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Eine Phase-1/2/3-Studie zur Bewertung der Sicherheit, Verträglichkeit und Immunogenität eines RNA-Impfstoffkandidaten gegen COVID-19 bei gesunden Kindern und jungen Erwachsenen

26. Mai 2026 aktualisiert von: BioNTech SE

EINE PHASE-1-STUDIE ZUR BEWERTUNG DER SICHERHEIT, VERTRÄGLICHKEIT UND IMMUNOGENITÄT UND PHASE-2/3-PLACEBO-KONTROLLIERTE, BEOBACHTERVERBLINDETE SICHERHEITS-, VERTRÄGLICHKEITS- UND IMMUNGENITÄTSSTUDIE EINES SARS-COV-2-RNA-IMPFKANDIDATEN GEGEN COVID -19 BEI GESUNDEN KINDERN UND JUNGEN ERWACHSENEN

Dies ist eine Phase-1/2/3-Studie mit gesunden Kindern und jungen Erwachsenen.

Abhängig von den im Verlauf dieser Studie generierten Sicherheits- und/oder Immunogenitätsdaten und der daraus resultierenden Nutzen-Risiko-Bewertung können anschließend die Sicherheit, Verträglichkeit und Immunogenität von BNT162b2 bei Teilnehmern im Alter von <6 Monaten bewertet werden.

Studienübersicht

Status

Abgeschlossen

Bedingungen

SARS-CoV-2-Infektion, COVID-19

Intervention / Behandlung

Detaillierte Beschreibung

Phase 1 Dosisfindung

Ist der offene Dosisfindungsteil der Studie, der die Sicherheit, Verträglichkeit und Immunogenität von BNT162b2 bewertet, das nach einem 2-Dosen-Impfschema (getrennt durch etwa 21 Tage) in bis zu 3 Altersgruppen (Teilnehmer ≥5 bis <12 Jahre, ≥2 bis <5 Jahre und ≥6 Monate bis <2 Jahre).

Die Dosisfindung wird in dieser Studie bei Teilnehmern im Alter von ≥ 5 bis < 12 Jahren basierend auf der akzeptablen verblindeten Sicherheitsbewertung der 30-µg-Dosis bei 12- bis 15-Jährigen in der Studie C4591001 eingeleitet.

Der Zweck von Phase 1 besteht darin, die bevorzugte(n) Dosisstufe(n) von BNT162b2 aus bis zu 3 verschiedenen Dosisstufen in jeder Altersgruppe zu identifizieren.

Abhängig von Sicherheits- und/oder Immunogenitätsdaten, die im Verlauf dieser Studie generiert wurden, ist es möglich, dass Dosierungen nicht begonnen, vorzeitig beendet und/oder mit Dosierungen unterhalb der niedrigsten angegebenen Dosis hinzugefügt werden.

Aktualisierung im Rahmen der Protokolländerung 6: Alle Teilnehmer erhalten eine dritte Dosis BNT162b2. Bei Teilnehmern ≥ 6 Monate bis < 5 Jahre erfolgt die dritte Dosis mindestens 8 Wochen nach der zweiten Dosis. Bei Teilnehmern im Alter von ≥ 5 bis < 12 Jahren wird die dritte Dosis mindestens 6 Monate nach der zweiten Dosis verabreicht. Das Intervall zwischen der zweiten und dritten Dosis richtet sich nach dem Alter des Teilnehmers zum Zeitpunkt der Einschreibung. Die Dosierung der dritten Dosis von BNT162b2 richtet sich nach dem Alter zum Zeitpunkt der Impfung: Teilnehmer <5 Jahre zum Zeitpunkt der dritten Dosis erhalten die 3-µg-Dosis, Teilnehmer ≥5 bis <12 Jahre Alter zum Zeitpunkt der dritten Dosis erhalten die Dosis von 10 µg, und Teilnehmer, die zum Zeitpunkt der dritten Dosis ≥ 12 Jahre alt sind, erhalten die Dosis von 30 µg.

Den Teilnehmern wird sowohl vor Dosis 1 als auch vor Dosis 2 und 7 Tage nach Dosis 2 Blut entnommen, um die Immunogenität zu bewerten und die ausgewählte BNT162b2-Dosis für Phase 2/3 zu bestimmen. Den Teilnehmern wird außerdem vor Dosis 3 und 1, 6 und 12 Monate nach Dosis 3 Blut abgenommen.

Phase 1 Niedrigere Dosisbewertung

Ist der Open-Label-Bewertungsteil mit niedrigerer Dosis der Studie, der die Sicherheit, Verträglichkeit und Immunogenität von 10 µg BNT162b2 aus 2 Zeitplänen in 2 Altersgruppen (Teilnehmer im Alter von 12 bis < 16 Jahren und 16 bis < 18 Jahren) bewertet .

Der Zweck der Phase-1-Bewertung mit niedrigerer Dosis besteht darin, die Sicherheit und Immunogenität von BNT162b2 anhand von 2 verschiedenen Dosierungsplänen in jeder Altersgruppe zu bewerten: (1) 2 Dosen im Abstand von etwa 21 Tagen und (2) 2 Dosen im Abstand von etwa 8 Wochen .

Den Teilnehmern wird vor Dosis 1, vor Dosis 2, 7 Tage nach Dosis 2 und 1 Monat nach Dosis 2 Blut entnommen, um die Immunogenität zu bewerten und den ausgewählten BNT162b2-Dosisplan für den Bewertungsteil der Phase 2/3 mit niedrigerer Dosis festzulegen lernen. Darüber hinaus wird den Teilnehmern 6 und 12 Monate nach Dosis 2 Blut entnommen, um die Persistenz der Immunantwort zu bestimmen.

Phase 2/3 Selected-Dose

Ist der Teil der Studie, der die Sicherheit, Verträglichkeit und Immunogenität in jeder Altersgruppe bei der ausgewählten Dosisstufe aus dem Phase-1-Dosisfindungsteil der Studie bewertet. Die Wirksamkeit wird innerhalb oder zwischen Altersgruppen bewertet, in denen die Immunüberbrückung erfolgreich ist, je nachdem, ob in diesen Altersgruppen eine ausreichende Anzahl von Fällen auftritt.

Den Teilnehmern wird zu Studienbeginn vor Dosis 1 und 6 Monate nach Dosis 2 Blut entnommen. Die Immunüberbrückung für Teilnehmer im Alter von 16 bis 25 Jahren in der C4591001-Studie basiert auf Immunogenitätsdaten, die zu (1) Studienbeginn und 1 Monat nach Dosis 2 und erhoben wurden (2) Ausgangswert und 1 Monat nach Dosis 3. Die Persistenz der Immunantwort basiert auf Immunogenitätsdaten, die bei den Teilnehmern (1) Ausgangswert und 1 und 6 Monate nach Dosis 2 und (2) Ausgangswert und 1, 6, 12 erhoben wurden und 18 Monate nach Dosis 3. Darüber hinaus wird die Wirksamkeit gegen bestätigtes COVID-19 und gegen asymptomatische Infektionen auch bei Teilnehmern im Alter von ≥ 5 bis < 12 Jahren bewertet.

An bestimmten US-Standorten wird eine zusätzliche optionale Vollblutprobe von ungefähr 10 ml vor Dosis 1 und 7 Tage und 6 Monate nach Dosis 2 von bis zu ungefähr 60 Teilnehmern ≥ 10 Jahren entnommen. Zusätzliche Proben werden vor Dosis 3 und 1 Monat nach Dosis 3 entnommen (nur ursprüngliche BNT162b2-Gruppe). Diese Proben werden auf explorativer Basis verwendet, um die zellvermittelte Immunantwort nach der Impfung zu diesen Zeitpunkten zu untersuchen.

Bei der Nachuntersuchung nach 6 Monaten werden alle Teilnehmer entblindet. Teilnehmern, die ursprünglich ein Placebo erhalten haben, wird die Möglichkeit geboten, BNT162b2 als Teil der Studie zu erhalten. Teilnehmer, die ursprünglich ein Placebo erhalten haben und für den Erhalt von BNT162b2 oder einem anderen COVID-19-Impfstoff gemäß den lokalen oder nationalen Empfehlungen vor dem 6-monatigen Nachsorgebesuch (Besuch 5 oder 405) in Frage kommen (separat aufgeführt und im elektronischen Studienreferenzportal verfügbar). ) haben die Möglichkeit, BNT162b2 (10 µg oder 3 µg) je nach Alter zum Zeitpunkt der Impfung zu erhalten.

Aktualisierung im Rahmen der Protokolländerung 6: Alle Teilnehmer erhalten eine dritte Dosis BNT162b2. Bei Teilnehmern ≥ 6 Monate bis < 5 Jahre erfolgt die dritte Dosis mindestens 8 Wochen nach der zweiten Dosis. Bei Teilnehmern im Alter von ≥ 5 bis < 12 Jahren wird die dritte Dosis mindestens 6 Monate nach der zweiten Dosis verabreicht. Das Intervall zwischen der zweiten und dritten Dosis richtet sich nach dem Alter des Teilnehmers zum Zeitpunkt der Einschreibung. Die Dosishöhe der zweiten und dritten Dosis von BNT162b2 richtet sich nach dem Alter zum Zeitpunkt der Impfung: Teilnehmer, die zum Zeitpunkt der zweiten/dritten Dosis < 5 Jahre alt sind, erhalten die Dosis von 3 µg, Teilnehmer ≥ 5 bis Personen unter 12 Jahren zum Zeitpunkt der zweiten/dritten Dosis erhalten die 10-µg-Dosis und Teilnehmer, die zum Zeitpunkt der zweiten/dritten Dosis ≥ 12 Jahre alt sind, erhalten die 30-µg-Dosis.

Phase 2/3 Niedrigere Dosisbewertung

Ist der Open-Label-Teil der Studie, der die Sicherheit, Verträglichkeit und Immunogenität des ausgewählten Dosierungsplans in jeder Altersgruppe aus der Phase-1-Evaluierung mit niedrigerer Dosis mit insgesamt etwa 600 aktiven Teilnehmern bewertet.

Ungefähr 300 aktive Teilnehmer in jeder Altersgruppe in dieser Phase werden 1 Monat nach Dosis 2 zur Immunbrückenanalyse und 6 und 12 Monate nach Dosis 2 zur Gesamtanalyse der Persistenz der Immunantwort beitragen.

Phase 2/3 Gewinnung von Serumproben für potenzielle Troponin-I-Tests

Wenn die Untersuchung des Troponin-I-Spiegels bei Personen, die kein BNT162b2 erhalten haben, darauf hindeutet, dass der Troponin-I-Spiegel ein zuverlässiger Indikator für eine potenzielle subklinische Myokarditis sein könnte, kann die Entnahme von Serumproben für potenzielle Troponin-I-Tests während des Zeitraums mit erhöhtem Risiko einer klinischen Myokarditis helfen, das Fehlen zu charakterisieren / Vorhandensein und Häufigkeit einer subklinischen Myokarditis. Zur Bewertung wird eine zusätzliche Gruppe von Teilnehmern eingeschlossen: ≥5 bis <12 Jahre: randomisiert 2:1, um BNT162b2 10 µg oder Placebo zu erhalten, und ≥12 bis <16 Jahre: unverblindeter Erhalt von BNT162b2 30 µg.

Aktualisierung im Rahmen der Protokolländerung 7: Alle Teilnehmer erhalten eine dritte Dosis BNT162b2. Bei allen Teilnehmern (≥5 bis <12 und ≥12 bis <16 Jahre) wird die dritte Dosis mindestens 5 Monate nach Dosis 2 verabreicht.

Die Dosierung der zweiten und dritten Dosis von BNT162b2 richtet sich nach dem Alter zum Zeitpunkt der Impfung: Teilnehmer im Alter von ≥ 5 bis < 12 Jahren zum Zeitpunkt der zweiten/dritten Dosis erhalten die Dosierung von 10 µg und Teilnehmer, die zum Zeitpunkt der zweiten/dritten Dosis ≥ 12 Jahre alt sind, erhalten die Dosis von 30 µg.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

11837

Phase

Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

6 Monate bis 18 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Beschreibung

Einschlusskriterien

Männliche oder weibliche Teilnehmer im Alter von ≥ 6 Monaten bis < 12 Jahren zum Zeitpunkt der Randomisierung bei Besuch 1 für die Dosisfindung/Evaluierung der ausgewählten Dosis und für Teilnehmer im Alter von ≥ 12 bis < 18 Jahren zum Zeitpunkt der Randomisierung , bei Besuch 1 für die Bewertung der niedrigeren Dosis. Für den Teil der Studie zur Gewinnung von Serumproben für potenzielle Troponin I-Tests: Männliche oder weibliche Teilnehmer zwischen ≥ 5 und < 16 Jahren.
Die Eltern/Erziehungsberechtigten der Teilnehmer und Teilnehmer, je nach Alter, die bereit und in der Lage sind, alle geplanten Besuche, den Behandlungsplan, Labortests, Überlegungen zum Lebensstil und andere Studienverfahren einzuhalten.
Gesunde Teilnehmer, bei denen anhand der Anamnese, der körperlichen Untersuchung und des klinischen Urteils des Prüfarztes festgestellt wurde, dass sie für die Aufnahme in die Studie geeignet sind.
Hinweis: Gesunde Teilnehmer mit vorbestehender stabiler Krankheit, definiert als Krankheit, die keine signifikante Änderung der Therapie oder Krankenhausaufenthalt wegen Verschlechterung der Krankheit während der 6 Wochen vor der Einschreibung erfordert, können eingeschlossen werden.
Von den Teilnehmern wird erwartet, dass sie für die Dauer der Studie zur Verfügung stehen und deren Eltern/Erziehungsberechtigte während der Studienteilnahme telefonisch erreichbar sind.
Negativer Urin-Schwangerschaftstest für Teilnehmerinnen, die biologisch kinderfähig sind.
Weibliche Teilnehmerin im gebärfähigen Alter oder männliche Teilnehmerin, die Kinder zeugen kann und bereit ist, eine hochwirksame Verhütungsmethode wie in diesem Protokoll beschrieben für mindestens 28 Tage nach der letzten Dosis der Studienintervention anzuwenden, wenn das Risiko einer Schwangerschaft mit ihrem/seinem Partner besteht ; oder weiblicher Teilnehmer, der nicht im gebärfähigen Alter ist, oder männlicher Teilnehmer, der nicht in der Lage ist, Kinder zu zeugen.
Der Teilnehmer oder die Eltern/Erziehungsberechtigten des Teilnehmers sind in der Lage, eine unterzeichnete Einverständniserklärung abzugeben, die die Einhaltung der Anforderungen und Einschränkungen umfasst, die im ICD und in diesem Protokoll aufgeführt sind. Je nach Alter des Teilnehmers und gemäß den örtlichen Anforderungen werden die Teilnehmer auch um eine entsprechende Zustimmung (mündlich oder schriftlich) gebeten.

Ausschlusskriterien

Nur Phase 1: Früher klinisch (basierend auf COVID-19-Symptomen/-Anzeichen allein, wenn kein SARS-CoV-2-NAAT-Ergebnis verfügbar war) oder mikrobiologisch (basierend auf COVID-19-Symptomen/-Anzeichen und einem positiven SARS-CoV-2-NAAT-Ergebnis) Diagnose von COVID 19.
Nur Phase 1: Bekannte Infektion mit HIV, HCV oder HBV.
Erhalt von Medikamenten zur Vorbeugung von COVID-19.
Frühere oder aktuelle Diagnose von MIS-C.
Andere medizinische oder psychiatrische Erkrankungen, einschließlich kürzlich aufgetretener (innerhalb des letzten Jahres) oder aktiver Suizidgedanken/-verhalten oder Laboranomalien, die das Risiko einer Studienteilnahme erhöhen oder den Teilnehmer nach Einschätzung des Prüfarztes für die Studie ungeeignet machen können. Hinweis: Dies schließt sowohl Zustände ein, die das mit der Verabreichung der Studienintervention verbundene Risiko erhöhen können, als auch Zustände, die die Interpretation der Studienergebnisse beeinträchtigen können
Vorgeschichte schwerer Nebenwirkungen im Zusammenhang mit einem Impfstoff und/oder einer schweren allergischen Reaktion (z. B. Anaphylaxie) auf eine Komponente der Studienintervention(en).
Immungeschwächte Personen mit bekannter oder vermuteter Immunschwäche, wie anhand der Anamnese und/oder Labor-/Körperuntersuchung festgestellt.
Personen mit einer Autoimmunerkrankung in der Vorgeschichte oder einer aktiven Autoimmunerkrankung, die eine therapeutische Intervention erfordert, einschließlich, aber nicht beschränkt auf systemischen Lupus erythematodes. Hinweis: Stabiler Typ-1-Diabetes und Hypothyreose sind erlaubt.
Blutende Diathese oder Zustand im Zusammenhang mit verlängerten Blutungen, die nach Meinung des Prüfarztes eine intramuskuläre Injektion kontraindizieren würden.
Schwangere oder stillende Frauen.
Vorherige Impfung mit einem Coronavirus-Impfstoff.
Personen, die eine Behandlung mit immunsuppressiver Therapie erhalten, einschließlich zytotoxischer Wirkstoffe oder systemischer Kortikosteroide, z. B. wegen Krebs oder einer Autoimmunerkrankung, oder die während der gesamten Studie eine geplante Behandlung erhalten. Wenn systemische Kortikosteroide kurzfristig (< 14 Tage) zur Behandlung einer akuten Erkrankung verabreicht wurden, sollten die Teilnehmer nicht in die Studie aufgenommen werden, bis die Kortikosteroidtherapie mindestens 28 Tage vor der Verabreichung der Studienintervention unterbrochen wurde. Inhalative/vernebelte, intraartikuläre, intrabursale oder topische (Haut oder Augen) Kortikosteroide sind erlaubt.
Erhalt von Blut-/Plasmaprodukten, Immunglobulin oder monoklonalen Antikörpern ab 60 Tagen vor der Verabreichung der Studienintervention oder Erhalt einer für COVID-19 spezifischen passiven Antikörpertherapie ab 90 Tagen vor der Verabreichung der Studienintervention oder geplanter Erhalt während der gesamten Studie.
Teilnahme an anderen Studien mit Studienintervention innerhalb von 28 Tagen vor Studieneintritt und/oder während der Studienteilnahme.
Vorherige Teilnahme an anderen Studien mit Studieninterventionen, die LNPs enthalten.
Teilnehmer, die direkte Nachkommen (Kind oder Enkelkind) von Mitarbeitern des Prüfzentrums oder Pfizer/BioNTech-Mitarbeitern sind, die direkt an der Durchführung der Studie beteiligt sind, Mitarbeiter des Prüfzentrums, die anderweitig vom Prüfer beaufsichtigt werden, und ihre jeweiligen Familienmitglieder.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Hauptzweck: Verhütung
Zuteilung: Nicht randomisiert
Interventionsmodell: Parallele Zuordnung
Maskierung: Keine (Offenes Etikett)

Anzahl der Arme

Waffen und Interventionen

Teilnehmergruppe / Arm	Intervention / Behandlung
Experimental: Niedrige/mittlere Dosis, ≥5 bis <12 Jahre Niedrige/mittlere Dosis (10 mcg), 2 Dosen im Abstand von 21 Tagen	Biologisch: Biologisch/Impfstoff: BNT162b2 10mcg BNT162b2 Low/Mid-Dose (10mcg) Level
Experimental: Mittlere Dosis, ≥5 bis <12 Jahre Mittlere Dosis (20 mcg), 2 Dosen im Abstand von 21 Tagen	Biologisch: BNT162b2 20mcg BNT162b2 mittlere Dosis (20 mcg) Ebene
Experimental: Hochdosiert, ≥5 bis <12 Jahre Hochdosis (30 mcg), 2 Dosen im Abstand von 21 Tagen	Biologisch: BNT162b2 30 mcg BNT162b2 Hochdosiertes (30mcg) Niveau
Experimental: Niedrige/mittlere Dosis, ≥2 bis < 5 Jahre Niedrige/mittlere Dosis (10 mcg), 2 Dosen im Abstand von 21 Tagen	Biologisch: Biologisch/Impfstoff: BNT162b2 10mcg BNT162b2 Low/Mid-Dose (10mcg) Level
Experimental: Mittlere Dosis, ≥2 bis <5 Jahre Mittlere Dosis (20 mcg), 2 Dosen im Abstand von 21 Tagen	Biologisch: BNT162b2 20mcg BNT162b2 mittlere Dosis (20 mcg) Ebene
Experimental: Hochdosiert, ≥2 bis <5 Jahre Hochdosiert (30 mcg), 2 Dosen im Abstand von 21 Tagen	Biologisch: BNT162b2 30 mcg BNT162b2 Hochdosiertes (30mcg) Niveau
Experimental: Niedrige/mittlere Dosis, ≥6 Monate bis <2 Jahre Niedrige/mittlere Dosis (10 mcg), 2 Dosen im Abstand von 21 Tagen	Biologisch: Biologisch/Impfstoff: BNT162b2 10mcg BNT162b2 Low/Mid-Dose (10mcg) Level
Experimental: Mittlere Dosis, ≥6 Monate bis <2 Jahre Mittlere Dosis (20 mcg), 2 Dosen im Abstand von 21 Tagen	Biologisch: BNT162b2 20mcg BNT162b2 mittlere Dosis (20 mcg) Ebene
Experimental: Hochdosiert, ≥6 Monate bis <2 Jahre Hochdosiert (30 mcg), 2 Dosen im Abstand von 21 Tagen	Biologisch: BNT162b2 30 mcg BNT162b2 Hochdosiertes (30mcg) Niveau
Placebo-Komparator: Placebo, ≥6 Monate bis <2 Jahre	Sonstiges: Placebo Intramuskuläre Injektion
Placebo-Komparator: Placebo, ≥2 bis <5 Jahre	Sonstiges: Placebo Intramuskuläre Injektion
Placebo-Komparator: Placebo, ≥5 bis <12 Jahre	Sonstiges: Placebo Intramuskuläre Injektion
Experimental: Niedrig dosiert, ≥6 Monate bis <2 Jahre Low-Dose (3mcg), 2 Dosen im Abstand von 21 Dosen	Biologisch: Biologisch/Impfstoff: BNT162b2 3mcg BNT162b2 Low-Dose (3mcg) Level
Experimental: Low-Dose, ≥2 bis <5 Jahre Low-Dose (3mcg), 2 Dosen im Abstand von 21 Tagen	Biologisch: Biologisch/Impfstoff: BNT162b2 3mcg BNT162b2 Low-Dose (3mcg) Level
Experimental: Hochdosiert, 12 bis <16 Jahre (Troponin-I-Test) Hochdosiert (30 mcg), 3 Dosen	Biologisch: BNT162b2 30 mcg BNT162b2 Hochdosiertes (30mcg) Niveau
Experimental: Niedrige/mittlere Dosis, ≥5 bis <12 Jahre (Troponin-I-Test) Niedrige/mittlere Dosis (10 mcg), 3 Dosen	Biologisch: Biologisch/Impfstoff: BNT162b2 10mcg BNT162b2 Low/Mid-Dose (10mcg) Level
Experimental: Placebo, ≥5 bis <12 Jahre (Troponin-I-Test)	Sonstiges: Placebo Intramuskuläre Injektion
Experimental: Niedrig dosiert, ≥ 6 Monate bis < 2 Jahre (3-Dosen-Schema) Low-Dose (3mcg), 3 Dosen	Biologisch: Biologisch/Impfstoff: BNT162b2 3mcg BNT162b2 Low-Dose (3mcg) Level
Experimental: Niedrig dosiert, ≥ 2 bis < 5 Jahre (3-Dosen-Schema) Low-Dose (3mcg), 3 Dosen	Biologisch: Biologisch/Impfstoff: BNT162b2 3mcg BNT162b2 Low-Dose (3mcg) Level
Placebo-Komparator: Placebo, ≥ 6 Monate bis < 2 Jahre (3-Dosen-Schema)	Sonstiges: Placebo Intramuskuläre Injektion
Placebo-Komparator: Placebo, ≥2 bis <5 Jahre (3-Dosen-Schema)	Sonstiges: Placebo Intramuskuläre Injektion

Was misst die Studie?

Primäre Ergebnismessungen

Sekundäre Ergebnismessungen

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

BioNTech SE

Mitarbeiter

Pfizer

Ermittler

Studienleiter: Pfizer CT.gov Call Center, Pfizer

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

24. März 2021

Primärer Abschluss (Tatsächlich)

4. Oktober 2023

Studienabschluss (Tatsächlich)

8. Dezember 2023

Studienanmeldedaten

Zuerst eingereicht

19. März 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. März 2021

Zuerst gepostet (Tatsächlich)

25. März 2021

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

26. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

C4591007
2020-005442-42 (EudraCT-Nummer)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur SARS-CoV-2-Infektion, COVID-19

Pfizer

Aktiv, nicht rekrutierend

Eine Studie, um zu erfahren, wie gut jährliche Aktualisierungen der Covid-19-Impfstoffarbeit zum Schutz der Menschen vor Covid-19 und wie viel Geld Menschen für das Gesundheitswesen für Covid-19 ausgeben

COVID-19 | Coronavirus-Krankheit 2019 (COVID-19) | Covid-19 Infektion | Covid-19 Impfungen | SARS-CoV-2-Infektion, COVID19 | COVID-19-Impfung | SARS-CoV-2-Infektion, COVID-19 | COVID-19 (Coronavirus-Krankheit 2019) | COVID-19 SARS-CoV-2-Infektion

Vereinigte Staaten
The Institute of Molecular and Translational Medicine...
University Hospital Olomouc; Palacky University

Abgeschlossen

Studie SARS-CoV-2-CZ-PREVAL-II - Arm der Region Olomouc

SARS-CoV-2 | SARS-CoV-2 (COVID-19) Infektion

Tschechien
AstraZeneca

Abgeschlossen

Studie zur intramuskulären Injektion oder intravenösen Infusion von AZD3152 bei gesunden japanischen erwachsenen Teilnehmern

COVID-19, SARS-CoV-2

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

Abgeschlossen

Sind SARS-CoV-2-spezifische Antikörper ein Korrelat für den Schutz? (ImmCoV)

COVID-19 | SARS-CoV-2

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

Abgeschlossen

Sicherheit, Verträglichkeit und Pharmakokinetik von SAB-185 bei gesunden Teilnehmern

COVID-19 | SARS-CoV-2

Vereinigte Staaten
University of Wisconsin, Madison
National Institutes of Health (NIH)

Abgeschlossen

Wiederholungstest auf SARS-CoV-2

COVID-19 | SARS-CoV-2

Vereinigte Staaten
Syneos Health
US Specialty Formulations, LLC

Abgeschlossen

Erste am Menschen durchgeführte Studie zu oral verabreichtem CoV2-OGEN1 bei gesunden Probanden

SARS-CoV-2 (COVID-19)

Neuseeland
Mayo Clinic

Abgeschlossen

Seroprevalence of SARS CoV 2 Antibodies in Previously Undiagnosed Healthcare Workers

COVID-19 | SARS-CoV-2

Vereinigte Staaten
University of Valladolid

Abgeschlossen

Auswirkungen der Elevation Training Maske bei CrossFit®-Infektion mit der SARS-CoV-2. (ETMEXCOVID)

SARS-CoV-2-Infektion (symptomatisch) | COVID-19 Lungenkomplikationen | SARS-CoV-2-positive Patienten | COVID19-Infektion mit SARS-CoV-2-Virus

Spanien
Medical University Innsbruck

Rekrutierung

Neurological Outcome After SARS-CoV-2 Infection (ATTRACT)

SARS-CoV-2 | Postakutes COVID-19-Syndrom

Österreich

Klinische Studien zur Placebo

Galderma R&D

Abgeschlossen

Wirkung von CD07805/47 Gel bei Rosacea Flushing

Rosazea

Deutschland
SamA Pharmaceutical Co., Ltd

Unbekannt

Klinische Studien zur Bewertung der Wirksamkeit und Sicherheit von HLIM

Akute Bronchitis | Akute Infektion der oberen Atemwege

Korea, Republik von
National Institute on Drug Abuse (NIDA)

Abgeschlossen

Auswirkungen der Verabreichungswege von Cannabis auf die menschliche Leistungsfähigkeit und Pharmakokinetik

Cannabiskonsum

Vereinigte Staaten
AstraZeneca
Parexel; Spandauer Damm 130; 14050; Berlin, Germany

Abgeschlossen

Bewertung der Sicherheit, Verträglichkeit und Pharmakodynamik nach Verabreichung einer Dosis von AZD8601 an männliche Patienten mit Diabetes mellitus Typ II (T2DM)

Männliche Probanden mit Typ-II-Diabetes (T2DM)

Deutschland
Cellmedis
Medical Network Sp. z o.o.

Noch keine Rekrutierung

New Topical tReatment Options for Symptomatic patiEnts With Nonerosive gastroesophageaL Reflux dIsease: rEsults oF a Single-center, Randomized, Double-blind, Placebo-controlled Crossover Trial. (The RELIEF Trial) (RELIEF)

GERD (Gastroösophageale Refluxkrankheit) | NERD

Polen
Texas A&M University
Nutrabolt

Abgeschlossen

Glycemic Response of a Commercial Food Bar (NB16)

Glukose- und Insulinreaktion
Instituto de Investigación Hospital Universitario...
Creaciones Aromáticas Industriales, S.A. (CARINSA)

Abgeschlossen

Wirkung von Fleischderivaten und Sättigungsmitteln auf das Sättigungsgefühl (SACIMEAT)

Übergewicht

Spanien
Soroka University Medical Center

Abgeschlossen

Effect of Probiotics in Childhood Abdominal Pain

Bauchschmerzen

Israel
Regado Biosciences, Inc.

Abgeschlossen

Safety, Tolerability and PK/PD of RB006 in a Healthy Volunteer SAD (SC101)

Gesunder Freiwilliger

Vereinigte Staaten
Heptares Therapeutics Limited

Abgeschlossen

Pharmakokinetik oraler Kapseln bei gesunden japanischen und kaukasischen Probanden (HTL0018318)

Pharmakokinetik | Sicherheitsprobleme

Vereinigtes Königreich

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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)

Ergebnis Maßnahme	Maßnahmenbeschreibung	Zeitfenster
Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=5 to <12 Years of Age Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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 Zeitfenster: 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

Eine Phase-1/2/3-Studie zur Bewertung der Sicherheit, Verträglichkeit und Immunogenität eines RNA-Impfstoffkandidaten gegen COVID-19 bei gesunden Kindern und jungen Erwachsenen

EINE PHASE-1-STUDIE ZUR BEWERTUNG DER SICHERHEIT, VERTRÄGLICHKEIT UND IMMUNOGENITÄT UND PHASE-2/3-PLACEBO-KONTROLLIERTE, BEOBACHTERVERBLINDETE SICHERHEITS-, VERTRÄGLICHKEITS- UND IMMUNGENITÄTSSTUDIE EINES SARS-COV-2-RNA-IMPFKANDIDATEN GEGEN COVID -19 BEI GESUNDEN KINDERN UND JUNGEN ERWACHSENEN

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