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Исследование фазы 1/2/3 по оценке безопасности, переносимости и иммуногенности РНК-вакцины-кандидата против COVID-19 у здоровых детей и молодых людей

26 мая 2026 г. обновлено: BioNTech SE

ЭТАП 1, ОТКРЫТОЕ ИССЛЕДОВАНИЕ ПО ПОДБОРУ ДОЗЫ ДЛЯ ОЦЕНКИ БЕЗОПАСНОСТИ, ПЕРЕНОСИМОСТИ И ИММУНОГЕННОСТИ, И ФАЗЫ 2/3, ПЛАЦЕБО-КОНТРОЛИРУЕМОЕ, СЛЕПОЕ ИССЛЕДОВАНИЕ БЕЗОПАСНОСТИ, ПЕРЕНОСИМОСТИ И ИММУНОГЕННОСТИ РНК-ВАКЦИНЫ-КАНДИДАТА SARS-COV-2 ПРОТИВ COVID -19 У ЗДОРОВЫХ ДЕТЕЙ И МОЛОДЕЖНЫХ ВЗРОСЛЫХ

Это исследование фазы 1/2/3 с участием здоровых детей и молодых людей.

В зависимости от данных о безопасности и/или иммуногенности, полученных в ходе этого исследования, и итоговой оценки соотношения польза-риск можно впоследствии оценить безопасность, переносимость и иммуногенность BNT162b2 у участников в возрасте до 6 месяцев.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

Фаза 1 подбор дозы

Это открытая часть исследования по определению дозы, в ходе которой будут оцениваться безопасность, переносимость и иммуногенность BNT162b2, вводимого по схеме из двух доз (с интервалом примерно 21 день) в трех возрастных группах (участники от ≥5 до <12 лет). лет, от ≥2 до <5 лет и от ≥6 месяцев до <2 лет).

В этом исследовании инициируется определение дозы у участников в возрасте от 5 до 12 лет на основе приемлемой слепой оценки безопасности дозы 30 мкг у детей в возрасте от 12 до 15 лет в исследовании C4591001.

Целью фазы 1 является определение предпочтительного уровня (уровней) дозы BNT162b2 из трех различных уровней доз в каждой возрастной группе.

В зависимости от данных по безопасности и/или иммуногенности, полученных в ходе этого исследования, возможно, что уровни доз не могут быть начаты, могут быть прекращены досрочно и/или могут быть добавлены с уровнями доз ниже самой низкой заявленной дозы.

Обновление в рамках поправки к протоколу 6: все участники получат третью дозу BNT162b2. Для участников в возрасте от ≥6 месяцев до <5 лет третья доза будет введена не менее чем через 8 недель после второй дозы. У участников в возрасте от 5 до 12 лет третья доза будет введена не менее чем через 6 месяцев после второй дозы. Интервал между второй и третьей дозами будет зависеть от возраста участника на момент регистрации. Уровень дозы третьей дозы BNT162b2 будет зависеть от возраста на момент вакцинации: участники моложе 5 лет на момент введения третьей дозы получат уровень дозы 3 мкг, участники от ≥5 до <12 лет возраст на момент введения третьей дозы получит уровень дозы 10 мкг, а участники в возрасте ≥12 лет на момент введения третьей дозы получат уровень дозы 30 мкг.

У участников будет взят забор крови до дозы 1 и дозы 2 и через 7 дней после дозы 2 для оценки иммуногенности и определения выбранного уровня дозы BNT162b2 для фазы 2/3. У участников также будет взята кровь до дозы 3 и через 1, 6 и 12 месяцев после дозы 3.

Фаза 1. Оценка низких доз

Это открытая оценочная часть исследования с более низкими дозами, в ходе которой будут оцениваться безопасность, переносимость и иммуногенность 10 мкг BNT162b2 из 2 схем в 2 возрастных группах (участники от 12 до <16 лет и от 16 до <18 лет) .

Цель оценки низких доз фазы 1 состоит в том, чтобы оценить безопасность и иммуногенность BNT162b2 при 2 различных схемах дозирования в каждой возрастной группе: (1) 2 дозы, разделенные примерно 21 днем, и (2) 2 дозы, разделенные примерно 8 неделями. .

У участников будет взят забор крови перед дозой 1, перед дозой 2, через 7 дней после дозы 2 и через 1 месяц после дозы 2 для оценки иммуногенности, чтобы определить выбранный график дозирования BNT162b2 для этапа оценки более низких доз Фазы 2/3. изучение. Кроме того, через 6 и 12 месяцев после введения дозы 2 у участников возьмут кровь для определения стойкости иммунного ответа.

Фаза 2/3, выбранная доза

Это часть исследования, в которой будут оцениваться безопасность, переносимость и иммуногенность в каждой возрастной группе при выбранном уровне дозы из фазы 1 исследования, посвященной определению дозы. Эффективность будет оцениваться внутри или между возрастными группами, в которых иммуномост оказался успешным, в зависимости от набора достаточного количества случаев в этих возрастных группах.

У участников будет взят забор крови на исходном уровне до дозы 1 и через 6 месяцев после дозы 2. Иммуно-мост для участников в возрасте от 16 до 25 лет в исследовании C4591001 будет основан на данных об иммуногенности, собранных на (1) исходном уровне и через 1 месяц после дозы 2 и (2) исходный уровень и 1 месяц после дозы 3. Стойкость иммунного ответа будет основываться на данных об иммуногенности, собранных у участников на (1) исходном уровне и через 1 и 6 месяцев после дозы 2 и (2) исходном уровне и 1, 6, 12 и через 18 месяцев после дозы 3. Кроме того, эффективность против подтвержденного COVID-19 и против бессимптомной инфекции также будет оцениваться у участников в возрасте от ≥5 до <12 лет.

В специально отведенных для этого центрах США перед дозой 1 и через 7 дней и 6 месяцев после дозы 2 будет получен дополнительный необязательный образец цельной крови объемом примерно 10 мл примерно у 60 участников в возрасте ≥10 лет. Дополнительные образцы будут получены до дозы 3 и через 1 месяц после дозы 3 (только исходная группа BNT162b2). Эти образцы будут использоваться на исследовательской основе для изучения поствакцинального клеточно-опосредованного иммунного ответа в эти моменты времени.

При последующем посещении через 6 месяцев все участники будут разоблачены. Участникам, которые первоначально получали плацебо, будет предложена возможность получить BNT162b2 в рамках исследования. Участники, которые первоначально получали плацебо и получили право на получение BNT162b2 или другой вакцины против COVID-19 в соответствии с местными или национальными рекомендациями до 6-месячного последующего визита (посещение 5 или 405) (подробности отдельно и доступны на электронном справочном портале исследования) ) будет иметь возможность получить BNT162b2 (10 мкг или 3 мкг) в зависимости от возраста на момент вакцинации.

Обновление в рамках поправки к протоколу 6: все участники получат третью дозу BNT162b2. Для участников в возрасте от ≥6 месяцев до <5 лет третья доза будет введена не менее чем через 8 недель после второй дозы. У участников в возрасте от 5 до 12 лет третья доза будет введена не менее чем через 6 месяцев после второй дозы. Интервал между второй и третьей дозами будет зависеть от возраста участника на момент регистрации. Уровень дозы второй и третьей доз BNT162b2 будет зависеть от возраста на момент вакцинации: участники младше 5 лет на момент введения второй/третьей дозы получат уровень дозы 3 мкг, участники от ≥5 до Дети младше 12 лет на момент введения второй/третьей дозы получат дозу 10 мкг, а участники в возрасте ≥12 лет на момент введения второй/третьей дозы получат дозу 30 мкг.

Фаза 2/3. Оценка низких доз.

Является открытой частью исследования, в ходе которого будет оцениваться безопасность, переносимость и иммуногенность выбранного режима дозирования в каждой возрастной группе из оценки низких доз Фазы 1, в общей сложности приблизительно с 600 активными участниками.

Приблизительно 300 активных участников в каждой возрастной группе на этом этапе будут участвовать в анализе иммунного моста через 1 месяц после дозы 2 и общем анализе персистенции иммунного ответа через 6 и 12 месяцев после дозы 2.

Фаза 2/3 Получение образцов сыворотки для потенциального тестирования тропонина I

Если тестирование уровней тропонина I у лиц, не получавших BNT162b2, указывает на то, что уровень тропонина I может быть надежным индикатором потенциального субклинического миокардита, получение образцов сыворотки для потенциального тестирования тропонина I в период повышенного риска клинического миокардита может помочь охарактеризовать отсутствие /наличие и частота субклинического миокардита. Для оценки будет включена дополнительная группа участников: от ≥5 до <12 лет: рандомизированные 2:1 для получения BNT162b2 10 мкг или плацебо, и от ≥12 до <16 лет: открытое получение BNT162b2 30 мкг.

Обновление в рамках поправки к протоколу 7: все участники получат третью дозу BNT162b2. Для всех участников (от ≥5 до <12 и от ≥12 до <16 лет) третья доза будет введена по крайней мере через 5 месяцев после дозы 2.

Уровень дозы второй и третьей доз BNT162b2 будет зависеть от возраста на момент вакцинации: участники в возрасте от 5 до 12 лет на момент введения второй/третьей дозы получат уровень дозы 10 мкг, и участники в возрасте ≥12 лет на момент введения второй/третьей дозы получат дозу 30 мкг.

Тип исследования

Интервенционный

Регистрация (Действительный)

11837

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 6 месяцев до 18 лет (Ребенок)

Принимает здоровых добровольцев

Да

Описание

Критерии включения

  1. Участники мужского или женского пола в возрасте от ≥6 месяцев до <12 лет на момент рандомизации, при визите 1 для определения дозы/оценки выбранной дозы и для участников в возрасте от ≥12 до <18 лет на момент рандомизации , при посещении 1 для оценки более низкой дозы. Для части исследования, связанной с получением образцов сыворотки для определения потенциального тропонина I: участники мужского или женского пола в возрасте от ≥5 до <16 лет.
  2. Родители участников/законные опекуны и участники, в зависимости от возраста, которые желают и могут соблюдать все запланированные посещения, план лечения, лабораторные анализы, рекомендации по образу жизни и другие процедуры исследования.

  3. Здоровые участники, которые на основании истории болезни, медицинского осмотра и клинического заключения исследователя определены как имеющие право на включение в исследование.

    Примечание. Могут быть включены здоровые участники с ранее существовавшим стабильным заболеванием, определяемым как заболевание, не требующее значительных изменений в терапии или госпитализации по поводу ухудшения заболевания в течение 6 недель до включения.

  4. Ожидается, что участники будут доступны на протяжении всего исследования, и с их родителями/законными опекунами можно будет связаться по телефону во время участия в исследовании.
  5. Отрицательный тест мочи на беременность для участников женского пола, которые биологически способны иметь детей.
  6. Участница женского пола с детородным потенциалом или участник мужского пола, способный стать отцом детей, который готов использовать высокоэффективный метод контрацепции, как указано в этом протоколе, в течение как минимум 28 дней после последней дозы исследуемого вмешательства, если существует риск беременности со своим партнером. ; или женщина-участник, не способная к деторождению, или мужчина-участник, не способный стать отцом детей.
  7. Участник или родитель (родители)/законный опекун участника могут дать подписанное информированное согласие, которое включает соблюдение требований и ограничений, перечисленных в МКБ и в настоящем протоколе. В зависимости от возраста участника и в соответствии с местными требованиями участников также попросят дать соответствующее согласие (устное или письменное).

Критерий исключения

  1. Только фаза 1: прошлые клинические (на основании только симптомов/признаков COVID-19, если результат МАНК на SARS-CoV-2 был недоступен) или микробиологический (на основании симптомов/признаков COVID-19 и положительный результат МАНК на SARS-CoV-2) диагноз COVID-19.
  2. Только фаза 1: известная инфекция ВИЧ, ВГС или ВГВ.
  3. Получение лекарств, предназначенных для профилактики COVID-19.
  4. Предыдущий или текущий диагноз MIS-C.
  5. Другое медицинское или психиатрическое состояние, включая недавние (в течение последнего года) или активные суицидальные мысли/поведение или лабораторные отклонения, которые могут увеличить риск участия в исследовании или, по мнению исследователя, сделать участника непригодным для участия в исследовании. Примечание. Сюда входят как состояния, которые могут увеличить риск, связанный с введением исследуемого вмешательства, так и состояния, которые могут помешать интерпретации результатов исследования.
  6. Тяжелая побочная реакция в анамнезе, связанная с вакциной, и/или тяжелая аллергическая реакция (например, анафилаксия) на любой компонент исследуемого вмешательства (вмешательств).
  7. Иммунодефицитные лица с известным или подозреваемым иммунодефицитом, что определяется анамнезом и/или лабораторным/физикальным обследованием.
  8. Лица с аутоиммунным заболеванием в анамнезе или активным аутоиммунным заболеванием, требующим терапевтического вмешательства, включая, помимо прочего, системную красную волчанку. Примечание. Допустимы стабильный диабет 1 типа и гипотиреоз.
  9. Кровоточащий диатез или состояние, связанное с длительным кровотечением, которое, по мнению исследователя, противопоказывает внутримышечную инъекцию.
  10. Женщина, которая беременна или кормит грудью.
  11. Предыдущая вакцинация любой коронавирусной вакциной.
  12. Лица, получающие лечение с помощью иммуносупрессивной терапии, включая цитостатические средства или системные кортикостероиды, например, по поводу рака или аутоиммунного заболевания, или плановое лечение на протяжении всего исследования. Если системные кортикостероиды применялись краткосрочно (<14 дней) для лечения острого заболевания, участники не должны быть включены в исследование до тех пор, пока терапия кортикостероидами не будет прекращена по крайней мере за 28 дней до введения исследуемого вмешательства. Разрешены ингаляционные/небулайзерные, внутрисуставные, интрабурсальные или местные (кожа или глаза) кортикостероиды.
  13. Получение продуктов крови/плазмы, иммуноглобулина или моноклональных антител за 60 дней до проведения исследовательского вмешательства, или получение любой терапии пассивными антителами, специфичными для COVID-19, за 90 дней до проведения исследуемого вмешательства, или запланированное получение на протяжении всего исследования.
  14. Участие в других исследованиях, включающих вмешательство в исследование, в течение 28 дней до начала исследования и/или во время участия в исследовании.
  15. Предыдущее участие в других исследованиях, включающих исследовательское вмешательство, содержащее LNP.
  16. Участники, являющиеся прямыми потомками (дети или внуки) сотрудников исследовательского центра или сотрудников Pfizer/BioNTech, непосредственно участвовавших в проведении исследования, сотрудников исследовательского центра, иным образом контролируемых исследователем, и членов их семей.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Профилактика
  • Распределение: Нерандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Низкая/средняя доза, от ≥5 до <12 лет
Низкая/средняя доза (10 мкг), 2 дозы с интервалом 21 день.
Биологический: Биологическое/Вакцина: BNT162b2 10 мкг
Уровень BNT162b2 в низкой/средней дозе (10 мкг)
Экспериментальный: Средняя доза, от ≥5 до <12 лет
Средняя доза, (20 мкг), 2 дозы с интервалом 21 день
Биологический: BNT162b2 20 мкг
Уровень средней дозы BNT162b2 (20 мкг)
Экспериментальный: Высокие дозы, от ≥5 до <12 лет
Высокая доза (30 мкг), 2 дозы с интервалом 21 день
Биологический: BNT162b2 30 мкг
Уровень BNT162b2 в высокой дозе (30 мкг)
Экспериментальный: Низкая/средняя доза, от ≥2 до <5 лет
Низкая/средняя доза (10 мкг), 2 дозы с интервалом 21 день.
Биологический: Биологическое/Вакцина: BNT162b2 10 мкг
Уровень BNT162b2 в низкой/средней дозе (10 мкг)
Экспериментальный: Средняя доза, от ≥2 до <5 лет
Средняя доза, (20 мкг), 2 дозы с интервалом 21 день
Биологический: BNT162b2 20 мкг
Уровень средней дозы BNT162b2 (20 мкг)
Экспериментальный: Высокие дозы, от ≥2 до <5 лет
Высокая доза (30 мкг), 2 дозы с интервалом 21 день.
Биологический: BNT162b2 30 мкг
Уровень BNT162b2 в высокой дозе (30 мкг)
Экспериментальный: Низкая/средняя доза, от ≥6 месяцев до <2 лет
Низкая/средняя доза, (10 мкг), 2 дозы с интервалом 21 день
Биологический: Биологическое/Вакцина: BNT162b2 10 мкг
Уровень BNT162b2 в низкой/средней дозе (10 мкг)
Экспериментальный: Средняя доза, от ≥6 месяцев до <2 лет
Средняя доза, (20 мкг), 2 дозы с интервалом 21 день
Биологический: BNT162b2 20 мкг
Уровень средней дозы BNT162b2 (20 мкг)
Экспериментальный: Высокие дозы, от ≥6 месяцев до <2 лет
Высокая доза (30 мкг), 2 дозы с интервалом 21 день.
Биологический: BNT162b2 30 мкг
Уровень BNT162b2 в высокой дозе (30 мкг)
Плацебо Компаратор: Плацебо, от ≥6 месяцев до <2 лет
Другой: Плацебо
Внутримышечная инъекция
Плацебо Компаратор: Плацебо, от ≥2 до <5 лет
Другой: Плацебо
Внутримышечная инъекция
Плацебо Компаратор: Плацебо, от ≥5 до <12 лет
Другой: Плацебо
Внутримышечная инъекция
Экспериментальный: Низкие дозы, от ≥6 месяцев до <2 лет
Низкая доза (3 мкг), 2 дозы с интервалом в 21 дозу
Биологический: Биологическое/Вакцина: BNT162b2 3 мкг
Уровень BNT162b2 в низкой дозе (3 мкг)
Экспериментальный: Низкая доза, от ≥2 до <5 лет
Низкая доза (3 мкг), 2 дозы с интервалом 21 день.
Биологический: Биологическое/Вакцина: BNT162b2 3 мкг
Уровень BNT162b2 в низкой дозе (3 мкг)
Экспериментальный: Высокие дозы, от 12 до <16 лет (тестирование тропонина I)
Высокая доза (30 мкг), 3 дозы
Биологический: BNT162b2 30 мкг
Уровень BNT162b2 в высокой дозе (30 мкг)
Экспериментальный: Низкая/средняя доза, от ≥5 до <12 лет (тестирование тропонина I)
Низкая/средняя доза (10 мкг), 3 дозы
Биологический: Биологическое/Вакцина: BNT162b2 10 мкг
Уровень BNT162b2 в низкой/средней дозе (10 мкг)
Экспериментальный: Плацебо, от ≥5 до <12 лет (тестирование тропонина I)
Другой: Плацебо
Внутримышечная инъекция
Экспериментальный: Низкие дозы, от ≥6 месяцев до <2 лет (схема из 3 доз)
Низкая доза (3 мкг), 3 дозы
Биологический: Биологическое/Вакцина: BNT162b2 3 мкг
Уровень BNT162b2 в низкой дозе (3 мкг)
Экспериментальный: Низкие дозы, от ≥2 до <5 лет (схема из 3 доз)
Низкая доза (3 мкг), 3 дозы
Биологический: Биологическое/Вакцина: BNT162b2 3 мкг
Уровень BNT162b2 в низкой дозе (3 мкг)
Плацебо Компаратор: Плацебо, от ≥6 месяцев до <2 лет (3-дозовый режим)
Другой: Плацебо
Внутримышечная инъекция
Плацебо Компаратор: Плацебо, от ≥2 до <5 лет (3-дозовый режим)
Другой: Плацебо
Внутримышечная инъекция

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=5 to <12 Years of Age
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

BioNTech SE

Соавторы

Pfizer

Следователи

  • Директор по исследованиям: Pfizer CT.gov Call Center, Pfizer

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

24 марта 2021 г.

Первичное завершение (Действительный)

4 октября 2023 г.

Завершение исследования (Действительный)

8 декабря 2023 г.

Даты регистрации исследования

Первый отправленный

19 марта 2021 г.

Впервые представлено, что соответствует критериям контроля качества

24 марта 2021 г.

Первый опубликованный (Действительный)

25 марта 2021 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

28 мая 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

26 мая 2026 г.

Последняя проверка

1 мая 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

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

Планирование данных отдельных участников (IPD)

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НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования Инфекция SARS-CoV-2, COVID-19

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