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Et fase 1/2/3-studie til evaluering af sikkerheden, tolerabiliteten og immunogeniciteten af en RNA-vaccinekandidat mod COVID-19 hos raske børn og unge voksne

26. maj 2026 opdateret af: BioNTech SE

ET FASE 1, ÅBEN LABEL DOSEFINDENDE UNDERSØGELSE TIL EVALUERING AF SIKKERHED, TOLERABILITET OG IMMUNOGENICITET OG FASE 2/3 PLACEBO-KONTROLLERET, OBSERVATØRBLINDET SIKKERHED, TOLERABILITET OG IMMUNOGENICITETSSTUDIE VIA ACCAVINE-2 SAGS. -19 HOS SUNDE BØRN OG UNGE VOKSNE

Dette er et fase 1/2/3 studie i raske børn og unge voksne.

Afhængig af sikkerheds- og/eller immunogenicitetsdata genereret i løbet af denne undersøgelse, og den resulterende vurdering af fordele-risiko, kan sikkerheden, tolerabiliteten og immunogeniciteten af BNT162b2 hos deltagere <6 måneder gamle efterfølgende evalueres.

Studieoversigt

Status

Afsluttet

Betingelser

SARS-CoV-2-infektion, COVID-19

Intervention / Behandling

Detaljeret beskrivelse

Fase 1 Dosis-finding

Er den åbne dosis-findende del af undersøgelsen, der vil evaluere sikkerhed, tolerabilitet og immunogenicitet af BNT162b2 administreret efter en 2-dosis (adskilt af ca. 21 dage) tidsplan i op til 3 aldersgrupper (deltagere ≥5 til <12) år, ≥2 til <5 år og ≥6 måneder til <2 år).

Dosisfund påbegyndes i denne undersøgelse hos deltagere ≥5 til <12 år baseret på den acceptable blindede sikkerhedsvurdering af 30-µg dosis hos 12- til 15-årige i C4591001-studiet.

Formålet med fase 1 er at identificere foretrukne dosisniveau(er) af BNT162b2 fra op til 3 forskellige dosisniveauer i hver aldersgruppe.

Afhængigt af sikkerheds- og/eller immunogenicitetsdata genereret i løbet af denne undersøgelse, er det muligt, at dosisniveauer muligvis ikke startes, kan afsluttes tidligt og/eller kan tilføjes med dosisniveauer under den lavest angivne dosis.

Opdatering som en del af protokolændring 6: Alle deltagere vil modtage en tredje dosis BNT162b2. For deltagere ≥6 måneder til <5 år, vil den tredje dosis forekomme mindst 8 uger efter den anden dosis. Hos deltagere ≥5 til <12 år vil den tredje dosis forekomme mindst 6 måneder efter den anden dosis. Intervallet mellem anden og tredje dosis vil være baseret på deltagerens alder på tilmeldingstidspunktet. Dosisniveauet for den tredje dosis af BNT162b2 vil være baseret på alderen på vaccinationstidspunktet: deltagere <5 år på tidspunktet for den tredje dosis vil modtage dosisniveauet på 3 µg, deltagere ≥5 til <12 år af alder på tidspunktet for den tredje dosis vil modtage 10-µg dosisniveauet, og deltagere ≥12 år på tidspunktet for den tredje dosis vil modtage 30-µg dosisniveauet.

Deltagerne vil få udtaget blod før både dosis 1 og dosis 2 og 7 dage efter dosis 2 for at vurdere immunogenicitet for at bestemme det valgte BNT162b2-dosisniveau for fase 2/3. Deltagerne vil også få taget blod før dosis 3 og 1, 6 og 12 måneder efter dosis 3.

Fase 1 Evaluering af lavere dosis

Er den åbne del af undersøgelsen med lavere dosisevaluering, der vil evaluere sikkerheden, tolerabiliteten og immunogeniciteten af 10 µg BNT162b2 fra 2 skemaer i 2 aldersgrupper (deltagere 12 til <16 år og 16 til <18 år) .

Formålet med fase 1-evalueringen af lavere dosis er at evaluere sikkerheden og immunogeniciteten af BNT162b2 ud fra 2 forskellige dosisskemaer i hver aldersgruppe: (1) 2 doser adskilt af cirka 21 dage og (2) 2 doser adskilt af cirka 8 uger .

Deltagerne vil få udtaget blod før dosis 1, før dosis 2, 7 dage efter dosis 2 og 1 måned efter dosis 2 for at vurdere immunogenicitet for at bestemme den valgte BNT162b2-dosisplan for fase 2/3-evalueringsdelen af den lavere dosis. undersøgelse. Derudover vil deltagerne få udtaget blod 6 og 12 måneder efter dosis 2 for at bestemme, om immunresponset varer ved.

Fase 2/3 Valgt-Dosis

Er den del af undersøgelsen, der vil evaluere sikkerheden, tolerabiliteten og immunogeniciteten i hver aldersgruppe ved det valgte dosisniveau fra fase 1 dosisfindende del af studiet. Effektiviteten vil blive evalueret inden for eller på tværs af aldersgrupper, hvor immunbridging er vellykket, afhængigt af, at der er opstået et tilstrækkeligt antal tilfælde i disse aldersgrupper.

Deltagerne vil få udtaget blod ved baseline før dosis 1 og 6 måneder efter dosis 2. Immunobriding til deltagere i alderen 16 til 25 år i C4591001-studiet vil være baseret på immunogenicitetsdata indsamlet ved (1) baseline og 1 måned efter dosis 2 og (2) baseline og 1 måned efter dosis 3. Vedvarende immunrespons vil være baseret på immunogenicitetsdata indsamlet hos deltagere ved (1) baseline og 1 og 6 måneder efter dosis 2 og (2) baseline og 1, 6, 12 , og 18 måneder efter dosis 3. Desuden vil virkning mod bekræftet COVID-19 og mod asymptomatisk infektion også blive vurderet hos deltagere ≥5 til <12 år.

På udpegede amerikanske steder vil der blive taget en yderligere valgfri fuldblodsprøve på ca. 10 ml før dosis 1 og 7 dage og 6 måneder efter dosis 2 fra op til ca. 60 deltagere ≥10 år. Yderligere prøver vil blive udtaget før dosis 3 og 1 måned efter dosis 3 (kun original BNT162b2-gruppe). Disse prøver vil blive brugt på et eksplorativt grundlag til at undersøge det postvaccinationscellemedierede immunrespons på disse tidspunkter.

Ved det 6-måneders opfølgningsbesøg vil alle deltagere blive afblindede. Deltagere, der oprindeligt fik placebo, vil blive tilbudt muligheden for at modtage BNT162b2 som en del af undersøgelsen. Deltagere, der oprindeligt modtog placebo og bliver berettiget til at modtage BNT162b2 eller en anden COVID-19-vaccine i henhold til lokale eller nationale anbefalinger forud for det 6 måneder lange opfølgningsbesøg (besøg 5 eller 405) (detaljeret separat og tilgængelig i den elektroniske undersøgelsesreferenceportal ) vil have mulighed for at modtage BNT162b2 (10 µg eller 3 µg) baseret på alder på vaccinationstidspunktet.

Opdatering som en del af protokolændring 6: Alle deltagere vil modtage en tredje dosis BNT162b2. For deltagere ≥6 måneder til <5 år, vil den tredje dosis forekomme mindst 8 uger efter den anden dosis. Hos deltagere ≥5 til <12 år vil den tredje dosis forekomme mindst 6 måneder efter den anden dosis. Intervallet mellem anden og tredje dosis vil være baseret på deltagerens alder på tilmeldingstidspunktet. Dosisniveauet for anden og tredje dosis af BNT162b2 vil være baseret på alderen på vaccinationstidspunktet: deltagere <5 år på tidspunktet for anden/tredje dosis vil modtage dosisniveauet på 3 µg, deltagere ≥5 til <12 år på tidspunktet for den anden/tredje dosis vil modtage dosisniveauet på 10 µg, og deltagere ≥12 år på tidspunktet for den anden/tredje dosis vil modtage dosisniveauet på 30 µg.

Fase 2/3 Evaluering af lavere dosis

Er den åbne del af undersøgelsen, der vil evaluere sikkerheden, tolerabiliteten og immunogeniciteten af det valgte dosisskema i hver aldersgruppe fra fase 1-evalueringen med lavere dosis, med i alt cirka 600 aktive deltagere.

Ca. 300 aktive deltagere i hver aldersgruppe i denne fase vil bidrage til immunbridging-analysen 1 måned efter dosis 2 og den overordnede analyse af persistensen af immunrespons 6 og 12 måneder efter dosis 2.

Fase 2/3 Indhentning af serumprøver til potentiel Troponin I-testning

Hvis test af troponin I-niveauer hos personer, der ikke modtog BNT162b2, indikerer, at troponin I-niveau kan være en pålidelig indikator for potentiel subklinisk myocarditis, kan indhentning af serumprøver til potentiel troponin I-testning i perioden med øget risiko for klinisk myocarditis hjælpe med at karakterisere fraværet /tilstedeværelse og hyppighed af subklinisk myocarditis. For at vurdere vil en yderligere gruppe deltagere blive inkluderet: ≥5 til <12 år: randomiseret 2:1 til at modtage BNT162b2 10 µg eller placebo, og ≥12 til <16 år: åben modtagelse af BNT162b2 30 µg.

Opdatering som en del af protokolændring 7: Alle deltagere vil modtage en tredje dosis BNT162b2. For alle deltagere (≥5 til <12 og ≥12 til <16 år) vil den tredje dosis forekomme mindst 5 måneder efter dosis 2.

Dosisniveauet for anden og tredje dosis af BNT162b2 vil være baseret på alderen på vaccinationstidspunktet: deltagere ≥5 til <12 år på tidspunktet for den anden/tredje dosis vil modtage dosisniveauet på 10 µg, og deltagere ≥12 år på tidspunktet for anden/tredje dosis vil modtage dosisniveauet på 30 µg.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

11837

Fase

Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

6 måneder til 18 år (Barn)

Tager imod sunde frivillige

Beskrivelse

Inklusionskriterier

Mandlige eller kvindelige deltagere ≥6 måneder til <12 år på randomiseringstidspunktet, ved besøg 1 for dosisfinding/udvalgt dosisevaluering og for deltagere ≥12 til <18 år på randomiseringstidspunktet , ved besøg 1 for evaluering af lavere dosis. Til opnåelse af-serum-prøver-til-potentiel-troponin I-testdel af undersøgelsen: Mandlige eller kvindelige deltagere mellem ≥5 og <16 år.
Deltagernes forældre/værge og deltagere, alt efter alder, som er villige og i stand til at overholde alle planlagte besøg, behandlingsplan, laboratorietests, livsstilsovervejelser og andre undersøgelsesprocedurer.
Raske deltagere, som er fastslået ved sygehistorie, fysisk undersøgelse og klinisk vurdering fra investigator for at være berettiget til inklusion i undersøgelsen.
Bemærk: Raske deltagere med allerede eksisterende stabil sygdom, defineret som sygdom, der ikke kræver væsentlig ændring i behandlingen eller hospitalsindlæggelse for forværring af sygdom i løbet af de 6 uger før tilmelding, kan inkluderes.
Deltagerne forventes at være tilgængelige i hele undersøgelsens varighed, og hvis forældre/værge kan kontaktes telefonisk under undersøgelsesdeltagelsen.
Negativ uringraviditetstest for kvindelige deltagere, der er biologisk i stand til at få børn.
Kvindelig deltager i den fødedygtige alder eller mandlig deltager i stand til at blive far til børn, som er villig til at bruge en yderst effektiv præventionsmetode som beskrevet i denne protokol i mindst 28 dage efter den sidste dosis af undersøgelsesintervention, hvis der er risiko for graviditet med sin partner ; eller kvindelig deltager, der ikke er i den fødedygtige alder, eller mandlig deltager, der ikke er i stand til at blive far til børn.
Deltagerens eller deltagerens forælder/værge er i stand til at give underskrevet informeret samtykke, som omfatter overholdelse af kravene og begrænsningerne i ICD'en og i denne protokol. Afhængigt af deltagerens alder og i henhold til lokale krav, vil deltagerne også blive bedt om at give samtykke efter behov (mundtligt eller skriftligt).

Eksklusionskriterier

Kun fase 1: Tidligere klinisk (baseret på COVID-19 symptomer/tegn alene, hvis et SARS CoV 2 NAAT resultat ikke var tilgængeligt) eller mikrobiologisk (baseret på COVID-19 symptomer/tegn og et positivt SARS-CoV-2 NAAT resultat) diagnose af COVID 19.
Kun fase 1: Kendt infektion med HIV, HCV eller HBV.
Modtagelse af medicin beregnet til at forebygge COVID-19.
Tidligere eller nuværende diagnose af MIS-C.
Anden medicinsk eller psykiatrisk tilstand, herunder nylig (inden for det seneste år) eller aktiv selvmordstanker/-adfærd eller laboratorieabnormitet, der kan øge risikoen for deltagelse i undersøgelsen eller, efter investigatorens vurdering, gøre deltageren upassende til undersøgelsen. Bemærk: Dette omfatter både tilstande, der kan øge risikoen forbundet med administration af undersøgelsesintervention eller en tilstand, der kan forstyrre fortolkningen af undersøgelsesresultater
Anamnese med alvorlige bivirkninger forbundet med en vaccine og/eller alvorlig allergisk reaktion (f.eks. anafylaksi) over for en hvilken som helst komponent i undersøgelsens intervention(er).
Immunkompromitterede personer med kendt eller formodet immundefekt, som bestemt af historie og/eller laboratorie-/fysisk undersøgelse.
Personer med en historie med autoimmun sygdom eller en aktiv autoimmun sygdom, der kræver terapeutisk intervention, herunder men ikke begrænset til systemisk lupus erythematosus. Bemærk: Stabil type 1-diabetes og hypothyroidisme er tilladt.
Blødende diatese eller tilstand forbundet med langvarig blødning, der efter investigatorens mening ville kontraindicere intramuskulær injektion.
Kvinde, der er gravid eller ammer.
Tidligere vaccination med enhver coronavirus-vaccine.
Personer, der modtager behandling med immunsuppressiv terapi, herunder cytotoksiske midler eller systemiske kortikosteroider, f.eks. mod cancer eller en autoimmun sygdom, eller planlagt modtagelse gennem hele undersøgelsen. Hvis systemiske kortikosteroider er blevet administreret kortvarigt (<14 dage) til behandling af en akut sygdom, bør deltagerne ikke optages i undersøgelsen, før kortikosteroidbehandling er afbrudt i mindst 28 dage før indgivelse af undersøgelsesintervention. Inhalerede/nebuliserede, intraartikulære, intrabursale eller topiske (hud eller øjne) kortikosteroider er tilladt.
Modtagelse af blod-/plasmaprodukter, immunoglobulin eller monoklonale antistoffer fra 60 dage før indgivelse af undersøgelsesintervention, eller modtagelse af enhver passiv antistofterapi, der er specifik for COVID-19, fra 90 dage før indgivelse af undersøgelsesintervention eller planlagt modtagelse gennem hele undersøgelsen.
Deltagelse i andre undersøgelser, der involverer undersøgelsesintervention inden for 28 dage før studiestart og/eller under undersøgelsesdeltagelse.
Tidligere deltagelse i andre undersøgelser, der involverer undersøgelsesintervention indeholdende LNP'er.
Deltagere, der er direkte efterkommere (barn eller børnebarn) af medarbejdere på undersøgelsesstedet eller Pfizer/BioNTech-medarbejdere, der er direkte involveret i udførelsen af undersøgelsen, personale på stedet, der ellers overvåges af investigator, og deres respektive familiemedlemmer.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Forebyggelse
Tildeling: Ikke-randomiseret
Interventionel model: Parallel tildeling
Maskning: Ingen (Åben etiket)

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Eksperimentel: Lav/mellem dosis, ≥5 til <12 år Lav/mellem dosis (10mcg), 2 doser med 21 dages mellemrum	Biologisk: Biologisk/Vaccine: BNT162b2 10mcg BNT162b2 Lav/Mid-Dosis (10mcg) niveau
Eksperimentel: Mid-Dosis, ≥5 til <12 år Mid-Dosis, (20mcg), 2 doser med 21 dages mellemrum	Biologisk: BNT162b2 20mcg BNT162b2 Mid-Dosis (20mcg) niveau
Eksperimentel: Højdosis, ≥5 til <12 år Højdosis (30mcg), 2 doser med 21 dages mellemrum	Biologisk: BNT162b2 30mcg BNT162b2 Højdosis (30mcg) niveau
Eksperimentel: Lav/mellem dosis, ≥2 til < 5 år Lav/mellem dosis (10mcg), 2 doser med 21 dages mellemrum	Biologisk: Biologisk/Vaccine: BNT162b2 10mcg BNT162b2 Lav/Mid-Dosis (10mcg) niveau
Eksperimentel: Mid-Dosis, ≥2 til <5 år Mid-Dosis, (20mcg), 2 doser med 21 dages mellemrum	Biologisk: BNT162b2 20mcg BNT162b2 Mid-Dosis (20mcg) niveau
Eksperimentel: Højdosis, ≥2 til <5 år Højdosis, (30mcg), 2 doser med 21 dages mellemrum	Biologisk: BNT162b2 30mcg BNT162b2 Højdosis (30mcg) niveau
Eksperimentel: Lav/mellem dosis, ≥6 måneder til <2 år Lav/mellem dosis, (10mcg), 2 doser med 21 dages mellemrum	Biologisk: Biologisk/Vaccine: BNT162b2 10mcg BNT162b2 Lav/Mid-Dosis (10mcg) niveau
Eksperimentel: Mid-dosis, ≥6 måneder til <2 år Mid-Dosis, (20mcg), 2 doser med 21 dages mellemrum	Biologisk: BNT162b2 20mcg BNT162b2 Mid-Dosis (20mcg) niveau
Eksperimentel: Højdosis, ≥6 måneder til <2 år Højdosis, (30mcg), 2 doser med 21 dages mellemrum	Biologisk: BNT162b2 30mcg BNT162b2 Højdosis (30mcg) niveau
Placebo komparator: Placebo, ≥6 måneder til <2 år	Andet: Placebo Intramuskulær injektion
Placebo komparator: Placebo, ≥2 til <5 år	Andet: Placebo Intramuskulær injektion
Placebo komparator: Placebo, ≥5 til <12 år	Andet: Placebo Intramuskulær injektion
Eksperimentel: Lav-dosis, ≥6 måneder til <2 år Lav-dosis (3mcg), 2 doser med 21 doser fra hinanden	Biologisk: Biologisk/Vaccine: BNT162b2 3mcg BNT162b2 Lavdosis (3mcg) niveau
Eksperimentel: Lav-dosis, ≥2 til <5 år Lav-dosis (3mcg), 2 doser med 21 dages mellemrum	Biologisk: Biologisk/Vaccine: BNT162b2 3mcg BNT162b2 Lavdosis (3mcg) niveau
Eksperimentel: Højdosis, 12 til <16 år (Troponin I-test) Højdosis (30mcg), 3 doser	Biologisk: BNT162b2 30mcg BNT162b2 Højdosis (30mcg) niveau
Eksperimentel: Lav/mellem dosis, ≥5 til <12 år (Troponin I-test) Lav/mellem dosis (10mcg), 3 doser	Biologisk: Biologisk/Vaccine: BNT162b2 10mcg BNT162b2 Lav/Mid-Dosis (10mcg) niveau
Eksperimentel: Placebo, ≥5 til <12 år (Troponin I-test)	Andet: Placebo Intramuskulær injektion
Eksperimentel: Lav dosis, ≥6 måneder til <2 år (3-dosis regime) Lav-dosis (3mcg), 3 doser	Biologisk: Biologisk/Vaccine: BNT162b2 3mcg BNT162b2 Lavdosis (3mcg) niveau
Eksperimentel: Lav dosis, ≥2 til <5 år (3-dosis regime) Lav-dosis (3mcg), 3 doser	Biologisk: Biologisk/Vaccine: BNT162b2 3mcg BNT162b2 Lavdosis (3mcg) niveau
Placebo komparator: Placebo, ≥6 måneder til <2 år (3-dosis regime)	Andet: Placebo Intramuskulær injektion
Placebo komparator: Placebo, ≥2 til <5 år (3-dosis regime)	Andet: Placebo Intramuskulær injektion

Hvad måler undersøgelsen?

Primære resultatmål

Sekundære resultatmål

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

BioNTech SE

Samarbejdspartnere

Pfizer

Efterforskere

Studieleder: Pfizer CT.gov Call Center, Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

24. marts 2021

Primær færdiggørelse (Faktiske)

4. oktober 2023

Studieafslutning (Faktiske)

8. december 2023

Datoer for studieregistrering

Først indsendt

19. marts 2021

Først indsendt, der opfyldte QC-kriterier

24. marts 2021

Først opslået (Faktiske)

25. marts 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

C4591007
2020-005442-42 (EudraCT nummer)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med SARS-CoV-2-infektion, COVID-19

IRCCS San Raffaele

Afsluttet

Retrospektiv observationsundersøgelse af immunrespons hos personer, der er vaccineret mod SARS-CoV-2-infektion (BioVAC-immunit)

Antistofrespons | Cellulær immunrespons | SAR-CoV-2

Italien
Unity Health Toronto
Canadian Institutes of Health Research (CIHR); Health Canada

Ikke rekrutterer endnu

Adaptiv Platformforsøg med Behandlinger af Luftvejsinfektioner i Samfundsmiljøer (TreatResp) (TreatResp)

Influenza A | Influenza B | Akutte luftvejsinfektioner (ARI'er) | SAR-CoV-2

Canada
Mayo Clinic
National Institute of Neurological Disorders and Stroke (NINDS)

Afsluttet

Langsigtede virkninger af COVID-19

COVID-19 | SAR-CoV-2

Forenede Stater
Pfizer

Aktiv, ikke rekrutterende

En undersøgelse for at lære om, hvor godt årlige opdateringer til Covid-19-vaccinearbejdet for at beskytte mennesker mod Covid-19, og hvor mange penge folk bruger på sundhedsydelser til Covid-19

COVID-19 | Coronavirus sygdom 2019 (COVID-19) | Covid-19-infektion | Vacciner mod covid-19 | SARS-CoV-2-infektion, COVID19 | COVID-19-vaccination | SARS-CoV-2-infektion, COVID-19 | COVID-19 (Coronavirus sygdom 2019) | COVID-19 SARS-CoV-2-infektion

Forenede Stater
The Institute of Molecular and Translational Medicine...
University Hospital Olomouc; Palacky University

Afsluttet

Studie SARS-CoV-2-CZ-PREVAL-II - Arm af Olomouc Regionen

SARS-CoV-2 | SARS-CoV-2 (COVID-19) infektion

Tjekkiet
AstraZeneca

Afsluttet

Undersøgelse af AZD3152 intramuskulær injektion eller intravenøs infusion hos raske japanske voksne deltagere

COVID-19, SARS-CoV-2

Japan
Institute of Tropical Medicine, Belgium
Jessa Hospital; University Hospital, Antwerp; Universiteit Antwerpen; Scien... og andre samarbejdspartnere

Afsluttet

Er SARS-CoV-2-specifikke antistoffer en sammenhæng til beskyttelse? (ImmCoV)

COVID-19 | SARS-CoV-2

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

Afsluttet

Sikkerhed, tolerabilitet og farmakokinetik af SAB-185 hos raske deltagere

COVID-19 | SARS-CoV-2

Forenede Stater
University of Wisconsin, Madison
National Institutes of Health (NIH)

Afsluttet

Gentag test for SARS-CoV-2

COVID-19 | SARS-CoV-2

Forenede Stater
Syneos Health
US Specialty Formulations, LLC

Afsluttet

Første-i-menneske-undersøgelse af oralt administreret CoV2-OGEN1 hos raske forsøgspersoner

SARS-CoV-2 (COVID-19)

New Zealand

Kliniske forsøg med Placebo

Galderma R&D

Afsluttet

Effekt af CD07805/47 Gel i Rosacea Flushing

Rosacea

Tyskland
SamA Pharmaceutical Co., Ltd

Ukendt

Kliniske forsøg for at vurdere effektiviteten og sikkerheden af HLIM

Akut bronkitis | Akut øvre luftvejsinfektion

Korea, Republikken
National Institute on Drug Abuse (NIDA)

Afsluttet

Virkninger af cannabisadministrationsveje på menneskelig ydeevne og farmakokinetik

Brug af cannabis

Forenede Stater
Akeso

Ikke rekrutterer endnu

En klinisk undersøgelse af AK120 hos unge med moderat til svær atopisk dermatitis

Atopisk dermatitis

Kina
Cellmedis
Medical Network Sp. z o.o.

Ikke rekrutterer endnu

New Topical tReatment Options for Symptomatic patiEnts With Nonerosive gastroesophageaL Reflux dIsease: rEsults oF a Single-center, Randomized, Double-blind, Placebo-controlled Crossover Trial. (The RELIEF Trial) (RELIEF)

GERD (gastroøsofageal reflukssygdom) | NERD

Polen
Texas A&M University
Nutrabolt

Afsluttet

Glycemic Response of a Commercial Food Bar (NB16)

Glukose og insulinrespons
AstraZeneca
Parexel; Spandauer Damm 130; 14050; Berlin, Germany

Afsluttet

Vurdering af sikkerhed, tolerabilitet og farmakodynamik efter administration af én dosis AZD8601 til mandlige patienter med type II diabetes mellitus (T2DM)

Mandlige forsøgspersoner med type II-diabetes (T2DM)

Tyskland
Heptares Therapeutics Limited

Afsluttet

Farmakokinetik af oral kapsel hos raske japanske vs. kaukasiske forsøgspersoner (HTL0018318)

Farmakokinetik | Sikkerhedsproblemer

Det Forenede Kongerige
LifeMine Therapeutics

Rekruttering

En fase I-undersøgelse for at evaluere Life-001

Sunde frivillige

Australien
Longeveron Inc.

Afsluttet

Allogeneic hMSC Injection in Patients With Hypoplastic Left Heart Syndrome (ELPIS)

Hypoplastisk venstre hjerte syndrom

Forenede Stater

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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)

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=5 to <12 Years of Age Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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

Et fase 1/2/3-studie til evaluering af sikkerheden, tolerabiliteten og immunogeniciteten af ​​en RNA-vaccinekandidat mod COVID-19 hos raske børn og unge voksne

ET FASE 1, ÅBEN LABEL DOSEFINDENDE UNDERSØGELSE TIL EVALUERING AF SIKKERHED, TOLERABILITET OG IMMUNOGENICITET OG FASE 2/3 PLACEBO-KONTROLLERET, OBSERVATØRBLINDET SIKKERHED, TOLERABILITET OG IMMUNOGENICITETSSTUDIE VIA ACCAVINE-2 SAGS. -19 HOS SUNDE BØRN OG UNGE VOKSNE

Studieoversigt

Status

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Undersøgelsestype

Tilmelding (Faktiske)

Fase

Kontakter og lokationer

Studiesteder

Deltagelseskriterier

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Aldre berettiget til at studere

Tager imod sunde frivillige

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Design detaljer

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Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

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Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

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Publikationer og nyttige links

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Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Faktiske)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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Planlægger du at dele individuelle deltagerdata (IPD)?

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt

Kliniske forsøg med SARS-CoV-2-infektion, COVID-19

Kliniske forsøg med Placebo

Søg i lignende forsøg

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CROs in Mongolia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Et fase 1/2/3-studie til evaluering af sikkerheden, tolerabiliteten og immunogeniciteten af en RNA-vaccinekandidat mod COVID-19 hos raske børn og unge voksne