Une étude de phase 1/2/3 pour évaluer l'innocuité, la tolérabilité et l'immunogénicité d'un candidat-vaccin à ARN contre le COVID-19 chez des enfants et des jeunes adultes en bonne santé
26 mai 2026 mis à jour par: BioNTech SE
UNE ÉTUDE DE PHASE 1, ÉTUDE OUVERTE DE RECHERCHE DE DOSE POUR ÉVALUER LA SÉCURITÉ, LA TOLÉRABILITÉ ET L'IMMUNOGÉNICITÉ ET LA PHASE 2/3 ÉTUDE DE SÉCURITÉ, DE TOLÉRABILITÉ ET D'IMMUNOGÉNICITÉ CONTRÔLÉE PAR PLACEBO ET À L'AVEUGLE DES OBSERVATEURS D'UN CANDIDAT VACCIN À ARN SARS-COV-2 CONTRE LE COVID -19 CHEZ LES ENFANTS ET LES JEUNES ADULTES EN BONNE SANTÉ
Il s'agit d'une étude de phase 1/2/3 chez des enfants et de jeunes adultes en bonne santé.
En fonction des données d'innocuité et/ou d'immunogénicité générées au cours de cette étude et de l'évaluation du rapport bénéfice/risque qui en résulte, l'innocuité, la tolérabilité et l'immunogénicité du BNT162b2 chez les participants de moins de 6 mois peuvent ensuite être évaluées.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
Recherche de dose de phase 1
Est-ce que la partie de recherche de dose en ouvert de l'étude qui évaluera l'innocuité, la tolérabilité et l'immunogénicité du BNT162b2 administré selon un calendrier à 2 doses (séparées d'environ 21 jours) dans jusqu'à 3 groupes d'âge (participants ≥ 5 à < 12 ans, ≥2 à <5 ans et ≥6 mois à <2 ans).
La détermination de la dose est initiée dans cette étude chez les participants âgés de ≥ 5 à < 12 ans sur la base de l'évaluation acceptable de l'innocuité en aveugle de la dose de 30 µg chez les 12 à 15 ans dans l'étude C4591001.
L'objectif de la phase 1 est d'identifier le(s) niveau(x) de dose préféré(s) de BNT162b2 parmi jusqu'à 3 niveaux de dose différents dans chaque tranche d'âge.
En fonction des données d'innocuité et/ou d'immunogénicité générées au cours de cette étude, il est possible que les niveaux de dose ne soient pas démarrés, qu'ils soient interrompus prématurément et/ou qu'ils soient ajoutés avec des niveaux de dose inférieurs à la dose la plus faible indiquée.
Mise à jour dans le cadre de l'amendement 6 au protocole : Tous les participants recevront une troisième dose de BNT162b2. Pour les participants âgés de ≥ 6 mois à < 5 ans, la troisième dose aura lieu au moins 8 semaines après la deuxième dose. Chez les participants ≥5 à <12 ans, la troisième dose aura lieu au moins 6 mois après la deuxième dose. L'intervalle entre la deuxième et la troisième dose sera basé sur l'âge du participant au moment de l'inscription. Le niveau de dose de la troisième dose de BNT162b2 sera basé sur l'âge au moment de la vaccination : les participants âgés de moins de 5 ans au moment de la troisième dose recevront le niveau de dose de 3 µg, les participants âgés de ≥ 5 à < 12 ans l'âge au moment de la troisième dose recevra le niveau de dose de 10 µg, et les participants âgés de ≥ 12 ans au moment de la troisième dose recevront le niveau de dose de 30 µg.
Les participants subiront une prise de sang avant la dose 1 et la dose 2 et 7 jours après la dose 2 pour évaluer l'immunogénicité afin de déterminer le niveau de dose de BNT162b2 sélectionné pour la phase 2/3. Les participants subiront également une prise de sang avant la dose 3 et 1, 6 et 12 mois après la dose 3.
Évaluation à faible dose de phase 1
Est-ce la partie d'évaluation à faible dose en ouvert de l'étude qui évaluera l'innocuité, la tolérabilité et l'immunogénicité de 10 µg de BNT162b2 à partir de 2 calendriers dans 2 groupes d'âge (participants de 12 à <16 ans et de 16 à <18 ans) .
Le but de l'évaluation de phase 1 à faible dose est d'évaluer l'innocuité et l'immunogénicité du BNT162b2 à partir de 2 schémas posologiques différents dans chaque groupe d'âge : (1) 2 doses séparées d'environ 21 jours et (2) 2 doses séparées d'environ 8 semaines .
Les participants subiront une prise de sang avant la dose 1, avant la dose 2, 7 jours après la dose 2 et 1 mois après la dose 2 pour évaluer l'immunogénicité afin de déterminer le schéma posologique de BNT162b2 sélectionné pour la partie d'évaluation à faible dose de la phase 2/3 de la étudier. De plus, les participants subiront une prise de sang 6 et 12 mois après la dose 2 pour déterminer la persistance de la réponse immunitaire.
Phase 2/3 dose sélectionnée
Est la partie de l'étude qui évaluera l'innocuité, la tolérabilité et l'immunogénicité dans chaque groupe d'âge au niveau de dose sélectionné à partir de la phase 1 de recherche de dose de l'étude. L'efficacité sera évaluée au sein ou entre les groupes d'âge dans lesquels l'immunobridging réussit, en fonction de l'accumulation d'un nombre suffisant de cas dans ces groupes d'âge.
Les participants subiront une prise de sang au départ avant la dose 1 et 6 mois après la dose 2. L'immunopontage pour les participants âgés de 16 à 25 ans dans l'étude C4591001 sera basé sur les données d'immunogénicité recueillies au (1) départ et 1 mois après la dose 2 et (2) au départ et 1 mois après la dose 3. La persistance de la réponse immunitaire sera basée sur les données d'immunogénicité recueillies chez les participants au (1) départ et 1 et 6 mois après la dose 2 et (2) au départ et 1, 6, 12 , et 18 mois après la dose 3. De plus, l'efficacité contre le COVID-19 confirmé et contre l'infection asymptomatique sera également évaluée chez les participants âgés de ≥ 5 à < 12 ans.
Dans les sites américains désignés, un échantillon de sang total facultatif supplémentaire d'environ 10 ml sera obtenu avant la dose 1 et 7 jours et 6 mois après la dose 2 jusqu'à environ 60 participants âgés de ≥ 10 ans. Des échantillons supplémentaires seront obtenus avant la dose 3 et 1 mois après la dose 3 (groupe BNT162b2 d'origine uniquement). Ces échantillons seront utilisés à titre exploratoire pour étudier la réponse immunitaire à médiation cellulaire post-vaccination à ces moments précis.
Lors de la visite de suivi de 6 mois, tous les participants seront levés en aveugle. Les participants qui ont initialement reçu un placebo se verront offrir la possibilité de recevoir du BNT162b2 dans le cadre de l'étude. Participants qui ont initialement reçu un placebo et deviennent éligibles pour recevoir le BNT162b2 ou un autre vaccin COVID-19 conformément aux recommandations locales ou nationales avant la visite de suivi de 6 mois (visite 5 ou 405) (détaillé séparément et disponible sur le portail électronique de référence de l'étude ) auront la possibilité de recevoir du BNT162b2 (10 µg ou 3 µg) en fonction de leur âge au moment de la vaccination.
Mise à jour dans le cadre de l'amendement 6 au protocole : Tous les participants recevront une troisième dose de BNT162b2. Pour les participants âgés de ≥ 6 mois à < 5 ans, la troisième dose aura lieu au moins 8 semaines après la deuxième dose. Chez les participants ≥5 à <12 ans, la troisième dose aura lieu au moins 6 mois après la deuxième dose. L'intervalle entre la deuxième et la troisième dose sera basé sur l'âge du participant au moment de l'inscription. Le niveau de dose des deuxième et troisième doses de BNT162b2 sera basé sur l'âge au moment de la vaccination : les participants âgés de moins de 5 ans au moment de la deuxième/troisième dose recevront le niveau de dose de 3 µg, les participants ≥ 5 à Les participants âgés de moins de 12 ans au moment de la deuxième/troisième dose recevront la dose de 10 µg, et les participants âgés de ≥ 12 ans au moment de la deuxième/troisième dose recevront la dose de 30 µg.
Évaluation à faible dose de phase 2/3
Il s'agit de la partie en ouvert de l'étude qui évaluera l'innocuité, la tolérabilité et l'immunogénicité du schéma posologique sélectionné dans chaque groupe d'âge à partir de l'évaluation de la phase 1 à faible dose, avec un total d'environ 600 participants actifs.
Environ 300 participants actifs dans chaque tranche d'âge de cette phase contribueront à l'analyse de pontage immunitaire 1 mois après la dose 2 et à l'analyse globale de la persistance de la réponse immunitaire à 6 et 12 mois après la dose 2.
Phase 2/3 Obtention d'échantillons de sérum pour un test potentiel de troponine I
Si le test des niveaux de troponine I chez les personnes qui n'ont pas reçu de BNT162b2 indique que le niveau de troponine I pourrait être un indicateur fiable d'une myocardite subclinique potentielle, l'obtention d'échantillons de sérum pour un test potentiel de troponine I pendant la période de risque accru de myocardite clinique peut aider à caractériser l'absence /présence et fréquence des myocardites subcliniques. Pour évaluer, un groupe supplémentaire de participants sera inclus : ≥5 à <12 ans : randomisés 2:1 pour recevoir BNT162b2 10 µg ou un placebo, et ≥12 à <16 ans : réception en ouvert de BNT162b2 30 µg.
Mise à jour dans le cadre de l'amendement 7 au protocole : Tous les participants recevront une troisième dose de BNT162b2. Pour tous les participants (≥5 à <12 ans et ≥12 à <16 ans), la troisième dose aura lieu au moins 5 mois après la dose 2.
Le niveau de dose des deuxième et troisième doses de BNT162b2 sera basé sur l'âge au moment de la vaccination : les participants âgés de ≥ 5 à <12 ans au moment de la deuxième/troisième dose recevront le niveau de dose de 10 µg, et les participants âgés de ≥ 12 ans au moment de la deuxième/troisième dose recevront la dose de 30 µg.
Type d'étude
Interventionnel
Inscription (Réel)
11837
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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São Paulo, Brésil, 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, Brésil, 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, Brésil, 30150-221
- Santa Casa de Misericordia de Belo Horizonte
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Paraná
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Curitiba, Paraná, Brésil, 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, Brésil, 59025-050
- CePCLIN - Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda
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Madrid, Espagne, 28041
- Hospital Universitario 12 de Octubre
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Seville, Espagne, 41012
- Instituto Hispalense de Pediatria
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A Coruña
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Santiago de Compostela, A Coruña, Espagne, 15706
- Hospital Clínico Universitario Santiago de Compostela
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Barcelona
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Centelles, Barcelona, Espagne, 08540
- EBA Centelles
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Esplugues de Llobregat, Barcelona, Espagne, 08950
- Hospital Sant Joan de Deu
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Sant Cugat del Vallès, Barcelona, Espagne, 08195
- Hospital Universitari General de Catalunya
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Madrid
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Boadilla del Monte, Madrid, Espagne, 28660
- Hospital Universitario HM Monteprincipe
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Madrid, Comunidad de
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Madrid, Madrid, Comunidad de, Espagne, 28938
- Hospital Universitario HM Puerta del Sur
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Málaga
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Antequera, Málaga, Espagne, 29200
- Hospital de Antequera
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Málaga, Málaga, Espagne, 29015
- Grupo Pediatrico Uncibay
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Espoo, Finlande, 02230
- FVR, Espoo Clinic
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Helsinki, Finlande, 00100
- FVR, Helsinki South Clinic
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Helsinki, Finlande, 00290
- MeVac - Meilahti Vaccine Research Center
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Helsinki, Finlande, 00930
- FVR, Helsinki East Clinic
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Kokkola, Finlande, 67100
- FVR, Kokkola Clinic
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Pori, Finlande, 28100
- FVR, Pori Clinic
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Seinäjoki, Finlande, 60100
- FVR, Seinäjoki Clinic
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Tampere, Finlande, 33100
- FVR, Tampere Clinic
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Turku, Finlande, 20520
- FVR, Turku Clinic
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North Ostrobothnia
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Oulu, North Ostrobothnia, Finlande, 90220
- FVR, Oulu Clinic
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Uusimaa
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Jarvenpaa, Uusimaa, Finlande, 04400
- FVR, Järvenpää Clinic
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Veracruz, Mexique, C.P. 91900
- Sociedad de Metabolismo y Corazón S.C.
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Nuevo León
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Monterrey, Nuevo León, Mexique, C.P. 64060
- Christus - Latam Hub Center of Excellence and Innovation S.C.
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Yucatán
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Mérida, Yucatán, Mexique, 97070
- Köhler & Milstein Research S.A. de C.V.
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Mérida, Yucatán, Mexique, 97130
- Centro Multidisciplinario Para El Desarrollo Especializado De La Investigacion
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Bydgoszcz, Pologne, 85-048
- IN-VIVO Bydgoszcz
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Krakow, Pologne, 30-348
- Centrum Badan Klinicznych JCI
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Lodz, Pologne, 90-349
- Osrodek Badan Klinicznych Appletreeclinics
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Lodz, Pologne, 91-347
- GRAVITA Diagnostyka i Leczenie nieplodnosci
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Luboń, Pologne, 62-030
- Rodzinne Centrum Medyczne LUBMED
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Siemianowice Śląskie, Pologne, 41-103
- Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Jarosz i Partnerzy Spolka Lekarska
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Warsaw, Pologne, 02-647
- Provita 001
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Kuyavian-Pomeranian Voivodeship
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Torun, Kuyavian-Pomeranian Voivodeship, Pologne, 87-100
- Mics Centrum Medyczne Toruń
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Alabama
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Birmingham, Alabama, États-Unis, 35233
- University of Alabama at Birmingham - School of Medicine
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Arizona
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Phoenix, Arizona, États-Unis, 85016
- Phoenix Children's Hospital
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California
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Los Angeles, California, États-Unis, 90057
- Matrix Clinical Research
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Los Angeles, California, États-Unis, 90027
- SCPMG/Kaiser Permanente Los Angeles Medical Center
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Madera, California, États-Unis, 93637
- Madera Family Medical Group
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Oakland, California, États-Unis, 94611
- Kaiser Permanente Oakland
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Palo Alto, California, États-Unis, 94304
- Lucile Packard Children's Hospital Stanford
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Palo Alto, California, États-Unis, 94304
- Clinical & Translational Research Unit (CTRU) & Spectrum BioBank, Stanford University
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Paramount, California, États-Unis, 90723
- Center for Clinical Trials, LLC
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Paramount, California, États-Unis, 90723
- Center for Clinical Trials
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Rolling Hills Estates, California, États-Unis, 90274
- Peninsula Research Associates
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Sacramento, California, États-Unis, 95815
- Kaiser Permanente Sacramento
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Santa Clara, California, États-Unis, 95051
- Kaiser Permanente Santa Clara
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Stanford, California, États-Unis, 94305
- Stanford Health Care
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Stanford, California, États-Unis, 94305
- Stanford Health Care Investigational Drug Service
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Valley Village, California, États-Unis, 91607
- Bayview Research Group, LLC
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Colorado
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Aurora, Colorado, États-Unis, 80045
- Children's Hospital Colorado
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Connecticut
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New Haven, Connecticut, États-Unis, 06519
- Yale Center for Clinical Investigation
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District of Columbia
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Washington D.C., District of Columbia, États-Unis, 20010
- Children's National Medical Center
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Washington D.C., District of Columbia, États-Unis, 20016
- Velocity Clinical Research, Washington DC
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Washington D.C., District of Columbia, États-Unis, 20009
- Emerson Clinical Research Institute
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Florida
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Jacksonville, Florida, États-Unis, 32256
- Clinical Neuroscience Solutions, Inc.
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Miami, Florida, États-Unis, 33142
- Acevedo Clinical Research Associates
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Orlando, Florida, États-Unis, 32801
- Clinical Neuroscience Solutions
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Georgia
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Atlanta, Georgia, États-Unis, 30331
- Atlanta Center for Medical Research
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Atlanta, Georgia, États-Unis, 30322
- Emory University School of Medicine
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Atlanta, Georgia, États-Unis, 30322
- Emory Children's Center Illness POD
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Macon, Georgia, États-Unis, 31210
- Meridian Clinical Research, LLC
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Union City, Georgia, États-Unis, 30291
- Rophe Adult and Pediatric Medicine/SKYCRNG
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Idaho
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Idaho Falls, Idaho, États-Unis, 83404
- Clinical Research Prime
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Meridian, Idaho, États-Unis, 83646
- Solaris Clinical Research
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Kansas
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Newton, Kansas, États-Unis, 67114
- Alliance for Multispecialty Research, LLC
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Wichita, Kansas, États-Unis, 67207
- Alliance for Multispecialty Research, LLC
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Kentucky
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Bardstown, Kentucky, États-Unis, 40004
- Kentucky Pediatric/ Adult Research
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Louisville, Kentucky, États-Unis, 40202
- Novak Center for Children's Health
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Louisiana
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New Orleans, Louisiana, États-Unis, 70121
- Ochsner Clinic Foundation
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Shreveport, Louisiana, États-Unis, 71101
- Louisiana State University Health Sciences Shreveport
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Maryland
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Baltimore, Maryland, États-Unis, 21224
- Johns Hopkins Bayview Medical Center
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Massachusetts
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Boston, Massachusetts, États-Unis, 02118
- Boston Medical Center
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Michigan
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Bingham Farms, Michigan, États-Unis, 48025
- Michigan Center of Medical Research
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Mississippi
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Ridgeland, Mississippi, États-Unis, 39157
- SKY Integrative Medical Center/SKYCRNG
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Missouri
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Chesterfield, Missouri, États-Unis, 63005
- Clinical Research Professionals
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Kansas City, Missouri, États-Unis, 64108
- Children's Mercy Hospital
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Nebraska
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Hastings, Nebraska, États-Unis, 68901
- Meridian Clinical Research, LLC
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Lincoln, Nebraska, États-Unis, 68510
- Velocity Clinical Research, Lincoln
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Omaha, Nebraska, États-Unis, 68114
- Children's Hospital & Medical Center
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Omaha, Nebraska, États-Unis, 68117
- Children's Physician's Clinic, Spring Valley
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New Jersey
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New Brunswick, New Jersey, États-Unis, 08901
- Cancer Institute Of New Jersey
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New Brunswick, New Jersey, États-Unis, 08901
- Rutgers University
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New York
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Binghamton, New York, États-Unis, 13905
- Meridian Clinical Research LLC
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Commack, New York, États-Unis, 11725
- Advanced Specialty Care
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Rochester, New York, États-Unis, 14642
- University of Rochester Medical Center
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Rochester, New York, États-Unis, 14609
- Rochester Clinical Research, Inc.
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Stony Brook, New York, États-Unis, 11794
- Stony Brook University
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Syracuse, New York, États-Unis, 13210
- SUNY Upstate Medical University
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North Carolina
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Charlotte, North Carolina, États-Unis, 28207
- Atrium Health-STRIVE Vaccine Research Clinic
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Charlotte, North Carolina, États-Unis, 28211
- Teen Health Connection (study visits)
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Durham, North Carolina, États-Unis, 27703
- Duke University - Main Hospital and Clinics
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Matthews, North Carolina, États-Unis, 28105
- Atrium Health-STRIVE Vaccine Research Clinic (study visits)
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Ohio
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Cincinnati, Ohio, États-Unis, 45229
- Cincinnati Children's Hospital Medical Center Vaccine Research Center
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Columbus, Ohio, États-Unis, 43213
- Centricity Research Columbus Ohio Multispecialty
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Dayton, Ohio, États-Unis, 45429
- Primed Clinical Research
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South Euclid, Ohio, États-Unis, 44121
- Senders Pediatrics
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Oregon
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Gresham, Oregon, États-Unis, 97030
- Cyn3rgy Research
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Pennsylvania
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Erie, Pennsylvania, États-Unis, 16506
- AHN Erie Health + Wellness Pavillion: West
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Rhode Island
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East Greenwich, Rhode Island, États-Unis, 02818
- Velocity Clinical Research-Providence
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South Carolina
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Charleston, South Carolina, États-Unis, 29414
- Coastal Pediatric Research
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Greenville, South Carolina, États-Unis, 29607
- Tribe Clinical Research, LLC
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Summerville, South Carolina, États-Unis, 29486
- Coastal Pediatric Research
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Tennessee
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Memphis, Tennessee, États-Unis, 38105
- St. Jude Children's Research Hospital
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Nashville, Tennessee, États-Unis, 37203
- Clinical Research Associates Inc
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Texas
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Austin, Texas, États-Unis, 78726
- Innovo Research - Austin Regional Clinic
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Corpus Christi, Texas, États-Unis, 78411
- Driscoll Children's Hospital
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Dallas, Texas, États-Unis, 75251
- Cedar Health Research
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Dickinson, Texas, États-Unis, 77539
- Bay Colony Pediatrics
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Edinburg, Texas, États-Unis, 78539
- Proactive Clinical Research, LLC
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Frisco, Texas, États-Unis, 75033
- Village Health Partners (Patient Seen Address)
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Houston, Texas, États-Unis, 77055
- West Houston Clinical Research Services
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Houston, Texas, États-Unis, 77008
- HG Pediatrics
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Houston, Texas, États-Unis, 77008
- Van Tran Family Practice
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Houston, Texas, États-Unis, 77030
- Texas Children's Hospital - Clinical Research Center
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Houston, Texas, États-Unis, 77087
- Pediatric Associates
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Houston, Texas, États-Unis, 77008
- Helios Clinical Research - HOU
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Houston, Texas, États-Unis, 77008
- Helios Clinical Research
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Houston, Texas, États-Unis, 77065
- DM Clinical Research - MDC
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Utah
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Salt Lake City, Utah, États-Unis, 84109
- J. Lewis Research, Inc. / Foothill Family Clinic
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Salt Lake City, Utah, États-Unis, 84121
- J. Lewis Research, Inc. / Foothill Family Clinic South
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Virginia
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Charlottesville, Virginia, États-Unis, 22902
- Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)
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Midlothian, Virginia, États-Unis, 23114
- Virginia Research Center
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Washington
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Seattle, Washington, États-Unis, 98105
- Seattle Children's Hospital
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
6 mois à 18 ans (Enfant)
Accepte les volontaires sains
Oui
La description
Critère d'intégration
- Participants masculins ou féminins âgés de ≥ 6 mois à < 12 ans, au moment de la randomisation, lors de la visite 1 pour l'évaluation de la dose/de la dose sélectionnée et pour les participants âgés de ≥ 12 à < 18 ans, au moment de la randomisation , lors de la visite 1 pour l'évaluation de la dose la plus faible. Pour la partie obtention d'échantillons de sérum pour le test potentiel de troponine I de l'étude : participants masculins ou féminins âgés de ≥ 5 à < 16 ans.
- Parent (s) / tuteur (s) légal (s) des participants et participants, selon l'âge, qui sont disposés et capables de se conformer à toutes les visites prévues, au plan de traitement, aux tests de laboratoire, aux considérations relatives au mode de vie et aux autres procédures d'étude.
Participants en bonne santé qui sont déterminés par les antécédents médicaux, l'examen physique et le jugement clinique de l'investigateur comme éligibles pour l'inclusion dans l'étude.
Remarque : Les participants en bonne santé atteints d'une maladie stable préexistante, définie comme une maladie ne nécessitant pas de changement significatif dans le traitement ou une hospitalisation pour aggravation de la maladie au cours des 6 semaines précédant l'inscription, peuvent être inclus.
- Les participants doivent être disponibles pendant toute la durée de l'étude et dont le(s) parent(s)/tuteur légal peuvent être contactés par téléphone pendant la participation à l'étude.
- Test de grossesse urinaire négatif pour les participantes qui sont biologiquement capables d'avoir des enfants.
- Participant féminin en âge de procréer ou participant masculin capable d'engendrer des enfants qui est disposé à utiliser une méthode de contraception très efficace comme indiqué dans ce protocole pendant au moins 28 jours après la dernière dose de l'intervention de l'étude s'il y a un risque de grossesse avec son partenaire ; ou une participante qui n'est pas en âge de procréer ou un participant qui n'est pas en mesure d'avoir des enfants.
- Le participant ou le(s) parent(s)/tuteur légal du participant est capable de donner un consentement éclairé signé, qui comprend le respect des exigences et des restrictions énumérées dans la CIM et dans ce protocole. Selon l'âge du participant et selon les exigences locales, il sera également demandé aux participants de donner leur consentement, le cas échéant (verbal ou écrit).
Critère d'exclusion
- Phase 1 uniquement : Antécédents cliniques (basés sur les symptômes/signes COVID-19 uniquement, si un résultat TAAN SRAS-CoV 2 n'était pas disponible) ou microbiologiques (basés sur les symptômes/signes COVID-19 et un résultat TAAN SRAS-CoV-2 positif) diagnostic de COVID 19.
- Phase 1 uniquement : Infection connue par le VIH, le VHC ou le VHB.
- Réception de médicaments destinés à prévenir le COVID-19.
- Diagnostic antérieur ou actuel de MIS-C.
- Autre condition médicale ou psychiatrique, y compris des idées/comportements suicidaires récents (au cours de la dernière année) ou actifs ou une anomalie de laboratoire qui peuvent augmenter le risque de participation à l'étude ou, selon le jugement de l'investigateur, rendre le participant inapproprié pour l'étude. Remarque : Cela inclut à la fois les conditions qui peuvent augmenter le risque associé à l'administration de l'intervention de l'étude ou une condition qui peut interférer avec l'interprétation des résultats de l'étude
- Antécédents de réaction indésirable grave associée à un vaccin et/ou de réaction allergique grave (p. ex., anaphylaxie) à l'un des composants de l'intervention ou des interventions à l'étude.
- Personnes immunodéprimées présentant une immunodéficience connue ou suspectée, déterminée par les antécédents et/ou un examen physique/de laboratoire.
- Les personnes ayant des antécédents de maladie auto-immune ou une maladie auto-immune active nécessitant une intervention thérapeutique, y compris, mais sans s'y limiter, le lupus érythémateux disséminé. Remarque : Le diabète de type 1 stable et l'hypothyroïdie sont autorisés.
- Diathèse hémorragique ou affection associée à un saignement prolongé qui, de l'avis de l'investigateur, contre-indiquerait l'injection intramusculaire.
- Femme enceinte ou qui allaite.
- Vaccination antérieure avec n'importe quel vaccin contre le coronavirus.
- Les personnes qui reçoivent un traitement par thérapie immunosuppressive, y compris des agents cytotoxiques ou des corticostéroïdes systémiques, par exemple, pour un cancer ou une maladie auto-immune, ou une réception prévue tout au long de l'étude. Si des corticostéroïdes systémiques ont été administrés à court terme (< 14 jours) pour le traitement d'une maladie aiguë, les participants ne doivent pas être recrutés dans l'étude tant que la corticothérapie n'a pas été interrompue pendant au moins 28 jours avant l'administration de l'intervention de l'étude. Les corticostéroïdes inhalés/nébulisés, intra-articulaires, intrabursaux ou topiques (cutanés ou oculaires) sont autorisés.
- Réception de produits sanguins/plasmatiques, d'immunoglobulines ou d'anticorps monoclonaux, à partir de 60 jours avant l'administration de l'intervention de l'étude, ou réception de toute thérapie passive par anticorps spécifique au COVID-19 à partir de 90 jours avant l'administration de l'intervention de l'étude, ou réception prévue tout au long de l'étude.
- Participation à d'autres études impliquant une intervention à l'étude dans les 28 jours précédant l'entrée à l'étude et/ou pendant la participation à l'étude.
- Participation antérieure à d'autres études impliquant une intervention d'étude contenant des LNP.
- Participants qui sont des descendants directs (enfants ou petits-enfants) des membres du personnel du site expérimental ou des employés de Pfizer/BioNTech directement impliqués dans la conduite de l'étude, du personnel du site autrement supervisé par l'investigateur et des membres de leur famille respectifs.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Dose faible/moyenne, ≥5 à <12 ans
Dose faible/moyenne (10 mcg), 2 doses à 21 jours d'intervalle
|
Niveau de dose faible/moyenne de BNT162b2 (10 mcg)
|
|
Expérimental: Dose moyenne, ≥ 5 à < 12 ans
Mid-Dose, (20mcg), 2 doses à 21 jours d'intervalle
|
Niveau de dose moyenne de BNT162b2 (20 mcg)
|
|
Expérimental: Haute dose, ≥5 à <12 ans
Haute dose (30mcg), 2 doses à 21 jours d'intervalle
|
BNT162b2 niveau à haute dose (30mcg)
|
|
Expérimental: Dose faible/moyenne, ≥ 2 à < 5 ans
Dose faible/moyenne (10 mcg), 2 doses à 21 jours d'intervalle
|
Niveau de dose faible/moyenne de BNT162b2 (10 mcg)
|
|
Expérimental: Dose moyenne, ≥ 2 à < 5 ans
Mid-Dose, (20mcg), 2 doses à 21 jours d'intervalle
|
Niveau de dose moyenne de BNT162b2 (20 mcg)
|
|
Expérimental: Haute dose, ≥2 à <5 ans
Haute dose, (30mcg), 2 doses à 21 jours d'intervalle
|
BNT162b2 niveau à haute dose (30mcg)
|
|
Expérimental: Dose faible/moyenne, ≥ 6 mois à < 2 ans
Dose faible/moyenne (10 mcg), 2 doses à 21 jours d'intervalle
|
Niveau de dose faible/moyenne de BNT162b2 (10 mcg)
|
|
Expérimental: Dose moyenne, ≥ 6 mois à < 2 ans
Mid-Dose, (20mcg), 2 doses à 21 jours d'intervalle
|
Niveau de dose moyenne de BNT162b2 (20 mcg)
|
|
Expérimental: Haute dose, ≥ 6 mois à < 2 ans
Haute dose, (30mcg), 2 doses à 21 jours d'intervalle
|
BNT162b2 niveau à haute dose (30mcg)
|
|
Comparateur placebo: Placebo, ≥ 6 mois à < 2 ans
|
Injection intramusculaire
|
|
Comparateur placebo: Placebo, ≥2 à <5 ans
|
Injection intramusculaire
|
|
Comparateur placebo: Placebo, ≥5 à <12 ans
|
Injection intramusculaire
|
|
Expérimental: Faible dose, ≥ 6 mois à < 2 ans
Faible dose (3 mcg), 2 doses à 21 doses d'intervalle
|
Niveau à faible dose de BNT162b2 (3 mcg)
|
|
Expérimental: Faible dose, ≥2 à <5 ans
Faible dose (3mcg), 2 doses à 21 jours d'intervalle
|
Niveau à faible dose de BNT162b2 (3 mcg)
|
|
Expérimental: Haute dose, 12 à <16 ans (Test de troponine I)
Haute dose (30mcg), 3 doses
|
BNT162b2 niveau à haute dose (30mcg)
|
|
Expérimental: Dose faible/moyenne, ≥5 à <12 ans (Test de troponine I)
Dose faible/moyenne (10mcg), 3 doses
|
Niveau de dose faible/moyenne de BNT162b2 (10 mcg)
|
|
Expérimental: Placebo, ≥5 à <12 ans (Test de troponine I)
|
Injection intramusculaire
|
|
Expérimental: Faible dose, ≥ 6 mois à < 2 ans (régime à 3 doses)
Faible dose (3mcg), 3 doses
|
Niveau à faible dose de BNT162b2 (3 mcg)
|
|
Expérimental: Faible dose, ≥ 2 à < 5 ans (régime à 3 doses)
Faible dose (3mcg), 3 doses
|
Niveau à faible dose de BNT162b2 (3 mcg)
|
|
Comparateur placebo: Placebo, ≥ 6 mois à < 2 ans (régime à 3 doses)
|
Injection intramusculaire
|
|
Comparateur placebo: Placebo, ≥ 2 à < 5 ans (régime à 3 doses)
|
Injection intramusculaire
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=5 to <12 Years of Age
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Pfizer CT.gov Call Center, Pfizer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
24 mars 2021
Achèvement primaire (Réel)
4 octobre 2023
Achèvement de l'étude (Réel)
8 décembre 2023
Dates d'inscription aux études
Première soumission
19 mars 2021
Première soumission répondant aux critères de contrôle qualité
24 mars 2021
Première publication (Réel)
25 mars 2021
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
28 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Infections des voies respiratoires
- Infections
- Infections par virus à ARN
- Maladies virales
- Maladies des voies respiratoires
- Maladies pulmonaires
- Pneumonie virale
- Pneumonie
- Infections à coronavirus
- Infections à Coronaviridae
- Infections à Nidovirales
- COVID-19 [feminine]
- Acides aminés, peptides et protéines
- Protéines
- Facteurs biologiques
- Mélanges complexes
- Vaccins
- Vaccins viraux
- vaccins d'ARNm
- Vaccins à base d'acide nucléique
- Vaccins, synthétiques
- Protéines recombinantes
- Vaccins contre le covid-19
- Antigènes
- Produits biologiques
- Vaccin BNT162
Autres numéros d'identification d'étude
- C4591007
- 2020-005442-42 (Numéro EudraCT)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Infection par le SRAS-CoV-2, COVID-19
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PfizerActif, ne recrute pasCOVID-19 [feminine] | Maladie à coronavirus 2019 (COVID-19) | Infection par covid-19 | Vaccins contre le covid-19 | Infection par le SRAS-CoV-2, COVID19 | Vaccination COVID-19 | Infection par le SRAS-CoV-2, COVID-19 | COVID-19 (maladie à coronavirus 2019) | COVID-19 Infection par le SRAS-CoV-2États-Unis
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IRCCS San RaffaeleComplétéRéponse d'anticorps | Réponse immunitaire cellulaire | SAR-CoV-2Italie
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The Institute of Molecular and Translational Medicine...University Hospital Olomouc; Palacky UniversityComplétéSRAS-CoV-2 | Infection par le SRAS-CoV-2 (COVID-19)Tchéquie
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University of MelbourneAustralian and New Zealand Intensive Care Research Centre; The Peter Doherty... et autres collaborateursActif, ne recrute pasInfection par le SRAS-CoV-2 (COVID-19)Australie
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Interna Therapeutics Ltd.Actif, ne recrute pasInfection par le SRAS-CoV-2 (COVID-19)Israël
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Leidos Life SciencesUnited States Department of DefenseComplétéCOVID-19 [feminine] | Covid19 | Maladie du coronavirus 2019 | Infection par le SRAS-CoV-2 | Maladie respiratoire aiguë SARS-CoV-2 | Pandémie de covid-19 | Infection par le virus COVID-19 | Maladie à virus COVID-19 | 2019 Nouvelle maladie à coronavirus | 2019 Nouvelle infection à coronavirus | 2019-nCoV... et d'autres conditionsÉtats-Unis
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PfizerRecrutementMaladies des voies respiratoires | COVID-19 [feminine] | Pneumonie | Maladies pulmonaires | Maladie du coronavirus 2019 | Maladie à coronavirus 2019 (COVID-19) | Infection par covid-19 | Infections des voies respiratoires supérieures | Infection des voies respiratoires | COVID-19 (maladie à coronavirus... et d'autres conditionsBelgique
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Unity Health TorontoCanadian Institutes of Health Research (CIHR); Health CanadaPas encore de recrutementGrippe A | Grippe B | Infections respiratoires aiguës (IRA) | SAR-CoV-2Canada
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University of ValladolidComplétéImpact du masque d'entraînement en élévation dans l'infection post-SAR-COV-2 CrossFit®. (ETMEXCOVID)Infection par le SRAS-CoV-2 (symptomatique) | Complications pulmonaires liées au COVID-19 | Patients positifs au SRAS-CoV-2 | Covid19- Infection par le virus SARS-COV-2Espagne
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Ono Pharmaceutical Co. LtdComplétéInfection par le SRAS-CoV-2 (COVID-19)Japon
Essais cliniques sur Placebo
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SamA Pharmaceutical Co., LtdInconnueBronchite aiguë | Infection aiguë des voies respiratoires supérieuresCorée, République de
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AkesoPas encore de recrutementLa dermatite atopiqueChine
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Heptares Therapeutics LimitedComplétéPharmacocinétique | Des problèmes de sécuritéRoyaume-Uni
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National Institute on Drug Abuse (NIDA)ComplétéConsommation de cannabisÉtats-Unis
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Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingComplétéMaladie de ParkinsonChine
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Chong Kun Dang PharmaceuticalInconnueHypertension | DyslipidémiesCorée, République de
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CellmedisMedical Network Sp. z o.o.Pas encore de recrutement
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Texas A&M UniversityNutraboltComplétéRéponse du glucose et de l'insuline
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West Penn Allegheny Health SystemComplétéAsthme | Rhinite allergiqueÉtats-Unis