1: 7 days post Dose 2	GMT of SARS-CoV-2 neutralizing titer after the study vaccination was reported in this outcome measure. GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titer and the corresponding CIs(based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. Evaluable Immunogenicity Population consisted of all eligible randomized participants who received 2 doses with the same dose level to which they were randomized, with Dose 2 received within the predefined window, had at least 1 valid and determinate immunogenicity result after Dose 2 from the blood sample collected within an appropriate window after Dose 2(within 6-8 days after Dose 2 for Phase 1), and had no other important protocol deviations as determined by the clinician.	Phase 1: 7 days post Dose 2
Phase 2/3: Geometric Mean Titer - Neutralizing Titer (NT50) : 5 to <12 Years of Age: Before Dose 1 and 1 Month After Dose 2:Participants Without Evidence of Infection Lasso di tempo: Phase 2/3: Before Dose 1 and 1 Month after Dose 2	GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titer and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ. Participants included in this analysis had no serological or virological evidence of past SARS-CoV-2 infection or had no medical history of COVID-19. Evaluable immunogenicity population included all eligible randomized participants who received the study intervention to which they were randomized, had a valid and determinate immunogenicity result within 28-42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician.	Phase 2/3: Before Dose 1 and 1 Month after Dose 2
Phase 2/3: Geometric Mean Titer - NT50: 5 to <12 Years of Age: Pre-Dose 3 and 1 Month After Dose 3:Participants Without Evidence of Infection Lasso di tempo: Phase 2/3: From Dose 3 set: Pre-Dose 3 and 1 Month after Dose 3	GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titer and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5 *LLOQ. Participants included in this analysis had no serological or virological evidence of past SARS-CoV-2 infection or had no medical history of COVID-19. Evaluable immunogenicity population (EIP) included all eligible randomized participants who received the study intervention to which they were randomized, had a valid and determinate immunogenicity result within 28-42 days after the study vaccination, and had no other important protocol deviations as determined by the clinician.	Phase 2/3: From Dose 3 set: Pre-Dose 3 and 1 Month after Dose 3
Phase 2/3: Geometric Mean Titer - NT50:2 to <5 Years of Age: Pre-Dose 1, Pre-Dose 3 and 1 Month After Dose 3: Participants Without Evidence of Infection Lasso di tempo: Phase 2/3: From Pre-Dose 1, Pre-Dose 3 and 1 Month After Dose 3	GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titer and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5 *LLOQ. Participants included in this analysis had no serological or virological evidence of past SARS-CoV-2 infection or had no medical history of COVID-19.	Phase 2/3: From Pre-Dose 1, Pre-Dose 3 and 1 Month After Dose 3
Phase 2/3: Geometric Mean Titer- NT50:6 Months to <2 Years of Age: Pre-Dose 1, Pre-Dose 3 and 1 Month After Dose 3: Participants Without Evidence of Infection Lasso di tempo: Phase 2/3: From Pre-Dose 1, Pre-Dose 3 and 1 Month After Dose 3	GMTs and the corresponding 2-sided CIs were calculated by exponentiating the mean logarithm of the titer and the corresponding CIs (based on Student's t distribution). Assay results below the LLOQ were set to 0.5*LLOQ. Participants included in this analysis had no serological or virological evidence of past SARS-CoV-2 infection or had no medical history of COVID-19.	Phase 2/3: From Pre-Dose 1, Pre-Dose 3 and 1 Month After Dose 3
Phase 2/3: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Neutralizing Titers From Dose 1 to 1 Month After Dose 2: >=5 to 12 Years of Age: Participants Without Evidence of Infection Lasso di tempo: Phase 2/3: From Dose 1 to 1 Month after Dose 2	GMFR of SARS-CoV-2 neutralizing titers from dose 1 to 1 month after dose 2 were reported in this outcome measure. GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Participants included in this analysis had no serological or virological evidence of past SARS-CoV-2 infection or had no medical history of COVID-19. Assay results below the LLOQ were set to 0.5* LLOQ in the analysis.	Phase 2/3: From Dose 1 to 1 Month after Dose 2
Phase 2/3:GMFR of SARS-CoV-2 Neutralizing Titers From Dose 3 to 1 Month After Dose 3: >=5 to 12 Years of Age: Participants Without Evidence of Infection Lasso di tempo: Phase 2/3: From Dose 3 to 1 Month after Dose 3	GMFR of SARS-CoV-2 neutralizing titers from before Dose 3 to 1 month after Dose were reported in this outcome measure. GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. Participants included in this analysis had no serological or virological evidence of past SARS-CoV-2 infection or had no medical history of COVID-19. Evaluable immunogenicity population included all eligible randomized participants who received the study interventions to which they were randomized, had a valid and determined immunogenicity result within 28-42 days after Dose 3, and had no other important protocol deviations as determined by the clinicians.	Phase 2/3: From Dose 3 to 1 Month after Dose 3
Phase 2/3: GMFR of SARS-CoV-2 Neutralizing Titers From Before Dose 1 to Pre-Dose 3 and 1 Month After Dose 3: >=2 to 5 Years of Age: Participants Without Evidence of Infection Lasso di tempo: Phase 2/3: From before dose 1 to Pre-Dose 3, 1 Month After Dose 3	GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs(based on the Student t distribution). Participants included in this analysis had no serological or virological evidence of past SARS-CoV-2 infection and had no medical history of COVID-19 infection.Assay results below the LLOQ were set to 0.5*LLOQ in the analysis.	Phase 2/3: From before dose 1 to Pre-Dose 3, 1 Month After Dose 3
Phase 2/3: GMFR of SARS-CoV-2 Neutralizing Titers From Before Dose 1 to Pre-Dose 3 and 1 Month After Dose 3: >=6 Months to 2 Years of Age: Participants Without Evidence of Infection Lasso di tempo: Phase 2/3: From before dose 1 to Pre-Dose 3, 1 Month After Dose 3	GMFRs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5*LLOQ in the analysis. Participants included in this analysis had no serological or virological evidence of past SARS-CoV-2 infection prior to the 1-month post-Dose 2.	Phase 2/3: From before dose 1 to Pre-Dose 3, 1 Month After Dose 3
Phase 2/3: COVID-19 Incidence From 7 Days After Dose 2 to Prior to Dose 3 Per 1000 Person-Years of Blinded Follow-up in Participants Without Serological or Virological Evidence: >=5 to <12 Years of Age Lasso di tempo: Phase 2/3: From 7 days after Dose 2 to prior to Dose 3 (Surveillance time [1000 person-years]: BNT162b2 - 0.591; Placebo - 0.292)	COVID-19 incidence from 7 days after dose 2 to prior to dose 3 without the evidence of infection were reported in this outcome measure. Evaluable efficacy population included all eligible randomized participants who received all vaccination as randomized, with Dose 2 received within the predefined window (within 19-42 days after Dose 1) and have no other important protocol deviations as determined by clinician on or before 7 days after Dose 2.	Phase 2/3: From 7 days after Dose 2 to prior to Dose 3 (Surveillance time [1000 person-years]: BNT162b2 - 0.591; Placebo - 0.292)
Phase 2/3: COVID-19 Incidence From 7 Days After Dose 2 to Prior to Dose 3 Per 1000 Person-Years of Blinded Follow-up in Participants With or Without Serological or Virological Evidence: >=5 to <12 Years of Age Lasso di tempo: Phase 2/3: From 7 Days After Dose 2 to prior to Dose 3 (Surveillance time [1000 person-years]: BNT162b2 - 0.653; Placebo - 0.326)	COVID-19 incidence from 7 days after dose 2 to prior to dose 3 with or without the evidence of infection were reported in this outcome measure. Evaluable efficacy population included all eligible randomized participants who received all vaccination as randomized, with Dose 2 received within the predefined window (within 19-42 days after Dose 1) and have no other important protocol deviation as determined by clinician on or before 7 days after Dose 2.	Phase 2/3: From 7 Days After Dose 2 to prior to Dose 3 (Surveillance time [1000 person-years]: BNT162b2 - 0.653; Placebo - 0.326)
Phase 2/3: COVID-19 Incidence From 7 Days After Dose 3 Per 1000 Person-Years of Blinded Follow-up in Participants Without Serological or Virological Evidence: >=6 Months to <5 Years of Age Lasso di tempo: Phase 2/3: From 7 Days After Dose 3 (Surveillance time [1000 person-years]: BNT162b2 - 0.124; Placebo - 0.054)	COVID-19 incidence from 7 days after dose 3 without the evidence of infection were reported in this outcome measure. Evaluable efficacy population included all eligible randomized participants who received all vaccination as randomized, with Dose 3 received within the predefined window (within 19-42 days after Dose 2) and have no other important protocol deviations as determined by clinician on or before 7 days after Dose 3.	Phase 2/3: From 7 Days After Dose 3 (Surveillance time [1000 person-years]: BNT162b2 - 0.124; Placebo - 0.054)
Phase 2/3: COVID-19 Incidence From 7 Days After Dose 3 Per 1000 Person-Years of Blinded Follow-up in Participants With or Without Serological or Virological Evidence: >=6 Months to <5 Years of Age Lasso di tempo: Phase 2/3: From 7 Days After Dose 3 (Surveillance time [1000 person-years]: BNT162b2 - 0.149; Placebo - 0.067)	COVID-19 incidence from 7 days after dose 3 without the evidence of infection were reported in this outcome measure. Evaluable efficacy population included all eligible randomized participants who received all vaccination as randomized, with Dose 3 received within the predefined window (within 19-42 days after Dose 2) and have no other important protocol deviations as determined by the clinician on or before 7 days after Dose 3.	Phase 2/3: From 7 Days After Dose 3 (Surveillance time [1000 person-years]: BNT162b2 - 0.149; Placebo - 0.067)

Misura del risultato	Misura Descrizione	Lasso di tempo
Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=5 to <12 Years of Age Lasso di tempo: Phase 1: From Day 1 to Day 7 after Dose 1	Local reactions were collected in electronic diary (e-diary) or during unscheduled clinical assessments from Day 1 to 7 after Dose 1. Redness and swelling were measured and recorded in measuring device unit (mdu) where, 1 mdu = 0.5 centimeter (cm) and were graded as mild (>=0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4 (necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 Emergency room (ER) visit or hospitalization). Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% confidence interval was based on Clopper and Pearson method.	Phase 1: From Day 1 to Day 7 after Dose 1
Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=5 to <12 Years of Age Lasso di tempo: Phase 1: Day 1 to Day 7 after Dose 2	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>=0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4 (necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization. Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 2
Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=5 to <12 Years of Age Lasso di tempo: Phase 1: Day 1 to Day 7 after Dose 3	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 3. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>=0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4(necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization. Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 3
Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=5 to <12 Years of Age Lasso di tempo: Phase 1: Day 1 to Day 7 after Dose 1	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to Day 7 after Dose 1. Fever: oral temperature >= 38.0 degree Celsius (deg C); categorized as >=38.0 deg C, 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain & new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: >2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 1
Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=5 to <12 Years of Age Lasso di tempo: Phase 1: Day 1 to Day 7 after Dose 2	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to Day 7 after Dose 2. Fever: oral temperature >= 38.0 C; categorized as >=38.0 deg C, 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain & new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: >2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 2
Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 3:>=5 to <12 Years of Age Lasso di tempo: Phase 1: Day 1 to Day 7 after Dose 3	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to Day 7 after Dose 3. Fever: oral temperature >= 38.0 C; categorized as >=38.0 deg C, 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain & new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: >2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 3
Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=2 to <5 Years of Age Lasso di tempo: Phase 1: Day 1 to Day 7 after Dose 1	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 1. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>=0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4 (necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization. Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 1
Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=2 to <5 Years of Age Lasso di tempo: Phase 1: Day 1 to Day 7 after Dose 2	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>=0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4 (necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization. Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 2
Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=2 to <5 Years of Age Lasso di tempo: Phase 1: Day 1 to Day 7 after Dose 3	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 3. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>=0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4 (necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization. Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 3
Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=2 to <5 Years of Age Lasso di tempo: Phase 1: Day 1 to Day 7 after Dose 1	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to Day 7 after Dose 1. Fever: oral temperature >= 38.0 C; categorized as >=38.0 deg C, 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain & new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: >2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 1
Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=2 to <5 Years of Age Lasso di tempo: Phase 1: Day 1 to Day 7 after Dose 2	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to Day 7 after Dose 2. Fever: oral temperature >= 38.0 C; categorized as >=38.0 deg C, 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain & new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: >2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 2
Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: >=2 to <5 Years of Age Lasso di tempo: Phase 1: Day 1 to Day 7 after Dose 3	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from Day 1 to Day 7 after Dose 3. Fever: oral temperature >= 38.0 C; categorized as >=38.0 deg C, 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain & new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: >2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 3
Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=6 Months to <2 Years of Age Lasso di tempo: Phase 1: Day 1 to Day 7 after Dose 1	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 1. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>=0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4 (necrosis [redness and swelling] or exfoliative dermatitis [redness]). Tenderness at injection site was graded as mild (hurts if gently touched), moderate (hurts if gently touched with crying), severe (causes limitation of limb movement) and Grade 4 ER visit or hospitalization. Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 1
Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=6 Months to <2 Years of Age Lasso di tempo: Phase 1: Day 1 to Day 7 after Dose 2	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>=0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4 (necrosis [redness and swelling] or exfoliative dermatitis [redness]). Tenderness at injection site was graded as mild (hurts if gently touched), moderate (hurts if gently touched with crying), severe (causes limitation of limb movement) and Grade 4 ER visit or hospitalization. Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 2
Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: >=6 Months to <2 Years of Age Lasso di tempo: Phase 1: Day 1 to Day 7 after Dose 3	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 3. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>=0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4 (necrosis [redness and swelling] or exfoliative dermatitis [redness]). Tenderness at injection site was graded as mild (hurts if gently touched), moderate (hurts if gently touched with crying), severe (causes limitation of limb movement) and Grade 4 ER visit or hospitalization for severe tenderness at injection site). Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination were also included. Two-sided 95% CI was based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 3
Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: >=6 Months to <2 Years of Age Lasso di tempo: Phase 1: Day 1 to Day 7 after Dose 1	Systemic events recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after Dose 1. Fever: oral temperature >= 38.0 C; categorized as >=38.0 deg C, 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake), severe (refusal to feed). Drowsiness: mild (increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity), severe (disabling; not interested in usual daily activity). Irritability: mild (easily consolable), moderate (requiring increased attention), severe (Inconsolable; crying cannot be comforted). Grade 4 for all events except fever: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 1
Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: >=6 Months to <2 Years of Age Lasso di tempo: Phase 1: Day 1 to Day 7 after Dose 2	Systemic events recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after Dose 2.Fever: oral temperature >= 38.0 C; categorized as >=38.0 deg C, 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake),severe (refusal to feed).Drowsiness: mild (increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity), severe (disabling; not interested in usual daily activity). Irritability: mild (easily consolable), moderate (requiring increased attention), severe (Inconsolable; crying cannot be comforted).Grade 4 for all events except fever: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 2
Phase 1: Percentage of Participants With Systemic Events Within 7 Days After Dose 3: >=6 Months to <2 Years of Age Lasso di tempo: Phase 1: Day 1 to Day 7 after Dose 3	Systemic events recorded in an e-diary and at unscheduled clinical assessments from Day 1 to 7 after Dose 3. Fever: oral temperature >= 38.0 C; categorized as >=38.0 deg C, 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Decreased appetite: mild (decreased interest in eating), moderate (decreased oral intake), severe (refusal to feed). Drowsiness: mild (increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity), severe (disabling; not interested in usual daily activity).Irritability: mild (easily consolable), moderate (requiring increased attention), severe(Inconsolable; crying cannot be comforted).Grade 4 for all events except fever: ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in the CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.	Phase 1: Day 1 to Day 7 after Dose 3
Phase 1: Percentage of Participants Reporting Adverse Events (AEs) From Dose 1 to 1 Month After Dose 2: >=5 to <12 Years of Age Lasso di tempo: Phase 1: From Dose 1 to 1 Month after Dose 2	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from dose 1 to 1 month after dose 2 were reported in this outcome measure. Exact 2-sided 95% CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.	Phase 1: From Dose 1 to 1 Month after Dose 2
Phase 1: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: >=5 to <12 Years of Age Lasso di tempo: Phase 1: From Dose 3 to 1 Month after Dose 3	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from dose 3 to 1 month after dose 3 were reported in this outcome measure. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure. Exact 2-sided 95% CI based on the Clopper and Pearson method.	Phase 1: From Dose 3 to 1 Month after Dose 3
Phase 1: Percentage of Participants Reporting Serious Adverse Events (SAEs) From Dose 1 to 6 Months After Dose 2: >=5 to <12 Years of Age Lasso di tempo: Phase 1: From Dose 1 to 6 Months after Dose 2	A SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI based on the Clopper and Pearson method.	Phase 1: From Dose 1 to 6 Months after Dose 2
Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3: >=5 to <12 Years of Age Lasso di tempo: Phase 1: From Dose 3 to 6 Months after Dose 3	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic Exact 2-sided 95% CI based on the Clopper and Pearson method.	Phase 1: From Dose 3 to 6 Months after Dose 3
Phase 1: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: >=2 to <5 Years of Age Lasso di tempo: Phase 1: From Dose 1 to 1 Month after Dose 2	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from dose 1 to 1 month after dose 2 were reported in this outcome measure. Exact 2-sided 95% CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.	Phase 1: From Dose 1 to 1 Month after Dose 2
Phase 1: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: >=2 to <5 Years of Age Lasso di tempo: Phase 1: From Dose 3 to 1 Month after Dose 3	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Exact 2-sided 95% CI based on the Clopper and Pearson method. Percentage of participants reporting AEs from dose 3 to 1 month after dose 3 were reported in this outcome measure. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.	Phase 1: From Dose 3 to 1 Month after Dose 3
Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: >=2 to <5 Years of Age Lasso di tempo: Phase 1: From Dose 1 to 6 Months after Dose 2	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI based on the Clopper and Pearson method.	Phase 1: From Dose 1 to 6 Months after Dose 2
Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3: >=2 to <5 Years of Age Lasso di tempo: Phase 1: From Dose 3 to 6 Months after Dose 3	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI based on the Clopper and Pearson method.	Phase 1: From Dose 3 to 6 Months after Dose 3
Phase 1: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: >=6 Months to <2 Years of Age Lasso di tempo: Phase 1: From Dose 1 to 1 Month after Dose 2	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from dose 1 to 1 month after dose 2 were reported in this outcome measure. Exact 2-sided 95% CI based on the Clopper and Pearson method. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.	Phase 1: From Dose 1 to 1 Month after Dose 2
Phase 1: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: >=6 Months to <2 Years of Age Lasso di tempo: Phase 1: From Dose 3 to 1 Month after Dose 3	An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants reporting AEs from dose 3 to 1 month after dose 3 were reported in this outcome measure. Exact 2-sided 95% CI based on the Clopper and Pearson method.Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.	Phase 1: From Dose 3 to 1 Month after Dose 3
Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: >=6 Months to <2 Years of Age Lasso di tempo: Phase 1: From Dose 1 to 6 Months after Dose 2	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic.Exact 2-sided 95% CI based on the Clopper and Pearson method.	Phase 1: From Dose 1 to 6 Months after Dose 2
Phase 1: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3: >=6 Months to <2 Years of Age Lasso di tempo: Phase 1: From Dose 3 to 6 Months after Dose 3	An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening; resulted in persistent disability/incapacity; constituted a congenital anomaly/birth defect; was an important medical event; required inpatient hospitalization or prolongation of existing hospitalization, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic. Exact 2-sided 95% CI based on the Clopper and Pearson method.	Phase 1: From Dose 3 to 6 Months after Dose 3
Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Troponin Group: >=5 to <12 Years of Age Lasso di tempo: Phase 2/3: From Day 1 to Day 7 after Dose 1	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 1. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild >2.0 to 5.0 cm), moderate (>5.0 to 10.0), severe >10.0 cm) and Grade 4 (necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.	Phase 2/3: From Day 1 to Day 7 after Dose 1
Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: Troponin Group: >=12 to <16 Years of Age Lasso di tempo: Phase 2/3: From Day 1 to Day 7 after Dose 1	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 1. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild >2.0 to 5.0 cm), moderate (>5.0 to 10.0), severe >10.0 cm) and Grade 4 (necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.	Phase 2/3: From Day 1 to Day 7 after Dose 1
Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Troponin Group: >=5 to <12 Years of Age Lasso di tempo: Phase 2/3: From Day 1 to Day 7 after Dose 2	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>=0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4 (necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.	Phase 2/3: From Day 1 to Day 7 after Dose 2
Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: Troponin Group: >=12 to <16 Years of Age Lasso di tempo: Phase 2/3: From Day 1 to Day 7 after Dose 2	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 2. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild >2.0 to 5.0 cm),moderate (>5.0 to 10.0), severe >10.0 cm) and Grade 4 (necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.	Phase 2/3: From Day 1 to Day 7 after Dose 2
Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Troponin Group: >=5 to <12 Years of Age Lasso di tempo: Phase 2/3: From Day 1 to Day 7 after Dose 3	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 3. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild (>=0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm), severe (>7.0 cm) and Grade 4 (necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 reactions were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.	Phase 2/3: From Day 1 to Day 7 after Dose 3
Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 3: Troponin Group: >=12 to <16 Years of Age Lasso di tempo: Phase 2/3: From Day 1 to Day 7 after Dose 3	Local reactions were collected in e-diary or during unscheduled clinical assessments from Day 1 to Day 7 after Dose 3. Redness and swelling were measured and recorded in mdu where, 1 mdu =0.5 cm and were graded as mild >2.0 to 5.0 cm), moderate (>5.0 to 10.0), severe >10.0 cm) and Grade 4 (necrosis [redness and swelling] or exfoliative dermatitis [redness]). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and Grade 4 ER visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person. Reactions reported as adverse events in case report form within 7 days of study vaccination also included. Two-sided 95% CI was based on Clopper and Pearson method.	Phase 2/3: From Day 1 to Day 7 after Dose 3
Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 1:Troponin Group: >=5 to <12 Years of Age Lasso di tempo: Phase 2/3: From Day 1 to Day 7 after Dose 1	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from up to Day 7 after Dose 1. Fever: oral temperature >= 38.0 C; categorized as >=38.0 deg C, 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain & new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: >2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.	Phase 2/3: From Day 1 to Day 7 after Dose 1
Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 1: Troponin Group: >=12 to <16 Years of Age Lasso di tempo: Phase 2/3: From Day 1 to Day 7 after Dose 1	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from up to Day 7 after Dose 1. Fever: oral temperature >= 38.0 C; categorized as >=38.0 deg C, 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain & new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: >2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.	Phase 2/3: From Day 1 to Day 7 after Dose 1
Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Troponin Group: >=5 to <12 Years of Age Lasso di tempo: Phase 2/3: From Day 1 to Day 7 after Dose 2	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from up to Day 7 after Dose 2. Fever: oral temperature >= 38.0 C; categorized as >=38.0 deg C, 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain & new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: >2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.	Phase 2/3: From Day 1 to Day 7 after Dose 2
Phase 2/3: Percentage of Participants With Systemic Events Within 7 Days After Dose 2: Troponin Group: >=12 to <16 Years of Age Lasso di tempo: Phase 2/3: From Day 1 to Day 7 after Dose 2	Systemic events were recorded in an e-diary and at unscheduled clinical assessments from up to Day 7 after Dose 2. Fever: oral temperature >= 38.0 C; categorized as >=38.0 deg C, 38.0 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain & new or worsened joint pain: mild (did not interfere with activity), moderate (some interference with activity), severe (prevented daily routine activity). Vomiting: mild:1-2 times in 24 hours, moderate: >2 times in 24 hours; severe: required intravenous hydration. Diarrhea: mild: 2-3 loose stools in 24 hours, moderate: 4-5 loose stools in 24 hours, severe: 6 or more loose stools in 24 hours. Grade 4 for all events: except fever; ER visit/hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were included. Exact 95% CI based on Clopper and Pearson method.	Phase 2/3: From Day 1 to Day 7 after Dose 2

Uno studio di fase 1/2/3 per valutare la sicurezza, la tollerabilità e l'immunogenicità di un candidato vaccino a RNA contro il COVID-19 in bambini e giovani adulti sani

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Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Prove cliniche su Infezione da SARS-CoV-2, COVID-19

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