Un estudio de fase 1/2/3 para evaluar la seguridad, la tolerabilidad y la inmunogenicidad de una vacuna candidata de ARN contra la COVID-19 en niños y adultos jóvenes sanos
26 de mayo de 2026 actualizado por: BioNTech SE
UN ESTUDIO ABIERTO DE BÚSQUEDA DE DOSIS DE FASE 1 PARA EVALUAR LA SEGURIDAD, TOLERABILIDAD E INMUNOGENICIDAD Y UN ESTUDIO DE SEGURIDAD, TOLERABILIDAD E INMUNOGENICIDAD DE OBSERVADOR CIEGO, CONTROLADO CON PLACEBO Y FASE 2/3 DE UNA CANDIDATA A VACUNA DE ARN DEL SARS-COV-2 CONTRA COVID -19 EN NIÑOS Y ADULTOS JÓVENES SANOS
Este es un estudio de Fase 1/2/3 en niños y adultos jóvenes sanos.
Dependiendo de los datos de seguridad y/o inmunogenicidad generados durante el curso de este estudio, y la evaluación resultante de la relación beneficio-riesgo, la seguridad, tolerabilidad e inmunogenicidad de BNT162b2 en participantes <6 meses de edad pueden evaluarse posteriormente.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
Búsqueda de dosis de fase 1
Es la parte abierta de búsqueda de dosis del estudio que evaluará la seguridad, la tolerabilidad y la inmunogenicidad de BNT162b2 administrado en un programa de 2 dosis (separadas por aproximadamente 21 días) en hasta 3 grupos de edad (participantes ≥5 a <12 años, ≥2 a <5 años y ≥6 meses a <2 años).
La búsqueda de dosis se está iniciando en este estudio en participantes de ≥5 a <12 años de edad en base a la evaluación de seguridad ciega aceptable de la dosis de 30 µg en niños de 12 a 15 años en el estudio C4591001.
El propósito de la Fase 1 es identificar los niveles de dosis preferidos de BNT162b2 de hasta 3 niveles de dosis diferentes en cada grupo de edad.
Dependiendo de los datos de seguridad y/o inmunogenicidad generados durante el curso de este estudio, es posible que los niveles de dosis no se inicien, se terminen antes de tiempo y/o se agreguen con niveles de dosis por debajo de la dosis más baja establecida.
Actualización como parte de la enmienda 6 del protocolo: Todos los participantes recibirán una tercera dosis de BNT162b2. Para los participantes de ≥6 meses a <5 años, la tercera dosis se administrará al menos 8 semanas después de la segunda dosis. En participantes de ≥5 a <12 años, la tercera dosis se administrará al menos 6 meses después de la segunda dosis. El intervalo entre la segunda y la tercera dosis se basará en la edad del participante en el momento de la inscripción. El nivel de dosis de la tercera dosis de BNT162b2 se basará en la edad en el momento de la vacunación: los participantes <5 años de edad en el momento de la tercera dosis recibirán el nivel de dosis de 3 µg, los participantes ≥5 a <12 años de la edad en el momento de la tercera dosis recibirá el nivel de dosis de 10 µg, y los participantes de ≥12 años de edad en el momento de la tercera dosis recibirán el nivel de dosis de 30 µg.
Se extraerá sangre de los participantes antes de la dosis 1 y la dosis 2 y 7 días después de la dosis 2 para evaluar la inmunogenicidad y determinar el nivel de dosis de BNT162b2 seleccionado para la fase 2/3. A los participantes también se les extraerá sangre antes de la dosis 3 y 1, 6 y 12 meses después de la dosis 3.
Evaluación de dosis más baja de fase 1
Es la parte abierta de evaluación de dosis más baja del estudio que evaluará la seguridad, la tolerabilidad y la inmunogenicidad de 10 µg de BNT162b2 de 2 esquemas en 2 grupos de edad (participantes de 12 a <16 años y de 16 a <18 años) .
El propósito de la evaluación de dosis más baja de Fase 1 es evaluar la seguridad y la inmunogenicidad de BNT162b2 de 2 programas de dosis diferentes en cada grupo de edad: (1) 2 dosis separadas por aproximadamente 21 días y (2) 2 dosis separadas por aproximadamente 8 semanas .
A los participantes se les extraerá sangre antes de la dosis 1, antes de la dosis 2, 7 días después de la dosis 2 y 1 mes después de la dosis 2 para evaluar la inmunogenicidad y determinar el programa de dosis de BNT162b2 seleccionado para la parte de evaluación de dosis más baja de la Fase 2/3 del estudiar. Además, a los participantes se les extraerá sangre a los 6 y 12 meses después de la dosis 2 para determinar la persistencia de la respuesta inmunitaria.
Dosis seleccionada de fase 2/3
Es la parte del estudio que evaluará la seguridad, la tolerabilidad y la inmunogenicidad en cada grupo de edad en el nivel de dosis seleccionado de la parte de búsqueda de dosis de la Fase 1 del estudio. La eficacia se evaluará dentro o entre grupos de edad en los que el inmunopuente tenga éxito, dependiendo de la acumulación de un número suficiente de casos en esos grupos de edad.
A los participantes se les extraerá sangre al inicio antes de la dosis 1 y 6 meses después de la dosis 2. El inmunopuente a los participantes de 16 a 25 años de edad en el estudio C4591001 se basará en los datos de inmunogenicidad recopilados en (1) inicio y 1 mes después de la dosis 2 y (2) línea de base y 1 mes después de la dosis 3. La persistencia de la respuesta inmunitaria se basará en los datos de inmunogenicidad recopilados en los participantes en (1) línea de base y 1 y 6 meses después de la dosis 2 y (2) línea de base y 1, 6, 12 , y 18 meses después de la dosis 3. Además, también se evaluará la eficacia contra la COVID-19 confirmada y contra la infección asintomática en participantes de ≥5 a <12 años de edad.
En los sitios designados de EE. UU., se obtendrá una muestra de sangre total opcional adicional de aproximadamente 10 ml antes de la dosis 1 y 7 días y 6 meses después de la dosis 2 de hasta aproximadamente 60 participantes ≥10 años de edad. Se obtendrán muestras adicionales antes de la dosis 3 y 1 mes después de la dosis 3 (solo grupo original BNT162b2). Estas muestras se utilizarán de manera exploratoria para investigar la respuesta inmunitaria mediada por células posterior a la vacunación en estos momentos.
En la visita de seguimiento a los 6 meses, se desbloqueará el cegamiento de todos los participantes. A los participantes que originalmente recibieron placebo se les ofrecerá la oportunidad de recibir BNT162b2 como parte del estudio. Participantes que originalmente recibieron placebo y se vuelven elegibles para recibir BNT162b2 u otra vacuna COVID-19 de acuerdo con las recomendaciones locales o nacionales antes de la visita de seguimiento de 6 meses (Visita 5 o 405) (detallado por separado y disponible en el portal electrónico de referencia del estudio ) tendrá la oportunidad de recibir BNT162b2 (10 µg o 3 µg) según la edad en el momento de la vacunación.
Actualización como parte de la enmienda 6 del protocolo: Todos los participantes recibirán una tercera dosis de BNT162b2. Para los participantes de ≥6 meses a <5 años, la tercera dosis se administrará al menos 8 semanas después de la segunda dosis. En participantes de ≥5 a <12 años, la tercera dosis se administrará al menos 6 meses después de la segunda dosis. El intervalo entre la segunda y la tercera dosis se basará en la edad del participante en el momento de la inscripción. El nivel de dosis de la segunda y tercera dosis de BNT162b2 se basará en la edad en el momento de la vacunación: los participantes <5 años de edad en el momento de la segunda/tercera dosis recibirán el nivel de dosis de 3 µg, los participantes ≥5 a <12 años de edad en el momento de la segunda/tercera dosis recibirán el nivel de dosis de 10 µg, y los participantes ≥12 años de edad en el momento de la segunda/tercera dosis recibirán el nivel de dosis de 30 µg.
Evaluación de dosis más baja de fase 2/3
Es la parte abierta del estudio que evaluará la seguridad, la tolerabilidad y la inmunogenicidad del programa de dosis seleccionado en cada grupo de edad de la evaluación de dosis más baja de la Fase 1, con un total de aproximadamente 600 participantes activos.
Aproximadamente 300 participantes activos en cada grupo de edad en esta fase contribuirán al análisis de inmunopuente 1 mes después de la dosis 2 y al análisis general de la persistencia de la respuesta inmunitaria a los 6 y 12 meses después de la dosis 2.
Fase 2/3 Obtención de muestras de suero para pruebas potenciales de troponina I
Si la prueba de los niveles de troponina I en personas que no recibieron BNT162b2 indica que el nivel de troponina I podría ser un indicador confiable de una posible miocarditis subclínica, la obtención de muestras de suero para la prueba potencial de troponina I durante el período de mayor riesgo de miocarditis clínica puede ayudar a caracterizar la ausencia. /presencia y frecuencia de miocarditis subclínica. Para evaluar, se incluirá un grupo adicional de participantes: ≥5 a <12 años: aleatorizados 2:1 para recibir BNT162b2 10 µg o placebo, y ≥12 a <16 años: recepción abierta de BNT162b2 30 µg.
Actualización como parte de la enmienda 7 del protocolo: Todos los participantes recibirán una tercera dosis de BNT162b2. Para todos los participantes (≥5 a <12 y ≥12 a <16 años de edad), la tercera dosis se administrará al menos 5 meses después de la dosis 2.
El nivel de dosis de la segunda y tercera dosis de BNT162b2 se basará en la edad en el momento de la vacunación: los participantes de ≥5 a <12 años de edad en el momento de la segunda/tercera dosis recibirán el nivel de dosis de 10 µg, y los participantes ≥12 años de edad en el momento de la segunda/tercera dosis recibirán el nivel de dosis de 30 µg.
Tipo de estudio
Intervencionista
Inscripción (Actual)
11837
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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São Paulo, Brasil, 04266-010
- CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda.
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Estado de Bahia
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Salvador, Estado de Bahia, Brasil, 40415-006
- Hospital Santo Antônio - Obras Sociais Irmã Dulce/ Centro de Pesquisa Clínica - CPEC
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brasil, 30150-221
- Santa Casa de Misericordia de Belo Horizonte
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Paraná
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Curitiba, Paraná, Brasil, 80810-050
- Serviço de Infectologia e Controle de Infecção Hospitalar de Curitiba/ Centro Médico São Francisco
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Rio Grande do Norte
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Natal, Rio Grande do Norte, Brasil, 59025-050
- CePCLIN - Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda
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Madrid, España, 28041
- Hospital Universitario 12 de Octubre
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Seville, España, 41012
- Instituto Hispalense de Pediatria
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A Coruña
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Santiago de Compostela, A Coruña, España, 15706
- Hospital Clinico Universitario Santiago de Compostela
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Barcelona
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Centelles, Barcelona, España, 08540
- EBA Centelles
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Esplugues de Llobregat, Barcelona, España, 08950
- Hospital Sant Joan de Déu
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Sant Cugat del Vallès, Barcelona, España, 08195
- Hospital Universitari General de Catalunya
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Madrid
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Boadilla del Monte, Madrid, España, 28660
- Hospital Universitario HM Monteprincipe
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Madrid, Comunidad de
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Madrid, Madrid, Comunidad de, España, 28938
- Hospital Universitario HM Puerta del Sur
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Málaga
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Antequera, Málaga, España, 29200
- Hospital de Antequera
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Málaga, Málaga, España, 29015
- Grupo Pediatrico Uncibay
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Alabama
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Birmingham, Alabama, Estados Unidos, 35233
- University of Alabama at Birmingham - School of Medicine
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Arizona
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Phoenix, Arizona, Estados Unidos, 85016
- Phoenix Children's Hospital
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California
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Los Angeles, California, Estados Unidos, 90057
- Matrix Clinical Research
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Los Angeles, California, Estados Unidos, 90027
- SCPMG/Kaiser Permanente Los Angeles Medical Center
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Madera, California, Estados Unidos, 93637
- Madera Family Medical Group
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Oakland, California, Estados Unidos, 94611
- Kaiser Permanente Oakland
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Palo Alto, California, Estados Unidos, 94304
- Lucile Packard Children's Hospital Stanford
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Palo Alto, California, Estados Unidos, 94304
- Clinical & Translational Research Unit (CTRU) & Spectrum BioBank, Stanford University
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Paramount, California, Estados Unidos, 90723
- Center for Clinical Trials, LLC
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Paramount, California, Estados Unidos, 90723
- Center for Clinical Trials
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Rolling Hills Estates, California, Estados Unidos, 90274
- Peninsula Research Associates
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Sacramento, California, Estados Unidos, 95815
- Kaiser Permanente Sacramento
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Santa Clara, California, Estados Unidos, 95051
- Kaiser Permanente Santa Clara
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Stanford, California, Estados Unidos, 94305
- Stanford Health Care
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Stanford, California, Estados Unidos, 94305
- Stanford Health Care Investigational Drug Service
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Valley Village, California, Estados Unidos, 91607
- Bayview Research Group, LLC
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- Children's Hospital Colorado
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06519
- Yale Center for Clinical Investigation
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District of Columbia
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Washington D.C., District of Columbia, Estados Unidos, 20010
- Children's National Medical Center
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Washington D.C., District of Columbia, Estados Unidos, 20016
- Velocity Clinical Research, Washington DC
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Washington D.C., District of Columbia, Estados Unidos, 20009
- Emerson Clinical Research Institute
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Florida
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Jacksonville, Florida, Estados Unidos, 32256
- Clinical Neuroscience Solutions, Inc.
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Miami, Florida, Estados Unidos, 33142
- Acevedo Clinical Research Associates
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Orlando, Florida, Estados Unidos, 32801
- Clinical Neuroscience Solutions
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Georgia
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Atlanta, Georgia, Estados Unidos, 30331
- Atlanta Center for Medical Research
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University School of Medicine
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Atlanta, Georgia, Estados Unidos, 30322
- Emory Children's Center Illness POD
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Macon, Georgia, Estados Unidos, 31210
- Meridian Clinical Research, LLC
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Union City, Georgia, Estados Unidos, 30291
- Rophe Adult and Pediatric Medicine/SKYCRNG
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Idaho
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Idaho Falls, Idaho, Estados Unidos, 83404
- Clinical Research Prime
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Meridian, Idaho, Estados Unidos, 83646
- Solaris Clinical Research
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Kansas
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Newton, Kansas, Estados Unidos, 67114
- Alliance for Multispecialty Research, LLC
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Wichita, Kansas, Estados Unidos, 67207
- Alliance for Multispecialty Research, LLC
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Kentucky
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Bardstown, Kentucky, Estados Unidos, 40004
- Kentucky Pediatric/ Adult Research
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Louisville, Kentucky, Estados Unidos, 40202
- Novak Center for Children's Health
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70121
- Ochsner Clinic Foundation
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Shreveport, Louisiana, Estados Unidos, 71101
- Louisiana State University Health Sciences Shreveport
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Maryland
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Baltimore, Maryland, Estados Unidos, 21224
- Johns Hopkins Bayview Medical Center
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02118
- Boston Medical Center
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Michigan
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Bingham Farms, Michigan, Estados Unidos, 48025
- Michigan Center of Medical Research
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Mississippi
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Ridgeland, Mississippi, Estados Unidos, 39157
- SKY Integrative Medical Center/SKYCRNG
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Missouri
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Chesterfield, Missouri, Estados Unidos, 63005
- Clinical Research Professionals
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Kansas City, Missouri, Estados Unidos, 64108
- Children's Mercy Hospital
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Nebraska
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Hastings, Nebraska, Estados Unidos, 68901
- Meridian Clinical Research, LLC
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Lincoln, Nebraska, Estados Unidos, 68510
- Velocity Clinical Research, Lincoln
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Omaha, Nebraska, Estados Unidos, 68114
- Children's Hospital & Medical Center
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Omaha, Nebraska, Estados Unidos, 68117
- Children's Physician's Clinic, Spring Valley
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New Jersey
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New Brunswick, New Jersey, Estados Unidos, 08901
- Cancer Institute Of New Jersey
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New Brunswick, New Jersey, Estados Unidos, 08901
- Rutgers University
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New York
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Binghamton, New York, Estados Unidos, 13905
- Meridian Clinical Research LLC
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Commack, New York, Estados Unidos, 11725
- Advanced Specialty Care
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Rochester, New York, Estados Unidos, 14642
- University of Rochester Medical Center
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Rochester, New York, Estados Unidos, 14609
- Rochester Clinical Research, Inc.
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Stony Brook, New York, Estados Unidos, 11794
- Stony Brook University
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Syracuse, New York, Estados Unidos, 13210
- SUNY Upstate Medical University
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28207
- Atrium Health-STRIVE Vaccine Research Clinic
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Charlotte, North Carolina, Estados Unidos, 28211
- Teen Health Connection (study visits)
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Durham, North Carolina, Estados Unidos, 27703
- Duke University - Main Hospital and Clinics
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Matthews, North Carolina, Estados Unidos, 28105
- Atrium Health-STRIVE Vaccine Research Clinic (study visits)
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45229
- Cincinnati Children's Hospital Medical Center Vaccine Research Center
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Columbus, Ohio, Estados Unidos, 43213
- Centricity Research Columbus Ohio Multispecialty
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Dayton, Ohio, Estados Unidos, 45429
- PriMED Clinical Research
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South Euclid, Ohio, Estados Unidos, 44121
- Senders Pediatrics
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Oregon
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Gresham, Oregon, Estados Unidos, 97030
- Cyn3rgy Research
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Pennsylvania
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Erie, Pennsylvania, Estados Unidos, 16506
- AHN Erie Health + Wellness Pavillion: West
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Rhode Island
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East Greenwich, Rhode Island, Estados Unidos, 02818
- Velocity Clinical Research-Providence
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29414
- Coastal Pediatric Research
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Greenville, South Carolina, Estados Unidos, 29607
- Tribe Clinical Research, LLC
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Summerville, South Carolina, Estados Unidos, 29486
- Coastal Pediatric Research
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38105
- St. Jude Children's Research Hospital
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Nashville, Tennessee, Estados Unidos, 37203
- Clinical Research Associates Inc
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Texas
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Austin, Texas, Estados Unidos, 78726
- Innovo Research - Austin Regional Clinic
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Corpus Christi, Texas, Estados Unidos, 78411
- Driscoll Children's Hospital
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Dallas, Texas, Estados Unidos, 75251
- Cedar Health Research
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Dickinson, Texas, Estados Unidos, 77539
- Bay Colony Pediatrics
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Edinburg, Texas, Estados Unidos, 78539
- Proactive Clinical Research, LLC
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Frisco, Texas, Estados Unidos, 75033
- Village Health Partners (Patient Seen Address)
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Houston, Texas, Estados Unidos, 77055
- West Houston Clinical Research Services
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Houston, Texas, Estados Unidos, 77008
- HG Pediatrics
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Houston, Texas, Estados Unidos, 77008
- Van Tran Family Practice
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Houston, Texas, Estados Unidos, 77030
- Texas Children's Hospital - Clinical Research Center
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Houston, Texas, Estados Unidos, 77087
- Pediatric Associates
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Houston, Texas, Estados Unidos, 77008
- Helios Clinical Research - HOU
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Houston, Texas, Estados Unidos, 77008
- Helios Clinical Research
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Houston, Texas, Estados Unidos, 77065
- DM Clinical Research - MDC
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Utah
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Salt Lake City, Utah, Estados Unidos, 84109
- J. Lewis Research, Inc. / Foothill Family Clinic
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Salt Lake City, Utah, Estados Unidos, 84121
- J. Lewis Research, Inc. / Foothill Family Clinic South
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22902
- Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)
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Midlothian, Virginia, Estados Unidos, 23114
- Virginia Research Center
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Washington
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Seattle, Washington, Estados Unidos, 98105
- Seattle Children's Hospital
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Espoo, Finlandia, 02230
- FVR, Espoo Clinic
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Helsinki, Finlandia, 00100
- FVR, Helsinki South Clinic
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Helsinki, Finlandia, 00290
- MeVac - Meilahti Vaccine Research Center
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Helsinki, Finlandia, 00930
- FVR, Helsinki East Clinic
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Kokkola, Finlandia, 67100
- FVR, Kokkola Clinic
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Pori, Finlandia, 28100
- FVR, Pori Clinic
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Seinäjoki, Finlandia, 60100
- FVR, Seinäjoki Clinic
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Tampere, Finlandia, 33100
- FVR, Tampere Clinic
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Turku, Finlandia, 20520
- FVR, Turku Clinic
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North Ostrobothnia
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Oulu, North Ostrobothnia, Finlandia, 90220
- FVR, Oulu Clinic
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Uusimaa
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Jarvenpaa, Uusimaa, Finlandia, 04400
- FVR, Järvenpää Clinic
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Veracruz, México, C.P. 91900
- Sociedad de Metabolismo y Corazón S.C.
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Nuevo León
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Monterrey, Nuevo León, México, C.P. 64060
- Christus - Latam Hub Center of Excellence and Innovation S.C.
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Yucatán
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Mérida, Yucatán, México, 97070
- Kohler & Milstein Research S.A. De C.V.
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Mérida, Yucatán, México, 97130
- Centro Multidisciplinario Para El Desarrollo Especializado De La Investigacion
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Bydgoszcz, Polonia, 85-048
- IN-VIVO Bydgoszcz
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Krakow, Polonia, 30-348
- Centrum Badan Klinicznych JCI
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Lodz, Polonia, 90-349
- Osrodek Badan Klinicznych Appletreeclinics
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Lodz, Polonia, 91-347
- GRAVITA Diagnostyka i Leczenie nieplodnosci
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Luboń, Polonia, 62-030
- Rodzinne Centrum Medyczne LUBMED
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Siemianowice Śląskie, Polonia, 41-103
- Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Jarosz i Partnerzy Spolka Lekarska
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Warsaw, Polonia, 02-647
- Provita 001
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Kuyavian-Pomeranian Voivodeship
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Torun, Kuyavian-Pomeranian Voivodeship, Polonia, 87-100
- MICS Centrum Medyczne Torun
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
6 meses a 18 años (Niño)
Acepta Voluntarios Saludables
Sí
Descripción
Criterios de inclusión
- Participantes masculinos o femeninos de ≥6 meses a <12 años de edad, en el momento de la aleatorización, en la Visita 1 para la búsqueda de dosis/evaluación de la dosis seleccionada y para participantes de ≥12 a <18 años de edad, en el momento de la aleatorización , en la Visita 1 para la evaluación de la dosis más baja. Para la parte del estudio de obtención de muestras de suero para la prueba de troponina I potencial: Participantes masculinos o femeninos entre ≥5 y <16 años de edad.
- Los padres/tutores legales de los participantes y los participantes, según corresponda a la edad, que estén dispuestos y sean capaces de cumplir con todas las visitas programadas, el plan de tratamiento, las pruebas de laboratorio, las consideraciones sobre el estilo de vida y otros procedimientos del estudio.
Participantes sanos que, según el historial médico, el examen físico y el juicio clínico del investigador, sean elegibles para su inclusión en el estudio.
Nota: Se pueden incluir participantes sanos con enfermedad estable preexistente, definida como enfermedad que no requiere cambios significativos en la terapia u hospitalización por empeoramiento de la enfermedad durante las 6 semanas anteriores a la inscripción.
- Se espera que los participantes estén disponibles durante la duración del estudio y cuyos padres/tutores legales puedan ser contactados por teléfono durante la participación en el estudio.
- Prueba de embarazo en orina negativa para participantes femeninas que son biológicamente capaces de tener hijos.
- Participante mujer en edad fértil o participante hombre capaz de engendrar hijos que esté dispuesto a usar un método anticonceptivo altamente efectivo como se describe en este protocolo durante al menos 28 días después de la última dosis de la intervención del estudio si tiene riesgo de embarazo con su pareja ; o participante femenina que no está en edad fértil o participante masculino que no puede engendrar hijos.
- El participante o los padres/tutores legales del participante pueden dar un consentimiento informado firmado, que incluye el cumplimiento de los requisitos y restricciones enumerados en el ICD y en este protocolo. Dependiendo de la edad del participante y de acuerdo con los requisitos locales, también se les pedirá a los participantes que brinden su consentimiento según corresponda (verbal o por escrito).
Criterio de exclusión
- Fase 1 únicamente: antecedentes clínicos (basado únicamente en los síntomas/signos de COVID-19, si no se dispuso de un resultado NAAT de SARS CoV 2) o microbiológicos (basado en los síntomas/signos de COVID-19 y un resultado positivo de SARS-CoV-2 NAAT) diagnóstico de covid19.
- Fase 1 únicamente: Infección conocida por VIH, VHC o VHB.
- Recepción de medicamentos destinados a la prevención del COVID-19.
- Diagnóstico anterior o actual de MIS-C.
- Otra afección médica o psiquiátrica, incluida la ideación/comportamiento suicida reciente (en el último año) o activo o anomalías de laboratorio que pueden aumentar el riesgo de participación en el estudio o, a juicio del investigador, hacer que el participante no sea apropiado para el estudio. Nota: Esto incluye condiciones que pueden aumentar el riesgo asociado con la administración de la intervención del estudio o una condición que puede interferir con la interpretación de los resultados del estudio.
- Antecedentes de reacción adversa grave asociada con una vacuna y/o reacción alérgica grave (p. ej., anafilaxia) a cualquier componente de la(s) intervención(es) del estudio.
- Individuos inmunocomprometidos con inmunodeficiencia conocida o sospechada, según lo determinen los antecedentes y/o el examen físico/de laboratorio.
- Individuos con antecedentes de enfermedad autoinmune o una enfermedad autoinmune activa que requiera intervención terapéutica, incluido, entre otros, lupus eritematoso sistémico. Nota: Se permiten la diabetes tipo 1 estable y el hipotiroidismo.
- Diátesis hemorrágica o condición asociada con sangrado prolongado que, en opinión del investigador, contraindicaría la inyección intramuscular.
- Mujer que está embarazada o amamantando.
- Vacunación previa con alguna vacuna contra el coronavirus.
- Individuos que reciben tratamiento con terapia inmunosupresora, incluidos agentes citotóxicos o corticosteroides sistémicos, por ejemplo, para el cáncer o una enfermedad autoinmune, o que reciben tratamiento planificado durante todo el estudio. Si se administraron corticosteroides sistémicos a corto plazo (<14 días) para el tratamiento de una enfermedad aguda, los participantes no deben inscribirse en el estudio hasta que se haya interrumpido la terapia con corticosteroides durante al menos 28 días antes de la administración de la intervención del estudio. Se permiten los corticosteroides inhalados/nebulizados, intraarticulares, intrabursales o tópicos (piel u ojos).
- Recepción de productos de sangre/plasma, inmunoglobulina o anticuerpos monoclonales, desde 60 días antes de la administración de la intervención del estudio, o recepción de cualquier terapia de anticuerpos pasiva específica para COVID-19 desde 90 días antes de la administración de la intervención del estudio, o recepción planificada durante todo el estudio.
- Participación en otros estudios que involucren la intervención del estudio dentro de los 28 días anteriores al ingreso al estudio y/o durante la participación en el estudio.
- Participación previa en otros estudios que involucran una intervención de estudio que contiene LNP.
- Participantes que sean descendientes directos (hijos o nietos) de miembros del personal del sitio de investigación o empleados de Pfizer/BioNTech directamente involucrados en la realización del estudio, personal del sitio supervisado por el investigador y sus respectivos familiares.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Dosis baja/media, ≥5 a <12 años
Dosis baja/media (10 mcg), 2 dosis con 21 días de diferencia
|
BNT162b2 Nivel de dosis baja/media (10 mcg)
|
|
Experimental: Dosis media, ≥5 a <12 años
Dosis media, (20 mcg), 2 dosis con 21 días de diferencia
|
BNT162b2 Nivel de dosis media (20 mcg)
|
|
Experimental: Dosis alta, ≥5 a <12 años
Dosis alta (30 mcg), 2 dosis con 21 días de diferencia
|
Nivel de dosis alta BNT162b2 (30 mcg)
|
|
Experimental: Dosis baja/media, ≥2 a < 5 años
Dosis baja/media (10 mcg), 2 dosis con 21 días de diferencia
|
BNT162b2 Nivel de dosis baja/media (10 mcg)
|
|
Experimental: Dosis media, ≥2 a <5 años
Dosis media, (20 mcg), 2 dosis con 21 días de diferencia
|
BNT162b2 Nivel de dosis media (20 mcg)
|
|
Experimental: Dosis alta, ≥2 a <5 años
Dosis alta, (30 mcg), 2 dosis con 21 días de diferencia
|
Nivel de dosis alta BNT162b2 (30 mcg)
|
|
Experimental: Dosis baja/media, ≥6 meses a <2 años
Dosis baja/media, (10 mcg), 2 dosis con 21 días de diferencia
|
BNT162b2 Nivel de dosis baja/media (10 mcg)
|
|
Experimental: Dosis media, ≥6 meses a <2 años
Dosis media, (20 mcg), 2 dosis con 21 días de diferencia
|
BNT162b2 Nivel de dosis media (20 mcg)
|
|
Experimental: Dosis alta, ≥6 meses a <2 años
Dosis alta, (30 mcg), 2 dosis con 21 días de diferencia
|
Nivel de dosis alta BNT162b2 (30 mcg)
|
|
Comparador de placebos: Placebo, ≥6 meses a <2 años
|
Inyección intramuscular
|
|
Comparador de placebos: Placebo, ≥2 a <5 años
|
Inyección intramuscular
|
|
Comparador de placebos: Placebo, ≥5 a <12 años
|
Inyección intramuscular
|
|
Experimental: Dosis baja, ≥6 meses a <2 años
Dosis baja (3 mcg), 2 dosis separadas por 21 dosis
|
BNT162b2 Nivel de dosis baja (3 mcg)
|
|
Experimental: Dosis baja, ≥2 a <5 años
Dosis baja (3 mcg), 2 dosis con 21 días de diferencia
|
BNT162b2 Nivel de dosis baja (3 mcg)
|
|
Experimental: Dosis alta, de 12 a <16 años (prueba de troponina I)
Dosis alta (30 mcg), 3 dosis
|
Nivel de dosis alta BNT162b2 (30 mcg)
|
|
Experimental: Dosis baja/media, ≥5 a <12 años (prueba de troponina I)
Dosis baja/media (10 mcg), 3 dosis
|
BNT162b2 Nivel de dosis baja/media (10 mcg)
|
|
Experimental: Placebo, ≥5 a <12 años (prueba de troponina I)
|
Inyección intramuscular
|
|
Experimental: Dosis baja, ≥6 meses a <2 años (régimen de 3 dosis)
Dosis baja (3mcg), 3 dosis
|
BNT162b2 Nivel de dosis baja (3 mcg)
|
|
Experimental: Dosis baja, ≥2 a <5 años (régimen de 3 dosis)
Dosis baja (3mcg), 3 dosis
|
BNT162b2 Nivel de dosis baja (3 mcg)
|
|
Comparador de placebos: Placebo, ≥6 meses a <2 años (régimen de 3 dosis)
|
Inyección intramuscular
|
|
Comparador de placebos: Placebo, ≥2 a <5 años (régimen de 3 dosis)
|
Inyección intramuscular
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=5 to <12 Years of Age
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Director de estudio: Pfizer CT.gov Call Center, Pfizer
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Walter EB, Talaat KR, Sabharwal C, Gurtman A, Lockhart S, Paulsen GC, Barnett ED, Munoz FM, Maldonado Y, Pahud BA, Domachowske JB, Simoes EAF, Sarwar UN, Kitchin N, Cunliffe L, Rojo P, Kuchar E, Ramet M, Munjal I, Perez JL, Frenck RW Jr, Lagkadinou E, Swanson KA, Ma H, Xu X, Koury K, Mather S, Belanger TJ, Cooper D, Tureci O, Dormitzer PR, Sahin U, Jansen KU, Gruber WC; C4591007 Clinical Trial Group. Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age. N Engl J Med. 2022 Jan 6;386(1):35-46. doi: 10.1056/NEJMoa2116298. Epub 2021 Nov 9.
- Pather S, Charpentier N, van den Ouweland F, Rizzi R, Finlayson A, Salisch N, Muik A, Lindemann C, Khanim R, Abduljawad S, Smith ER, Gurwith M, Chen RT; Benefit-Risk Assessment of VAccines by TechnolOgy Working Group (BRAVATO; ex-V3SWG). A Brighton Collaboration standardized template with key considerations for a benefit-risk assessment for the Comirnaty COVID-19 mRNA vaccine. Vaccine. 2024 Sep 17;42(22):126165. doi: 10.1016/j.vaccine.2024.126165. Epub 2024 Aug 27.
- Simoes EAF, Klein NP, Sabharwal C, Gurtman A, Kitchin N, Ukkonen B, Korbal P, Zou J, Xie X, Sarwar UN, Xu X, Lockhart S, Cunliffe L, Lu C, Ma H, Swanson KA, Koury K, Shi PY, Cooper D, Tureci Ӧ, Jansen KU, Sahin U, Gruber WC. Immunogenicity and Safety of a Third COVID-19 BNT162b2 mRNA Vaccine Dose in 5- to 11-Year Olds. J Pediatric Infect Dis Soc. 2023 Apr 28;12(4):234-238. doi: 10.1093/jpids/piad015.
- Munoz FM, Sher LD, Sabharwal C, Gurtman A, Xu X, Kitchin N, Lockhart S, Riesenberg R, Sexter JM, Czajka H, Paulsen GC, Maldonado Y, Walter EB, Talaat KR, Englund JA, Sarwar UN, Hansen C, Iwamoto M, Webber C, Cunliffe L, Ukkonen B, Martinez SN, Pahud BA, Munjal I, Domachowske JB, Swanson KA, Ma H, Koury K, Mather S, Lu C, Zou J, Xie X, Shi PY, Cooper D, Tureci O, Sahin U, Jansen KU, Gruber WC; C4591007 Clinical Trial Group. Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age. N Engl J Med. 2023 Feb 16;388(7):621-634. doi: 10.1056/NEJMoa2211031.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
24 de marzo de 2021
Finalización primaria (Actual)
4 de octubre de 2023
Finalización del estudio (Actual)
8 de diciembre de 2023
Fechas de registro del estudio
Enviado por primera vez
19 de marzo de 2021
Primero enviado que cumplió con los criterios de control de calidad
24 de marzo de 2021
Publicado por primera vez (Actual)
25 de marzo de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
26 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Infecciones del Tracto Respiratorio
- Infecciones
- Infecciones por virus de ARN
- Enfermedades virales
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Neumonía Viral
- Neumonía
- Infecciones por coronavirus
- Infecciones por coronaviridae
- Infecciones por Nidovirales
- COVID-19
- Aminoácidos, péptidos y proteínas
- Proteínas
- Factores biológicos
- Mezclas complejas
- Vacunas
- Vacunas virales
- Vacunas de ARNm
- Vacunas a base de ácido nucleico
- Vacunas, sintéticas
- Proteínas recombinantes
- Vacunas para COVID-19
- Antígenos
- Productos biológicos
- Vacuna BNT162
Otros números de identificación del estudio
- C4591007
- 2020-005442-42 (Número EudraCT)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Infección por SARS-CoV-2, COVID-19
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PfizerActivo, no reclutandoCOVID-19 | Enfermedad por coronavirus 2019 (COVID-19) | Contagio de COVID-19 | Vacunas para COVID-19 | Infección por SARS-CoV-2, COVID19 | Vacunación COVID-19 | Infección por SARS-CoV-2, COVID-19 | COVID-19 (Enfermedad por coronavirus 2019) | Infección por COVID-19 SARS-CoV-2Estados Unidos
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The Institute of Molecular and Translational Medicine...University Hospital Olomouc; Palacky UniversityTerminadoSARS-CoV-2 | Infección por SARS-CoV-2 (COVID-19)Chequia
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AstraZenecaTerminado
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Institute of Tropical Medicine, BelgiumJessa Hospital; University Hospital, Antwerp; Universiteit Antwerpen; Sciensano; Me...TerminadoCOVID-19 | SARS-CoV-2Bélgica
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SAb Biotherapeutics, Inc.Department of Health and Human Services; JPEO, Chemical, Biological, Radiological...TerminadoCOVID-19 | SARS-CoV-2Estados Unidos
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Susanne ArnoldTerminadoCOVID-19 | SARS-CoV-2Estados Unidos
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University of Wisconsin, MadisonNational Institutes of Health (NIH)Terminado
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Azienda Ospedaliero, Universitaria PisanaTerminadoSARS-CoV-2 | COVID-19Italia
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St George's University Hospitals NHS Foundation...Desconocido
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Syneos HealthUS Specialty Formulations, LLCTerminadoSARS-CoV-2 (COVID-19)Nueva Zelanda