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Vaiheen 1/2/3 tutkimus RNA-rokoteehdokkaiden turvallisuuden, siedettävyyden ja immunogeenisuuden arvioimiseksi COVID-19:tä vastaan terveillä lapsilla ja nuorilla aikuisilla

tiistai 26. toukokuuta 2026 päivittänyt: BioNTech SE

VAIHE 1, AVOIN ANNOSTUTKIMUS TUTKIMUS TURVALLISUUDEN, SIEDETTÄVYYDEN JA IMMUNOGEENISUUDEN ARVIOIMISEKSI SEKÄ VAIHE 2/3 PLACEBO-OHJELMAT, TARKASTAJIEN SOKOITETUT TURVALLISUUS, SIEDETTÄVYYS JA IMMUNOGENISUUSVAPAUS2 -19 TERVEILLÄ LAPSILLE JA NUORILLE AIKUISILLE

Tämä on vaiheen 1/2/3 tutkimus terveillä lapsilla ja nuorilla aikuisilla.

Tämän tutkimuksen aikana saaduista turvallisuus- ja/tai immunogeenisyystiedoista ja tuloksena olevasta hyöty-riski-arvioinnista riippuen BNT162b2:n turvallisuus, siedettävyys ja immunogeenisyys alle 6 kuukauden ikäisillä osallistujilla voidaan myöhemmin arvioida.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

SARS-CoV-2-infektio, COVID-19

Interventio / Hoito

Yksityiskohtainen kuvaus

Vaihe 1 Annoksen löytäminen

Onko tutkimuksen avoin annoshakuosa, jossa arvioidaan BNT162b2:n turvallisuutta, siedettävyyttä ja immunogeenisyyttä annettuna 2 annoksen (noin 21 päivän välein) aikataulussa enintään 3 ikäryhmässä (osallistujat ≥5–<12). vuotta, ≥2 - <5 vuotta ja ≥6 kuukautta - <2 vuoden ikä).

Tässä tutkimuksessa aloitetaan annoksen määrittäminen ≥5–<12-vuotiaille osallistujille C4591001-tutkimuksessa 12–15-vuotiaiden 30 µg:n annoksen hyväksyttävän sokkoutetun turvallisuusarvioinnin perusteella.

Vaiheen 1 tarkoituksena on tunnistaa BNT162b2:n edulliset annostasot jopa 3 eri annostasosta kussakin ikäryhmässä.

Tämän tutkimuksen aikana saaduista turvallisuus- ja/tai immunogeenisyystiedoista riippuen on mahdollista, että annostasoja ei aloiteta, ne voidaan lopettaa ennenaikaisesti ja/tai niitä voidaan lisätä pienimmän ilmoitettua annosta pienemmillä annostasoilla.

Päivitys osana protokollamuutosta 6: Kaikki osallistujat saavat kolmannen annoksen BNT162b2:ta. ≥6 kuukauden ja <5 vuoden ikäisille osallistujille kolmas annos annetaan vähintään 8 viikkoa toisen annoksen jälkeen. Osallistujille, jotka ovat ≥5–<12-vuotiaita, kolmas annos annetaan vähintään 6 kuukautta toisen annoksen jälkeen. Toisen ja kolmannen annoksen välinen aika määräytyy osallistujan iän mukaan ilmoittautumishetkellä. Kolmannen BNT162b2-annoksen annostaso perustuu ikään rokotushetkellä: osallistujat, jotka ovat alle 5-vuotiaita kolmannen annoksen ottohetkellä, saavat 3 µg:n annostason, osallistujat ≥ 5 - <12 vuotta. ikä kolmannen annoksen ajankohtana saa 10 µg:n annostason ja osallistujat, jotka ovat ≥ 12-vuotiaita kolmannen annoksen ajankohtana, saavat 30 µg:n annostason.

Osallistujilta otetaan verikoe ennen sekä annosta 1 että annosta 2 ja 7 päivää annoksen 2 jälkeen immunogeenisuuden arvioimiseksi valitun BNT162b2-annostason määrittämiseksi vaiheelle 2/3. Osallistujilta otetaan myös veri ennen annosta 3 ja 1, 6 ja 12 kuukautta annoksen 3 jälkeen.

Vaihe 1 pienemmän annoksen arviointi

Onko tutkimuksen avoin pienemmän annoksen arviointiosuus, jossa arvioidaan 10 µg:n BNT162b2:n turvallisuutta, siedettävyyttä ja immunogeenisyyttä kahdessa aikataulussa kahdessa ikäryhmässä (osallistujat 12-<16-vuotiaat ja 16-<18-vuotiaat) .

Vaiheen 1 pienemmän annoksen arvioinnin tarkoituksena on arvioida BNT162b2:n turvallisuutta ja immunogeenisyyttä kahdella eri annosohjelmalla kussakin ikäryhmässä: (1) 2 annosta noin 21 päivän välein ja (2) 2 annosta noin 8 viikon välein. .

Osallistujilta otetaan verikoe ennen annosta 1, ennen annosta 2, 7 päivää annoksen 2 jälkeen ja 1 kuukausi annoksen 2 jälkeen immunogeenisuuden arvioimiseksi valitun BNT162b2-annosohjelman määrittämiseksi vaiheen 2/3 pienemmän annoksen arviointiosuutta varten. opiskella. Lisäksi osallistujilta otetaan verikoe 6 ja 12 kuukauden kuluttua annoksen 2 jälkeen immuunivasteen pysyvyyden määrittämiseksi.

Vaihe 2/3 Valittu annos

Onko se osa tutkimuksesta, jossa arvioidaan turvallisuutta, siedettävyyttä ja immunogeenisyyttä kussakin ikäryhmässä valitulla annostasolla tutkimuksen vaiheen 1 annoksenhakuosasta. Tehoa arvioidaan ikäryhmissä tai niiden välillä, joissa immuunisidonta on onnistunut, riippuen siitä, onko kyseisissä ikäryhmissä kertynyt riittävä määrä tapauksia.

Osallistujilta otetaan verinäyte lähtötilanteessa ennen annosta 1 ja 6 kuukautta annoksen 2 jälkeen. C4591001-tutkimuksen 16–25-vuotiaiden osallistujien immuunivaste perustuu immunogeenisyystietoihin, jotka on kerätty (1) lähtötilanteessa ja 1 kuukausi annoksen 2 jälkeen ja (2) lähtötaso ja 1 kuukausi annoksen 3 jälkeen. Immuunivasteen pysyvyys perustuu immunogeenisuustietoihin, jotka on kerätty osallistujilta (1) lähtötilanteessa ja 1 ja 6 kuukautta annoksen 2 jälkeen ja (2) lähtötilanteessa ja 1, 6, 12 , ja 18 kuukautta annoksen 3 jälkeen. Lisäksi tehoa vahvistettua COVID-19:ää ja oireetonta infektiota vastaan arvioidaan myös osallistujilla, joiden ikä on ≥5–<12 vuotta.

Nimetyistä yhdysvaltalaisista paikoista otetaan valinnainen noin 10 ml:n ylimääräinen kokoverinäyte ennen annosta 1 ja 7 päivää ja 6 kuukautta annoksen 2 jälkeen enintään noin 60 osallistujalta, joiden ikä on ≥10 vuotta. Lisänäytteet otetaan ennen annosta 3 ja 1 kuukausi annoksen 3 jälkeen (vain alkuperäinen BNT162b2-ryhmä). Näitä näytteitä käytetään kokeellisella pohjalla rokotuksen jälkeisen soluvälitteisen immuunivasteen tutkimiseen näinä ajankohtina.

Kuuden kuukauden seurantakäynnillä kaikki osallistujat vapautetaan sokeutumisesta. Alun perin lumelääkettä saaneille osallistujille tarjotaan mahdollisuus saada BNT162b2 osana tutkimusta. Osallistujat, jotka saivat alun perin lumelääkettä ja jotka ovat oikeutettuja saamaan BNT162b2- tai muun COVID-19-rokotteen paikallisten tai kansallisten suositusten mukaisesti ennen kuuden kuukauden seurantakäyntiä (käynti 5 tai 405) (yksityiskohtaisesti ja saatavilla sähköisessä tutkimusviiteportaalissa ) on mahdollisuus saada BNT162b2:ta (10 µg tai 3 µg) rokotushetken iän perusteella.

Päivitys osana protokollamuutosta 6: Kaikki osallistujat saavat kolmannen annoksen BNT162b2:ta. ≥6 kuukauden ja <5 vuoden ikäisille osallistujille kolmas annos annetaan vähintään 8 viikkoa toisen annoksen jälkeen. Osallistujille, jotka ovat ≥5–<12-vuotiaita, kolmas annos annetaan vähintään 6 kuukautta toisen annoksen jälkeen. Toisen ja kolmannen annoksen välinen aika määräytyy osallistujan iän mukaan ilmoittautumishetkellä. Toisen ja kolmannen BNT162b2-annoksen annostaso perustuu ikään rokotushetkellä: osallistujat, jotka ovat alle 5-vuotiaita toisen/kolmannen annoksen ottohetkellä, saavat 3 µg:n annostason, osallistujat ≥ 5–5. Alle 12-vuotiaat toisen/kolmannen annoksen ottohetkellä saavat 10 µg:n annostason, ja osallistujat, jotka ovat ≥12-vuotiaita toisen/kolmannen annoksen ottohetkellä, saavat 30 µg:n annostason.

Vaihe 2/3 pienemmän annoksen arviointi

Onko tutkimuksen avoin osa, joka arvioi valitun annostusohjelman turvallisuutta, siedettävyyttä ja immunogeenisyyttä kussakin ikäryhmässä vaiheen 1 pienemmän annoksen arvioinnista, yhteensä noin 600 aktiivista osallistujaa.

Noin 300 aktiivista osallistujaa kustakin tämän vaiheen ikäryhmästä osallistuu immunobled-analyysiin kuukauden kuluttua annoksen 2 jälkeen ja immuunivasteen pysyvyyden kokonaisanalyysiin 6 ja 12 kuukauden kohdalla annoksen 2 jälkeen.

Vaihe 2/3 Seeruminäytteiden ottaminen potentiaalisen troponiini I -testausta varten

Jos troponiini I -tasojen testaus henkilöillä, jotka eivät saaneet BNT162b2:ta, osoittavat, että troponiini I -taso voi olla luotettava indikaattori mahdollisesta subkliinisestä sydänlihastulehduksesta, seeruminäytteiden ottaminen mahdollisen troponiini I -testaukseen kliinisen sydänlihastulehduksen lisääntyneen riskin aikana voi auttaa luonnehtimaan poissaoloa. /subkliinisen sydänlihastulehduksen esiintyminen ja esiintyvyys. Arviointia varten otetaan mukaan ylimääräinen osallistujaryhmä: ≥5–<12-vuotiaat: satunnaistettu 2:1 saamaan BNT162b2:ta 10 µg tai lumelääkettä, ja ≥12–<16-vuotiaat: avoin BNT162b2:n vastaanotto 30 µg.

Päivitys osana protokollamuutosta 7: Kaikki osallistujat saavat kolmannen annoksen BNT162b2:ta. Kaikille osallistujille (≥5–<12 ja ≥12–<16-vuotiaat) kolmas annos annetaan vähintään 5 kuukautta annoksen 2 jälkeen.

Toisen ja kolmannen BNT162b2-annoksen annostaso perustuu ikään rokotushetkellä: osallistujat, jotka ovat ≥5–<12-vuotiaita toisen/kolmannen annoksen ottohetkellä, saavat 10 µg:n annostason, ja osallistujat, jotka ovat ≥ 12-vuotiaita toisen/kolmannen annoksen ottohetkellä, saavat 30 µg:n annostason.

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

11837

Vaihe

Vaihe 3

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

6 kuukautta - 18 vuotta (Lapsi)

Hyväksyy terveitä vapaaehtoisia

Joo

Kuvaus

Sisällyttämiskriteerit

Mies- tai naispuoliset osallistujat, jotka ovat ≥6 kuukauden ja <12 vuoden ikäisiä, satunnaistamisen aikaan, käynnillä 1 annoksen määrittämisen/valitun annoksen arviointia varten ja osallistujat, jotka ovat ≥12-<18-vuotiaita satunnaistamisen aikaan Käynnissä 1 pienemmän annoksen arviointia varten. Potentiaalisen troponiini I -testausosuuden seeruminäytteiden hankkiminen: Mies- tai naispuolinen osallistuja ≥5–<16-vuotiaat.
Osallistujien vanhemmat/lailliset huoltajat ja osallistujat iän mukaan, jotka ovat halukkaita ja kykeneviä noudattamaan kaikkia suunniteltuja käyntejä, hoitosuunnitelmaa, laboratoriotestejä, elämäntapanäkökohtia ja muita tutkimustoimenpiteitä.
Terveet osallistujat, jotka ovat lääketieteellisen historian, fyysisen tutkimuksen ja tutkijan kliinisen arvion perusteella kelvollisia osallistumaan tutkimukseen.
Huomautus: Terveet osallistujat, joilla on stabiili sairaus, joka määritellään sairaudeksi, joka ei vaadi merkittävää muutosta terapiassa tai sairaalahoitoa taudin pahenemisen vuoksi 6 viikon aikana ennen ilmoittautumista.
Osallistujien odotetaan olevan tavoitettavissa koko tutkimuksen ajan ja joiden vanhemmat/lailliset huoltajat voivat olla puhelimitse yhteydessä tutkimukseen osallistumisen aikana.
Negatiivinen virtsan raskaustesti naisille, jotka ovat biologisesti kykeneviä synnyttämään lapsia.
Hedelmällisessä iässä oleva naispuolinen osallistuja tai miespuolinen osallistuja, joka pystyy synnyttämään lapsia ja joka on halukas käyttämään erittäin tehokasta ehkäisymenetelmää, joka on kuvattu tässä protokollassa vähintään 28 päivän ajan viimeisen tutkimustoimenpiteen annoksen jälkeen, jos hänellä on riski tulla raskaaksi kumppaninsa kanssa ; tai naispuolinen osallistuja, joka ei ole hedelmällisessä iässä tai miespuolinen osallistuja, joka ei pysty synnyttämään lapsia.
Osallistujan tai osallistujan vanhemmat/laillinen huoltaja pystyy antamaan allekirjoitetun tietoon perustuvan suostumuksen, joka sisältää ICD:ssä ja tässä pöytäkirjassa lueteltujen vaatimusten ja rajoitusten noudattamisen. Osallistujan iästä riippuen ja paikallisten vaatimusten mukaisesti osallistujia pyydetään myös antamaan suostumus tarvittaessa (suullisesti tai kirjallisesti).

Poissulkemiskriteerit

Vain vaihe 1: aiempi kliininen (perustuu pelkästään COVID-19-oireisiin/-oireisiin, jos SARS CoV 2 NAAT -tulosta ei ollut saatavilla) tai mikrobiologinen (COVID-19-oireiden/merkkien ja positiivisen SARS-CoV-2 NAAT-tuloksen perusteella) COVID 19 -diagnoosi.
Vain vaihe 1: Tunnettu HIV-, HCV- tai HBV-infektio.
COVID-19:n ehkäisyyn tarkoitettujen lääkkeiden vastaanottaminen.
Aiempi tai nykyinen MIS-C-diagnoosi.
Muu lääketieteellinen tai psykiatrinen tila, mukaan lukien äskettäiset (viime vuoden aikana) tai aktiiviset itsemurha-ajatukset/käyttäytyminen tai poikkeavuus laboratorioissa, jotka voivat lisätä tutkimukseen osallistumisen riskiä tai tutkijan harkinnan mukaan tehdä osallistujasta sopimattoman tutkimukseen. Huomautus: Tämä sisältää sekä olosuhteet, jotka voivat lisätä tutkimusinterventioiden antamiseen liittyvää riskiä, että tilan, joka voi häiritä tutkimustulosten tulkintaa
Aiempi rokotteeseen liittyvä vakava haittavaikutus ja/tai vakava allerginen reaktio (esim. anafylaksia) jollekin tutkimustoimenpiteen osalle.
Immuunipuutteiset henkilöt, joilla tiedetään tai epäillään immuunivajausta historian ja/tai laboratorio-/fyysisen tutkimuksen perusteella.
Henkilöt, joilla on ollut autoimmuunisairaus tai aktiivinen autoimmuunisairaus, joka vaatii terapeuttista toimenpiteitä, mukaan lukien, mutta ei rajoittuen, systeeminen lupus erythematosus. Huomautus: Stabiili tyypin 1 diabetes ja kilpirauhasen vajaatoiminta ovat sallittuja.
Verenvuotodiateesi tai pitkittyneeseen verenvuotoon liittyvä tila, joka on tutkijan mielestä vasta-aiheinen lihakseen annettavan injektion antamiseksi.
Nainen, joka on raskaana tai imettää.
Aiempi rokotus millä tahansa koronavirusrokotteella.
Henkilöt, jotka saavat hoitoa immunosuppressiivisella hoidolla, mukaan lukien sytotoksiset aineet tai systeemiset kortikosteroidit, esim. syövän tai autoimmuunisairauden vuoksi, tai jotka saavat suunnitellun vastaanoton koko tutkimuksen ajan. Jos systeemisiä kortikosteroideja on annettu lyhytaikaisesti (< 14 päivää) akuutin sairauden hoitoon, osallistujia ei pidä ottaa mukaan tutkimukseen ennen kuin kortikosteroidihoito on keskeytetty vähintään 28 päivää ennen tutkimuksen interventiota. Inhaloitavat/sumutetut, nivelensisäiset, intrabursaaliset tai paikalliset (iho tai silmät) kortikosteroidit ovat sallittuja.
Veri-/plasmatuotteiden, immunoglobuliinin tai monoklonaalisten vasta-aineiden vastaanotto 60 päivää ennen tutkimuksen interventiota tai minkä tahansa COVID-19-spesifisen passiivisen vasta-ainehoidon vastaanottaminen 90 päivää ennen tutkimusinterventiota tai suunniteltu vastaanotto koko tutkimuksen ajan.
Osallistuminen muihin tutkimuksiin, joihin liittyy tutkimusinterventio 28 päivän sisällä ennen tutkimukseen tuloa ja/tai tutkimukseen osallistumisen aikana.
Aikaisempi osallistuminen muihin tutkimuksiin, joissa on mukana LNP:itä sisältäviä tutkimusinterventioita.
Osallistujat, jotka ovat tutkimuspaikan henkilöstön tai tutkimuksen suorittamiseen suoraan osallistuvien Pfizer/BioNTechin työntekijöiden suoria jälkeläisiä (lapsi tai lapsenlapsi), tutkijan muuten valvoma työpaikan henkilökunta ja heidän perheenjäsenensä.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

Ensisijainen käyttötarkoitus: Ennaltaehkäisy
Jako: Ei satunnaistettu
Inventiomalli: Rinnakkaistehtävä
Naamiointi: Ei mitään (avoin tarra)

Aseiden lukumäärä

Aseet ja interventiot

Osallistujaryhmä / Arm	Interventio / Hoito
Kokeellinen: Pieni/keskimääräinen annos, ≥5 - <12 vuotta Pieni/keskimääräinen annos (10 mikrogrammaa), 2 annosta 21 päivän välein	Biologinen: Biologinen/rokote: BNT162b2 10mcg BNT162b2 Pienen/keskiannoksen (10 mikrogrammaa) taso
Kokeellinen: Keskiannos, ≥5 - <12 vuotta Keskiannos, (20 mikrogrammaa), 2 annosta 21 päivän välein	Biologinen: BNT162b2 20mcg BNT162b2 keskiannoksen (20 mcg) taso
Kokeellinen: Suuriannos, ≥5 - <12 vuotta Suuri annos (30 mikrogrammaa), 2 annosta 21 päivän välein	Biologinen: BNT162b2 30mcg BNT162b2 suuren annoksen (30 mcg) taso
Kokeellinen: Pieni/keskimääräinen annos, ≥ 2 - < 5 vuotta Pieni/keskimääräinen annos (10 mikrogrammaa), 2 annosta 21 päivän välein	Biologinen: Biologinen/rokote: BNT162b2 10mcg BNT162b2 Pienen/keskiannoksen (10 mikrogrammaa) taso
Kokeellinen: Keskiannos, ≥2 - <5 vuotta Keskiannos, (20 mikrogrammaa), 2 annosta 21 päivän välein	Biologinen: BNT162b2 20mcg BNT162b2 keskiannoksen (20 mcg) taso
Kokeellinen: Suuriannos, ≥2 - <5 vuotta Suuriannos, (30 mikrogrammaa), 2 annosta 21 päivän välein	Biologinen: BNT162b2 30mcg BNT162b2 suuren annoksen (30 mcg) taso
Kokeellinen: Pieni/keskimääräinen annos, ≥6 kuukautta - <2 vuotta Pieni/keskimääräinen annos (10 mikrogrammaa), 2 annosta 21 päivän välein	Biologinen: Biologinen/rokote: BNT162b2 10mcg BNT162b2 Pienen/keskiannoksen (10 mikrogrammaa) taso
Kokeellinen: Keskiannos, ≥6 kuukautta - <2 vuotta Keskiannos, (20 mikrogrammaa), 2 annosta 21 päivän välein	Biologinen: BNT162b2 20mcg BNT162b2 keskiannoksen (20 mcg) taso
Kokeellinen: Suuret annokset, ≥6 kuukautta - <2 vuotta Suuriannos, (30 mikrogrammaa), 2 annosta 21 päivän välein	Biologinen: BNT162b2 30mcg BNT162b2 suuren annoksen (30 mcg) taso
Placebo Comparator: Placebo, ≥6 kuukautta - <2 vuotta	Muut: Plasebo Lihaksensisäinen injektio
Placebo Comparator: Plasebo, ≥2 - <5 vuotta	Muut: Plasebo Lihaksensisäinen injektio
Placebo Comparator: Plasebo, ≥5 - <12 vuotta	Muut: Plasebo Lihaksensisäinen injektio
Kokeellinen: Pienet annokset, ≥6 kuukautta - <2 vuotta Pieni annos (3 mcg), 2 annosta 21 annoksen välein	Biologinen: Biologinen/rokote: BNT162b2 3mcg BNT162b2 Pienen annoksen (3 mcg) taso
Kokeellinen: Pienet annokset, ≥2 - <5 vuotta Pieni annos (3 mcg), 2 annosta 21 päivän välein	Biologinen: Biologinen/rokote: BNT162b2 3mcg BNT162b2 Pienen annoksen (3 mcg) taso
Kokeellinen: Suuret annokset, 12 - <16 vuotta (Troponin I -testaus) Suuri annos (30 mcg), 3 annosta	Biologinen: BNT162b2 30mcg BNT162b2 suuren annoksen (30 mcg) taso
Kokeellinen: Pieni/keskimääräinen annos, ≥5 - <12 vuotta (troponiini I -testaus) Pieni/keskimääräinen annos (10 mikrogrammaa), 3 annosta	Biologinen: Biologinen/rokote: BNT162b2 10mcg BNT162b2 Pienen/keskiannoksen (10 mikrogrammaa) taso
Kokeellinen: Plasebo, ≥5 - <12 vuotta (Troponiini I -testaus)	Muut: Plasebo Lihaksensisäinen injektio
Kokeellinen: Pienet annokset, ≥6 kuukautta - <2 vuotta (3 annoksen hoito) Pieni annos (3 mcg), 3 annosta	Biologinen: Biologinen/rokote: BNT162b2 3mcg BNT162b2 Pienen annoksen (3 mcg) taso
Kokeellinen: Pienet annokset, ≥2 - <5 vuotta (3 annoksen hoito) Pieni annos (3 mcg), 3 annosta	Biologinen: Biologinen/rokote: BNT162b2 3mcg BNT162b2 Pienen annoksen (3 mcg) taso
Placebo Comparator: Lume, ≥6 kuukautta - <2 vuotta (3 annoksen hoito)	Muut: Plasebo Lihaksensisäinen injektio
Placebo Comparator: Lume, ≥ 2 - < 5 vuotta (3 annoksen hoito)	Muut: Plasebo Lihaksensisäinen injektio

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Toissijaiset tulostoimenpiteet

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

BioNTech SE

Yhteistyökumppanit

Pfizer

Tutkijat

Opintojohtaja: Pfizer CT.gov Call Center, Pfizer

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Hyödyllisiä linkkejä

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

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Keskiviikko 24. maaliskuuta 2021

Ensisijainen valmistuminen (Todellinen)

Keskiviikko 4. lokakuuta 2023

Opintojen valmistuminen (Todellinen)

Perjantai 8. joulukuuta 2023

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Perjantai 19. maaliskuuta 2021

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Keskiviikko 24. maaliskuuta 2021

Ensimmäinen Lähetetty (Todellinen)

Torstai 25. maaliskuuta 2021

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Torstai 28. toukokuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Tiistai 26. toukokuuta 2026

Viimeksi vahvistettu

Perjantai 1. toukokuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

C4591007
2020-005442-42 (EudraCT-numero)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Joo

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

Kliiniset tutkimukset SARS-CoV-2-infektio, COVID-19

Pfizer

Aktiivinen, ei rekrytointi

Tutkimus oppia siitä, kuinka hyvin vuosittaiset päivitykset COVID-19-rokotetyöhön ihmisten suojelemiseksi COVID-19: ltä ja kuinka paljon rahaa ihmiset käyttävät terveydenhuoltoon COVID-19: lle

COVID-19 | Koronavirustauti 2019 (COVID-19) | Covid-19-tartunta | Covid-19-rokotteet | SARS-CoV-2-infektio, COVID19 | COVID-19-rokotus | SARS-CoV-2-infektio, COVID-19 | COVID-19 (koronavirustauti 2019) | COVID-19 SARS-CoV-2 -infektio

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

Valmis

Tutkimus SARS-CoV-2-CZ-PREVAL-II - Olomoucin alueen haara

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

Tšekki
AstraZeneca

Valmis

Tutkimus AZD3152:n lihaksensisäisestä injektiosta tai suonensisäisestä infuusiosta terveillä japanilaisilla aikuisilla osallistujilla

COVID-19, SARS-CoV-2

Japani
Institute of Tropical Medicine, Belgium
Jessa Hospital; University Hospital, Antwerp; Universiteit Antwerpen; Sciensano ja muut yhteistyökumppanit

Valmis

Ovatko SARS-CoV-2-spesifiset vasta-aineet korrelaattia suojalle? (ImmCoV)

COVID-19 | SARS-CoV-2

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

Valmis

SAB-185:n turvallisuus, siedettävyys ja farmakokinetiikka terveillä osallistujilla

COVID-19 | SARS-CoV-2

Yhdysvallat
University of Wisconsin, Madison
National Institutes of Health (NIH)

Valmis

Toista SARS-CoV-2:n testaus

COVID-19 | SARS-CoV-2

Yhdysvallat
Syneos Health
US Specialty Formulations, LLC

Valmis

Ensimmäinen ihmisissä suoritettu tutkimus suun kautta annetusta CoV2-OGEN1:stä terveillä koehenkilöillä

SARS-CoV-2 (COVID-19)

Uusi Seelanti
Mayo Clinic

Valmis

Seroprevalence of SARS CoV 2 Antibodies in Previously Undiagnosed Healthcare Workers

COVID-19 | SARS-CoV-2

Yhdysvallat
University of Valladolid

Valmis

Korkeuskoulutusnaamion vaikutus CrossFit® Post-SARS-COV-2 -infektiossa. (ETMEXCOVID)

SARS-CoV-2-infektio (oireinen) | COVID-19-keuhkokomplikaatiot | SARS-CoV-2-positiiviset potilaat | COVID19-infektio SARS-COV-2-viruksella

Espanja
St. Olavs Hospital
The Research Council of Norway; Helse Nord-Trøndelag HF; Alesund Hospital; Namsos... ja muut yhteistyökumppanit

Valmis

Keski-Norjan koronatutkimus (CUT COVID-19)

SARS-CoV-2 akuutti hengityselinsairaus | SARS-CoV-2 Sepsis | SARS CoV 2 -infektio

Norja

Kliiniset tutkimukset Plasebo

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

Valmis

Turvallisuuden, siedettävyyden ja farmakodynamiikan arviointi yhden AZD8601-annoksen antamisen jälkeen miespotilaille, joilla on tyypin II diabetes (T2DM)

Miespotilaat, joilla on tyypin II diabetes (T2DM)

Saksa
National Institute on Drug Abuse (NIDA)

Valmis

Kannabiksen antoreittien vaikutukset ihmisen suorituskykyyn ja farmakokinetiikkaan

Kannabiksen käyttö

Yhdysvallat
Beijing Inno Medicine Co., Ltd.
The TIMI Study Group

Ei vielä rekrytointia

Fas 2b kliininen tutkimus YN001:stä aikuisilla, joilla on sepelvaltimoiden ateroskleroosi (PURIFY-TIMI 81)

Sepelvaltimotauti | Ateroskleroosi

Kiina
Chiesi Farmaceutici S.p.A.

Valmis

Tutkimus, jossa vertaillaan kahden ponneaineen vaikutuksia aikuisilla, joilla on lievä astma

Astma

Yhdistynyt kuningaskunta
CHIA-HUI MA
Mackay Memorial Hospital

Valmis

Mobiili jaettu päätöksenteko-ohjelma teho-osaston omaishoitajille

Terminaalisesti sairaat potilaat

Taiwan
Central Jutland Regional Hospital
Aarhus University Hospital; University of Aarhus

Aktiivinen, ei rekrytointi

Ulosteisen mikrobiston siirron interventio mikrobiston koostumukseen ja insuliiniherkkyyteen diabeteksessa (FeMIC)

Tyypin 2 diabetes mellitus | Suun glukoositoleranssitesti | Jatkuva glukoosin seuranta | Ulosteen mikrobiston siirto (FMT)

Tanska
MedImmune LLC

Valmis

MEDI6012:n turvallisuuden, farmakokinetiikan ja farmakodynamiikan arvioimiseksi potilailla, joilla on stabiili sepelvaltimotauti

Sepelvaltimotauti

Yhdysvallat
Eli Lilly and Company

Lopetettu

Tutkimus nivelreumaa sairastavilla osallistujilla (FLEX V)

Nivelreuma

Yhdysvallat, Saksa, Taiwan, Ranska, Japani, Meksiko, Puola, Venäjän federaatio, Espanja, Kolumbia, Argentiina, Kreikka, Uusi Seelanti, Etelä-Afrikka, Australia, Korean tasavalta, Brasilia, Italia, Malesia
Universidad Miguel Hernandez de Elche

Ei vielä rekrytointia

Kronisen supraspinatus-tendinopatian potilaiden lävistävän sähköärsykkeen vaikutukset

Supraspinatus tendinopatia

Espanja
Dong-A ST Co., Ltd.

Valmis

Tutkimus DA-7503:n turvallisuuden, siedettävyyden ja PK:n arvioimiseksi terveillä aikuisilla ja iäkkäillä osallistujilla

Terve

Etelä -Korea

Tulosmittaus	Toimenpiteen kuvaus	Aikaikkuna
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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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)

Tulosmittaus	Toimenpiteen kuvaus	Aikaikkuna
Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=5 to <12 Years of Age Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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 Aikaikkuna: 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

Vaiheen 1/2/3 tutkimus RNA-rokoteehdokkaiden turvallisuuden, siedettävyyden ja immunogeenisuuden arvioimiseksi COVID-19:tä vastaan ​​terveillä lapsilla ja nuorilla aikuisilla

VAIHE 1, AVOIN ANNOSTUTKIMUS TUTKIMUS TURVALLISUUDEN, SIEDETTÄVYYDEN JA IMMUNOGEENISUUDEN ARVIOIMISEKSI SEKÄ VAIHE 2/3 PLACEBO-OHJELMAT, TARKASTAJIEN SOKOITETUT TURVALLISUUS, SIEDETTÄVYYS JA IMMUNOGENISUUSVAPAUS2 -19 TERVEILLÄ LAPSILLE JA NUORILLE AIKUISILLE

Tutkimuksen yleiskatsaus

Tila

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

Opintotyyppi

Ilmoittautuminen (Todellinen)

Vaihe

Yhteystiedot ja paikat

Opiskelupaikat

Osallistumiskriteerit

Kelpoisuusvaatimukset

Opintokelpoiset iät

Hyväksyy terveitä vapaaehtoisia

Kuvaus

Opintosuunnitelma

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

Aseiden lukumäärä

Aseet ja interventiot

Osallistujaryhmä / Arm

Interventio / Hoito

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus

Toimenpiteen kuvaus

Aikaikkuna

Toissijaiset tulostoimenpiteet

Tulosmittaus

Toimenpiteen kuvaus

Aikaikkuna

Yhteistyökumppanit ja tutkijat

Sponsori

Yhteistyökumppanit

Tutkijat

Julkaisuja ja hyödyllisiä linkkejä

Yleiset julkaisut

Hyödyllisiä linkkejä

Opintojen ennätyspäivät

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Ensisijainen valmistuminen (Todellinen)

Opintojen valmistuminen (Todellinen)

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Ensimmäinen Lähetetty (Todellinen)

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Viimeksi vahvistettu

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Kliiniset tutkimukset SARS-CoV-2-infektio, COVID-19

Kliiniset tutkimukset Plasebo

Hae vastaavia kokeiluja

Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

CROs by country

CROs in Kazakhstan

Ehdot

Harvinaiset sairaudet

Huumeiden interventiot

Ravintolisät

Sponsori / yhteistyökumppanit

Sijainnit

Vaiheen 1/2/3 tutkimus RNA-rokoteehdokkaiden turvallisuuden, siedettävyyden ja immunogeenisuuden arvioimiseksi COVID-19:tä vastaan terveillä lapsilla ja nuorilla aikuisilla