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Um estudo de fase 1/2/3 para avaliar a segurança, tolerabilidade e imunogenicidade de uma vacina candidata de RNA contra COVID-19 em crianças e adultos jovens saudáveis

26 de maio de 2026 atualizado por: BioNTech SE

UM ESTUDO ABERTO DE DEFINIÇÃO DE DOSE DE FASE 1 PARA AVALIAR A SEGURANÇA, TOLERABILIDADE E IMUNOGENICIDADE E ESTUDO DE SEGURANÇA, TOLERABILIDADE E IMUNOGENICIDADE DE FASE 2/3, CONTROLADO POR PLACEBO, OBSERVADOR-CEGO, TOLERABILIDADE E IMUNOGENICIDADE DE UM CANDIDATO A VACINA DE RNA SARS-COV-2 CONTRA COVID -19 EM CRIANÇAS E ADULTOS JOVENS SAUDÁVEIS

Este é um estudo de Fase 1/2/3 em crianças saudáveis e adultos jovens.

Dependendo dos dados de segurança e/ou imunogenicidade gerados durante o curso deste estudo, e a avaliação resultante do risco-benefício, a segurança, tolerabilidade e imunogenicidade do BNT162b2 em participantes <6 meses de idade podem ser avaliados posteriormente.

Visão geral do estudo

Status

Concluído

Condições

Infecção por SARS-CoV-2, COVID-19

Intervenção / Tratamento

Descrição detalhada

Fase 1 Determinação de Dose

É a porção de descoberta de dose aberta do estudo que avaliará a segurança, tolerabilidade e imunogenicidade do BNT162b2 administrado em um cronograma de 2 doses (separadas por aproximadamente 21 dias) em até 3 faixas etárias (participantes ≥5 a <12 anos, ≥2 a <5 anos e ≥6 meses a <2 anos de idade).

A determinação da dose está sendo iniciada neste estudo em participantes ≥5 a <12 anos de idade com base na avaliação de segurança cega aceitável da dose de 30 µg em crianças de 12 a 15 anos no estudo C4591001.

O objetivo da Fase 1 é identificar o(s) nível(is) de dose preferido(s) de BNT162b2 de até 3 níveis de dose diferentes em cada faixa etária.

Dependendo dos dados de segurança e/ou imunogenicidade gerados durante o curso deste estudo, é possível que os níveis de dose não sejam iniciados, possam ser interrompidos precocemente e/ou possam ser adicionados com níveis de dose abaixo da dose mais baixa indicada.

Atualização como parte da alteração 6 do protocolo: Todos os participantes receberão uma terceira dose de BNT162b2. Para participantes ≥6 meses a <5 anos, a terceira dose ocorrerá pelo menos 8 semanas após a segunda dose. Em participantes ≥5 a <12 anos, a terceira dose ocorrerá pelo menos 6 meses após a segunda dose. O intervalo entre a segunda e terceira doses será baseado na idade do participante no momento da inscrição. O nível de dose da terceira dose de BNT162b2 será baseado na idade no momento da vacinação: participantes <5 anos de idade no momento da terceira dose receberão o nível de dose de 3 µg, participantes ≥5 a <12 anos de idade a idade no momento da terceira dose receberá o nível de dose de 10 µg, e os participantes ≥12 anos de idade no momento da terceira dose receberão o nível de dose de 30 µg.

Os participantes terão sangue coletado antes da Dose 1 e da Dose 2 e 7 dias após a Dose 2 para avaliar a imunogenicidade para determinar o nível de dose de BNT162b2 selecionado para a Fase 2/3. Os participantes também terão sangue coletado antes da Dose 3 e 1, 6 e 12 meses após a Dose 3.

Fase 1 Avaliação de dose mais baixa

É a parte aberta de avaliação de dose mais baixa do estudo que avaliará a segurança, tolerabilidade e imunogenicidade de 10 µg de BNT162b2 de 2 esquemas em 2 faixas etárias (participantes de 12 a <16 anos e de 16 a <18 anos de idade) .

O objetivo da avaliação da dose mais baixa da Fase 1 é avaliar a segurança e a imunogenicidade do BNT162b2 de 2 esquemas de dose diferentes em cada faixa etária: (1) 2 doses separadas por aproximadamente 21 dias e (2) 2 doses separadas por aproximadamente 8 semanas .

Os participantes terão sangue coletado antes da Dose 1, antes da Dose 2, 7 dias após a Dose 2 e 1 mês após a Dose 2 para avaliar a imunogenicidade para determinar o cronograma de dose de BNT162b2 selecionado para a parte de avaliação de dose mais baixa da Fase 2/3 do estudar. Além disso, os participantes terão sangue coletado 6 e 12 meses após a Dose 2 para determinar a persistência da resposta imune.

Fase 2/3 Dose Selecionada

É a parte do estudo que avaliará a segurança, a tolerabilidade e a imunogenicidade em cada faixa etária no nível de dosagem selecionado da parte de determinação da dosagem da Fase 1 do estudo. A eficácia será avaliada dentro ou entre as faixas etárias nas quais a imunoponte é bem-sucedida, dependendo do acúmulo de um número suficiente de casos nessas faixas etárias.

Os participantes terão sangue coletado na linha de base antes da Dose 1 e 6 meses após a Dose 2. A imunoponte para participantes de 16 a 25 anos de idade no estudo C4591001 será baseada em dados de imunogenicidade coletados na (1) linha de base e 1 mês após a Dose 2 e (2) linha de base e 1 mês após a Dose 3. A persistência da resposta imune será baseada em dados de imunogenicidade coletados em participantes em (1) linha de base e 1 e 6 meses após a Dose 2 e (2) linha de base e 1, 6, 12 , e 18 meses após a Dose 3. Além disso, a eficácia contra COVID-19 confirmado e contra infecção assintomática também será avaliada em participantes ≥5 a <12 anos de idade.

Em locais de US designados, uma amostra adicional opcional de sangue total de aproximadamente 10 mL será obtida antes da Dose 1 e 7 dias e 6 meses após a Dose 2 de até aproximadamente 60 participantes ≥10 anos de idade. Amostras adicionais serão obtidas antes da Dose 3 e 1 mês após a Dose 3 (somente grupo BNT162b2 original). Estas amostras serão utilizadas numa base exploratória para investigar a resposta imune mediada por células pós-vacinação nestes momentos.

Na visita de acompanhamento de 6 meses, todos os participantes serão revelados. Os participantes que originalmente receberam placebo terão a oportunidade de receber BNT162b2 como parte do estudo. Participantes que originalmente receberam placebo e se tornaram elegíveis para receber BNT162b2 ou outra vacina COVID-19 de acordo com as recomendações locais ou nacionais antes da visita de acompanhamento de 6 meses (Visita 5 ou 405) (detalhado separadamente e disponível no portal eletrônico de referência do estudo ) terá a oportunidade de receber BNT162b2 (10 µg ou 3 µg) com base na idade no momento da vacinação.

Atualização como parte da alteração 6 do protocolo: Todos os participantes receberão uma terceira dose de BNT162b2. Para participantes ≥6 meses a <5 anos, a terceira dose ocorrerá pelo menos 8 semanas após a segunda dose. Em participantes ≥5 a <12 anos, a terceira dose ocorrerá pelo menos 6 meses após a segunda dose. O intervalo entre a segunda e terceira doses será baseado na idade do participante no momento da inscrição. O nível de dose da segunda e terceira doses de BNT162b2 será baseado na idade no momento da vacinação: participantes <5 anos de idade no momento da segunda/terceira dose receberão o nível de dose de 3 µg, participantes ≥5 a <12 anos de idade no momento da segunda/terceira dose receberão o nível de dose de 10 µg, e os participantes ≥12 anos de idade no momento da segunda/terceira dose receberão o nível de dose de 30 µg.

Fase 2/3 Avaliação de dose mais baixa

É a parte aberta do estudo que avaliará a segurança, tolerabilidade e imunogenicidade do esquema de dose selecionado em cada faixa etária da avaliação de dose mais baixa da Fase 1, com um total de aproximadamente 600 participantes ativos.

Aproximadamente 300 participantes ativos em cada faixa etária nesta fase contribuirão para a análise de imunoponte 1 mês após a Dose 2 e a análise geral da persistência da resposta imune em 6 e 12 meses após a Dose 2.

Fase 2/3 Obtenção de amostras de soro para teste de troponina I potencial

Se o teste dos níveis de troponina I em indivíduos que não receberam BNT162b2 indica que o nível de troponina I pode ser um indicador confiável de potencial miocardite subclínica, a obtenção de amostras de soro para teste potencial de troponina I durante o período de risco aumentado de miocardite clínica pode ajudar a caracterizar a ausência /presença e frequência de miocardite subclínica. Para avaliar, um grupo adicional de participantes será incluído: ≥5 a <12 anos: randomizado 2:1 para receber BNT162b2 10 µg ou placebo, e ≥12 a <16 anos de idade: recebimento aberto de BNT162b2 30 µg.

Atualização como parte da alteração 7 do protocolo: Todos os participantes receberão uma terceira dose de BNT162b2. Para todos os participantes (≥5 a <12 e ≥12 a <16 anos de idade), a terceira dose ocorrerá pelo menos 5 meses após a Dose 2.

O nível de dose da segunda e terceira doses de BNT162b2 será baseado na idade no momento da vacinação: participantes ≥5 a <12 anos de idade no momento da segunda/terceira dose receberão o nível de dose de 10 µg e participantes com ≥12 anos de idade no momento da segunda/terceira dose receberão o nível de dose de 30 µg.

Tipo de estudo

Intervencional

Inscrição (Real)

11837

Estágio

Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

Brasil
- - São Paulo, Brasil, 04266-010
    - CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda.
- Estado de Bahia
  - Salvador, Estado de Bahia, Brasil, 40415-006
    - Hospital Santo Antônio - Obras Sociais Irmã Dulce/ Centro de Pesquisa Clínica - CPEC
- Minas Gerais
  - Belo Horizonte, Minas Gerais, Brasil, 30150-221
    - Santa Casa de Misericórdia de Belo Horizonte
- Paraná
  - Curitiba, Paraná, Brasil, 80810-050
    - Serviço de Infectologia e Controle de Infecção Hospitalar de Curitiba/ Centro Médico São Francisco
- Rio Grande do Norte
  - Natal, Rio Grande do Norte, Brasil, 59025-050
    - CePCLIN - Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda
Espanha
- - Madrid, Espanha, 28041
    - Hospital Universitario 12 de Octubre
  - Seville, Espanha, 41012
    - Instituto Hispalense de Pediatria
- A Coruña
  - Santiago de Compostela, A Coruña, Espanha, 15706
    - Hospital Clinico Universitario Santiago de Compostela
- Barcelona
  - Centelles, Barcelona, Espanha, 08540
    - EBA Centelles
  - Esplugues de Llobregat, Barcelona, Espanha, 08950
    - Hospital Sant Joan de Déu
  - Sant Cugat del Vallès, Barcelona, Espanha, 08195
    - Hospital Universitari General de Catalunya
- Madrid
  - Boadilla del Monte, Madrid, Espanha, 28660
    - Hospital Universitario HM Monteprincipe
- Madrid, Comunidad de
  - Madrid, Madrid, Comunidad de, Espanha, 28938
    - Hospital Universitario HM Puerta del Sur
- Málaga
  - Antequera, Málaga, Espanha, 29200
    - Hospital de Antequera
  - Málaga, Málaga, Espanha, 29015
    - Grupo Pediatrico Uncibay
Estados Unidos
- Alabama
  - Birmingham, Alabama, Estados Unidos, 35233
    - University of Alabama at Birmingham - School of Medicine
- Arizona
  - Phoenix, Arizona, Estados Unidos, 85016
    - Phoenix Children's Hospital
- California
  - Los Angeles, California, Estados Unidos, 90057
    - Matrix Clinical Research
  - Los Angeles, California, Estados Unidos, 90027
    - SCPMG/Kaiser Permanente Los Angeles Medical Center
  - Madera, California, Estados Unidos, 93637
    - Madera Family Medical Group
  - Oakland, California, Estados Unidos, 94611
    - Kaiser Permanente Oakland
  - Palo Alto, California, Estados Unidos, 94304
    - Lucile Packard Children's Hospital Stanford
  - Palo Alto, California, Estados Unidos, 94304
    - Clinical & Translational Research Unit (CTRU) & Spectrum BioBank, Stanford University
  - Paramount, California, Estados Unidos, 90723
    - Center for Clinical Trials, LLC
  - Paramount, California, Estados Unidos, 90723
    - Center for Clinical Trials
  - Rolling Hills Estates, California, Estados Unidos, 90274
    - Peninsula Research Associates
  - Sacramento, California, Estados Unidos, 95815
    - Kaiser Permanente Sacramento
  - Santa Clara, California, Estados Unidos, 95051
    - Kaiser Permanente Santa Clara
  - Stanford, California, Estados Unidos, 94305
    - Stanford Health Care
  - Stanford, California, Estados Unidos, 94305
    - Stanford Health Care Investigational Drug Service
  - Valley Village, California, Estados Unidos, 91607
    - Bayview Research Group, LLC
- Colorado
  - Aurora, Colorado, Estados Unidos, 80045
    - Children's Hospital Colorado
- Connecticut
  - New Haven, Connecticut, Estados Unidos, 06519
    - Yale Center for Clinical Investigation
- District of Columbia
  - Washington D.C., District of Columbia, Estados Unidos, 20010
    - Children's National Medical Center
  - Washington D.C., District of Columbia, Estados Unidos, 20016
    - Velocity Clinical Research, Washington DC
  - Washington D.C., District of Columbia, Estados Unidos, 20009
    - Emerson Clinical Research Institute
- Florida
  - Jacksonville, Florida, Estados Unidos, 32256
    - Clinical Neuroscience Solutions, Inc.
  - Miami, Florida, Estados Unidos, 33142
    - Acevedo Clinical Research Associates
  - Orlando, Florida, Estados Unidos, 32801
    - Clinical Neuroscience Solutions
- Georgia
  - Atlanta, Georgia, Estados Unidos, 30331
    - Atlanta Center for Medical Research
  - Atlanta, Georgia, Estados Unidos, 30322
    - Emory University School of Medicine
  - Atlanta, Georgia, Estados Unidos, 30322
    - Emory Children's Center Illness POD
  - Macon, Georgia, Estados Unidos, 31210
    - Meridian Clinical Research, LLC
  - Union City, Georgia, Estados Unidos, 30291
    - Rophe Adult and Pediatric Medicine/SKYCRNG
- Idaho
  - Idaho Falls, Idaho, Estados Unidos, 83404
    - Clinical Research Prime
  - Meridian, Idaho, Estados Unidos, 83646
    - Solaris Clinical Research
- Kansas
  - Newton, Kansas, Estados Unidos, 67114
    - Alliance for Multispecialty Research, LLC
  - Wichita, Kansas, Estados Unidos, 67207
    - Alliance for Multispecialty Research, LLC
- Kentucky
  - Bardstown, Kentucky, Estados Unidos, 40004
    - Kentucky Pediatric/ Adult Research
  - Louisville, Kentucky, Estados Unidos, 40202
    - Novak Center for Children's Health
- Louisiana
  - New Orleans, Louisiana, Estados Unidos, 70121
    - Ochsner Clinic Foundation
  - Shreveport, Louisiana, Estados Unidos, 71101
    - Louisiana State University Health Sciences Shreveport
- Maryland
  - Baltimore, Maryland, Estados Unidos, 21224
    - Johns Hopkins Bayview Medical Center
- Massachusetts
  - Boston, Massachusetts, Estados Unidos, 02118
    - Boston Medical Center
- Michigan
  - Bingham Farms, Michigan, Estados Unidos, 48025
    - Michigan Center of Medical Research
- Mississippi
  - Ridgeland, Mississippi, Estados Unidos, 39157
    - SKY Integrative Medical Center/SKYCRNG
- Missouri
  - Chesterfield, Missouri, Estados Unidos, 63005
    - Clinical Research Professionals
  - Kansas City, Missouri, Estados Unidos, 64108
    - Children's Mercy Hospital
- Nebraska
  - Hastings, Nebraska, Estados Unidos, 68901
    - Meridian Clinical Research, LLC
  - Lincoln, Nebraska, Estados Unidos, 68510
    - Velocity Clinical Research, Lincoln
  - Omaha, Nebraska, Estados Unidos, 68114
    - Children's Hospital & Medical Center
  - Omaha, Nebraska, Estados Unidos, 68117
    - Children's Physician's Clinic, Spring Valley
- New Jersey
  - New Brunswick, New Jersey, Estados Unidos, 08901
    - Cancer Institute of New Jersey
  - New Brunswick, New Jersey, Estados Unidos, 08901
    - Rutgers University
- New York
  - Binghamton, New York, Estados Unidos, 13905
    - Meridian Clinical Research LLC
  - Commack, New York, Estados Unidos, 11725
    - Advanced Specialty Care
  - Rochester, New York, Estados Unidos, 14642
    - University of Rochester Medical Center
  - Rochester, New York, Estados Unidos, 14609
    - Rochester Clinical Research, Inc.
  - Stony Brook, New York, Estados Unidos, 11794
    - Stony Brook University
  - Syracuse, New York, Estados Unidos, 13210
    - SUNY Upstate Medical University
- North Carolina
  - Charlotte, North Carolina, Estados Unidos, 28207
    - Atrium Health-STRIVE Vaccine Research Clinic
  - Charlotte, North Carolina, Estados Unidos, 28211
    - Teen Health Connection (study visits)
  - Durham, North Carolina, Estados Unidos, 27703
    - Duke University - Main Hospital and Clinics
  - Matthews, North Carolina, Estados Unidos, 28105
    - Atrium Health-STRIVE Vaccine Research Clinic (study visits)
- Ohio
  - Cincinnati, Ohio, Estados Unidos, 45229
    - Cincinnati Children's Hospital Medical Center Vaccine Research Center
  - Columbus, Ohio, Estados Unidos, 43213
    - Centricity Research Columbus Ohio Multispecialty
  - Dayton, Ohio, Estados Unidos, 45429
    - PriMed Clinical Research
  - South Euclid, Ohio, Estados Unidos, 44121
    - Senders Pediatrics
- Oregon
  - Gresham, Oregon, Estados Unidos, 97030
    - Cyn3rgy Research
- Pennsylvania
  - Erie, Pennsylvania, Estados Unidos, 16506
    - AHN Erie Health + Wellness Pavillion: West
- Rhode Island
  - East Greenwich, Rhode Island, Estados Unidos, 02818
    - Velocity Clinical Research-Providence
- South Carolina
  - Charleston, South Carolina, Estados Unidos, 29414
    - Coastal Pediatric Research
  - Greenville, South Carolina, Estados Unidos, 29607
    - Tribe Clinical Research, LLC
  - Summerville, South Carolina, Estados Unidos, 29486
    - Coastal Pediatric Research
- Tennessee
  - Memphis, Tennessee, Estados Unidos, 38105
    - St. Jude Children's Research Hospital
  - Nashville, Tennessee, Estados Unidos, 37203
    - Clinical Research Associates Inc
- Texas
  - Austin, Texas, Estados Unidos, 78726
    - Innovo Research - Austin Regional Clinic
  - Corpus Christi, Texas, Estados Unidos, 78411
    - Driscoll Children's Hospital
  - Dallas, Texas, Estados Unidos, 75251
    - Cedar Health Research
  - Dickinson, Texas, Estados Unidos, 77539
    - Bay Colony Pediatrics
  - Edinburg, Texas, Estados Unidos, 78539
    - Proactive Clinical Research, LLC
  - Frisco, Texas, Estados Unidos, 75033
    - Village Health Partners (Patient Seen Address)
  - Houston, Texas, Estados Unidos, 77055
    - West Houston Clinical Research Services
  - Houston, Texas, Estados Unidos, 77008
    - HG Pediatrics
  - Houston, Texas, Estados Unidos, 77008
    - Van Tran Family Practice
  - Houston, Texas, Estados Unidos, 77030
    - Texas Children's Hospital - Clinical Research Center
  - Houston, Texas, Estados Unidos, 77087
    - Pediatric Associates
  - Houston, Texas, Estados Unidos, 77008
    - Helios Clinical Research - HOU
  - Houston, Texas, Estados Unidos, 77008
    - Helios Clinical Research
  - Houston, Texas, Estados Unidos, 77065
    - DM Clinical Research - MDC
- Utah
  - Salt Lake City, Utah, Estados Unidos, 84109
    - J. Lewis Research, Inc. / Foothill Family Clinic
  - Salt Lake City, Utah, Estados Unidos, 84121
    - J. Lewis Research, Inc. / Foothill Family Clinic South
- Virginia
  - Charlottesville, Virginia, Estados Unidos, 22902
    - Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)
  - Midlothian, Virginia, Estados Unidos, 23114
    - Virginia Research Center
- Washington
  - Seattle, Washington, Estados Unidos, 98105
    - Seattle Children's Hospital
Finlândia
- - Espoo, Finlândia, 02230
    - FVR, Espoo Clinic
  - Helsinki, Finlândia, 00100
    - FVR, Helsinki South Clinic
  - Helsinki, Finlândia, 00290
    - MeVac - Meilahti Vaccine Research Center
  - Helsinki, Finlândia, 00930
    - FVR, Helsinki East Clinic
  - Kokkola, Finlândia, 67100
    - FVR, Kokkola Clinic
  - Pori, Finlândia, 28100
    - FVR, Pori Clinic
  - Seinäjoki, Finlândia, 60100
    - FVR, Seinäjoki Clinic
  - Tampere, Finlândia, 33100
    - FVR, Tampere Clinic
  - Turku, Finlândia, 20520
    - FVR, Turku Clinic
- North Ostrobothnia
  - Oulu, North Ostrobothnia, Finlândia, 90220
    - FVR, Oulu Clinic
- Uusimaa
  - Jarvenpaa, Uusimaa, Finlândia, 04400
    - FVR, Järvenpää Clinic
México
- - Veracruz, México, C.P. 91900
    - Sociedad de Metabolismo y Corazón S.C.
- Nuevo León
  - Monterrey, Nuevo León, México, C.P. 64060
    - Christus - Latam Hub Center of Excellence and Innovation S.C.
- Yucatán
  - Mérida, Yucatán, México, 97070
    - Kohler & Milstein Research S.A. De C.V.
  - Mérida, Yucatán, México, 97130
    - Centro Multidisciplinario Para El Desarrollo Especializado De La Investigacion
Polônia
- - Bydgoszcz, Polônia, 85-048
    - IN-VIVO Bydgoszcz
  - Krakow, Polônia, 30-348
    - Centrum Badan Klinicznych JCI
  - Lodz, Polônia, 90-349
    - Osrodek Badan Klinicznych Appletreeclinics
  - Lodz, Polônia, 91-347
    - GRAVITA Diagnostyka i Leczenie nieplodnosci
  - Luboń, Polônia, 62-030
    - Rodzinne Centrum Medyczne LUBMED
  - Siemianowice Śląskie, Polônia, 41-103
    - Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Jarosz i Partnerzy Spolka Lekarska
  - Warsaw, Polônia, 02-647
    - Provita 001
- Kuyavian-Pomeranian Voivodeship
  - Torun, Kuyavian-Pomeranian Voivodeship, Polônia, 87-100
    - MICS Centrum Medyczne Torun

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

6 meses a 18 anos (Filho)

Aceita Voluntários Saudáveis

Sim

Descrição

Critério de inclusão

Participantes do sexo masculino ou feminino ≥6 meses a <12 anos de idade, no momento da randomização, na Visita 1 para determinação da dose/avaliação de dose selecionada e para participantes ≥12 a <18 anos de idade, no momento da randomização , na Visita 1 para a avaliação de dose mais baixa. Para a parte do estudo de obtenção de amostras de soro para teste de troponina I potencial: Participantes do sexo masculino ou feminino entre ≥5 e <16 anos de idade.
Pai(s)/responsável(is) legal(ais) dos participantes e participantes, de acordo com a idade apropriada, que estejam dispostos e sejam capazes de cumprir todas as visitas agendadas, plano de tratamento, exames laboratoriais, considerações sobre estilo de vida e outros procedimentos do estudo.
Participantes saudáveis que são determinados pelo histórico médico, exame físico e julgamento clínico do investigador como elegíveis para inclusão no estudo.
Nota: Podem ser incluídos participantes saudáveis com doença estável preexistente, definida como doença que não requer mudança significativa na terapia ou hospitalização por piora da doença durante as 6 semanas anteriores à inscrição.
Espera-se que os participantes estejam disponíveis durante o estudo e cujos pais/responsáveis legais possam ser contatados por telefone durante a participação no estudo.
Teste de gravidez de urina negativo para participantes do sexo feminino biologicamente capazes de ter filhos.
Participante do sexo feminino com potencial para engravidar ou participante do sexo masculino capaz de gerar filhos que esteja disposto a usar um método contraceptivo altamente eficaz, conforme descrito neste protocolo, por pelo menos 28 dias após a última dose da intervenção do estudo, se estiver em risco de gravidez com seu parceiro ; ou participante do sexo feminino sem potencial para engravidar ou participante do sexo masculino incapaz de gerar filhos.
O participante ou o(s) pai(s)/responsável legal do participante é capaz de dar consentimento informado assinado, o que inclui o cumprimento dos requisitos e restrições listados no CID e neste protocolo. Dependendo da idade do participante e de acordo com os requisitos locais, os participantes também serão solicitados a fornecer consentimento conforme apropriado (verbal ou escrito).

Critério de exclusão

Fase 1 apenas: histórico clínico (com base apenas nos sintomas/sinais de COVID-19, se um resultado de SARS CoV 2 NAAT não estiver disponível) ou microbiológico (com base em sintomas/sinais de COVID-19 e resultado positivo de SARS-CoV-2 NAAT) diagnóstico de COVID 19.
Somente fase 1: infecção conhecida por HIV, HCV ou HBV.
Recebimento de medicamentos destinados à prevenção do COVID-19.
Diagnóstico anterior ou atual de MIS-C.
Outra condição médica ou psiquiátrica, incluindo ideação/comportamento suicida recente (no último ano) ou ativa ou anormalidade laboratorial que pode aumentar o risco de participação no estudo ou, na opinião do investigador, tornar o participante inadequado para o estudo. Nota: Isso inclui ambas as condições que podem aumentar o risco associado à administração da intervenção do estudo ou uma condição que pode interferir na interpretação dos resultados do estudo
Histórico de reação adversa grave associada a uma vacina e/ou reação alérgica grave (por exemplo, anafilaxia) a qualquer componente da(s) intervenção(ões) do estudo.
Indivíduos imunocomprometidos com imunodeficiência conhecida ou suspeita, conforme determinado pela história e/ou exame laboratorial/físico.
Indivíduos com histórico de doença autoimune ou doença autoimune ativa que requer intervenção terapêutica, incluindo, entre outros, lúpus eritematoso sistêmico. Nota: Diabetes tipo 1 estável e hipotireoidismo são permitidos.
Diátese hemorrágica ou condição associada a sangramento prolongado que, na opinião do investigador, contra-indicaria a injeção intramuscular.
Mulher que está grávida ou amamentando.
Vacinação anterior com qualquer vacina contra o coronavírus.
Indivíduos que recebem tratamento com terapia imunossupressora, incluindo agentes citotóxicos ou corticosteroides sistêmicos, por exemplo, para câncer ou doença autoimune, ou recebimento planejado durante o estudo. Se corticosteroides sistêmicos tiverem sido administrados a curto prazo (<14 dias) para o tratamento de uma doença aguda, os participantes não devem ser incluídos no estudo até que a terapia com corticosteroides seja descontinuada por pelo menos 28 dias antes da administração da intervenção do estudo. Corticosteróides inalados/nebulizados, intra-articulares, intrabursais ou tópicos (pele ou olhos) são permitidos.
Recebimento de produtos de sangue/plasma, imunoglobulina ou anticorpos monoclonais, de 60 dias antes da administração da intervenção do estudo, ou recebimento de qualquer terapia passiva de anticorpos específica para COVID-19 de 90 dias antes da administração da intervenção do estudo, ou recebimento planejado ao longo do estudo.
Participação em outros estudos envolvendo intervenção no estudo dentro de 28 dias antes da entrada no estudo e/ou durante a participação no estudo.
Participação anterior em outros estudos envolvendo intervenção de estudo contendo LNPs.
Participantes que sejam descendentes diretos (filhos ou netos) de funcionários do centro de investigação ou funcionários da Pfizer/BioNTech diretamente envolvidos na condução do estudo, funcionários do centro supervisionados pelo investigador e seus respectivos familiares.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Finalidade Principal: Prevenção
Alocação: Não randomizado
Modelo Intervencional: Atribuição Paralela
Mascaramento: Nenhum (rótulo aberto)

Número de braços

Armas e Intervenções

Grupo de Participantes / Braço	Intervenção / Tratamento
Experimental: Dose baixa/média, ≥5 a <12 anos Dose baixa/média (10mcg), 2 doses com 21 dias de intervalo	Biológico: Biológica/Vacina: BNT162b2 10mcg Nível de dose baixa/média de BNT162b2 (10mcg)
Experimental: Dose média, ≥5 a <12 anos Dose média, (20mcg), 2 doses com 21 dias de intervalo	Biológico: BNT162b2 20mcg Nível de dose média BNT162b2 (20mcg)
Experimental: Dose alta, ≥5 a <12 anos Dose alta (30mcg), 2 doses com 21 dias de intervalo	Biológico: BNT162b2 30mcg Nível de alta dose BNT162b2 (30mcg)
Experimental: Dose baixa/média, ≥2 a <5 anos Dose baixa/média (10mcg), 2 doses com 21 dias de intervalo	Biológico: Biológica/Vacina: BNT162b2 10mcg Nível de dose baixa/média de BNT162b2 (10mcg)
Experimental: Dose média, ≥2 a <5 anos Dose média, (20mcg), 2 doses com 21 dias de intervalo	Biológico: BNT162b2 20mcg Nível de dose média BNT162b2 (20mcg)
Experimental: Dose alta, ≥2 a <5 anos Dose alta, (30mcg), 2 doses com 21 dias de intervalo	Biológico: BNT162b2 30mcg Nível de alta dose BNT162b2 (30mcg)
Experimental: Dose baixa/média, ≥6 meses a <2 anos Dose baixa/média, (10mcg), 2 doses com 21 dias de intervalo	Biológico: Biológica/Vacina: BNT162b2 10mcg Nível de dose baixa/média de BNT162b2 (10mcg)
Experimental: Dose média, ≥6 meses a <2 anos Dose média, (20mcg), 2 doses com 21 dias de intervalo	Biológico: BNT162b2 20mcg Nível de dose média BNT162b2 (20mcg)
Experimental: Dose alta, ≥6 meses a <2 anos Dose alta, (30mcg), 2 doses com 21 dias de intervalo	Biológico: BNT162b2 30mcg Nível de alta dose BNT162b2 (30mcg)
Comparador de Placebo: Placebo, ≥6 meses a <2 anos	Outro: Placebo Injeção intramuscular
Comparador de Placebo: Placebo, ≥2 a <5 anos	Outro: Placebo Injeção intramuscular
Comparador de Placebo: Placebo, ≥5 a <12 anos	Outro: Placebo Injeção intramuscular
Experimental: Dose baixa, ≥6 meses a <2 anos Dose baixa (3mcg), 2 doses com 21 doses de intervalo	Biológico: Biológica/Vacina: BNT162b2 3mcg Nível de baixa dose de BNT162b2 (3mcg)
Experimental: Dose baixa, ≥2 a <5 anos Baixa dose (3mcg), 2 doses com 21 dias de intervalo	Biológico: Biológica/Vacina: BNT162b2 3mcg Nível de baixa dose de BNT162b2 (3mcg)
Experimental: Dose alta, 12 a <16 anos (teste de troponina I) Dose alta (30mcg), 3 doses	Biológico: BNT162b2 30mcg Nível de alta dose BNT162b2 (30mcg)
Experimental: Dose baixa/média, ≥5 a <12 anos (teste de troponina I) Dose baixa/média (10mcg), 3 doses	Biológico: Biológica/Vacina: BNT162b2 10mcg Nível de dose baixa/média de BNT162b2 (10mcg)
Experimental: Placebo, ≥5 a <12 anos (teste de troponina I)	Outro: Placebo Injeção intramuscular
Experimental: Dose baixa, ≥6 meses a <2 anos (regime de 3 doses) Dose baixa (3mcg), 3 doses	Biológico: Biológica/Vacina: BNT162b2 3mcg Nível de baixa dose de BNT162b2 (3mcg)
Experimental: Dose baixa, ≥2 a <5 anos (regime de 3 doses) Dose baixa (3mcg), 3 doses	Biológico: Biológica/Vacina: BNT162b2 3mcg Nível de baixa dose de BNT162b2 (3mcg)
Comparador de Placebo: Placebo, ≥6 meses a <2 anos (regime de 3 doses)	Outro: Placebo Injeção intramuscular
Comparador de Placebo: Placebo, ≥2 a <5 anos (regime de 3 doses)	Outro: Placebo Injeção intramuscular

O que o estudo está medindo?

Medidas de resultados primários

Medidas de resultados secundários

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

BioNTech SE

Colaboradores

Pfizer

Investigadores

Diretor de estudo: Pfizer CT.gov Call Center, Pfizer

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Links úteis

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

24 de março de 2021

Conclusão Primária (Real)

4 de outubro de 2023

Conclusão do estudo (Real)

8 de dezembro de 2023

Datas de inscrição no estudo

Enviado pela primeira vez

19 de março de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

24 de março de 2021

Primeira postagem (Real)

25 de março de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

28 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

26 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

C4591007
2020-005442-42 (Número EudraCT)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Ensaios clínicos em Infecção por SARS-CoV-2, COVID-19

IRCCS San Raffaele

Concluído

Estudo observacional retrospectivo da resposta imune em indivíduos vacinados contra a infecção SARS-CoV-2 (BioVAC-immunit)

Resposta de Anticorpo | Resposta Imune Celular | SAR-CoV-2

Itália
Pfizer

Ativo, não recrutando

Um estudo para aprender sobre como as atualizações anuais do CoVID-19 trabalham para proteger as pessoas do CoVID-19 e quanto dinheiro as pessoas gastam em saúde para Covid-19

COVID-19 | Doença de Coronavírus 2019 (COVID-19) | Contágio do covid-19 | Vacinas para o covid-19 | Infecção por SARS-CoV-2, COVID19 | Vacinação COVID-19 | Infecção por SARS-CoV-2, COVID-19 | COVID-19 (doença de coronavírus 2019) | Infecção por SARS-CoV-2 por COVID-19

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

Ainda não está recrutando

Estudo de Plataforma Adaptativa de Tratamentos para Infeções Respiratórias em Contexto Comunitário (TreatResp) (TreatResp)

Gripe A | Influenza B | Infecções Respiratórias Agudas (IRAs) | SAR-CoV-2

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

Concluído

Efeitos a longo prazo do COVID-19

COVID-19 | SAR-CoV-2

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

Concluído

Estudo SARS-CoV-2-CZ-PREVAL-II - Braço da Região de Olomouc

SARS-CoV-2 | Infecção por SARS-CoV-2 (COVID-19)

Tcheca
AstraZeneca

Concluído

Estudo da injeção intramuscular ou infusão intravenosa de AZD3152 em participantes adultos japoneses saudáveis

COVID-19, SARS-CoV-2

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

Concluído

Os anticorpos específicos para SARS-CoV-2 são correlatos para proteção? (ImmCoV)

COVID-19 | SARS-CoV-2

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

Concluído

Segurança, tolerabilidade e farmacocinética do SAB-185 em participantes saudáveis

COVID-19 | SARS-CoV-2

Estados Unidos
University of Wisconsin, Madison
National Institutes of Health (NIH)

Concluído

Repita o teste para SARS-CoV-2

COVID-19 | SARS-CoV-2

Estados Unidos
Syneos Health
US Specialty Formulations, LLC

Concluído

Primeiro estudo em humanos de CoV2-OGEN1 administrado por via oral em indivíduos saudáveis

SARS-CoV-2 (COVID-19)

Nova Zelândia

Ensaios clínicos em Placebo

University of Oxford
Hospital General Universitario Gregorio Marañon; Charite University, Berlin,... e outros colaboradores

Ainda não está recrutando

Estudo de Estratificação e Tratamento em Psicose Precoce - ASSIST (STEP-ASSIST)

Psicose | Psicose Resistente ao Tratamento

Espanha, Reino Unido, Alemanha, Israel, Grécia, Itália, Holanda, Suíça

Medida de resultado	Descrição da medida	Prazo
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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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)

Medida de resultado	Descrição da medida	Prazo
Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=5 to <12 Years of Age Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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 Prazo: 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

Um estudo de fase 1/2/3 para avaliar a segurança, tolerabilidade e imunogenicidade de uma vacina candidata de RNA contra COVID-19 em crianças e adultos jovens saudáveis

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