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Een fase 1/2/3-onderzoek om de veiligheid, verdraagbaarheid en immunogeniciteit van een RNA-vaccinkandidaat tegen COVID-19 bij gezonde kinderen en jonge volwassenen te evalueren

26 mei 2026 bijgewerkt door: BioNTech SE

EEN FASE 1, OPEN-LABEL DOSISBEVINDINGSONDERZOEK OM DE VEILIGHEID, VERDRAAGBAARHEID EN IMMUNOGENITEIT TE EVALUEREN EN FASE 2/3 PLACEBOGECONTROLEERDE, DOOR WAARNEMER GEBLINDE VEILIGHEIDS-, VERDRAAGBAARHEID EN IMMUNOGENITEITSONDERZOEK VAN EEN SARS-COV-2 RNA-VACCINOKANDIDAAT TEGEN COVID -19 BIJ GEZONDE KINDEREN EN JONG VOLWASSENEN

Dit is een fase 1/2/3 studie bij gezonde kinderen en jonge volwassenen.

Afhankelijk van veiligheids- en/of immunogeniciteitsgegevens die in de loop van dit onderzoek zijn gegenereerd, en de resulterende beoordeling van baten en risico's, kunnen vervolgens de veiligheid, verdraagbaarheid en immunogeniciteit van BNT162b2 bij deelnemers <6 maanden oud worden geëvalueerd.

Studie Overzicht

Toestand

Voltooid

Conditie

SARS-CoV-2-infectie, COVID-19

Interventie / Behandeling

Gedetailleerde beschrijving

Fase 1 dosisbepaling

Is het open-label dosisbepalingsgedeelte van het onderzoek dat de veiligheid, verdraagbaarheid en immunogeniciteit van BNT162b2 zal evalueren, toegediend volgens een schema van 2 doses (gescheiden door ongeveer 21 dagen) in maximaal 3 leeftijdsgroepen (deelnemers ≥5 tot <12 jaar, ≥2 tot <5 jaar en ≥6 maanden tot <2 jaar).

In dit onderzoek wordt gestart met het bepalen van de dosis bij deelnemers van ≥5 tot <12 jaar op basis van de aanvaardbare geblindeerde veiligheidsbeoordeling van de dosis van 30 µg bij 12- tot 15-jarigen in het C4591001-onderzoek.

Het doel van fase 1 is om voorkeursdosisniveau(s) van BNT162b2 te identificeren uit maximaal 3 verschillende dosisniveaus in elke leeftijdsgroep.

Afhankelijk van veiligheids- en/of immunogeniciteitsgegevens die in de loop van dit onderzoek zijn gegenereerd, is het mogelijk dat dosisniveaus niet worden gestart, vroegtijdig worden beëindigd en/of worden toegevoegd met dosisniveaus onder de laagst vermelde dosis.

Update als onderdeel van protocolamendement 6: Alle deelnemers krijgen een derde dosis BNT162b2. Voor deelnemers ≥6 maanden tot <5 jaar zal de derde dosis ten minste 8 weken na de tweede dosis plaatsvinden. Bij deelnemers ≥5 tot <12 jaar zal de derde dosis minstens 6 maanden na de tweede dosis plaatsvinden. Het interval tussen de tweede en derde dosis is gebaseerd op de leeftijd van de deelnemer op het moment van inschrijving. Het dosisniveau van de derde dosis BNT162b2 zal gebaseerd zijn op de leeftijd op het moment van vaccinatie: deelnemers <5 jaar oud op het moment van de derde dosis krijgen het dosisniveau van 3 µg, deelnemers ≥5 tot <12 jaar leeftijd op het moment van de derde dosis krijgt het dosisniveau van 10 µg, en deelnemers ≥12 jaar oud op het moment van de derde dosis krijgen het dosisniveau van 30 µg.

Bij de deelnemers wordt voorafgaand aan zowel Dosis 1 als Dosis 2 en 7 dagen na Dosis 2 bloed afgenomen om de immunogeniciteit te beoordelen om het geselecteerde BNT162b2-dosisniveau voor Fase 2/3 te bepalen. Bij deelnemers wordt ook bloed afgenomen voorafgaand aan dosis 3 en 1, 6 en 12 maanden na dosis 3.

Fase 1 evaluatie met lagere dosis

Is het open-label evaluatiegedeelte met lagere dosis van het onderzoek dat de veiligheid, verdraagbaarheid en immunogeniciteit zal evalueren van 10 µg BNT162b2 uit 2 schema's in 2 leeftijdsgroepen (deelnemers van 12 tot <16 jaar en 16 tot <18 jaar) .

Het doel van de fase 1-evaluatie met een lagere dosis is het evalueren van de veiligheid en immunogeniciteit van BNT162b2 uit 2 verschillende doseringsschema's in elke leeftijdsgroep: (1) 2 doses met een tussenpoos van ongeveer 21 dagen en (2) 2 doses met een tussenpoos van ongeveer 8 weken .

Bij deelnemers wordt voorafgaand aan dosis 1, voorafgaand aan dosis 2, 7 dagen na dosis 2 en 1 maand na dosis 2 bloed afgenomen om de immunogeniciteit te beoordelen om het geselecteerde BNT162b2-dosisschema te bepalen voor het fase 2/3-evaluatiegedeelte met lagere dosis van de studie. Bovendien zullen deelnemers 6 en 12 maanden na dosis 2 bloed laten afnemen om de persistentie van de immuunrespons te bepalen.

Fase 2/3 geselecteerde dosis

Is het gedeelte van het onderzoek dat de veiligheid, verdraagbaarheid en immunogeniciteit in elke leeftijdsgroep zal evalueren bij het geselecteerde dosisniveau uit het fase 1-dosisbepalingsgedeelte van het onderzoek. De werkzaamheid zal worden geëvalueerd binnen of tussen leeftijdsgroepen waarin immunobridging succesvol is, afhankelijk van de toename van een voldoende aantal gevallen in die leeftijdsgroepen.

Bij de deelnemers zal bloed worden afgenomen bij baseline voorafgaand aan dosis 1 en 6 maanden na dosis 2. Immunobridging voor deelnemers van 16 tot 25 jaar in de C4591001-studie zal gebaseerd zijn op immunogeniciteitsgegevens verzameld bij (1) baseline en 1 maand na dosis 2 en (2) basislijn en 1 maand na dosis 3. De persistentie van de immuunrespons zal gebaseerd zijn op immunogeniciteitsgegevens verzameld bij deelnemers bij (1) basislijn en 1 en 6 maanden na dosis 2 en (2) basislijn en 1, 6, 12 en 18 maanden na dosis 3. Daarnaast zal de werkzaamheid tegen bevestigde COVID-19 en tegen asymptomatische infectie ook worden beoordeeld bij deelnemers van ≥5 tot <12 jaar.

Op aangewezen locaties in de VS zal voorafgaand aan dosis 1 en 7 dagen en 6 maanden na dosis 2 een aanvullend optioneel volbloedmonster van ongeveer 10 ml worden verkregen bij maximaal ongeveer 60 deelnemers ≥10 jaar oud. Er zullen extra monsters worden genomen vóór dosis 3 en 1 maand na dosis 3 (alleen originele BNT162b2-groep). Deze monsters zullen op verkennende basis worden gebruikt om de celgemedieerde immuunrespons na vaccinatie op deze tijdstippen te onderzoeken.

Bij het vervolgbezoek na 6 maanden worden alle deelnemers gedeblindeerd. Deelnemers die oorspronkelijk een placebo kregen, krijgen de kans om BNT162b2 te krijgen als onderdeel van het onderzoek. Deelnemers die oorspronkelijk een placebo kregen en in aanmerking komen voor ontvangst van BNT162b2 of een ander COVID-19-vaccin volgens lokale of nationale aanbevelingen voorafgaand aan het follow-upbezoek van 6 maanden (bezoek 5 of 405) (afzonderlijk gedetailleerd en beschikbaar in het elektronische onderzoeksreferentieportaal) ) de kans krijgen om BNT162b2 (10 µg of 3 µg) te krijgen op basis van de leeftijd op het moment van vaccinatie.

Update als onderdeel van protocolamendement 6: Alle deelnemers krijgen een derde dosis BNT162b2. Voor deelnemers ≥6 maanden tot <5 jaar zal de derde dosis ten minste 8 weken na de tweede dosis plaatsvinden. Bij deelnemers ≥5 tot <12 jaar zal de derde dosis minstens 6 maanden na de tweede dosis plaatsvinden. Het interval tussen de tweede en derde dosis is gebaseerd op de leeftijd van de deelnemer op het moment van inschrijving. Het dosisniveau van de tweede en derde dosis BNT162b2 zal gebaseerd zijn op de leeftijd op het moment van vaccinatie: deelnemers <5 jaar oud op het moment van de tweede/derde dosis krijgen het dosisniveau van 3 µg, deelnemers ≥5 tot <12 jaar oud op het moment van de tweede/derde dosis krijgt het dosisniveau van 10 µg, en deelnemers ≥12 jaar oud op het moment van de tweede/derde dosis krijgen het dosisniveau van 30 µg.

Fase 2/3 evaluatie met lagere dosis

Is het open-label gedeelte van het onderzoek dat de veiligheid, verdraagbaarheid en immunogeniciteit van het geselecteerde dosisschema in elke leeftijdsgroep van de fase 1-evaluatie met lagere dosis zal evalueren, met in totaal ongeveer 600 actieve deelnemers.

Ongeveer 300 actieve deelnemers in elke leeftijdsgroep in deze fase zullen bijdragen aan de immunooverbruggingsanalyse 1 maand na dosis 2 en de algehele analyse van de persistentie van de immuunrespons 6 en 12 maanden na dosis 2.

Fase 2/3 Serummonsters verkrijgen voor potentiële troponine I-testen

Als het testen van troponine I-spiegels bij personen die geen BNT162b2 hebben gekregen aangeeft dat troponine I-spiegel een betrouwbare indicator zou kunnen zijn van mogelijke subklinische myocarditis, kan het verkrijgen van serummonsters voor mogelijke troponine I-testen tijdens de periode van verhoogd risico op klinische myocarditis helpen bij het karakteriseren van de afwezigheid /aanwezigheid en frequentie van subklinische myocarditis. Ter beoordeling wordt een extra groep deelnemers opgenomen: ≥5 tot <12 jaar: 2:1 gerandomiseerd om BNT162b2 10 µg of placebo te krijgen, en ≥12 tot <16 jaar: open-label ontvangst van BNT162b2 30 µg.

Update als onderdeel van protocolamendement 7: Alle deelnemers krijgen een derde dosis BNT162b2. Voor alle deelnemers (≥5 tot <12 en ≥12 tot <16 jaar) zal de derde dosis ten minste 5 maanden na dosis 2 plaatsvinden.

Het dosisniveau van de tweede en derde dosis BNT162b2 zal gebaseerd zijn op de leeftijd op het moment van vaccinatie: deelnemers ≥5 tot <12 jaar oud op het moment van de tweede/derde dosis krijgen het dosisniveau van 10 µg, en deelnemers ≥12 jaar oud op het moment van de tweede/derde dosis krijgen het dosisniveau van 30 µg.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

11837

Fase

Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

6 maanden tot 18 jaar (Kind)

Accepteert gezonde vrijwilligers

Beschrijving

Inclusiecriteria

Mannelijke of vrouwelijke deelnemers ≥6 maanden tot <12 jaar oud, op het moment van randomisatie, bij bezoek 1 voor de dosisbepaling/geselecteerde dosisevaluatie en voor deelnemers van ≥12 tot <18 jaar, op het moment van randomisatie , bij Bezoek 1 voor de evaluatie van de lagere dosis. Voor het gedeelte van het onderzoek om serummonsters te verkrijgen voor potentiële troponine I-testen: mannelijke of vrouwelijke deelnemers tussen ≥5 en <16 jaar.
De ouder(s)/wettelijke voogd(en) van de deelnemers en deelnemers, afhankelijk van de leeftijd, die bereid en in staat zijn om te voldoen aan alle geplande bezoeken, behandelplannen, laboratoriumtests, levensstijloverwegingen en andere onderzoeksprocedures.
Gezonde deelnemers die op basis van hun medische geschiedenis, lichamelijk onderzoek en klinisch oordeel van de onderzoeker worden bepaald om in aanmerking te komen voor opname in het onderzoek.
Opmerking: gezonde deelnemers met een reeds bestaande stabiele ziekte, gedefinieerd als een ziekte die geen significante verandering in de therapie of ziekenhuisopname vereist vanwege verergering van de ziekte gedurende de 6 weken voorafgaand aan inschrijving, kunnen worden opgenomen.
Van deelnemers wordt verwacht dat zij gedurende de duur van het onderzoek beschikbaar zijn en van wie de ouder(s)/wettelijke voogd telefonisch bereikbaar is tijdens deelname aan het onderzoek.
Negatieve urinezwangerschapstest voor vrouwelijke deelnemers die biologisch in staat zijn om kinderen te krijgen.
Vrouwelijke deelnemer in de vruchtbare leeftijd of mannelijke deelnemer die in staat is om kinderen te verwekken en die bereid is een zeer effectieve anticonceptiemethode te gebruiken zoals uiteengezet in dit protocol gedurende ten minste 28 dagen na de laatste dosis van de studie-interventie als ze het risico loopt zwanger te worden met haar/zijn partner ; of vrouwelijke deelnemer die geen kinderen kan krijgen of mannelijke deelnemer die geen kinderen kan verwekken.
De deelnemer of de ouder(s)/wettelijke voogd van de deelnemer is in staat om ondertekende geïnformeerde toestemming te geven, waaronder naleving van de vereisten en beperkingen vermeld in de ICD en in dit protocol. Afhankelijk van de leeftijd van de deelnemer en in overeenstemming met de lokale vereisten, wordt de deelnemers ook gevraagd om hun instemming te verlenen (mondeling of schriftelijk).

Uitsluitingscriteria

Alleen fase 1: in het verleden klinisch (op basis van alleen COVID-19-symptomen/-tekenen, als er geen SARS CoV 2 NAAT-resultaat beschikbaar was) of microbiologisch (op basis van COVID-19-symptomen/-tekenen en een positief SARS-CoV-2 NAAT-resultaat) diagnose van COVID 19.
Alleen fase 1: bekende infectie met HIV, HCV of HBV.
Ontvangst van medicijnen bedoeld om COVID-19 te voorkomen.
Vorige of huidige diagnose van MIS-C.
Andere medische of psychiatrische aandoeningen, waaronder recente (in het afgelopen jaar) of actieve zelfmoordgedachten/-gedrag of laboratoriumafwijkingen die het risico op deelname aan het onderzoek kunnen verhogen of, naar het oordeel van de onderzoeker, de deelnemer ongeschikt kunnen maken voor het onderzoek. Opmerking: dit omvat zowel aandoeningen die het risico kunnen verhogen dat gepaard gaat met de toediening van onderzoeksinterventie als een aandoening die de interpretatie van onderzoeksresultaten kan verstoren.
Voorgeschiedenis van ernstige bijwerkingen geassocieerd met een vaccin en/of ernstige allergische reactie (bijv. anafylaxie) op een onderdeel van de onderzoeksinterventie(s).
Immuungecompromitteerde personen met bekende of vermoede immunodeficiëntie, zoals bepaald door anamnese en/of laboratorium-/lichamelijk onderzoek.
Personen met een voorgeschiedenis van auto-immuunziekte of een actieve auto-immuunziekte die therapeutische interventie vereist, inclusief maar niet beperkt tot systemische lupus erythematosus. Let op: Stabiele diabetes type 1 en hypothyreoïdie zijn toegestaan.
Bloeddiathese of aandoening geassocieerd met langdurige bloeding die, naar de mening van de onderzoeker, een contra-indicatie zou zijn voor intramusculaire injectie.
Vrouw die zwanger is of borstvoeding geeft.
Eerdere vaccinatie met elk coronavirusvaccin.
Individuen die behandeld worden met immunosuppressieve therapie, waaronder cytotoxische middelen of systemische corticosteroïden, bijvoorbeeld voor kanker of een auto-immuunziekte, of die gepland zijn tijdens het onderzoek. Als systemische corticosteroïden op korte termijn (<14 dagen) zijn toegediend voor de behandeling van een acute ziekte, mogen deelnemers niet worden opgenomen in het onderzoek totdat de behandeling met corticosteroïden is stopgezet gedurende ten minste 28 dagen vóór toediening van de onderzoeksinterventie. Geïnhaleerde/vernevelde, intra-articulaire, intrabursale of topische (huid of ogen) corticosteroïden zijn toegestaan.
Ontvangst van bloed-/plasmaproducten, immunoglobuline of monoklonale antilichamen, vanaf 60 dagen vóór de toediening van de onderzoeksinterventie, of ontvangst van een passieve antilichaamtherapie die specifiek is voor COVID-19 vanaf 90 dagen vóór de toediening van de onderzoeksinterventie, of geplande ontvangst gedurende de hele studie.
Deelname aan andere onderzoeken waarbij studieinterventie betrokken is binnen 28 dagen voorafgaand aan deelname aan het onderzoek en/of tijdens deelname aan het onderzoek.
Eerdere deelname aan andere onderzoeken met studie-interventie die LNP's bevat.
Deelnemers die directe afstammelingen zijn (kind of kleinkind) van medewerkers van de onderzoekslocatie of Pfizer/BioNTech-medewerkers die direct betrokken zijn bij de uitvoering van het onderzoek, locatiemedewerkers die anderszins onder toezicht staan van de onderzoeker, en hun respectievelijke familieleden.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Primair doel: Preventie
Toewijzing: Niet-gerandomiseerd
Interventioneel model: Parallelle opdracht
Masker: Geen (open label)

Aantal wapens

Wapens en interventies

Deelnemersgroep / Arm	Interventie / Behandeling
Experimenteel: Lage/middosis, ≥5 tot <12 jaar Lage/middelhoge dosis (10mcg), 2 doses met een tussenpoos van 21 dagen	Biologisch: Biologisch/vaccin: BNT162b2 10mcg BNT162b2 Lage/middeldosis (10mcg) niveau
Experimenteel: Gemiddelde dosering, ≥5 tot <12 jaar Mid-Dose, (20mcg), 2 doses met een tussenpoos van 21 dagen	Biologisch: BNT162b2 20mcg BNT162b2 Mid-Dosis (20mcg) niveau
Experimenteel: Hoge dosis, ≥5 tot <12 jaar Hoge dosis (30mcg), 2 doses met een tussenpoos van 21 dagen	Biologisch: BNT162b2 30mcg BNT162b2 Hooggedoseerd (30mcg) niveau
Experimenteel: Lage/middosis, ≥2 tot <5 jaar Lage/middelhoge dosis (10mcg), 2 doses met een tussenpoos van 21 dagen	Biologisch: Biologisch/vaccin: BNT162b2 10mcg BNT162b2 Lage/middeldosis (10mcg) niveau
Experimenteel: Middendosis, ≥2 tot <5 jaar Mid-Dose, (20mcg), 2 doses met een tussenpoos van 21 dagen	Biologisch: BNT162b2 20mcg BNT162b2 Mid-Dosis (20mcg) niveau
Experimenteel: Hoge dosis, ≥2 tot <5 jaar Hoge dosis, (30mcg), 2 doses met een tussenpoos van 21 dagen	Biologisch: BNT162b2 30mcg BNT162b2 Hooggedoseerd (30mcg) niveau
Experimenteel: Lage/middosis, ≥6 maanden tot <2 jaar Lage/middeldosis, (10mcg), 2 doses met een tussenpoos van 21 dagen	Biologisch: Biologisch/vaccin: BNT162b2 10mcg BNT162b2 Lage/middeldosis (10mcg) niveau
Experimenteel: Mid-dosis, ≥6 maanden tot <2 jaar Mid-Dose, (20mcg), 2 doses met een tussenpoos van 21 dagen	Biologisch: BNT162b2 20mcg BNT162b2 Mid-Dosis (20mcg) niveau
Experimenteel: Hoge dosis, ≥6 maanden tot <2 jaar Hoge dosis, (30mcg), 2 doses met een tussenpoos van 21 dagen	Biologisch: BNT162b2 30mcg BNT162b2 Hooggedoseerd (30mcg) niveau
Placebo-vergelijker: Placebo, ≥6 maanden tot <2 jaar	Ander: Placebo Intramusculaire injectie
Placebo-vergelijker: Placebo, ≥2 tot <5 jaar	Ander: Placebo Intramusculaire injectie
Placebo-vergelijker: Placebo, ≥5 tot <12 jaar	Ander: Placebo Intramusculaire injectie
Experimenteel: Lage dosis, ≥6 maanden tot <2 jaar Lage dosis (3mcg), 2 doses met 21 doses ertussen	Biologisch: Biologisch/vaccin: BNT162b2 3mcg BNT162b2 Lage dosis (3mcg) niveau
Experimenteel: Lage dosis, ≥2 tot <5 jaar Lage dosis (3mcg), 2 doses met een tussenpoos van 21 dagen	Biologisch: Biologisch/vaccin: BNT162b2 3mcg BNT162b2 Lage dosis (3mcg) niveau
Experimenteel: Hoge dosis, 12 tot <16 jaar (Troponine I-test) Hoge dosis (30mcg), 3 doses	Biologisch: BNT162b2 30mcg BNT162b2 Hooggedoseerd (30mcg) niveau
Experimenteel: Lage/middelhoge dosis, ≥5 tot <12 jaar (Troponine I-test) Lage/middeldosis (10mcg), 3 doses	Biologisch: Biologisch/vaccin: BNT162b2 10mcg BNT162b2 Lage/middeldosis (10mcg) niveau
Experimenteel: Placebo, ≥5 tot <12 jaar (Troponine I-test)	Ander: Placebo Intramusculaire injectie
Experimenteel: Lage dosis, ≥6 maanden tot <2 jaar (regime met 3 doses) Lage dosis (3mcg), 3 doses	Biologisch: Biologisch/vaccin: BNT162b2 3mcg BNT162b2 Lage dosis (3mcg) niveau
Experimenteel: Lage dosis, ≥2 tot <5 jaar (regime met 3 doses) Lage dosis (3mcg), 3 doses	Biologisch: Biologisch/vaccin: BNT162b2 3mcg BNT162b2 Lage dosis (3mcg) niveau
Placebo-vergelijker: Placebo, ≥6 maanden tot <2 jaar (regime met 3 doses)	Ander: Placebo Intramusculaire injectie
Placebo-vergelijker: Placebo, ≥2 tot <5 jaar (regime met 3 doses)	Ander: Placebo Intramusculaire injectie

Wat meet het onderzoek?

Primaire uitkomstmaten

Secundaire uitkomstmaten

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

BioNTech SE

Medewerkers

Pfizer

Onderzoekers

Studie directeur: Pfizer CT.gov Call Center, Pfizer

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

24 maart 2021

Primaire voltooiing (Werkelijk)

4 oktober 2023

Studie voltooiing (Werkelijk)

8 december 2023

Studieregistratiedata

Eerst ingediend

19 maart 2021

Eerst ingediend dat voldeed aan de QC-criteria

24 maart 2021

Eerst geplaatst (Werkelijk)

25 maart 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

26 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

C4591007
2020-005442-42 (EudraCT-nummer)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op SARS-CoV-2-infectie, COVID-19

IRCCS San Raffaele

Voltooid

Retrospectieve observationele studie van immuunrespons bij proefpersonen gevaccineerd tegen SARS-COV-2-infectie (BioVAC-immunit)

Antilichaam reactie | Cellulaire immuunrespons | SAR-CoV-2

Italië
Pfizer

Actief, niet wervend

Een studie om te leren over hoe goed jaarlijkse updates van het Covid-19-vaccinwerk om mensen te beschermen tegen COVID-19 en hoeveel geld mensen uitgeven aan gezondheidszorg voor Covid-19

COVID-19 | Coronavirusziekte 2019 (COVID-19) | Covid-19-besmetting | Covid-19-vaccins | SARS-CoV-2-infectie, COVID19 | COVID-19-vaccinatie | SARS-CoV-2-infectie, COVID-19 | COVID-19 (Coronavirusziekte 2019) | COVID-19 SARS-CoV-2-infectie

Verenigde Staten
Unity Health Toronto
Canadian Institutes of Health Research (CIHR); Health Canada

Nog niet aan het werven

Adaptief Platformonderzoek naar Behandelingen voor Luchtweginfecties in de Gemeenschap (TreatResp) (TreatResp)

Griep A | Influenza B | Acute luchtweginfecties (ARI's) | SAR-CoV-2

Canada
Mayo Clinic
National Institute of Neurological Disorders and Stroke (NINDS)

Voltooid

Langetermijneffecten van COVID-19

COVID-19 | SAR-CoV-2

Verenigde Staten
The Institute of Molecular and Translational Medicine...
University Hospital Olomouc; Palacky University

Voltooid

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

Tsjechië
AstraZeneca

Voltooid

Studie van AZD3152 intramusculaire injectie of intraveneuze infusie bij gezonde Japanse volwassen deelnemers

COVID-19, SARS-CoV-2

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

Voltooid

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COVID-19 | SARS-CoV-2

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

Voltooid

Veiligheid, verdraagbaarheid en farmacokinetiek van SAB-185 bij gezonde deelnemers

COVID-19 | SARS-CoV-2

Verenigde Staten
University of Wisconsin, Madison
National Institutes of Health (NIH)

Voltooid

Herhaal de tests voor SARS-CoV-2

COVID-19 | SARS-CoV-2

Verenigde Staten
Syneos Health
US Specialty Formulations, LLC

Voltooid

Eerste studie bij mensen van oraal toegediend CoV2-OGEN1 bij gezonde proefpersonen

SARS-CoV-2 (COVID-19)

Nieuw-Zeeland

Klinische onderzoeken op Placebo

Galderma R&D

Voltooid

Effect van CD07805/47-gel bij rosacea blozen

Rosacea

Duitsland
SamA Pharmaceutical Co., Ltd

Onbekend

Klinische proeven om de werkzaamheid en veiligheid van HLIM te beoordelen

Acute bronchitis | Acute bovenste luchtweginfectie

Korea, republiek van
National Institute on Drug Abuse (NIDA)

Voltooid

Effecten van cannabistoedieningsroutes op menselijke prestaties en farmacokinetiek

Cannabisgebruik

Verenigde Staten
Akeso

Nog niet aan het werven

Een klinische studie van AK120 bij adolescenten met matige tot ernstige atopische dermatitis

Atopische dermatitis

China
AstraZeneca
Parexel; Spandauer Damm 130; 14050; Berlin, Germany

Voltooid

Beoordeling van de veiligheid, verdraagbaarheid en farmacodynamiek na toediening van één dosis AZD8601 aan mannelijke patiënten met diabetes mellitus type II (T2DM)

Mannelijke proefpersonen met diabetes type II (T2DM)

Duitsland
Heptares Therapeutics Limited

Voltooid

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Farmacokinetiek | Veiligheid problemen

Verenigd Koninkrijk
Cellmedis
Medical Network Sp. z o.o.

Nog niet aan het werven

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)

GORZ (gastro-oesofageale refluxziekte) | NERD

Polen
Texas A&M University
Nutrabolt

Voltooid

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Glucose- en insuline -reactie
Soroka University Medical Center

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Buikpijn

Israël
Regado Biosciences, Inc.

Voltooid

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Gezonde vrijwilliger

Verenigde Staten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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)

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=5 to <12 Years of Age Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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 Tijdsspanne: 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

Een fase 1/2/3-onderzoek om de veiligheid, verdraagbaarheid en immunogeniciteit van een RNA-vaccinkandidaat tegen COVID-19 bij gezonde kinderen en jonge volwassenen te evalueren

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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

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