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En fas 1/2/3-studie för att utvärdera säkerheten, tolerabiliteten och immunogeniciteten hos en RNA-vaccinkandidat mot covid-19 hos friska barn och unga vuxna

26 maj 2026 uppdaterad av: BioNTech SE

EN STUDIE FÖR FAS 1, ÖPPEN ETIKETT DOSFINNANDE FÖR ATT UTVÄRDERA SÄKERHET, TOLERABILITET OCH IMMUNOGENICITET OCH FAS 2/3 PLACEBOKONTROLLERAD, OBSERVATÖR-BLINDAD SÄKERHET, TOLERABILITET OCH IMMUNOGENICITETSSTUDIE AV ACOVID-2 OCH IMMUNOGENICITETSSTUDIE AV ACCAIN-2 SAGS. -19 HOS FRISKA BARN OCH UNGA VUXNA

Detta är en fas 1/2/3-studie på friska barn och unga vuxna.

Beroende på säkerhets- och/eller immunogenicitetsdata som genererats under studiens gång, och den resulterande bedömningen av nytta-risk, kan säkerheten, tolerabiliteten och immunogeniciteten för BNT162b2 hos deltagare <6 månaders ålder därefter utvärderas.

Studieöversikt

Status

Avslutad

Betingelser

SARS-CoV-2-infektion, COVID-19

Intervention / Behandling

Detaljerad beskrivning

Fas 1 Dos-Finding

Är den öppna dosavkännande delen av studien som kommer att utvärdera säkerhet, tolerabilitet och immunogenicitet för BNT162b2 administrerat enligt ett 2-dosschema (separerade med cirka 21 dagar) i upp till 3 åldersgrupper (deltagare ≥5 till <12) år, ≥2 till <5 år och ≥6 månader till <2 år).

Dosfynd initieras i denna studie hos deltagare ≥5 till <12 år, baserat på den acceptabla blindade säkerhetsbedömningen av 30-µg dosen hos 12- till 15-åringar i C4591001-studien.

Syftet med fas 1 är att identifiera föredragna dosnivåer av BNT162b2 från upp till 3 olika dosnivåer i varje åldersgrupp.

Beroende på säkerhets- och/eller immunogenicitetsdata som genererats under loppet av denna studie är det möjligt att dosnivåer kanske inte påbörjas, kan avslutas tidigt och/eller kan läggas till med dosnivåer under den lägsta angivna dosen.

Uppdatering som en del av protokolltillägg 6: Alla deltagare kommer att få en tredje dos av BNT162b2. För deltagare ≥6 månader till <5 år kommer den tredje dosen att ske minst 8 veckor efter den andra dosen. Hos deltagare ≥5 till <12 år kommer den tredje dosen att ske minst 6 månader efter den andra dosen. Intervallet mellan den andra och tredje dosen kommer att baseras på deltagarens ålder vid tidpunkten för registreringen. Dosnivån för den tredje dosen av BNT162b2 kommer att baseras på ålder vid tidpunkten för vaccination: deltagare <5 år vid tidpunkten för den tredje dosen kommer att få dosnivån på 3 µg, deltagare ≥5 till <12 år av ålder vid tidpunkten för den tredje dosen kommer att få dosnivån på 10 µg, och deltagare ≥12 år vid tidpunkten för den tredje dosen kommer att få dosnivån på 30 µg.

Deltagarna kommer att ta blodprov före både dos 1 och dos 2 och 7 dagar efter dos 2 för att bedöma immunogenicitet för att bestämma den valda BNT162b2-dosnivån för fas 2/3. Deltagarna kommer också att ta blodprov före dos 3 och 1, 6 och 12 månader efter dos 3.

Fas 1 utvärdering av lägre dos

Är den öppna delen för utvärdering av lägre dos av studien som kommer att utvärdera säkerheten, tolerabiliteten och immunogeniciteten för 10 µg BNT162b2 från 2 scheman i 2 åldersgrupper (deltagare 12 till <16 år och 16 till <18 år) .

Syftet med Fas 1-utvärderingen av lägre dos är att utvärdera säkerheten och immunogeniciteten av BNT162b2 från 2 olika dosscheman i varje åldersgrupp: (1) 2 doser åtskilda med cirka 21 dagar och (2) 2 doser åtskilda med cirka 8 veckor .

Deltagarna kommer att ta blodprov före dos 1, före dos 2, 7 dagar efter dos 2 och 1 månad efter dos 2 för att bedöma immunogenicitet för att bestämma det valda dosschemat för BNT162b2 för fas 2/3-delen av lägre dosutvärdering av studie. Dessutom kommer deltagarna att ta blodprov 6 och 12 månader efter dos 2 för att fastställa hur länge immunsvaret är.

Fas 2/3 Vald-dos

Är den del av studien som kommer att utvärdera säkerheten, tolerabiliteten och immunogeniciteten i varje åldersgrupp vid den valda dosnivån från fas 1-dosen av studien. Effekten kommer att utvärderas inom eller över åldersgrupper där immunobridning är framgångsrik, beroende på att ett tillräckligt antal fall har samlats i dessa åldersgrupper.

Deltagarna kommer att ta blodprov vid baslinjen före dos 1 och 6 månader efter dos 2. Immunobridning till deltagare 16 till 25 år i C4591001-studien kommer att baseras på immunogenicitetsdata som samlats in vid (1) baslinje och 1 månad efter dos 2 och (2) baslinje och 1 månad efter dos 3. Ihållande immunsvar kommer att baseras på immunogenicitetsdata som samlats in från deltagarna vid (1) baslinje och 1 och 6 månader efter dos 2 och (2) baslinje och 1, 6, 12 , och 18 månader efter dos 3. Dessutom kommer effekten mot bekräftad covid-19 och mot asymtomatisk infektion också att bedömas hos deltagare ≥5 till <12 år.

På utsedda ställen i USA kommer ytterligare ett valfritt helblodsprov på cirka 10 ml att tas före dos 1 och 7 dagar och 6 månader efter dos 2 från upp till cirka 60 deltagare ≥10 år gamla. Ytterligare prover kommer att tas före dos 3 och 1 månad efter dos 3 (endast den ursprungliga BNT162b2-gruppen). Dessa prover kommer att användas på en explorativ basis för att undersöka det cellförmedlade immunsvaret efter vaccination vid dessa tidpunkter.

Vid det 6 månader långa uppföljningsbesöket kommer alla deltagare att avblindas. Deltagare som ursprungligen fick placebo kommer att erbjudas möjligheten att få BNT162b2 som en del av studien. Deltagare som ursprungligen fick placebo och blir berättigade till att få BNT162b2 eller annat COVID-19-vaccin enligt lokala eller nationella rekommendationer före det 6 månader långa uppföljningsbesöket (besök 5 eller 405) (detaljerad separat och tillgänglig i den elektroniska studiereferensportalen ) kommer att ha möjlighet att få BNT162b2 (10 µg eller 3 µg) baserat på ålder vid vaccinationstillfället.

Uppdatering som en del av protokolltillägg 6: Alla deltagare kommer att få en tredje dos av BNT162b2. För deltagare ≥6 månader till <5 år kommer den tredje dosen att ske minst 8 veckor efter den andra dosen. Hos deltagare ≥5 till <12 år kommer den tredje dosen att ske minst 6 månader efter den andra dosen. Intervallet mellan den andra och tredje dosen kommer att baseras på deltagarens ålder vid tidpunkten för registreringen. Dosnivån för den andra och tredje dosen av BNT162b2 kommer att baseras på ålder vid tidpunkten för vaccinationen: deltagare <5 år vid tidpunkten för den andra/tredje dosen kommer att få dosnivån på 3 µg, deltagare ≥5 till <12 år vid tidpunkten för den andra/tredje dosen kommer att få dosnivån på 10 µg, och deltagare ≥12 år vid tidpunkten för den andra/tredje dosen kommer att få dosnivån på 30 µg.

Fas 2/3 utvärdering av lägre dos

Är den öppna delen av studien som kommer att utvärdera säkerheten, tolerabiliteten och immunogeniciteten för det valda dosschemat i varje åldersgrupp från Fas 1-utvärderingen med lägre dos, med totalt cirka 600 aktiva deltagare.

Ungefär 300 aktiva deltagare i varje åldersgrupp i denna fas kommer att bidra till immunförstärkningsanalysen 1 månad efter dos 2 och den övergripande analysen av ihållande immunsvar 6 och 12 månader efter dos 2.

Fas 2/3 Erhållande av serumprover för potentiell troponin I-testning

Om testning av troponin I-nivåer hos individer som inte fått BNT162b2 indikerar att troponin I-nivåer kan vara en tillförlitlig indikator på potentiell subklinisk myokardit, kan serumprover för potentiell troponin I-testning under perioden med ökad risk för klinisk myokardit hjälpa till att karakterisera frånvaron /närvaro och frekvens av subklinisk myokardit. För att bedöma kommer ytterligare en grupp deltagare att inkluderas: ≥5 till <12 år: randomiserat 2:1 för att få BNT162b2 10 µg eller placebo, och ≥12 till <16 år: öppet mottagande av BNT162b2 30 µg.

Uppdatering som en del av protokolltillägg 7: Alla deltagare kommer att få en tredje dos av BNT162b2. För alla deltagare (≥5 till <12 och ≥12 till <16 år) kommer den tredje dosen att ske minst 5 månader efter dos 2.

Dosnivån för den andra och tredje dosen av BNT162b2 kommer att baseras på ålder vid tidpunkten för vaccinationen: deltagare ≥5 till <12 år vid tidpunkten för den andra/tredje dosen kommer att få dosnivån på 10 µg, och deltagare ≥12 år vid tidpunkten för den andra/tredje dosen kommer att få dosnivån på 30 µg.

Studietyp

Interventionell

Inskrivning (Faktisk)

11837

Fas

Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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
Förenta staterna
- Alabama
  - Birmingham, Alabama, Förenta staterna, 35233
    - University of Alabama at Birmingham - School of Medicine
- Arizona
  - Phoenix, Arizona, Förenta staterna, 85016
    - Phoenix Children's Hospital
- California
  - Los Angeles, California, Förenta staterna, 90057
    - Matrix Clinical Research
  - Los Angeles, California, Förenta staterna, 90027
    - SCPMG/Kaiser Permanente Los Angeles Medical Center
  - Madera, California, Förenta staterna, 93637
    - Madera Family Medical Group
  - Oakland, California, Förenta staterna, 94611
    - Kaiser Permanente Oakland
  - Palo Alto, California, Förenta staterna, 94304
    - Lucile Packard Children's Hospital Stanford
  - Palo Alto, California, Förenta staterna, 94304
    - Clinical & Translational Research Unit (CTRU) & Spectrum BioBank, Stanford University
  - Paramount, California, Förenta staterna, 90723
    - Center for Clinical Trials, LLC
  - Paramount, California, Förenta staterna, 90723
    - Center for Clinical Trials
  - Rolling Hills Estates, California, Förenta staterna, 90274
    - Peninsula Research Associates
  - Sacramento, California, Förenta staterna, 95815
    - Kaiser Permanente Sacramento
  - Santa Clara, California, Förenta staterna, 95051
    - Kaiser Permanente Santa Clara
  - Stanford, California, Förenta staterna, 94305
    - Stanford Health Care
  - Stanford, California, Förenta staterna, 94305
    - Stanford Health Care Investigational Drug Service
  - Valley Village, California, Förenta staterna, 91607
    - Bayview Research Group, LLC
- Colorado
  - Aurora, Colorado, Förenta staterna, 80045
    - Children's Hospital Colorado
- Connecticut
  - New Haven, Connecticut, Förenta staterna, 06519
    - Yale Center for Clinical Investigation
- District of Columbia
  - Washington D.C., District of Columbia, Förenta staterna, 20010
    - Children's National Medical Center
  - Washington D.C., District of Columbia, Förenta staterna, 20016
    - Velocity Clinical Research, Washington DC
  - Washington D.C., District of Columbia, Förenta staterna, 20009
    - Emerson Clinical Research Institute
- Florida
  - Jacksonville, Florida, Förenta staterna, 32256
    - Clinical Neuroscience Solutions, Inc.
  - Miami, Florida, Förenta staterna, 33142
    - Acevedo Clinical Research Associates
  - Orlando, Florida, Förenta staterna, 32801
    - Clinical Neuroscience Solutions
- Georgia
  - Atlanta, Georgia, Förenta staterna, 30331
    - Atlanta Center for Medical Research
  - Atlanta, Georgia, Förenta staterna, 30322
    - Emory University School of Medicine
  - Atlanta, Georgia, Förenta staterna, 30322
    - Emory Children's Center Illness POD
  - Macon, Georgia, Förenta staterna, 31210
    - Meridian Clinical Research, LLC
  - Union City, Georgia, Förenta staterna, 30291
    - Rophe Adult and Pediatric Medicine/SKYCRNG
- Idaho
  - Idaho Falls, Idaho, Förenta staterna, 83404
    - Clinical Research Prime
  - Meridian, Idaho, Förenta staterna, 83646
    - Solaris Clinical Research
- Kansas
  - Newton, Kansas, Förenta staterna, 67114
    - Alliance for Multispecialty Research, LLC
  - Wichita, Kansas, Förenta staterna, 67207
    - Alliance for Multispecialty Research, LLC
- Kentucky
  - Bardstown, Kentucky, Förenta staterna, 40004
    - Kentucky Pediatric/ Adult Research
  - Louisville, Kentucky, Förenta staterna, 40202
    - Novak Center for Children's Health
- Louisiana
  - New Orleans, Louisiana, Förenta staterna, 70121
    - Ochsner Clinic Foundation
  - Shreveport, Louisiana, Förenta staterna, 71101
    - Louisiana State University Health Sciences Shreveport
- Maryland
  - Baltimore, Maryland, Förenta staterna, 21224
    - Johns Hopkins Bayview Medical Center
- Massachusetts
  - Boston, Massachusetts, Förenta staterna, 02118
    - Boston Medical Center
- Michigan
  - Bingham Farms, Michigan, Förenta staterna, 48025
    - Michigan Center of Medical Research
- Mississippi
  - Ridgeland, Mississippi, Förenta staterna, 39157
    - SKY Integrative Medical Center/SKYCRNG
- Missouri
  - Chesterfield, Missouri, Förenta staterna, 63005
    - Clinical Research Professionals
  - Kansas City, Missouri, Förenta staterna, 64108
    - Children's Mercy Hospital
- Nebraska
  - Hastings, Nebraska, Förenta staterna, 68901
    - Meridian Clinical Research, LLC
  - Lincoln, Nebraska, Förenta staterna, 68510
    - Velocity Clinical Research, Lincoln
  - Omaha, Nebraska, Förenta staterna, 68114
    - Children's Hospital & Medical Center
  - Omaha, Nebraska, Förenta staterna, 68117
    - Children's Physician's Clinic, Spring Valley
- New Jersey
  - New Brunswick, New Jersey, Förenta staterna, 08901
    - Cancer Institute Of New Jersey
  - New Brunswick, New Jersey, Förenta staterna, 08901
    - Rutgers University
- New York
  - Binghamton, New York, Förenta staterna, 13905
    - Meridian Clinical Research LLC
  - Commack, New York, Förenta staterna, 11725
    - Advanced Specialty Care
  - Rochester, New York, Förenta staterna, 14642
    - University of Rochester Medical Center
  - Rochester, New York, Förenta staterna, 14609
    - Rochester Clinical Research, Inc.
  - Stony Brook, New York, Förenta staterna, 11794
    - Stony Brook University
  - Syracuse, New York, Förenta staterna, 13210
    - SUNY Upstate Medical University
- North Carolina
  - Charlotte, North Carolina, Förenta staterna, 28207
    - Atrium Health-STRIVE Vaccine Research Clinic
  - Charlotte, North Carolina, Förenta staterna, 28211
    - Teen Health Connection (study visits)
  - Durham, North Carolina, Förenta staterna, 27703
    - Duke University - Main Hospital and Clinics
  - Matthews, North Carolina, Förenta staterna, 28105
    - Atrium Health-STRIVE Vaccine Research Clinic (study visits)
- Ohio
  - Cincinnati, Ohio, Förenta staterna, 45229
    - Cincinnati Children's Hospital Medical Center Vaccine Research Center
  - Columbus, Ohio, Förenta staterna, 43213
    - Centricity Research Columbus Ohio Multispecialty
  - Dayton, Ohio, Förenta staterna, 45429
    - PriMED Clinical Research
  - South Euclid, Ohio, Förenta staterna, 44121
    - Senders Pediatrics
- Oregon
  - Gresham, Oregon, Förenta staterna, 97030
    - Cyn3rgy Research
- Pennsylvania
  - Erie, Pennsylvania, Förenta staterna, 16506
    - AHN Erie Health + Wellness Pavillion: West
- Rhode Island
  - East Greenwich, Rhode Island, Förenta staterna, 02818
    - Velocity Clinical Research-Providence
- South Carolina
  - Charleston, South Carolina, Förenta staterna, 29414
    - Coastal Pediatric Research
  - Greenville, South Carolina, Förenta staterna, 29607
    - Tribe Clinical Research, LLC
  - Summerville, South Carolina, Förenta staterna, 29486
    - Coastal Pediatric Research
- Tennessee
  - Memphis, Tennessee, Förenta staterna, 38105
    - St. Jude Children's Research Hospital
  - Nashville, Tennessee, Förenta staterna, 37203
    - Clinical Research Associates Inc
- Texas
  - Austin, Texas, Förenta staterna, 78726
    - Innovo Research - Austin Regional Clinic
  - Corpus Christi, Texas, Förenta staterna, 78411
    - Driscoll Children's Hospital
  - Dallas, Texas, Förenta staterna, 75251
    - Cedar Health Research
  - Dickinson, Texas, Förenta staterna, 77539
    - Bay Colony Pediatrics
  - Edinburg, Texas, Förenta staterna, 78539
    - Proactive Clinical Research, LLC
  - Frisco, Texas, Förenta staterna, 75033
    - Village Health Partners (Patient Seen Address)
  - Houston, Texas, Förenta staterna, 77055
    - West Houston Clinical Research Services
  - Houston, Texas, Förenta staterna, 77008
    - HG Pediatrics
  - Houston, Texas, Förenta staterna, 77008
    - Van Tran Family Practice
  - Houston, Texas, Förenta staterna, 77030
    - Texas Children's Hospital - Clinical Research Center
  - Houston, Texas, Förenta staterna, 77087
    - Pediatric Associates
  - Houston, Texas, Förenta staterna, 77008
    - Helios Clinical Research - HOU
  - Houston, Texas, Förenta staterna, 77008
    - Helios Clinical Research
  - Houston, Texas, Förenta staterna, 77065
    - DM Clinical Research - MDC
- Utah
  - Salt Lake City, Utah, Förenta staterna, 84109
    - J. Lewis Research, Inc. / Foothill Family Clinic
  - Salt Lake City, Utah, Förenta staterna, 84121
    - J. Lewis Research, Inc. / Foothill Family Clinic South
- Virginia
  - Charlottesville, Virginia, Förenta staterna, 22902
    - Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)
  - Midlothian, Virginia, Förenta staterna, 23114
    - Virginia Research Center
- Washington
  - Seattle, Washington, Förenta staterna, 98105
    - Seattle Children's Hospital
Mexiko
- - Veracruz, Mexiko, C.P. 91900
    - Sociedad de Metabolismo y Corazón S.C.
- Nuevo León
  - Monterrey, Nuevo León, Mexiko, C.P. 64060
    - Christus - Latam Hub Center of Excellence and Innovation S.C.
- Yucatán
  - Mérida, Yucatán, Mexiko, 97070
    - Kohler & Milstein Research S.A. De C.V.
  - Mérida, Yucatán, Mexiko, 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 Toruń
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 Pediátrico Uncibay

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

6 månader till 18 år (Barn)

Tar emot friska volontärer

Beskrivning

Inklusionskriterier

Manliga eller kvinnliga deltagare ≥6 månader till <12 år, vid tidpunkten för randomisering, vid besök 1 för utvärdering av dos/vald dos och för deltagare ≥12 till <18 år, vid tidpunkten för randomisering , vid besök 1 för utvärdering av lägre dos. För att erhålla-serumprover-för-potentiella-troponin I-testningsdelen av studien: Manliga eller kvinnliga deltagare mellan ≥5 och <16 år.
Deltagarnas föräldrar/vårdnadshavare och deltagare, beroende på ålder, som är villiga och kan följa alla schemalagda besök, behandlingsplan, laboratorietester, livsstilsöverväganden och andra studieprocedurer.
Friska deltagare som bedöms av utredarens medicinska historia, fysisk undersökning och klinisk bedömning vara berättigade till inkludering i studien.
Obs: Friska deltagare med redan existerande stabil sjukdom, definierad som sjukdom som inte kräver signifikant förändring av behandlingen eller sjukhusvistelse för förvärrad sjukdom under de 6 veckorna före inskrivningen, kan inkluderas.
Deltagare förväntas vara tillgängliga under studiens varaktighet och vars föräldrar/vårdnadshavare kan kontaktas per telefon under studiedeltagandet.
Negativt uringraviditetstest för kvinnliga deltagare som är biologiskt kapabla att skaffa barn.
Kvinnlig deltagare i fertil ålder eller manlig deltagare som kan bli far till barn som är villig att använda en mycket effektiv preventivmetod enligt beskrivningen i detta protokoll under minst 28 dagar efter den sista dosen av studieinterventionen om de riskerar att bli gravid med sin partner ; eller kvinnlig deltagare som inte är i fertil ålder eller manlig deltagare som inte kan skaffa barn.
Deltagaren eller deltagarens förälder/vårdnadshavare kan ge undertecknat informerat samtycke, vilket inkluderar efterlevnad av kraven och begränsningarna som anges i ICD och i detta protokoll. Beroende på deltagarens ålder och enligt lokala krav kommer deltagarna också att uppmanas att ge sitt samtycke (muntligt eller skriftligt).

Exklusions kriterier

Endast fas 1: Tidigare klinisk (baserat på enbart COVID-19-symtom/tecken, om ett SARS CoV 2 NAAT-resultat inte var tillgängligt) eller mikrobiologiskt (baserat på COVID-19-symtom/tecken och ett positivt SARS-CoV-2 NAAT-resultat) diagnos av covid 19.
Endast fas 1: Känd infektion med HIV, HCV eller HBV.
Mottagande av mediciner avsedda att förebygga covid-19.
Tidigare eller aktuell diagnos av MIS-C.
Andra medicinska eller psykiatriska tillstånd inklusive nyligen (inom det senaste året) eller aktiva självmordstankar/-beteende eller laboratorieavvikelser som kan öka risken för studiedeltagande eller, enligt utredarens bedömning, göra deltagaren olämplig för studien. Obs: Detta inkluderar både tillstånd som kan öka risken förknippade med administration av studieinterventioner eller ett tillstånd som kan störa tolkningen av studieresultat
Anamnes med allvarliga biverkningar i samband med ett vaccin och/eller allvarlig allergisk reaktion (t.ex. anafylaxi) mot någon komponent i studieinterventionen.
Immunförsvagade individer med känd eller misstänkt immunbrist, enligt anamnes och/eller laboratorie-/fysisk undersökning.
Individer med en historia av autoimmun sjukdom eller en aktiv autoimmun sjukdom som kräver terapeutisk intervention, inklusive men inte begränsat till systemisk lupus erythematosus. Obs: Stabil typ 1-diabetes och hypotyreos är tillåtna.
Blödande diates eller tillstånd i samband med långvarig blödning som, enligt utredarens uppfattning, skulle kontraindicera intramuskulär injektion.
Kvinna som är gravid eller ammar.
Tidigare vaccination med valfritt coronavirusvaccin.
Individer som får behandling med immunsuppressiv terapi, inklusive cytotoxiska medel eller systemiska kortikosteroider, t.ex. för cancer eller en autoimmun sjukdom, eller planerat mottagande under hela studien. Om systemiska kortikosteroider har administrerats kortvarigt (<14 dagar) för behandling av en akut sjukdom, ska deltagarna inte inkluderas i studien förrän kortikosteroidbehandlingen har avbrutits under minst 28 dagar före administrering av studieintervention. Inhalerade/nebuliserade, intraartikulära, intrabursala eller topiska (hud eller ögon) kortikosteroider är tillåtna.
Mottagande av blod-/plasmaprodukter, immunglobulin eller monoklonala antikroppar, från 60 dagar före administrering av studieintervention, eller mottagande av någon passiv antikroppsterapi specifik för COVID-19 från 90 dagar före administrering av studieintervention, eller planerat mottagande under hela studien.
Deltagande i andra studier som involverar studieintervention inom 28 dagar före studiestart och/eller under studiedeltagande.
Tidigare deltagande i andra studier med studieintervention innehållande LNP.
Deltagare som är direkta ättlingar (barn eller barnbarn) till undersökningsplatspersonal eller Pfizer/BioNTech-anställda som är direkt involverade i genomförandet av studien, platspersonal som annars övervakas av undersökningsledaren och deras respektive familjemedlemmar.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Primärt syfte: Förebyggande
Tilldelning: Icke-randomiserad
Interventionsmodell: Parallellt uppdrag
Maskning: Ingen (Open Label)

Antal vapen

Vapen och interventioner

Deltagargrupp / Arm	Intervention / Behandling
Experimentell: Låg/mellandos, ≥5 till <12 år Låg/Mellandos (10mcg), 2 doser med 21 dagars mellanrum	Biologisk: Biologiskt/vaccin: BNT162b2 10mcg BNT162b2 Låg/Mellandosnivå (10 mcg).
Experimentell: Mellandos, ≥5 till <12 år Mid-Dos, (20mcg), 2 doser med 21 dagars mellanrum	Biologisk: BNT162b2 20mcg BNT162b2 mellandosnivå (20 mcg).
Experimentell: Högdos, ≥5 till <12 år Högdos (30mcg), 2 doser med 21 dagars mellanrum	Biologisk: BNT162b2 30mcg BNT162b2 högdosnivå (30 mcg).
Experimentell: Låg/mellandos, ≥2 till < 5 år Låg/Mellandos (10mcg), 2 doser med 21 dagars mellanrum	Biologisk: Biologiskt/vaccin: BNT162b2 10mcg BNT162b2 Låg/Mellandosnivå (10 mcg).
Experimentell: Mellandos, ≥2 till <5 år Mid-Dos, (20mcg), 2 doser med 21 dagars mellanrum	Biologisk: BNT162b2 20mcg BNT162b2 mellandosnivå (20 mcg).
Experimentell: Högdos, ≥2 till <5 år Högdos, (30 mcg), 2 doser med 21 dagars mellanrum	Biologisk: BNT162b2 30mcg BNT162b2 högdosnivå (30 mcg).
Experimentell: Låg/mellandos, ≥6 månader till <2 år Låg/mellandos, (10 mcg), 2 doser med 21 dagars mellanrum	Biologisk: Biologiskt/vaccin: BNT162b2 10mcg BNT162b2 Låg/Mellandosnivå (10 mcg).
Experimentell: Mellandos, ≥6 månader till <2 år Mid-Dos, (20mcg), 2 doser med 21 dagars mellanrum	Biologisk: BNT162b2 20mcg BNT162b2 mellandosnivå (20 mcg).
Experimentell: Hög dos, ≥6 månader till <2 år Högdos, (30 mcg), 2 doser med 21 dagars mellanrum	Biologisk: BNT162b2 30mcg BNT162b2 högdosnivå (30 mcg).
Placebo-jämförare: Placebo, ≥6 månader till <2 år	Övrig: Placebo Intramuskulär injektion
Placebo-jämförare: Placebo, ≥2 till <5 år	Övrig: Placebo Intramuskulär injektion
Placebo-jämförare: Placebo, ≥5 till <12 år	Övrig: Placebo Intramuskulär injektion
Experimentell: Låg dos, ≥6 månader till <2 år Lågdos (3mcg), 2 doser med 21 doser ifrån varandra	Biologisk: Biologiskt/vaccin: BNT162b2 3mcg BNT162b2 Lågdosnivå (3mcg).
Experimentell: Låg dos, ≥2 till <5 år Lågdos (3mcg), 2 doser med 21 dagars mellanrum	Biologisk: Biologiskt/vaccin: BNT162b2 3mcg BNT162b2 Lågdosnivå (3mcg).
Experimentell: Högdos, 12 till <16 år (Troponin I-testning) Högdos (30mcg), 3 doser	Biologisk: BNT162b2 30mcg BNT162b2 högdosnivå (30 mcg).
Experimentell: Låg/mellandos, ≥5 till <12 år (Troponin I-testning) Låg/mellandos (10mcg), 3 doser	Biologisk: Biologiskt/vaccin: BNT162b2 10mcg BNT162b2 Låg/Mellandosnivå (10 mcg).
Experimentell: Placebo, ≥5 till <12 år (Troponin I-testning)	Övrig: Placebo Intramuskulär injektion
Experimentell: Låg dos, ≥6 månader till <2 år (3-dos regim) Lågdos (3mcg), 3 doser	Biologisk: Biologiskt/vaccin: BNT162b2 3mcg BNT162b2 Lågdosnivå (3mcg).
Experimentell: Låg dos, ≥2 till <5 år (3-dosregim) Lågdos (3mcg), 3 doser	Biologisk: Biologiskt/vaccin: BNT162b2 3mcg BNT162b2 Lågdosnivå (3mcg).
Placebo-jämförare: Placebo, ≥6 månader till <2 år (3-dos regim)	Övrig: Placebo Intramuskulär injektion
Placebo-jämförare: Placebo, ≥2 till <5 år (3-dos regim)	Övrig: Placebo Intramuskulär injektion

Vad mäter studien?

Primära resultatmått

Sekundära resultatmått

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

BioNTech SE

Samarbetspartners

Pfizer

Utredare

Studierektor: Pfizer CT.gov Call Center, Pfizer

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

24 mars 2021

Primärt slutförande (Faktisk)

4 oktober 2023

Avslutad studie (Faktisk)

8 december 2023

Studieregistreringsdatum

Först inskickad

19 mars 2021

Först inskickad som uppfyllde QC-kriterierna

24 mars 2021

Första postat (Faktisk)

25 mars 2021

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

28 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 maj 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

C4591007
2020-005442-42 (EudraCT-nummer)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Resultatmått	Åtgärdsbeskrivning	Tidsram
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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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)

Resultatmått	Åtgärdsbeskrivning	Tidsram
Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=5 to <12 Years of Age Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 Tidsram: 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 fas 1/2/3-studie för att utvärdera säkerheten, tolerabiliteten och immunogeniciteten hos en RNA-vaccinkandidat mot covid-19 hos friska barn och unga vuxna

Studieöversikt

Status

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Studietyp

Inskrivning (Faktisk)

Fas

Kontakter och platser

Studieorter

Deltagandekriterier

Urvalskriterier

Åldrar som är berättigade till studier

Tar emot friska volontärer

Beskrivning

Studieplan

Hur är studien utformad?

Designdetaljer

Antal vapen

Vapen och interventioner

Deltagargrupp / Arm

Intervention / Behandling

Vad mäter studien?

Primära resultatmått

Resultatmått

Åtgärdsbeskrivning

Tidsram

Sekundära resultatmått

Resultatmått

Åtgärdsbeskrivning

Tidsram

Samarbetspartners och utredare

Sponsor

Samarbetspartners

Utredare

Publikationer och användbara länkar

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

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Studiestart (Faktisk)

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Studieregistreringsdatum

Först inskickad

Först inskickad som uppfyllde QC-kriterierna

Första postat (Faktisk)

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Senaste uppdatering publicerad (Faktisk)

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

Senast verifierad

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