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一项评估 RNA 候选 COVID-19 疫苗在健康儿童和年轻人中的安全性、耐受性和免疫原性的 1/2/3 期研究

2026年5月26日 更新者：BioNTech SE

评估安全性、耐受性和免疫原性的第 1 阶段、开放标签剂量探索研究和针对 COVID 的 SARS-COV-2 RNA 候选疫苗的第 2/3 阶段安慰剂对照、观察员盲法的安全性、耐受性和免疫原性研究-19 在健康儿童和年轻人中

这是一项针对健康儿童和年轻人的 1/2/3 期研究。

根据本研究过程中产生的安全性和/或免疫原性数据，以及由此产生的利益-风险评估，BNT162b2在 6 个月以下的参与者中的安全性、耐受性和免疫原性随后可能会得到评估。

研究概览

地位

完全的

条件

干预/治疗

详细说明

1 期剂量探索

该研究的开放标签剂量探索部分将评估 BNT162b2 在多达 3 个年龄组（参与者≥5 至 <12岁，≥2 至 <5 岁，≥6 个月至 <2 岁）。

根据 C4591001 研究中 12 至 15 岁儿童 30 µg 剂量可接受的盲法安全评估，本研究开始对 ≥ 5 岁至 <12 岁的参与者进行剂量探索。

第 1 阶段的目的是从每个年龄组的多达 3 个不同剂量水平中确定 BNT162b2 的首选剂量水平。

根据本研究过程中产生的安全性和/或免疫原性数据，剂量水平可能不会开始，可能会提前终止，和/或可能会以低于最低规定剂量的剂量水平添加。

作为协议修正案 6 的一部分进行更新：所有参与者将接受第三剂 BNT162b2。 对于≥6 个月至 <5 岁的参与者，第三剂将在第二剂后至少 8 周进行。 在 ≥ 5 岁至 <12 岁的参与者中，第三剂将在第二剂后至少 6 个月进行。 第二剂和第三剂之间的间隔时间将根据参加者入组时的年龄而定。 第三剂 BNT162b2 的剂量水平将取决于接种疫苗时的年龄：第三剂时年龄 <5 岁的参与者将接受 3-µg 剂量水平，年龄≥5 至 <12 岁的参与者第三剂时的年龄将接受 10 µg 的剂量水平，第三剂时年龄≥12 岁的参与者将接受 30 µg 的剂量水平。

参与者将在第 1 剂和第 2 剂之前以及第 2 剂后 7 天抽血，以评估免疫原性，以确定第 2/3 期的选定 BNT162b2 剂量水平。 参与者还将在第 3 剂之前以及第 3 剂之后的 1、6 和 12 个月抽血。

第一阶段低剂量评估

是该研究的开放标签低剂量评估部分，将评估来自 2 个年龄组（12 至 <16 岁和 16 至 <18 岁）的 2 个方案的 10 µg BNT162b2 的安全性、耐受性和免疫原性.

1 期低剂量评估的目的是评估 BNT162b2 在每个年龄组的 2 种不同剂量方案的安全性和免疫原性：(1) 2 剂间隔约 21 天和 (2) 2 剂间隔约 8 周.

参与者将在第 1 剂之前、第 2 剂之前、第 2 剂后 7 天和第 2 剂后 1 个月抽血，以评估免疫原性，以确定选定的 BNT162b2 剂量方案，用于 2/3 期低剂量评估部分学习。 此外，参与者将在第 2 剂接种后 6 个月和 12 个月时抽血以确定免疫反应的持续性。

2/3 期选定剂量

是研究的一部分，将评估每个年龄组的安全性、耐受性和免疫原性，在研究的第 1 阶段剂量发现部分选择的剂量水平。 将在免疫桥接成功的年龄组内或跨年龄组评估疗效，这取决于这些年龄组中足够数量的病例。

参与者将在第 1 剂之前和第 2 剂后 6 个月的基线抽血。C4591001 研究中 16 至 25 岁参与者的免疫桥接将基于在 (1) 基线和第 2 剂后 1 个月收集的免疫原性数据，以及(2) 基线和第 3 剂后 1 个月。免疫反应的持久性将基于在 (1) 基线和第 2 剂后 1 个月和 6 个月以及 (2) 基线和第 1、6、12 个月时在参与者中收集的免疫原性数据，和第 3 剂后 18 个月。此外，还将在≥5 岁至 <12 岁的参与者中评估针对确诊的 COVID-19 和无症状感染的疗效。

在美国指定地点，将在第 1 剂之前以及第 2 剂后 7 天和 6 个月从多达约 60 名年龄≥10 岁的参与者中获取额外的约 10 mL 全血样本。 在第 3 剂之前和第 3 剂之后 1 个月（仅限原始 BNT162b2 组）将获得额外的样品。 这些样本将在探索性的基础上用于研究这些时间点的疫苗接种后细胞介导的免疫反应。

在 6 个月的随访中，所有参与者都将被揭盲。 作为研究的一部分，最初接受安慰剂的参与者将有机会接受 BNT162b2。 在 6 个月的随访访问（访问 5 或 405）之前，最初接受安慰剂并根据当地或国家建议有资格接受 BNT162b2 或另一种 COVID-19 疫苗的参与者（单独详述并可在电子研究参考门户网站上获得） ) 将有机会根据接种疫苗时的年龄获得 BNT162b2（10 µg 或 3 µg）。

作为协议修正案 6 的一部分进行更新：所有参与者将接受第三剂 BNT162b2。 对于≥6 个月至 <5 岁的参与者，第三剂将在第二剂后至少 8 周进行。 在 ≥ 5 岁至 <12 岁的参与者中，第三剂将在第二剂后至少 6 个月进行。 第二剂和第三剂之间的间隔时间将根据参加者入组时的年龄而定。 第二剂和第三剂 BNT162b2 的剂量水平将取决于接种疫苗时的年龄：第二剂/第三剂时年龄 <5 岁的参与者将接受 3-µg 剂量水平，参与者≥5 至在第二次/第三次接种时 <12 岁的参与者将接受 10-µg 的剂量水平，在第二次/第三次接种时年龄≥12 岁的参与者将接受 30-µg 的剂量水平。

2/3 期低剂量评估

是该研究的开放标签部分，将评估第一阶段低剂量评估中每个年龄组所选剂量方案的安全性、耐受性和免疫原性，共有约 600 名活跃参与者。

此阶段每个年龄组的大约 300 名活跃参与者将参与第 2 剂后 1 个月的免疫桥接分析以及第 2 剂后 6 个月和 12 个月免疫反应持续性的总体分析。

2/3 期获取血清样本以进行潜在的肌钙蛋白 I 测试

如果对未接受 BNT162b2 的个体进行的肌钙蛋白 I 水平检测表明肌钙蛋白 I 水平可能是潜在亚临床心肌炎的可靠指标，那么在临床心肌炎风险增加期间获取用于潜在肌钙蛋白 I 检测的血清样本可能有助于确定不存在的特征/亚临床心肌炎的存在和频率。 为了进行评估，将包括另一组参与者：≥5 岁至 <12 岁：随机分配 2:1 接受 BNT162b2 10 µg 或安慰剂，≥12 岁至 <16 岁：开放标签接受 BNT162b2 30 µg。

作为协议修正案 7 的一部分进行更新：所有参与者将接受第三剂 BNT162b2。 对于所有参与者（≥5 至 <12 岁和≥12 至 <16 岁），第三​​剂将在第 2 剂后至少 5 个月进行。

第二剂和第三剂 BNT162b2 的剂量水平将根据接种疫苗时的年龄而定：第二剂/第三剂时≥5 岁至 <12 岁的参与者将接受 10 µg 剂量水平，并且在第二次/第三次给药时年龄≥12 岁的参与者将接受 30 µg 剂量水平。

研究类型

介入性

注册 (实际的)

11837

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

6个月 至 18年 (孩子)

接受健康志愿者

是的

描述

纳入标准

  1. 年龄≥6 个月至 <12 岁的男性或女性参与者，在随机化时，在第 1 次就诊时进行剂量探索/选择剂量评估，对于年龄≥12 岁至 <18 岁的参与者，在随机化时, 在第 1 次就诊时进行低剂量评估。 对于研究的潜在肌钙蛋白 I 测试部分的获取血清样本：≥5 岁和 <16 岁之间的男性或女性参与者。
  2. 参与者的父母/法定监护人和参与者（视年龄而定）愿意并能够遵守所有预定的就诊、治疗计划、实验室检查、生活方式注意事项和其他研究程序。

  3. 研究者根据病史、体格检查和临床判断确定符合纳入研究条件的健康受试者。

    注意：可以包括预先存在稳定疾病的健康参与者，定义为在入组前 6 周内不需要显着改变治疗或因疾病恶化而住院的疾病。

  4. 预计参与者将在研究期间可用，并且在研究参与期间可以通过电话联系其父母/法定监护人。
  5. 对生理上有生育能力的女性参与者进行尿液妊娠试验阴性。
  6. 有生育潜力的女性参与者或能够生育孩子的男性参与者，如果与她/他的伴侣有怀孕的风险，愿意在最后一次研究干预后至少 28 天使用本方案中概述的高效避孕方法;或没有生育能力的女性参与者或不能生育孩子的男性参与者。
  7. 参与者或参与者的父母/法定监护人能够签署知情同意书，其中包括遵守 ICD 和本协议中列出的要求和限制。 根据参与者的年龄和当地要求，还将要求参与者提供适当的同意（口头或书面）。

排除标准

  1. 仅第 1 阶段：既往临床（仅基于 COVID-19 症状/体征，如果没有 SARS CoV 2 NAAT 结果）或微生物学（基于 COVID-19 症状/体征和 SARS-CoV-2 NAAT 阳性结果） COVID 19 的诊断。
  2. 仅第 1 阶段：已知感染 HIV、HCV 或 HBV。
  3. 收到旨在预防 COVID-19 的药物。
  4. MIS-C 的先前或当前诊断。
  5. 其他医疗或精神状况，包括最近（过去一年内）或活跃的自杀意念/行为或实验室异常，可能会增加参与研究的风险，或者根据研究者的判断，使参与者不适合研究。 注意：这包括可能增加与研究干预管理相关的风险的情况或可能干扰研究结果解释的情况
  6. 与疫苗相关的严重不良反应史和/或对研究干预的任何成分的严重过敏反应（例如，过敏反应）。
  7. 根据病史和/或实验室/体检确定的已知或疑似免疫缺陷的免疫功能低下个体。
  8. 有自身免疫性疾病病史或需要治疗干预的活动性自身免疫性疾病的个体，包括但不限于系统性红斑狼疮。 注意：稳定的 1 型糖尿病和甲状腺功能减退症是允许的。
  9. 与长期出血相关的出血素质或病症，在研究者看来，禁忌肌内注射。
  10. 怀孕或哺乳的女性。
  11. 以前接种过任何冠状病毒疫苗。
  12. 接受免疫抑制治疗的个体，包括细胞毒性药物或全身性皮质类固醇，例如，用于治疗癌症或自身免疫性疾病，或在整个研究期间计划接受治疗。 如果短期（<14 天）给予全身性皮质类固醇治疗急性疾病，则在研究干预给药前至少停止皮质类固醇治疗 28 天之前，不应将参与者纳入研究。 允许吸入/雾化、关节内、囊内或局部（皮肤或眼睛）皮质类固醇。
  13. 在研究干预实施前 60 天接受血液/血浆制品、免疫球蛋白或单克隆抗体，或在研究干预实施前 90 天接受任何针对 COVID-19 的被动抗体治疗，或计划在整个研究期间接受。
  14. 在进入研究前 28 天内和/或参与研究期间参与涉及研究干预的其他研究。
  15. 以前参与过其他涉及含有 LNP 的研究干预的研究。
  16. 研究现场工作人员或辉瑞/BioNTech 员工直接参与研究的直系后代（子女或孙辈）的参与者、由研究者监督的现场工作人员，以及他们各自的家庭成员。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：非随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：低/中剂量，≥5 至 <12 岁
低/中剂量 (10mcg)，2 剂，间隔 21 天
生物：生物/疫苗：BNT162b2 10mcg
BNT162b2 低/中剂量 (10mcg) 水平
实验性的：中等剂量，≥5 至 <12 岁
中剂量 (20mcg)，2 剂，间隔 21 天
生物：BNT162b2 20微克
BNT162b2 中剂量 (20mcg) 水平
实验性的：高剂量，≥5 至 <12 岁
高剂量 (30mcg)，2 剂，间隔 21 天
生物：BNT162b2 30微克
BNT162b2 高剂量 (30mcg) 水平
实验性的：低/中剂量，≥2 至 < 5 年
低/中剂量 (10mcg)，2 剂，间隔 21 天
生物：生物/疫苗：BNT162b2 10mcg
BNT162b2 低/中剂量 (10mcg) 水平
实验性的：中等剂量，≥2 至 <5 年
中剂量 (20mcg)，2 剂，间隔 21 天
生物：BNT162b2 20微克
BNT162b2 中剂量 (20mcg) 水平
实验性的：高剂量，≥2 至 <5 年
高剂量 (30mcg)，2 剂，间隔 21 天
生物：BNT162b2 30微克
BNT162b2 高剂量 (30mcg) 水平
实验性的：低/中剂量，≥6 个月至 <2 年
低/中剂量，(10mcg)，2 剂，间隔 21 天
生物：生物/疫苗：BNT162b2 10mcg
BNT162b2 低/中剂量 (10mcg) 水平
实验性的：中剂量，≥6 个月至 <2 岁
中剂量 (20mcg)，2 剂，间隔 21 天
生物：BNT162b2 20微克
BNT162b2 中剂量 (20mcg) 水平
实验性的：高剂量，≥6 个月至 <2 年
高剂量 (30mcg)，2 剂，间隔 21 天
生物：BNT162b2 30微克
BNT162b2 高剂量 (30mcg) 水平
安慰剂比较：安慰剂，≥6 个月至 <2 年
其他：安慰剂
肌肉注射
安慰剂比较：安慰剂，≥2 至 <5 年
其他：安慰剂
肌肉注射
安慰剂比较：安慰剂，≥5 至 <12 岁
其他：安慰剂
肌肉注射
实验性的：低剂量，≥6 个月至 <2 年
低剂量 (3mcg)，2 剂，间隔 21 剂
生物：生物/疫苗：BNT162b2 3mcg
BNT162b2 低剂量 (3mcg) 水平
实验性的：低剂量，≥2 至 <5 年
低剂量 (3mcg)，2 剂，间隔 21 天
生物：生物/疫苗：BNT162b2 3mcg
BNT162b2 低剂量 (3mcg) 水平
实验性的：高剂量，12 至 <16 岁（肌钙蛋白 I 测试）
高剂量 (30mcg)，3 剂
生物：BNT162b2 30微克
BNT162b2 高剂量 (30mcg) 水平
实验性的：低/中剂量，≥5 至 <12 岁（肌钙蛋白 I 测试）
低/中剂量 (10mcg)，3 剂
生物：生物/疫苗：BNT162b2 10mcg
BNT162b2 低/中剂量 (10mcg) 水平
实验性的：安慰剂，≥5 至 <12 岁（肌钙蛋白 I 测试）
其他：安慰剂
肌肉注射
实验性的：低剂量，≥6 个月至 <2 年（3 剂量方案）
低剂量 (3mcg)，3 剂
生物：生物/疫苗：BNT162b2 3mcg
BNT162b2 低剂量 (3mcg) 水平
实验性的：低剂量，≥2 至 <5 年（3 剂量方案）
低剂量 (3mcg)，3 剂
生物：生物/疫苗：BNT162b2 3mcg
BNT162b2 低剂量 (3mcg) 水平
安慰剂比较：安慰剂，≥6 个月至 <2 年（3 剂量方案）
其他：安慰剂
肌肉注射
安慰剂比较：安慰剂，≥2 至 <5 岁（3 剂方案）
其他：安慰剂
肌肉注射

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=5 to <12 Years of Age
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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 3: Troponin Group: >=5 to <12 Years of Age
大体时间：Phase 2/3: From Day 1 to Day 7 after Dose 3
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from up 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 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 3: Troponin Group: >=12 to <16 Years of Age
大体时间：Phase 2/3: From Day 1 to Day 7 after Dose 3
Systemic events were recorded in an e-diary and at unscheduled clinical assessments from up 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 2/3: From Day 1 to Day 7 after Dose 3
Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: Troponin Group: >=5 to <12 Years of Age
大体时间：Phase 2/3: 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 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 2/3: From Dose 1 to 1 Month after Dose 2
Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: Troponin Group: >=12 to <16 Years of Age
大体时间：Phase 2/3: 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 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 2/3: From Dose 1 to 1 Month after Dose 2
Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: Troponin Group: >=5 to <12 Years of Age
大体时间：Phase 2/3: 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 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 2/3: From Dose 3 to 1 Month after Dose 3
Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: Troponin Group:>=12 to <16 Years of Age
大体时间：Phase 2/3: 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 after dose 3 to 1 month from dose 3 were reported in this outcome measure. Exact 2-sided 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 2/3: From Dose 3 to 1 Month after Dose 3
Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2 : Troponin Group: >=5 to <12 Years of Age
大体时间：Phase 2/3: 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 was based on the Clopper and Pearson method.
Phase 2/3: From Dose 1 to 6 Months after Dose 2
Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: Troponin Group: >=12 to <16 Years of Age
大体时间：Phase 2/3: 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 was based on the Clopper and Pearson method.
Phase 2/3: From Dose 1 to 6 Months after Dose 2
Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3: Troponin Group: >=5 to <12 Years of Age
大体时间：Phase 2/3: 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 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 was based on the Clopper and Pearson method.
Phase 2/3: From Dose 3 to 6 Months after Dose 3
Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3 : Troponin Group:>=12 to <16 Years of Age
大体时间：Phase 2/3: 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 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 was based on the Clopper and Pearson method.
Phase 2/3: From Dose 3 to 6 Months after Dose 3
Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=5 to <12 Years of Age
大体时间：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 (>=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 1
Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 2: >=5 to <12 Years of Age
大体时间：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 3: >=5 to <12 Years of Age
大体时间：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 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: >=5 to <12 Years of Age
大体时间：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 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: >=5 to <12 Years of Age
大体时间：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 up to Day 7 after Dose 2. Fever: oral temperature >= 38.0 deg C; categorized as >=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 3: >=5 to <12 Years of Age
大体时间：Phase 2/3: From Day 1 to Day 7 after Dose 3
Systemic events were recorded in an e-diary and at unscheduled clinical assessments up to Day 7 after Dose 3. Fever: oral temperature >= 38.0 deg C; categorized as >=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 3
Phase 2/3: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=2 to <5 Years of Age
大体时间：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 (>=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 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: >=2 to <5 Years of Age
大体时间：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. 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 3: >=2 to <5 Years of Age
大体时间：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. 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 Systemic Events Within 7 Days After Dose 1: >=2 to <5 Years of Age
大体时间：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 Day 1 to Day 7 after Dose 1. Fever: oral temperature >= 38.0 deg C; categorized as >=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: >=2 to <5 Years of Age
大体时间：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 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 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 3: >=2 to <5 Years of Age
大体时间：Phase 2/3: From 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 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 1: >=6 Months to <2 Years of Age
大体时间：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 (>=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 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 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: >=6 Months to <2 Years of Age
大体时间：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]). 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 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 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: >=6 Months to <2 Years of Age
大体时间：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]). 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 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 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: >=6 Months to <2 Years of Age
大体时间：Phase 2/3: From Day 1 to Day 7 after Dose 1
Systemic events recorded in an e-diary & at unscheduled clinical assessments up to Day 7 after Dose 1. Fever: oral temperature >= 38.0 deg C; categorised as >=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: ER visit or hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were also 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: >=6 Months to <2 Years of Age
大体时间：Phase 2/3: From Day 1 to Day 7 after Dose 2
Systemic events recorded in an e-diary & at unscheduled clinical assessments up to Day 7 after Dose 2. Fever: oral temperature >= 38.0 deg C; categorised as >=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: ER visit or hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were also 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 3: >=6 Months to <2 Years of Age
大体时间：Phase 2/3: From Day 1 to Day 7 after Dose 3
Systemic events recorded in an e-diary and at unscheduled clinical assessments up to Day 7 after Dose 3. Fever: oral temperature >= 38.0 deg C; categorised as >=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: ER visit or hospitalization and were classified by investigator or medically qualified person. Events reported as AEs in CRF within 7 days after vaccination were also included. Exact 95% CI based on Clopper and Pearson method.
Phase 2/3: From Day 1 to Day 7 after Dose 3
Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: >=5 to <12 Years of Age
大体时间：Phase 2/3: 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 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 2/3: From Dose 1 to 1 Month after Dose 2
Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3: >=5 to <12 Years of Age
大体时间：Phase 2/3: 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 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 2/3: From Dose 3 to 1 Month after Dose 3
Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2 : >=5 to <12 Years of Age
大体时间：Phase 2/3: 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 was based on the Clopper and Pearson method.
Phase 2/3: From Dose 1 to 6 Months after Dose 2
Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3: >=5 to <12 Years of Age
大体时间：Phase 2/3: 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 was based on the Clopper and Pearson method.
Phase 2/3: From Dose 3 to 6 Months after Dose 3
Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2: >=2 to <5 Years of Age
大体时间：Phase 2/3: 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 after dose 1 to 1 month from dose 2 were reported in this outcome measure. Exact 2-sided 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 2/3: From Dose 1 to 1 Month after Dose 2
Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3:>=2 to <5 Years of Age
大体时间：Phase 2/3: 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 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 2/3: From Dose 3 to 1 Month after Dose 3
Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2: >=2 to <5 Years of Age
大体时间：Phase 2/3: 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 was based on the Clopper and Pearson method.
Phase 2/3: From Dose 1 to 6 Months after Dose 2
Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3:>=2 to <5 Years of Age
大体时间：Phase 2/3: 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 was based on the Clopper and Pearson method.
Phase 2/3: From Dose 3 to 6 Months after Dose 3
Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 1 to 1 Month After Dose 2 : >=6 Months to <2 Years of Age
大体时间：Phase 2/3: 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 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 2/3: From Dose 1 to 1 Month after Dose 2
Phase 2/3: Percentage of Participants Reporting Adverse Events From Dose 3 to 1 Month After Dose 3 : >=6 Months to <2 Years of Age
大体时间：Phase 2/3: 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 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 2/3: From Dose 3 to 1 Month after Dose 3
Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 1 to 6 Months After Dose 2 : >=6 Months to <2 Years of Age
大体时间：Phase 2/3: 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 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 was based on the Clopper and Pearson method.
Phase 2/3: From Dose 1 to 6 Months after Dose 2
Phase 2/3: Percentage of Participants Reporting Serious Adverse Events From Dose 3 to 6 Months After Dose 3: >=6 Months to <2 Years of Age
大体时间：Phase 2/3: 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 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 was based on the Clopper and Pearson method.
Phase 2/3: From Dose 3 to 6 Months after Dose 3
Phase2/3:Geometric Mean Ratio(GMR)Based on GMT for SARS-CoV-2 Neutralizing Titers in Participants>=5 to<12 Years of Age Compared With Study C4591001 Phase 2/3 16 to 25 Years Historical Cohort:1 Month After Dose 2:Participants Without Evidence of Infection
大体时间：C4591007 (>=5 to <12 years): 1 Month after Dose 2 and C4591001 Historical cohort (16-25 years): 1 Month after Dose 2
GMRs and the corresponding 2-sided CIs were calculated by exponentiating the mean difference of the logarithm of the titers and the corresponding CIs (based on student t distribution). GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the lower limit of quantitation (LLOQ) were set to 0.5*LLOQ. Results include those from a comparator group of C4591001 (NCT04368728) Phase 2/3 participants of the age 16 to 25 years who received 2 doses of original BNT162b2 30 mcg who had no serological or virological evidence of past SARS-CoV-2 infection and had no medical history of COVID-19 were also included. GMT is reported in descriptive analysis section and GMR is reported under statistical analysis.
C4591007 (>=5 to <12 years): 1 Month after Dose 2 and C4591001 Historical cohort (16-25 years): 1 Month after Dose 2
Phase 2/3: Difference in Percentage of Participants Who Achieved Seroresponse in >=5 to <12 Years of Age Compared With Study C4591001 Phase 2/3 16 to 25 Years Historical Cohort: 1 Month After Dose 2: Participants Without Evidence of Infection
大体时间：C4591007 (>=5 to <12 years): 1 Month after Dose 2 and C4591001 Historical cohort (16-25 years): 1 Month after Dose 2
Seroresponse is defined as achieving a >=4 fold rise from baseline (before Dose 1). Assay result below a postvaccination >=4*LLOQ is considered a seroresponse. Results include those from a comparator group of C4591001 (NCT04368728) Phase 2/3 participants who had no serological or virological evidence (prior to the 1-month post-Dose 2 blood sample collection) of past SARS-CoV-2 infection were included for this analysis. Percentage of participants with seroresponse is reported in descriptive analysis section and the difference in percentage of participants is reported under statistical analysis. 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.
C4591007 (>=5 to <12 years): 1 Month after Dose 2 and C4591001 Historical cohort (16-25 years): 1 Month after Dose 2
Phase 2/3: GMR Based on GMT for SARS-CoV-2 Neutralizing Titers in Participants >=2 to <5 Years of Age Compared With Study C4591001 Phase 2/3 16 to 25 Years Historical Cohort: 1 Month After Dose 2: Participants Without Evidence of Infection
大体时间：C4591007 (>=2 to <5 years): 1 Month after Dose 2 and C4591001 Historical cohort (16-25 years): 1 Month after Dose 2
GMRs & corresponding 2-sided CIs were calculated by exponentiating mean difference of logarithm of titers & corresponding CIs(based on student t distribution).GMTs & 2-sided 95% CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs(based on the Student t distribution).Assay results below LLOQ were set to 0.5*LLOQ.Results include those from comparator group of C4591001(NCT04368728) Phase2/3 participants of age 16-25 years who received 2 doses of original BNT162b2 30mcg who had no serological or virological evidence of past SARS-CoV-2 infection& had no medical history of COVID-19 were also included.GMT is reported in descriptive analysis section & GMR is reported under statistical analysis.EIP included all eligible randomized participants who received study intervention to which they were randomized,had a valid&determinate immunogenicity result within 28-42 days after study vaccination,had no other important protocol deviations as determined by clinician.
C4591007 (>=2 to <5 years): 1 Month after Dose 2 and C4591001 Historical cohort (16-25 years): 1 Month after Dose 2
Phase 2/3: Difference in Percentage of Participants Who Achieved Seroresponse in >=2 to <5 Years of Age Compared With Study C4591001 Phase 2/3 16 to 25 Years Historical Cohort: 1 Month After Dose 2: Participants Without Evidence of Infection
大体时间：C4591007 (>=2 to <5 years): 1 Month after Dose 2 and C4591001 Historical cohort (16-25 years): 1 Month after Dose 2
Seroresponse is defined as achieving a >=4-fold rise from baseline (before Dose 1). Assay result below a postvaccination >=4*LLOQ is considered a seroresponse. Results include those from a comparator group of C4591001 (NCT04368728) Phase 2/3 participants who had no serological or virological evidence (prior to the 1-month post-Dose 2 blood sample collection) of past SARS-CoV-2 infection were included for this analysis. Percentage of participants with seroresponse is reported in descriptive analysis section and the difference in percentage of participants is reported under statistical analysis. 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.
C4591007 (>=2 to <5 years): 1 Month after Dose 2 and C4591001 Historical cohort (16-25 years): 1 Month after Dose 2
Phase 2/3: GMR Based on GMT for SARS-CoV-2 Neutralizing Titers in Participants >=6 Months to <2 Years of Age Compared With Study C4591001 Phase 2/3 16 to 25 Years Historical Cohort: 1 Month After Dose 2: Participants Without Evidence of Infection
大体时间：C4591007 (>=6 Months to <2 years): 1 Month after Dose 2 and C4591001 Historical cohort (16-25 years): 1 Month after Dose 2
GMRs & corresponding 2-sided CIs were calculated by exponentiating mean difference of logarithm of titers & corresponding CIs(based on student t distribution).GMTs & 2-sided 95% CIs were calculated by exponentiating mean logarithm of titers and corresponding CIs(based on the Student t distribution).Assay results below LLOQ were set to 0.5*LLOQ.Results include those from comparator group of C4591001(NCT04368728) Phase2/3 participants of age 16-25 years who received 2 doses of original BNT162b2 30mcg who had no serological or virological evidence of past SARS-CoV-2 infection& had no medical history of COVID-19 were also included.GMT is reported in descriptive analysis section & GMR is reported under statistical analysis.EIP included all eligible randomized participants who received study intervention to which they were randomized,had a valid&determinate immunogenicity result within 28-42 days after study vaccination,had no other important protocol deviations as determined by clinician.
C4591007 (>=6 Months to <2 years): 1 Month after Dose 2 and C4591001 Historical cohort (16-25 years): 1 Month after Dose 2
Phase 2/3: Difference in Percentage of Participants Who Achieved Seroresponse in >=6 Months to <2 Years of Age Compared With Study C4591001 Phase 2/3 16 to 25 Years Historical Cohort : 1 Month After Dose 2: Participants Without Evidence of Infection
大体时间：C4591007 (>=6 Months to <2 years): 1 Month after Dose 2 and C4591001 Historical cohort (16-25 years): 1 Month after Dose 2
Seroresponse is defined as achieving a >=4-fold rise from baseline(before Dose 1). Assay result below a postvaccination >=4*LLOQ is considered a seroresponse. Results include those from a comparator group of C4591001 (NCT04368728) Phase 2/3 participants who had no serological or virological evidence (prior to the 1-month post-Dose 2 blood sample collection) of past SARS-CoV-2 infection were included for this analysis. Percentage of participants with seroresponse is reported in descriptive analysis section and the difference in percentage of participants is reported under statistical analysis. 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.
C4591007 (>=6 Months to <2 years): 1 Month after Dose 2 and C4591001 Historical cohort (16-25 years): 1 Month after Dose 2
Phase 2/3:GMR Based on GMT for SARS-CoV-2 Neutralizing Titers at 1 Month After Dose 3 in Participants Aged>=2 to<5Years Compared With Study C4591001 Phase2/3 16 to 25 Years Historical Cohort(1 Month After Dose 2):Participants Without Evidence of Infection
大体时间：C4591007 (>=2 to <5 years):1 Month after Dose 2 and C4591001 Historical cohort (16-25 years):1 Month after Dose 2
GMRs and the corresponding 2-sided CIs were calculated by exponentiating the mean difference of logarithm of the titers and the corresponding CIs(based on student t distribution).GMTs & 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below LLOQ were set to 0.5*LLOQ. Results include those from comparator group of C4591001 (NCT04368728) Phase2/3 participants of age 16-25 years who received 2 doses of original BNT162b2 30 mcg who had no serological or virological evidence of past SARS-CoV-2 infection & had no medical history of COVID-19 were also included. GMT is reported in descriptive analysis section & GMR is reported under statistical analysis.
C4591007 (>=2 to <5 years):1 Month after Dose 2 and C4591001 Historical cohort (16-25 years):1 Month after Dose 2
Phase 2/3:Difference in Percentage of Participants With Seroresponse in 2 to <5 Years of Age Compared With Study C4591001 Phase 2/3 16 to 25 Years of Age Historical Cohort: Participants Without Evidence of Infection
大体时间：C4591007 (>=2 to <5 years): 1 Month after Dose 3 and C4591001 Historical cohort (16-25 years): 1 Month after Dose 2
Seroresponse is defined as achieving a >=4-fold rise from baseline(before Dose 1). Assay result below a postvaccination >=4*LLOQ is considered a seroresponse.Results include those from a comparator group of C4591001 (NCT04368728) Phase 2/3 participants who had no serological or virological evidence (prior to the 1-month post-Dose 2 blood sample collection) of past SARS-CoV-2 infection were included for this analysis. Percentage of participants with seroresponse is reported in descriptive analysis section and the difference in percentage of participants is reported under statistical analysis. 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.
C4591007 (>=2 to <5 years): 1 Month after Dose 3 and C4591001 Historical cohort (16-25 years): 1 Month after Dose 2
Phase2/3:GMR Based on GMT for SARS-CoV-2 Neutralizing Titers at 1 Month After Dose3 in Participants Aged 6Month to 2Year Compared With Study C4591001 Phase2/3 16 to 25Years Historical Cohort(1 Month After Dose 2):Participants Without Evidence of Infection
大体时间：C4591007 (>=6 months to <2 years):1 Month after Dose 3 and C4591001 Historical cohort (16-25 years):1 Month after Dose 2
GMRs and the corresponding 2-sided CIs were calculated by exponentiating the mean difference of the logarithm of titers and the corresponding CIs (based on student t distribution). GMTs and the 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below LLOQ were set to 0.5*LLOQ. Results include those from comparator group of C4591001 (NCT04368728) Phase2/3 participants of age 16-25 years who received 2 doses of original BNT162b2 30mcg who had no serological or virological evidence of past SARS-CoV-2 infection& had no medical history of COVID-19 were also included. GMT is reported in descriptive analysis section & GMR is reported under statistical analysis.
C4591007 (>=6 months to <2 years):1 Month after Dose 3 and C4591001 Historical cohort (16-25 years):1 Month after Dose 2
Phase 2/3:Difference in Percentage of Participants With Seroresponse in 6 Months to <2 Years (1 Month After Dose 3) Compared With Study C4591001 Phase 2/3 16 to 25 Years Historical Cohort (1 Month After Dose 2): Participants Without Evidence of Infection
大体时间：C4591007 (>=6 Months to <2 years):1 Month after Dose 3 and C4591001 Historical cohort (16-25 years):1 month after Dose 2
Seroresponse is defined as achieving a >=4-fold rise from baseline(before Dose 1). Assay result below a postvaccination >=4*LLOQ is considered a seroresponse. Results include those from a comparator group of C4591001(NCT04368728)Phase 2/3 participants who had no serological or virological evidence (prior to the 1-month post-Dose 2 blood sample collection) of past SARS-CoV-2 infection were included for this analysis. Percentage of participants with seroresponse is reported in descriptive analysis section and the difference in percentage of participants is reported under statistical analysis. 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.
C4591007 (>=6 Months to <2 years):1 Month after Dose 3 and C4591001 Historical cohort (16-25 years):1 month after Dose 2

次要结果测量

结果测量
措施说明
大体时间
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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)

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BioNTech SE

合作者

Pfizer

调查人员

  • 研究主任：Pfizer CT.gov Call Center、Pfizer

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研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年3月24日

初级完成 (实际的)

2023年10月4日

研究完成 (实际的)

2023年12月8日

研究注册日期

首次提交

2021年3月19日

首先提交符合 QC 标准的

2021年3月24日

首次发布 (实际的)

2021年3月25日

研究记录更新

最后更新发布 (实际的)

2026年5月28日

上次提交的符合 QC 标准的更新

2026年5月26日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • C4591007
  • 2020-005442-42 (EudraCT编号)

计划个人参与者数据 (IPD)

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不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

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