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Studie fáze 1/2/3 k vyhodnocení bezpečnosti, snášenlivosti a imunogenicity kandidáta na RNA vakcínu proti COVID-19 u zdravých dětí a mladých dospělých

26. května 2026 aktualizováno: BioNTech SE

FÁZE 1, OTEVŘENÁ STUDIE VYHLEDÁVÁNÍ DÁVKY K HODNOCENÍ BEZPEČNOSTI, SNÁŠENÍ A IMUNOGENICITY A FÁZE 2/3 PLACEBEM KONTROLOVANÁ, POZOROVATELEM ZASLEPÁ STUDIE BEZPEČNOSTI, SNÁŠENÍ A IMUNOGENICITY - 2 AGASTIN CARDOVADOVICOV -19 U ZDRAVÝCH DĚTÍ A MLADÝCH DOSPĚLÝCH

Toto je studie fáze 1/2/3 u zdravých dětí a mladých dospělých.

V závislosti na údajích o bezpečnosti a/nebo imunogenicitě generovaných v průběhu této studie a výsledném hodnocení přínosu a rizika lze následně vyhodnotit bezpečnost, snášenlivost a imunogenicitu BNT162b2 u účastníků <6 měsíců věku.

Přehled studie

Postavení

Dokončeno

Podmínky

Infekce SARS-CoV-2, COVID-19

Intervence / Léčba

Detailní popis

Fáze 1 Vyhledání dávky

Je otevřená část studie zaměřená na zjištění dávky, která bude hodnotit bezpečnost, snášenlivost a imunogenicitu BNT162b2 podávaného ve 2-dávkovém (odděleném přibližně 21 dnů) schématu až ve 3 věkových skupinách (účastníci ≥5 až <12 let, ≥2 až <5 let a ≥6 měsíců až <2 roky).

Zjišťování dávky je v této studii zahájeno u účastníků ve věku ≥5 až <12 let na základě přijatelného zaslepeného hodnocení bezpečnosti dávky 30 µg u 12- až 15letých ve studii C4591001.

Účelem Fáze 1 je identifikovat preferovanou dávku (úrovně) BNT162b2 až ze 3 různých úrovní dávky v každé věkové skupině.

V závislosti na údajích o bezpečnosti a/nebo imunogenicitě generovaných v průběhu této studie je možné, že úrovně dávek nemusí být zahájeny, mohou být ukončeny předčasně a/nebo mohou být přidány s úrovněmi dávek pod nejnižší uvedenou dávkou.

Aktualizace v rámci dodatku protokolu 6: Všichni účastníci dostanou třetí dávku BNT162b2. U účastníků ve věku ≥6 měsíců až <5 let se třetí dávka podá nejméně 8 týdnů po druhé dávce. U účastníků ≥5 až <12 let se třetí dávka podá nejméně 6 měsíců po druhé dávce. Interval mezi druhou a třetí dávkou bude vycházet z věku účastníka v době registrace. Úroveň dávky třetí dávky BNT162b2 bude založena na věku v době očkování: účastníci <5 let ve věku v době třetí dávky dostanou dávku 3 µg, účastníci ≥5 až <12 let věk v době třetí dávky dostanou dávku 10 ug a účastníci ve věku ≥12 let v době třetí dávky dostanou dávku 30 ug.

Účastníkům bude odebrána krev před jak dávkou 1, tak dávkou 2 a 7 dní po dávce 2, aby se vyhodnotila imunogenicita pro stanovení zvolené úrovně dávky BNT162b2 pro fázi 2/3. Účastníkům bude také odebrána krev před dávkou 3 a 1, 6 a 12 měsíců po dávce 3.

Fáze 1 vyhodnocení nižší dávky

Je otevřená část studie s hodnocením nižších dávek, která bude hodnotit bezpečnost, snášenlivost a imunogenicitu 10 µg BNT162b2 ze 2 schémat ve 2 věkových skupinách (účastníci 12 až <16 let a 16 až <18 let) .

Účelem fáze 1 hodnocení nižších dávek je vyhodnotit bezpečnost a imunogenicitu BNT162b2 ze 2 různých dávkovacích schémat v každé věkové skupině: (1) 2 dávky oddělené přibližně 21 dny a (2) 2 dávky oddělené přibližně 8 týdny .

Účastníkům bude odebrána krev před dávkou 1, před dávkou 2, 7 dní po dávce 2 a 1 měsíc po dávce 2, aby se vyhodnotila imunogenicita za účelem stanovení zvoleného dávkovacího schématu BNT162b2 pro fázi 2/3 hodnotící části s nižší dávkou. studie. Kromě toho bude účastníkům odebrána krev 6 a 12 měsíců po dávce 2, aby se určilo přetrvávání imunitní odpovědi.

Fáze 2/3 vybraná dávka

Je to část studie, která vyhodnotí bezpečnost, snášenlivost a imunogenicitu v každé věkové skupině při zvolené hladině dávky z fáze 1 studie zaměřené na zjištění dávky. Účinnost bude hodnocena v rámci nebo napříč věkovými skupinami, ve kterých je imunobridgeing úspěšný, v závislosti na přírůstku dostatečného počtu případů v těchto věkových skupinách.

Účastníkům bude odebrána krev na začátku před dávkou 1 a 6 měsíců po dávce 2. Imunobridgeing účastníkům ve věku 16 až 25 let ve studii C4591001 bude založen na údajích o imunogenicitě shromážděných při (1) výchozí hodnotě a 1 měsíc po dávce 2 a (2) výchozí a 1 měsíc po dávce 3. Přetrvávání imunitní odpovědi bude založeno na údajích o imunogenicitě shromážděných u účastníků na (1) výchozí hodnotě a 1 a 6 měsíců po dávce 2 a (2) výchozí hodnotě a 1, 6, 12 a 18 měsíců po dávce 3. Kromě toho bude u účastníků ve věku ≥5 až <12 let hodnocena také účinnost proti potvrzenému COVID-19 a proti asymptomatické infekci.

Na určených místech v USA bude odebrán další volitelný vzorek plné krve o objemu přibližně 10 ml před dávkou 1 a 7 dní a 6 měsíců po dávce 2 až od přibližně 60 účastníků ve věku ≥ 10 let. Další vzorky budou odebrány před dávkou 3 a 1 měsíc po dávce 3 (pouze původní skupina BNT162b2). Tyto vzorky budou použity na průzkumné bázi ke zkoumání postvakcinační buňkami zprostředkované imunitní reakce v těchto časových bodech.

Při 6měsíční následné návštěvě budou všichni účastníci odslepeni. Účastníkům, kteří původně dostávali placebo, bude v rámci studie nabídnuta možnost získat BNT162b2. Účastníci, kteří původně dostávali placebo a stali se způsobilými pro příjem BNT162b2 nebo jiné vakcíny COVID-19 podle místních nebo národních doporučení před 6měsíční následnou návštěvou (návštěva 5 nebo 405) (podrobnosti samostatně a dostupné na referenčním portálu elektronické studie ) bude mít možnost dostávat BNT162b2 (10 µg nebo 3 µg) na základě věku v době očkování.

Aktualizace v rámci dodatku protokolu 6: Všichni účastníci dostanou třetí dávku BNT162b2. U účastníků ve věku ≥6 měsíců až <5 let se třetí dávka podá nejméně 8 týdnů po druhé dávce. U účastníků ≥5 až <12 let se třetí dávka podá nejméně 6 měsíců po druhé dávce. Interval mezi druhou a třetí dávkou bude vycházet z věku účastníka v době registrace. Úroveň dávky druhé a třetí dávky BNT162b2 bude založena na věku v době očkování: účastníci <5 let věku v době druhé/třetí dávky dostanou dávku 3 µg, účastníci ≥5 až <12 let v době druhé/třetí dávky dostanou dávku 10 µg a účastníci ve věku ≥12 let v době druhé/třetí dávky dostanou dávku 30 µg.

Fáze 2/3 Hodnocení nižší dávky

Je otevřená část studie, která vyhodnotí bezpečnost, snášenlivost a imunogenicitu zvoleného dávkovacího schématu v každé věkové skupině z fáze 1 hodnocení nižších dávek, s celkovým počtem přibližně 600 aktivních účastníků.

Přibližně 300 aktivních účastníků v každé věkové skupině v této fázi přispěje k analýze imunobridgeingu 1 měsíc po dávce 2 a celkové analýze přetrvávání imunitní odpovědi 6 a 12 měsíců po dávce 2.

Fáze 2/3 Získání vzorků séra pro potenciální testování troponinu I

Pokud testování hladin troponinu I u jedinců, kteří nedostávali BNT162b2, naznačuje, že hladina troponinu I by mohla být spolehlivým indikátorem potenciální subklinické myokarditidy, získání vzorků séra pro potenciální testování troponinu I během období zvýšeného rizika klinické myokarditidy může pomoci charakterizovat absenci. /přítomnost a frekvence subklinické myokarditidy. Pro posouzení bude zahrnuta další skupina účastníků: ≥5 až <12 let: randomizováni 2:1 pro příjem BNT162b2 10 µg nebo placebo a ≥12 až <16 let: otevřené podávání BNT162b2 30 µg.

Aktualizace v rámci dodatku protokolu 7: Všichni účastníci obdrží třetí dávku BNT162b2. U všech účastníků (≥5 až <12 a ≥12 až <16 let) se třetí dávka podá nejméně 5 měsíců po dávce 2.

Úroveň dávky druhé a třetí dávky BNT162b2 bude založena na věku v době očkování: účastníci ve věku ≥5 až <12 let v době druhé/třetí dávky dostanou dávku 10 µg a účastníci ve věku ≥12 let v době druhé/třetí dávky dostanou dávku 30 µg.

Typ studie

Intervenční

Zápis (Aktuální)

11837

Fáze

Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

6 měsíců až 18 let (Dítě)

Přijímá zdravé dobrovolníky

Ano

Popis

Kritéria pro zařazení

Účastníci mužského nebo ženského pohlaví ve věku ≥6 měsíců až <12 let, v době randomizace, při návštěvě 1 pro zjištění dávky/vyhodnocení zvolené dávky a pro účastníky ve věku ≥12 až <18 let v době randomizace při návštěvě 1 pro hodnocení nižších dávek. Pro část studie týkající se získání vzorků séra pro testování potenciálního troponinu I: Účastníci mužského nebo ženského pohlaví ve věku ≥ 5 až < 16 let.
Rodiče/zákonní zástupci účastníků a účastníci podle věku, kteří jsou ochotni a schopni dodržet všechny plánované návštěvy, plán léčby, laboratorní testy, úvahy o životním stylu a další studijní postupy.
Zdraví účastníci, u kterých lékařská anamnéza, fyzikální vyšetření a klinický úsudek zkoušejícího určili, že jsou způsobilí k zařazení do studie.
Poznámka: Mohou být zahrnuti zdraví účastníci s již existujícím stabilním onemocněním, definovaným jako onemocnění nevyžadující významnou změnu v terapii nebo hospitalizaci pro zhoršení onemocnění během 6 týdnů před zařazením.
Předpokládá se, že účastníci budou k dispozici po dobu trvání studie a jejich rodiče/zákonní zástupci mohou být během účasti ve studii telefonicky kontaktováni.
Negativní těhotenský test z moči pro ženy, které jsou biologicky schopné mít děti.
Účastnice ve fertilním věku nebo mužský účastník schopný zplodit děti, který je ochoten používat vysoce účinnou metodu antikoncepce, jak je uvedeno v tomto protokolu, po dobu nejméně 28 dnů po poslední dávce studijní intervence, je-li ohroženo těhotenství s partnerem/partnerkou ; nebo účastník, který není v plodném věku, nebo účastník mužského pohlaví, který není schopen zplodit děti.
Účastník nebo rodič (rodiče)/zákonný zástupce účastníka je schopen dát podepsaný informovaný souhlas, který zahrnuje dodržování požadavků a omezení uvedených v MKN a v tomto protokolu. V závislosti na věku účastníka a podle místních požadavků budou účastníci rovněž požádáni, aby poskytli souhlas podle potřeby (ústní nebo písemný).

Kritéria vyloučení

Pouze fáze 1: Minulá klinická (na základě samotných příznaků/příznaků COVID-19, pokud nebyl k dispozici výsledek NAAT SARS CoV 2) nebo mikrobiologické (na základě příznaků/příznaků COVID-19 a pozitivního výsledku NAAT SARS-CoV-2) diagnóza COVID 19.
Pouze fáze 1: Známá infekce HIV, HCV nebo HBV.
Příjem léků určených k prevenci COVID-19.
Předchozí nebo současná diagnóza MIS-C.
Jiný zdravotní nebo psychiatrický stav včetně nedávných (během posledního roku) nebo aktivních sebevražedných myšlenek/chování nebo laboratorních abnormalit, které mohou zvýšit riziko účasti ve studii nebo podle úsudku výzkumníka způsobit, že účastník nebude pro studii nevhodný. Poznámka: To zahrnuje jak stavy, které mohou zvýšit riziko spojené s administrací studijní intervence, tak stav, který může narušovat interpretaci výsledků studie.
Závažná nežádoucí reakce v anamnéze spojená s vakcínou a/nebo závažná alergická reakce (např. anafylaxe) na kteroukoli složku intervence studie.
Imunokompromitovaní jedinci se známou nebo suspektní imunodeficiencí podle anamnézy a/nebo laboratorního/fyzikálního vyšetření.
Jedinci s anamnézou autoimunitního onemocnění nebo aktivního autoimunitního onemocnění vyžadujícího terapeutickou intervenci, včetně, ale bez omezení, systémového lupus erythematodes. Poznámka: Stabilní diabetes 1. typu a hypotyreóza jsou povoleny.
Krvácivá diatéza nebo stav spojený s prodlouženým krvácením, který by podle názoru zkoušejícího kontraindikoval intramuskulární injekci.
Žena, která je těhotná nebo kojí.
Předchozí očkování jakoukoli vakcínou proti koronaviru.
Jedinci, kteří dostávají léčbu imunosupresivní terapií, včetně cytotoxických činidel nebo systémových kortikosteroidů, např. pro rakovinu nebo autoimunitní onemocnění, nebo plánovaní příjem v průběhu studie. Pokud byly systémové kortikosteroidy podávány krátkodobě (<14 dnů) k léčbě akutního onemocnění, účastníci by neměli být zařazeni do studie, dokud nebyla léčba kortikosteroidy přerušena po dobu alespoň 28 dnů před podáním intervence ve studii. Inhalační/nebulizované, intraartikulární, intraburzální nebo topické (kůže nebo oči) kortikosteroidy jsou povoleny.
Příjem krevních/plazmatických produktů, imunoglobulinu nebo monoklonálních protilátek od 60 dnů před podáním studijní intervence nebo přijetí jakékoli pasivní protilátkové terapie specifické pro COVID-19 od 90 dnů před podáním studijní intervence nebo plánovaný příjem v průběhu studie.
Účast v jiných studiích zahrnujících studijní intervenci během 28 dnů před vstupem do studie a/nebo během účasti ve studii.
Předchozí účast na jiných studiích zahrnujících studijní intervenci obsahující LNP.
Účastníci, kteří jsou přímými potomky (dítě nebo vnuk) zaměstnanců výzkumného pracoviště nebo zaměstnanců Pfizer/BioNTech přímo zapojených do provádění studie, pracovníků pracoviště jinak pod dohledem výzkumného pracovníka a jejich příslušných rodinných příslušníků.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Primární účel: Prevence
Přidělení: Nerandomizované
Intervenční model: Paralelní přiřazení
Maskování: Žádné (otevřený štítek)

Počet zbraní

Zbraně a zásahy

Skupina účastníků / Arm	Intervence / Léčba
Experimentální: Nízká/střední dávka, ≥5 až <12 let Nízká/střední dávka (10 mcg), 2 dávky s odstupem 21 dnů	Biologický: Biologická/Vakcína: BNT162b2 10mcg Nízká/střední dávka BNT162b2 (10 mcg).
Experimentální: Střední dávka, ≥5 až <12 let Střední dávka (20 mcg), 2 dávky s odstupem 21 dnů	Biologický: BNT162b2 20 mcg Úroveň střední dávky BNT162b2 (20 mcg).
Experimentální: Vysoká dávka, ≥5 až <12 let Vysoká dávka (30 mcg), 2 dávky s odstupem 21 dnů	Biologický: BNT162b2 30 mcg BNT162b2 High-Dose (30 mcg) hladina
Experimentální: Nízká/střední dávka, ≥2 až <5 let Nízká/střední dávka (10 mcg), 2 dávky s odstupem 21 dnů	Biologický: Biologická/Vakcína: BNT162b2 10mcg Nízká/střední dávka BNT162b2 (10 mcg).
Experimentální: Střední dávka, ≥2 až <5 let Střední dávka (20 mcg), 2 dávky s odstupem 21 dnů	Biologický: BNT162b2 20 mcg Úroveň střední dávky BNT162b2 (20 mcg).
Experimentální: Vysoká dávka, ≥2 až <5 let Vysoká dávka (30 mcg), 2 dávky s odstupem 21 dnů	Biologický: BNT162b2 30 mcg BNT162b2 High-Dose (30 mcg) hladina
Experimentální: Nízká/střední dávka, ≥6 měsíců až <2 roky Nízká/střední dávka (10 mcg), 2 dávky po 21 dnech	Biologický: Biologická/Vakcína: BNT162b2 10mcg Nízká/střední dávka BNT162b2 (10 mcg).
Experimentální: Střední dávka, ≥6 měsíců až <2 roky Střední dávka (20 mcg), 2 dávky s odstupem 21 dnů	Biologický: BNT162b2 20 mcg Úroveň střední dávky BNT162b2 (20 mcg).
Experimentální: Vysoká dávka, ≥6 měsíců až <2 roky Vysoká dávka (30 mcg), 2 dávky s odstupem 21 dnů	Biologický: BNT162b2 30 mcg BNT162b2 High-Dose (30 mcg) hladina
Komparátor placeba: Placebo, ≥6 měsíců až <2 roky	Jiný: Placebo Intramuskulární injekce
Komparátor placeba: Placebo, ≥2 až <5 let	Jiný: Placebo Intramuskulární injekce
Komparátor placeba: Placebo, ≥5 až <12 let	Jiný: Placebo Intramuskulární injekce
Experimentální: Nízká dávka, ≥6 měsíců až <2 roky Nízká dávka (3 mcg), 2 dávky po 21 dávkách	Biologický: Biologická/Vakcína: BNT162b2 3 mcg Nízká dávka BNT162b2 (3 mcg).
Experimentální: Nízká dávka, ≥2 až <5 let Nízká dávka (3 mcg), 2 dávky s odstupem 21 dnů	Biologický: Biologická/Vakcína: BNT162b2 3 mcg Nízká dávka BNT162b2 (3 mcg).
Experimentální: Vysoká dávka, 12 až <16 let (testování troponinu I) Vysoká dávka (30 mcg), 3 dávky	Biologický: BNT162b2 30 mcg BNT162b2 High-Dose (30 mcg) hladina
Experimentální: Nízká/střední dávka, ≥5 až <12 let (testování troponinu I) Nízká/střední dávka (10 mcg), 3 dávky	Biologický: Biologická/Vakcína: BNT162b2 10mcg Nízká/střední dávka BNT162b2 (10 mcg).
Experimentální: Placebo, ≥5 až <12 let (testování troponinu I)	Jiný: Placebo Intramuskulární injekce
Experimentální: Nízká dávka, ≥ 6 měsíců až < 2 roky (3dávkový režim) Nízká dávka (3 mcg), 3 dávky	Biologický: Biologická/Vakcína: BNT162b2 3 mcg Nízká dávka BNT162b2 (3 mcg).
Experimentální: Nízká dávka, ≥2 až <5 let (3dávkový režim) Nízká dávka (3 mcg), 3 dávky	Biologický: Biologická/Vakcína: BNT162b2 3 mcg Nízká dávka BNT162b2 (3 mcg).
Komparátor placeba: Placebo, ≥6 měsíců až <2 roky (3dávkový režim)	Jiný: Placebo Intramuskulární injekce
Komparátor placeba: Placebo, ≥2 až <5 let (3dávkový režim)	Jiný: Placebo Intramuskulární injekce

Co je měření studie?

Primární výstupní opatření

Sekundární výstupní opatření

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

BioNTech SE

Spolupracovníci

Pfizer

Vyšetřovatelé

Ředitel studie: Pfizer CT.gov Call Center, Pfizer

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

24. března 2021

Primární dokončení (Aktuální)

4. října 2023

Dokončení studie (Aktuální)

8. prosince 2023

Termíny zápisu do studia

První předloženo

19. března 2021

První předloženo, které splnilo kritéria kontroly kvality

24. března 2021

První zveřejněno (Aktuální)

25. března 2021

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

28. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

26. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

C4591007
2020-005442-42 (Číslo EudraCT)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Klinické studie na Infekce SARS-CoV-2, COVID-19

Pfizer

Aktivní, ne nábor

Studie, která se dozvědí o tom, jak dobře roční aktualizace práce vakcíny Covid-19 na ochranu lidí před Covid-19 a kolik peněz, které lidé utratí za zdravotní péči za Covid-19

COVID-19 | Coronavirus Disease 2019 (COVID-19) | Infekce covid-19 | Vakcíny na covid-19 | Infekce SARS-CoV-2, COVID19 | Očkování proti COVID-19 | Infekce SARS-CoV-2, COVID-19 | COVID-19 (koronavirová nemoc 2019) | Infekce COVID-19 SARS-CoV-2

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

Dokončeno

Studie SARS-CoV-2-CZ-PREVAL-II - Rameno Olomouckého kraje

SARS-CoV-2 | Infekce SARS-CoV-2 (COVID-19).

Česko
AstraZeneca

Dokončeno

Studie AZD3152 intramuskulární injekce nebo intravenózní infuze u zdravých dospělých japonských účastníků

COVID-19, SARS-CoV-2

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

Dokončeno

Jsou specifické protilátky SARS-CoV-2 korelátem pro ochranu? (ImmCoV)

COVID-19 | SARS-CoV-2

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

Dokončeno

Bezpečnost, snášenlivost a farmakokinetika SAB-185 u zdravých účastníků

COVID-19 | SARS-CoV-2

Spojené státy
University of Wisconsin, Madison
National Institutes of Health (NIH)

Dokončeno

Opakujte testování na SARS-CoV-2

COVID-19 | SARS-CoV-2

Spojené státy
Syneos Health
US Specialty Formulations, LLC

Dokončeno

První studie na lidech orálně podávaného CoV2-OGEN1 u zdravých jedinců

SARS-CoV-2 (COVID-19)

Nový Zéland
Mayo Clinic

Dokončeno

Seroprevalence of SARS CoV 2 Antibodies in Previously Undiagnosed Healthcare Workers

COVID-19 | SARS-CoV-2

Spojené státy
St. Olavs Hospital
The Research Council of Norway; Helse Nord-Trøndelag HF; Alesund Hospital; Namsos... a další spolupracovníci

Dokončeno

Koronová studie středního Norska (CUT COVID-19)

SARS-CoV-2 Akutní respirační onemocnění | Sepse SARS-CoV-2 | SARS CoV 2 infekce

Norsko
University of Valladolid

Dokončeno

Dopad tréninkové masky na výšku na infekci CrossFit® Post-SARS-CoV-2. (ETMEXCOVID)

Infekce SARS-CoV-2 (symptomatická) | Plicní komplikace COVID-19 | Pacienti s pozitivním SARS-CoV-2 | Covid19-infekce virem SARS-CoV-2

Španělsko

Měření výsledku	Popis opatření	Časové okno
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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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)

Měření výsledku	Popis opatření	Časové okno
Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=5 to <12 Years of Age Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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 Časové okno: 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

Studie fáze 1/2/3 k vyhodnocení bezpečnosti, snášenlivosti a imunogenicity kandidáta na RNA vakcínu proti COVID-19 u zdravých dětí a mladých dospělých

FÁZE 1, OTEVŘENÁ STUDIE VYHLEDÁVÁNÍ DÁVKY K HODNOCENÍ BEZPEČNOSTI, SNÁŠENÍ A IMUNOGENICITY A FÁZE 2/3 PLACEBEM KONTROLOVANÁ, POZOROVATELEM ZASLEPÁ STUDIE BEZPEČNOSTI, SNÁŠENÍ A IMUNOGENICITY - 2 AGASTIN CARDOVADOVICOV -19 U ZDRAVÝCH DĚTÍ A MLADÝCH DOSPĚLÝCH

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Studuje lékový produkt regulovaný americkým FDA

Studuje produkt zařízení regulovaný americkým úřadem FDA

Klinické studie na Infekce SARS-CoV-2, COVID-19

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