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En fase 1/2/3-studie for å evaluere sikkerheten, tolerabiliteten og immunogenisiteten til en RNA-vaksinekandidat mot COVID-19 hos friske barn og unge voksne

26. mai 2026 oppdatert av: BioNTech SE

EN FASE 1, ÅPEN ETIKET DOSEFINNSTUDIE FOR Å EVALUERE SIKKERHET, TOLERABILITET OG IMMUNOGENISITET OG FASE 2/3 PLACEBO-KONTROLLERT, OBSERVATØRBLINDET SIKKERHET, TOLERABILITET OG IMMUNOGENISITETSSTUDIE AVACCVINE-2 SAGSTIRS. -19 HOS FRISKE BARN OG UNGE

Dette er en fase 1/2/3 studie på friske barn og unge voksne.

Avhengig av sikkerhets- og/eller immunogenisitetsdata generert i løpet av denne studien, og den resulterende vurderingen av nytte-risiko, kan sikkerheten, toleransen og immunogenisiteten til BNT162b2 hos deltakere <6 måneders alder i etterkant bli evaluert.

Studieoversikt

Status

Fullført

Forhold

SARS-CoV-2-infeksjon, COVID-19

Intervensjon / Behandling

Detaljert beskrivelse

Fase 1 Dose-finning

Er den åpne delen av studien som vil evaluere sikkerhet, tolerabilitet og immunogenisitet til BNT162b2 administrert etter en 2-dose (atskilt med ca. 21 dager) i opptil 3 aldersgrupper (deltakere ≥5 til <12) år, ≥2 til <5 år og ≥6 måneder til <2 år).

Dosefunn blir initiert i denne studien hos deltakere ≥5 til <12 år, basert på den akseptable blindede sikkerhetsvurderingen av 30 µg dosen hos 12- til 15-åringer i C4591001-studien.

Hensikten med fase 1 er å identifisere foretrukne dosenivå(er) av BNT162b2 fra opptil 3 forskjellige dosenivåer i hver aldersgruppe.

Avhengig av sikkerhets- og/eller immunogenisitetsdata generert i løpet av denne studien, er det mulig at dosenivåer kanskje ikke startes, kan avsluttes tidlig og/eller kan legges til med dosenivåer under den laveste oppgitte dosen.

Oppdatering som en del av protokollendringer 6: Alle deltakere vil motta en tredje dose av BNT162b2. For deltakere ≥6 måneder til <5 år vil den tredje dosen skje minst 8 uker etter den andre dosen. Hos deltakere ≥5 til <12 år vil den tredje dosen skje minst 6 måneder etter den andre dosen. Intervallet mellom den andre og tredje dosen vil være basert på deltakerens alder på registreringstidspunktet. Dosenivået for den tredje dosen av BNT162b2 vil være basert på alder på vaksinasjonstidspunktet: deltakere <5 år ved tidspunktet for den tredje dosen vil motta dosenivået på 3 µg, deltakere ≥5 til <12 år av alder ved tidspunktet for den tredje dosen vil motta dosenivået på 10 µg, og deltakere ≥12 år ved tidspunktet for den tredje dosen vil motta dosenivået på 30 µg.

Deltakerne vil få tatt blod før både dose 1 og dose 2 og 7 dager etter dose 2 for å vurdere immunogenisitet for å bestemme det valgte BNT162b2-dosenivået for fase 2/3. Deltakerne vil også få tatt blod før dose 3 og 1, 6 og 12 måneder etter dose 3.

Fase 1 Evaluering av lavere dose

Er den åpne delen for evaluering av lavere doser av studien som vil evaluere sikkerheten, toleransen og immunogenisiteten til 10 µg BNT162b2 fra 2 skjemaer i 2 aldersgrupper (deltakere 12 til <16 år og 16 til <18 år) .

Hensikten med fase 1-evalueringen av lavere doser er å evaluere sikkerheten og immunogenisiteten til BNT162b2 fra 2 forskjellige doseplaner i hver aldersgruppe: (1) 2 doser adskilt med omtrent 21 dager og (2) 2 doser adskilt med omtrent 8 uker .

Deltakerne vil få tatt blod før dose 1, før dose 2, 7 dager etter dose 2 og 1 måned etter dose 2 for å vurdere immunogenisitet for å bestemme den valgte BNT162b2-doseplanen for fase 2/3-delen med lavere doseevaluering av studere. I tillegg vil deltakerne få blodtappet 6 og 12 måneder etter dose 2 for å bestemme vedvaren av immunresponsen.

Fase 2/3 Valgt-dose

Er den delen av studien som vil evaluere sikkerheten, tolerabiliteten og immunogenisiteten i hver aldersgruppe ved det valgte dosenivået fra fase 1-dosefinnende delen av studien. Effekten vil bli evaluert innenfor eller på tvers av aldersgrupper der immunbridging er vellykket, avhengig av påløp av et tilstrekkelig antall tilfeller i disse aldersgruppene.

Deltakerne vil få tatt blod ved baseline før dose 1 og 6 måneder etter dose 2. Immunobriding til deltakere 16 til 25 år i C4591001-studien vil være basert på immunogenisitetsdata samlet ved (1) baseline og 1 måned etter dose 2 og (2) baseline og 1 måned etter dose 3. Vedvarende immunrespons vil være basert på immunogenisitetsdata samlet inn hos deltakerne ved (1) baseline og 1 og 6 måneder etter dose 2 og (2) baseline og 1, 6, 12 , og 18 måneder etter dose 3. I tillegg vil effekt mot bekreftet COVID-19 og mot asymptomatisk infeksjon også bli vurdert hos deltakere ≥5 til <12 år.

På utpekte amerikanske steder vil en ekstra valgfri fullblodprøve på ca. 10 ml bli tatt før dose 1 og 7 dager og 6 måneder etter dose 2 fra opptil ca. 60 deltakere ≥10 år. Ytterligere prøver vil bli tatt før dose 3 og 1 måned etter dose 3 (kun original BNT162b2-gruppe). Disse prøvene vil bli brukt på en eksplorativ basis for å undersøke den cellemedierte immunresponsen etter vaksinasjon på disse tidspunktene.

Ved det 6-måneders oppfølgingsbesøket vil alle deltakerne bli avblind. Deltakere som opprinnelig fikk placebo vil bli tilbudt muligheten til å motta BNT162b2 som en del av studien. Deltakere som opprinnelig fikk placebo og blir kvalifisert for mottak av BNT162b2 eller en annen COVID-19-vaksine i henhold til lokale eller nasjonale anbefalinger før det 6 måneder lange oppfølgingsbesøket (besøk 5 eller 405) (detaljert separat og tilgjengelig i den elektroniske studiereferanseportalen ) vil ha mulighet til å motta BNT162b2 (10 µg eller 3 µg) basert på alder på vaksinasjonstidspunktet.

Oppdatering som en del av protokollendringer 6: Alle deltakere vil motta en tredje dose av BNT162b2. For deltakere ≥6 måneder til <5 år vil den tredje dosen skje minst 8 uker etter den andre dosen. Hos deltakere ≥5 til <12 år vil den tredje dosen skje minst 6 måneder etter den andre dosen. Intervallet mellom den andre og tredje dosen vil være basert på deltakerens alder på registreringstidspunktet. Dosenivået for den andre og tredje dosen av BNT162b2 vil være basert på alder på vaksinasjonstidspunktet: deltakere <5 år på tidspunktet for andre/tredje dose vil motta dosenivået på 3 µg, deltakere ≥5 til <12 år ved tidspunktet for den andre/tredje dosen vil motta dosenivået på 10 µg, og deltakere ≥12 år ved tidspunktet for den andre/tredje dosen vil motta dosenivået på 30 µg.

Fase 2/3 Evaluering av lavere dose

Er den åpne delen av studien som vil evaluere sikkerheten, tolerabiliteten og immunogenisiteten til den valgte doseplanen i hver aldersgruppe fra fase 1-evalueringen med lavere doser, med totalt ca. 600 aktive deltakere.

Omtrent 300 aktive deltakere i hver aldersgruppe i denne fasen vil bidra til immunbridging-analysen 1 måned etter dose 2 og den overordnede analysen av vedvarende immunrespons 6 og 12 måneder etter dose 2.

Fase 2/3 Innhenting av serumprøver for potensiell Troponin I-testing

Hvis testing av troponin I-nivåer hos personer som ikke mottok BNT162b2 indikerer at troponin I-nivå kan være en pålitelig indikator på potensiell subklinisk myokarditt, kan innhenting av serumprøver for potensiell troponin I-testing i perioden med økt risiko for klinisk myokarditt bidra til å karakterisere fraværet /tilstedeværelse og hyppighet av subklinisk myokarditt. For å vurdere vil en ekstra gruppe deltakere inkluderes: ≥5 til <12 år: randomisert 2:1 for å motta BNT162b2 10 µg eller placebo, og ≥12 til <16 år: åpen mottak av BNT162b2 30 µg.

Oppdatering som en del av protokollendringer 7: Alle deltakere vil motta en tredje dose av BNT162b2. For alle deltakere (≥5 til <12 og ≥12 til <16 år), vil den tredje dosen skje minst 5 måneder etter dose 2.

Dosenivået for den andre og tredje dosen av BNT162b2 vil være basert på alder på vaksinasjonstidspunktet: deltakere ≥5 til <12 år på tidspunktet for den andre/tredje dosen vil motta dosenivået på 10 µg, og deltakere ≥12 år på tidspunktet for den andre/tredje dosen vil motta dosenivået på 30 µg.

Studietype

Intervensjonell

Registrering (Faktiske)

11837

Fase

Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Brasil
- - São Paulo, Brasil, 04266-010
    - CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda.
- Estado de Bahia
  - Salvador, Estado de Bahia, Brasil, 40415-006
    - Hospital Santo Antônio - Obras Sociais Irmã Dulce/ Centro de Pesquisa Clínica - CPEC
- Minas Gerais
  - Belo Horizonte, Minas Gerais, Brasil, 30150-221
    - Santa Casa de Misericordia de Belo Horizonte
- Paraná
  - Curitiba, Paraná, Brasil, 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, Brasil, 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
Forente stater
- Alabama
  - Birmingham, Alabama, Forente stater, 35233
    - University of Alabama at Birmingham - School of Medicine
- Arizona
  - Phoenix, Arizona, Forente stater, 85016
    - Phoenix Children's Hospital
- California
  - Los Angeles, California, Forente stater, 90057
    - Matrix Clinical Research
  - Los Angeles, California, Forente stater, 90027
    - SCPMG/Kaiser Permanente Los Angeles Medical Center
  - Madera, California, Forente stater, 93637
    - Madera Family Medical Group
  - Oakland, California, Forente stater, 94611
    - Kaiser Permanente Oakland
  - Palo Alto, California, Forente stater, 94304
    - Lucile Packard Children's Hospital Stanford
  - Palo Alto, California, Forente stater, 94304
    - Clinical & Translational Research Unit (CTRU) & Spectrum BioBank, Stanford University
  - Paramount, California, Forente stater, 90723
    - Center for Clinical Trials, LLC
  - Paramount, California, Forente stater, 90723
    - Center for Clinical Trials
  - Rolling Hills Estates, California, Forente stater, 90274
    - Peninsula Research Associates
  - Sacramento, California, Forente stater, 95815
    - Kaiser Permanente Sacramento
  - Santa Clara, California, Forente stater, 95051
    - Kaiser Permanente Santa Clara
  - Stanford, California, Forente stater, 94305
    - Stanford Health Care
  - Stanford, California, Forente stater, 94305
    - Stanford Health Care Investigational Drug Service
  - Valley Village, California, Forente stater, 91607
    - Bayview Research Group, LLC
- Colorado
  - Aurora, Colorado, Forente stater, 80045
    - Children's Hospital Colorado
- Connecticut
  - New Haven, Connecticut, Forente stater, 06519
    - Yale Center for Clinical Investigation
- District of Columbia
  - Washington D.C., District of Columbia, Forente stater, 20010
    - Children's National Medical Center
  - Washington D.C., District of Columbia, Forente stater, 20016
    - Velocity Clinical Research, Washington DC
  - Washington D.C., District of Columbia, Forente stater, 20009
    - Emerson Clinical Research Institute
- Florida
  - Jacksonville, Florida, Forente stater, 32256
    - Clinical Neuroscience Solutions, Inc.
  - Miami, Florida, Forente stater, 33142
    - Acevedo Clinical Research Associates
  - Orlando, Florida, Forente stater, 32801
    - Clinical Neuroscience Solutions
- Georgia
  - Atlanta, Georgia, Forente stater, 30331
    - Atlanta Center for Medical Research
  - Atlanta, Georgia, Forente stater, 30322
    - Emory University School Of Medicine
  - Atlanta, Georgia, Forente stater, 30322
    - Emory Children's Center Illness POD
  - Macon, Georgia, Forente stater, 31210
    - Meridian Clinical Research, LLC
  - Union City, Georgia, Forente stater, 30291
    - Rophe Adult and Pediatric Medicine/SKYCRNG
- Idaho
  - Idaho Falls, Idaho, Forente stater, 83404
    - Clinical Research Prime
  - Meridian, Idaho, Forente stater, 83646
    - Solaris Clinical Research
- Kansas
  - Newton, Kansas, Forente stater, 67114
    - Alliance For multispecialty Research, LLC
  - Wichita, Kansas, Forente stater, 67207
    - Alliance For multispecialty Research, LLC
- Kentucky
  - Bardstown, Kentucky, Forente stater, 40004
    - Kentucky Pediatric/ Adult Research
  - Louisville, Kentucky, Forente stater, 40202
    - Novak Center for Children's Health
- Louisiana
  - New Orleans, Louisiana, Forente stater, 70121
    - Ochsner Clinic Foundation
  - Shreveport, Louisiana, Forente stater, 71101
    - Louisiana State University Health Sciences Shreveport
- Maryland
  - Baltimore, Maryland, Forente stater, 21224
    - Johns Hopkins Bayview Medical Center
- Massachusetts
  - Boston, Massachusetts, Forente stater, 02118
    - Boston Medical Center
- Michigan
  - Bingham Farms, Michigan, Forente stater, 48025
    - Michigan Center of Medical Research
- Mississippi
  - Ridgeland, Mississippi, Forente stater, 39157
    - SKY Integrative Medical Center/SKYCRNG
- Missouri
  - Chesterfield, Missouri, Forente stater, 63005
    - Clinical Research Professionals
  - Kansas City, Missouri, Forente stater, 64108
    - Children's Mercy Hospital
- Nebraska
  - Hastings, Nebraska, Forente stater, 68901
    - Meridian Clinical Research, LLC
  - Lincoln, Nebraska, Forente stater, 68510
    - Velocity Clinical Research, Lincoln
  - Omaha, Nebraska, Forente stater, 68114
    - Children's Hospital & Medical Center
  - Omaha, Nebraska, Forente stater, 68117
    - Children's Physician's Clinic, Spring Valley
- New Jersey
  - New Brunswick, New Jersey, Forente stater, 08901
    - Cancer Institute Of New Jersey
  - New Brunswick, New Jersey, Forente stater, 08901
    - Rutgers University
- New York
  - Binghamton, New York, Forente stater, 13905
    - Meridian Clinical Research LLC
  - Commack, New York, Forente stater, 11725
    - Advanced Specialty Care
  - Rochester, New York, Forente stater, 14642
    - University of Rochester Medical Center
  - Rochester, New York, Forente stater, 14609
    - Rochester Clinical Research, Inc.
  - Stony Brook, New York, Forente stater, 11794
    - Stony Brook University
  - Syracuse, New York, Forente stater, 13210
    - SUNY Upstate Medical University
- North Carolina
  - Charlotte, North Carolina, Forente stater, 28207
    - Atrium Health-STRIVE Vaccine Research Clinic
  - Charlotte, North Carolina, Forente stater, 28211
    - Teen Health Connection (study visits)
  - Durham, North Carolina, Forente stater, 27703
    - Duke University - Main Hospital and Clinics
  - Matthews, North Carolina, Forente stater, 28105
    - Atrium Health-STRIVE Vaccine Research Clinic (study visits)
- Ohio
  - Cincinnati, Ohio, Forente stater, 45229
    - Cincinnati Children's Hospital Medical Center Vaccine Research Center
  - Columbus, Ohio, Forente stater, 43213
    - Centricity Research Columbus Ohio Multispecialty
  - Dayton, Ohio, Forente stater, 45429
    - PriMED Clinical Research
  - South Euclid, Ohio, Forente stater, 44121
    - Senders Pediatrics
- Oregon
  - Gresham, Oregon, Forente stater, 97030
    - Cyn3rgy Research
- Pennsylvania
  - Erie, Pennsylvania, Forente stater, 16506
    - AHN Erie Health + Wellness Pavillion: West
- Rhode Island
  - East Greenwich, Rhode Island, Forente stater, 02818
    - Velocity Clinical Research-Providence
- South Carolina
  - Charleston, South Carolina, Forente stater, 29414
    - Coastal Pediatric Research
  - Greenville, South Carolina, Forente stater, 29607
    - Tribe Clinical Research, LLC
  - Summerville, South Carolina, Forente stater, 29486
    - Coastal Pediatric Research
- Tennessee
  - Memphis, Tennessee, Forente stater, 38105
    - St. Jude Children's Research Hospital
  - Nashville, Tennessee, Forente stater, 37203
    - Clinical Research Associates Inc
- Texas
  - Austin, Texas, Forente stater, 78726
    - Innovo Research - Austin Regional Clinic
  - Corpus Christi, Texas, Forente stater, 78411
    - Driscoll Children's Hospital
  - Dallas, Texas, Forente stater, 75251
    - Cedar Health Research
  - Dickinson, Texas, Forente stater, 77539
    - Bay Colony Pediatrics
  - Edinburg, Texas, Forente stater, 78539
    - Proactive Clinical Research, LLC
  - Frisco, Texas, Forente stater, 75033
    - Village Health Partners (Patient Seen Address)
  - Houston, Texas, Forente stater, 77055
    - West Houston Clinical Research Services
  - Houston, Texas, Forente stater, 77008
    - HG Pediatrics
  - Houston, Texas, Forente stater, 77008
    - Van Tran Family Practice
  - Houston, Texas, Forente stater, 77030
    - Texas Children's Hospital - Clinical Research Center
  - Houston, Texas, Forente stater, 77087
    - Pediatric Associates
  - Houston, Texas, Forente stater, 77008
    - Helios Clinical Research - HOU
  - Houston, Texas, Forente stater, 77008
    - Helios Clinical Research
  - Houston, Texas, Forente stater, 77065
    - DM Clinical Research - MDC
- Utah
  - Salt Lake City, Utah, Forente stater, 84109
    - J. Lewis Research, Inc. / Foothill Family Clinic
  - Salt Lake City, Utah, Forente stater, 84121
    - J. Lewis Research, Inc. / Foothill Family Clinic South
- Virginia
  - Charlottesville, Virginia, Forente stater, 22902
    - Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)
  - Midlothian, Virginia, Forente stater, 23114
    - Virginia Research Center
- Washington
  - Seattle, Washington, Forente 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
Spania
- - Madrid, Spania, 28041
    - Hospital Universitario 12 de Octubre
  - Seville, Spania, 41012
    - Instituto Hispalense de Pediatria
- A Coruña
  - Santiago de Compostela, A Coruña, Spania, 15706
    - Hospital Clinico Universitario Santiago de Compostela
- Barcelona
  - Centelles, Barcelona, Spania, 08540
    - EBA Centelles
  - Esplugues de Llobregat, Barcelona, Spania, 08950
    - Hospital Sant Joan de Déu
  - Sant Cugat del Vallès, Barcelona, Spania, 08195
    - Hospital Universitari General de Catalunya
- Madrid
  - Boadilla del Monte, Madrid, Spania, 28660
    - Hospital Universitario HM Monteprincipe
- Madrid, Comunidad de
  - Madrid, Madrid, Comunidad de, Spania, 28938
    - Hospital Universitario HM Puerta del Sur
- Málaga
  - Antequera, Málaga, Spania, 29200
    - Hospital de Antequera
  - Málaga, Málaga, Spania, 29015
    - Grupo Pediatrico Uncibay

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

6 måneder til 18 år (Barn)

Tar imot friske frivillige

Beskrivelse

Inklusjonskriterier

Mannlige eller kvinnelige deltakere ≥6 måneder til <12 år, ved randomiseringstidspunktet, ved besøk 1 for evaluering av dosefinning/valgt dose og for deltakere ≥12 til <18 år, ved randomiseringstidspunktet , ved besøk 1 for evaluering av lavere dose. For å oppnå-serumprøver-for-potensiell-troponin I-testing delen av studien: Mannlige eller kvinnelige deltakere mellom ≥5 og <16 år.
Deltakernes foreldre/verge(r) og deltakere, avhengig av alder, som er villige og i stand til å overholde alle planlagte besøk, behandlingsplan, laboratorietester, livsstilshensyn og andre studieprosedyrer.
Friske deltakere som er bestemt av sykehistorie, fysisk undersøkelse og klinisk vurdering av etterforskeren for å være kvalifisert for inkludering i studien.
Merk: Friske deltakere med eksisterende stabil sykdom, definert som sykdom som ikke krever signifikant endring i behandlingen eller sykehusinnleggelse for forverret sykdom i løpet av de 6 ukene før registrering, kan inkluderes.
Deltakerne forventes å være tilgjengelige under studiens varighet og hvis foresatte/foresatte kan kontaktes på telefon under studiedeltakelsen.
Negativ uringraviditetstest for kvinnelige deltakere som er biologisk i stand til å få barn.
Kvinnelig deltaker i fertil alder eller mannlig deltaker som er i stand til å bli far til barn som er villig til å bruke en svært effektiv prevensjonsmetode som beskrevet i denne protokollen i minst 28 dager etter siste dose av studieintervensjonen hvis de er i fare for graviditet med sin partner ; eller kvinnelig deltaker som ikke er i fertil alder eller mannlig deltaker som ikke er i stand til å bli far til barn.
Deltakeren eller deltakerens forelder/verge er i stand til å gi signert informert samtykke, som inkluderer overholdelse av kravene og begrensningene som er oppført i ICD og i denne protokollen. Avhengig av deltakerens alder og i henhold til lokale krav, vil deltakerne også bli bedt om å gi samtykke etter behov (muntlig eller skriftlig).

Eksklusjonskriterier

Bare fase 1: Tidligere klinisk (basert på COVID-19 symptomer/tegn alene, hvis et SARS CoV 2 NAAT-resultat ikke var tilgjengelig) eller mikrobiologisk (basert på COVID-19-symptomer/-tegn og et positivt SARS-CoV-2 NAAT-resultat) diagnose av covid 19.
Bare fase 1: Kjent infeksjon med HIV, HCV eller HBV.
Mottak av medisiner beregnet på å forebygge COVID-19.
Tidligere eller nåværende diagnose av MIS-C.
Andre medisinske eller psykiatriske tilstander inkludert nylig (i løpet av det siste året) eller aktive selvmordstanker/-adferd eller laboratorieavvik som kan øke risikoen for studiedeltakelse eller, etter etterforskerens vurdering, gjøre deltakeren upassende for studien. Merk: Dette inkluderer både tilstander som kan øke risikoen forbundet med studieintervensjonsadministrasjon eller en tilstand som kan forstyrre tolkningen av studieresultatene
Anamnese med alvorlig bivirkning assosiert med en vaksine og/eller alvorlig allergisk reaksjon (f.eks. anafylaksi) på en hvilken som helst komponent i studieintervensjonen(e).
Immunkompromitterte individer med kjent eller mistenkt immunsvikt, bestemt ved anamnese og/eller laboratorie-/fysisk undersøkelse.
Personer med en historie med autoimmun sykdom eller en aktiv autoimmun sykdom som krever terapeutisk intervensjon, inkludert men ikke begrenset til systemisk lupus erythematosus. Merk: Stabil type 1 diabetes og hypotyreose er tillatt.
Blødende diatese eller tilstand assosiert med langvarig blødning som etter utrederens oppfatning vil kontraindisere intramuskulær injeksjon.
Kvinne som er gravid eller ammer.
Tidligere vaksinasjon med eventuell koronavirusvaksine.
Personer som mottar behandling med immunsuppressiv terapi, inkludert cytotoksiske midler eller systemiske kortikosteroider, for eksempel for kreft eller en autoimmun sykdom, eller planlagt mottak gjennom hele studien. Hvis systemiske kortikosteroider har blitt administrert kortvarig (<14 dager) for behandling av en akutt sykdom, bør deltakerne ikke meldes inn i studien før kortikosteroidbehandling er avbrutt i minst 28 dager før studieintervensjonsadministrasjon. Inhalerte/nebuliserte, intraartikulære, intrabursale eller topiske (hud eller øyne) kortikosteroider er tillatt.
Mottak av blod/plasmaprodukter, immunglobulin eller monoklonale antistoffer, fra 60 dager før studieintervensjonsadministrasjon, eller mottak av passiv antistoffterapi spesifikk for COVID-19 fra 90 dager før studieintervensjonsadministrasjon, eller planlagt mottak gjennom hele studien.
Deltakelse i andre studier som involverer studieintervensjon innen 28 dager før studiestart og/eller under studiedeltakelse.
Tidligere deltakelse i andre studier som involverer studieintervensjon som inneholder LNP.
Deltakere som er direkte etterkommere (barn eller barnebarn) av ansatte på undersøkelsesstedet eller Pfizer/BioNTech-ansatte som er direkte involvert i gjennomføringen av undersøkelsen, anleggspersonale som ellers overvåkes av etterforskeren, og deres respektive familiemedlemmer.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Forebygging
Tildeling: Ikke-randomisert
Intervensjonsmodell: Parallell tildeling
Masking: Ingen (Open Label)

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm	Intervensjon / Behandling
Eksperimentell: Lav/mellomdose, ≥5 til <12 år Lav/Middose (10mcg), 2 doser med 21 dagers mellomrom	Biologisk: Biologisk/vaksine: BNT162b2 10mcg BNT162b2 Lavt/Middeldose (10mcg) nivå
Eksperimentell: Midtdose, ≥5 til <12 år Mid-dose, (20mcg), 2 doser med 21 dagers mellomrom	Biologisk: BNT162b2 20mcg BNT162b2 mellomdose (20mcg) nivå
Eksperimentell: Høy dose, ≥5 til <12 år Høydose (30mcg), 2 doser med 21 dagers mellomrom	Biologisk: BNT162b2 30mcg BNT162b2 Høydose (30mcg) nivå
Eksperimentell: Lav/mellomdose, ≥2 til < 5 år Lav/Middose (10mcg), 2 doser med 21 dagers mellomrom	Biologisk: Biologisk/vaksine: BNT162b2 10mcg BNT162b2 Lavt/Middeldose (10mcg) nivå
Eksperimentell: Midtdose, ≥2 til <5 år Mid-dose, (20mcg), 2 doser med 21 dagers mellomrom	Biologisk: BNT162b2 20mcg BNT162b2 mellomdose (20mcg) nivå
Eksperimentell: Høy dose, ≥2 til <5 år Høydose, (30mcg), 2 doser med 21 dagers mellomrom	Biologisk: BNT162b2 30mcg BNT162b2 Høydose (30mcg) nivå
Eksperimentell: Lav/mellomdose, ≥6 måneder til <2 år Lav/Middose, (10mcg), 2 doser med 21 dagers mellomrom	Biologisk: Biologisk/vaksine: BNT162b2 10mcg BNT162b2 Lavt/Middeldose (10mcg) nivå
Eksperimentell: Midtdose, ≥6 måneder til <2 år Mid-dose, (20mcg), 2 doser med 21 dagers mellomrom	Biologisk: BNT162b2 20mcg BNT162b2 mellomdose (20mcg) nivå
Eksperimentell: Høy dose, ≥6 måneder til <2 år Høydose, (30mcg), 2 doser med 21 dagers mellomrom	Biologisk: BNT162b2 30mcg BNT162b2 Høydose (30mcg) nivå
Placebo komparator: Placebo, ≥6 måneder til <2 år	Annen: Placebo Intramuskulær injeksjon
Placebo komparator: Placebo, ≥2 til <5 år	Annen: Placebo Intramuskulær injeksjon
Placebo komparator: Placebo, ≥5 til <12 år	Annen: Placebo Intramuskulær injeksjon
Eksperimentell: Lavdose, ≥6 måneder til <2 år Lav-dose (3mcg), 2 doser med 21 doser fra hverandre	Biologisk: Biologisk/vaksine: BNT162b2 3mcg BNT162b2 lavdose (3mcg) nivå
Eksperimentell: Lavdose, ≥2 til <5 år Lavdose (3mcg), 2 doser med 21 dagers mellomrom	Biologisk: Biologisk/vaksine: BNT162b2 3mcg BNT162b2 lavdose (3mcg) nivå
Eksperimentell: Høydose, 12 til <16 år (Troponin I-testing) Høydose (30mcg), 3 doser	Biologisk: BNT162b2 30mcg BNT162b2 Høydose (30mcg) nivå
Eksperimentell: Lav/mellomdose, ≥5 til <12 år (Troponin I-testing) Lav/Middose (10mcg), 3 doser	Biologisk: Biologisk/vaksine: BNT162b2 10mcg BNT162b2 Lavt/Middeldose (10mcg) nivå
Eksperimentell: Placebo, ≥5 til <12 år (Troponin I-testing)	Annen: Placebo Intramuskulær injeksjon
Eksperimentell: Lavdose, ≥6 måneder til <2 år (3-doseregime) Lavdose (3mcg), 3 doser	Biologisk: Biologisk/vaksine: BNT162b2 3mcg BNT162b2 lavdose (3mcg) nivå
Eksperimentell: Lav dose, ≥2 til <5 år (3-dose regime) Lavdose (3mcg), 3 doser	Biologisk: Biologisk/vaksine: BNT162b2 3mcg BNT162b2 lavdose (3mcg) nivå
Placebo komparator: Placebo, ≥6 måneder til <2 år (3-dose regime)	Annen: Placebo Intramuskulær injeksjon
Placebo komparator: Placebo, ≥2 til <5 år (3-dose regime)	Annen: Placebo Intramuskulær injeksjon

Hva måler studien?

Primære resultatmål

Sekundære resultatmål

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

BioNTech SE

Samarbeidspartnere

Pfizer

Etterforskere

Studieleder: Pfizer CT.gov Call Center, Pfizer

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

24. mars 2021

Primær fullføring (Faktiske)

4. oktober 2023

Studiet fullført (Faktiske)

8. desember 2023

Datoer for studieregistrering

Først innsendt

19. mars 2021

Først innsendt som oppfylte QC-kriteriene

24. mars 2021

Først lagt ut (Faktiske)

25. mars 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

C4591007
2020-005442-42 (EudraCT-nummer)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på SARS-CoV-2-infeksjon, COVID-19

IRCCS San Raffaele

Fullført

Retrospektiv observasjonsstudie av immunrespons hos personer vaksinert mot SARS-COV-2-infeksjon (BioVAC-immunit)

Antistoffrespons | Cellulær immunrespons | SAR-CoV-2

Italia
Pfizer

Aktiv, ikke rekrutterende

En studie for å lære om hvor godt årlige oppdateringer til vaksinearbeidet Covid-19 for å beskytte mennesker mot Covid-19 og hvor mye penger folk bruker på helsetjenester for Covid-19

Covid-19 | Coronavirus Disease 2019 (COVID-19) | Covid-19-infeksjon | Covid-19-vaksiner | SARS-CoV-2-infeksjon, COVID19 | COVID-19-vaksinasjon | SARS-CoV-2-infeksjon, COVID-19 | COVID-19 (Coronavirus Disease 2019) | COVID-19 SARS-CoV-2-infeksjon

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

Har ikke rekruttert ennå

Adaptiv Plattformstudie av Behandlinger for Luftveisinfeksjoner i Samfunnsinnstillinger (TreatResp) (TreatResp)

Influensa A | Influensa B | Akutte luftveisinfeksjoner (ARI) | SAR-CoV-2

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

Fullført

Langsiktige effekter av covid-19

Covid-19 | SAR-CoV-2

Forente stater
The Institute of Molecular and Translational Medicine...
University Hospital Olomouc; Palacky University

Fullført

Studie SARS-CoV-2-CZ-PREVAL-II - Arm av Olomouc-regionen

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

Tsjekkia
AstraZeneca

Fullført

Studie av AZD3152 intramuskulær injeksjon eller intravenøs infusjon hos friske japanske voksne deltakere

COVID-19, SARS-CoV-2

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

Fullført

Er SARS-CoV-2-spesifikke antistoffer en korrelasjon for beskyttelse? (ImmCoV)

Covid-19 | SARS-CoV-2

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

Fullført

Sikkerhet, tolerabilitet og farmakokinetikk av SAB-185 hos friske deltakere

Covid-19 | SARS-CoV-2

Forente stater
University of Wisconsin, Madison
National Institutes of Health (NIH)

Fullført

Gjenta testing for SARS-CoV-2

Covid-19 | SARS-CoV-2

Forente stater
Syneos Health
US Specialty Formulations, LLC

Fullført

Første-i-menneske-studie av oralt administrert CoV2-OGEN1 hos friske personer

SARS-CoV-2 (COVID-19)

New Zealand

Kliniske studier på Placebo

Galderma R&D

Fullført

Effekt av CD07805/47 Gel i Rosacea Flushing

Rosacea

Tyskland
SamA Pharmaceutical Co., Ltd

Ukjent

Kliniske studier for å vurdere effektiviteten og sikkerheten til HLIM

Akutt bronkitt | Akutt øvre luftveisinfeksjon

Korea, Republikken
National Institute on Drug Abuse (NIDA)

Fullført

Effekter av administrasjonsveier for cannabis på menneskelig ytelse og farmakokinetikk

Cannabisbruk

Forente stater
Akeso

Har ikke rekruttert ennå

En klinisk studie av AK120 hos ungdom med moderat til alvorlig atopisk dermatitt

Atopisk dermatitt

Kina
AstraZeneca
Parexel; Spandauer Damm 130; 14050; Berlin, Germany

Fullført

Vurdering av sikkerhet, tolerabilitet og farmakodynamikk etter administrering av én dose AZD8601 til mannlige pasienter med type II diabetes mellitus (T2DM)

Mannlige personer med type II diabetes (T2DM)

Tyskland
Heptares Therapeutics Limited

Fullført

Farmakokinetikk av oral kapsel hos sunne japanske vs. kaukasiske personer (HTL0018318)

Farmakokinetikk | Sikkerhetsproblemer

Storbritannia
Cellmedis
Medical Network Sp. z o.o.

Har ikke rekruttert ennå

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 reflukssykdom) | NERD

Polen
Texas A&M University
Nutrabolt

Fullført

Glycemic Response of a Commercial Food Bar (NB16)

Glukose og insulinrespons
Regado Biosciences, Inc.

Fullført

Safety, Tolerability and PK/PD of RB006 in a Healthy Volunteer SAD (SC101)

Frivillig frisk

Forente stater
LifeMine Therapeutics

Rekruttering

En fase I-studie for å evaluere Life-001

Friske Frivillige

Australia

Resultatmål	Tiltaksbeskrivelse	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	Tiltaksbeskrivelse	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

En fase 1/2/3-studie for å evaluere sikkerheten, tolerabiliteten og immunogenisiteten til en RNA-vaksinekandidat mot COVID-19 hos friske barn og unge voksne

EN FASE 1, ÅPEN ETIKET DOSEFINNSTUDIE FOR Å EVALUERE SIKKERHET, TOLERABILITET OG IMMUNOGENISITET OG FASE 2/3 PLACEBO-KONTROLLERT, OBSERVATØRBLINDET SIKKERHET, TOLERABILITET OG IMMUNOGENISITETSSTUDIE AVACCVINE-2 SAGSTIRS. -19 HOS FRISKE BARN OG UNGE

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