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Badanie fazy 1/2/3 oceniające bezpieczeństwo, tolerancję i immunogenność kandydata na szczepionkę RNA przeciwko COVID-19 u zdrowych dzieci i młodych dorosłych

26 maja 2026 zaktualizowane przez: BioNTech SE

FAZA 1, OTWARTE BADANIE W CELU USTALENIA DAWKI W CELU OCENY BEZPIECZEŃSTWA, TOLERANCJI I IMMUNOGENNOŚCI ORAZ FAZY 2/3 BADANIE BEZPIECZEŃSTWA, TOLERANCJI I IMUNOGENNOŚCI FAZY 2/3 Z KONTROLĄ PLACEBO, BADANIE BEZPIECZEŃSTWA, TOLERANCJI I IMMUNOGENNOŚCI Z KONTROLĄ PLACEBO, BADANIE KANDYDATA NA SZCZEPIONKĘ RNA SARS-COV-2 PRZECIWKO COVID -19 U ZDROWYCH DZIECI I MŁODYCH DOROSŁYCH

Jest to badanie fazy 1/2/3 z udziałem zdrowych dzieci i młodych dorosłych.

W zależności od danych dotyczących bezpieczeństwa i/lub immunogenności uzyskanych w trakcie tego badania oraz wynikającej z tego oceny stosunku korzyści do ryzyka, można następnie ocenić bezpieczeństwo, tolerancję i immunogenność BNT162b2 u uczestników w wieku <6 miesięcy.

Przegląd badań

Status

Zakończony

Warunki

Zakażenie SARS-CoV-2, COVID-19

Interwencja / Leczenie

Szczegółowy opis

Faza 1 Ustalanie dawki

Czy otwarta część badania polegająca na ustaleniu dawki, która oceni bezpieczeństwo, tolerancję i immunogenność BNT162b2 podawanego w schemacie 2-dawkowym (w odstępie około 21 dni) w maksymalnie 3 grupach wiekowych (uczestnicy ≥5 do <12 lat, ≥2 do <5 lat i ≥6 miesięcy do <2 lat).

Ustalenie dawki rozpoczyna się w tym badaniu u uczestników w wieku od ≥5 do <12 lat w oparciu o akceptowalną, zaślepioną ocenę bezpieczeństwa dawki 30 µg u dzieci w wieku od 12 do 15 lat w badaniu C4591001.

Celem fazy 1 jest określenie preferowanych poziomów dawki BNT162b2 z maksymalnie 3 różnych poziomów dawki w każdej grupie wiekowej.

W zależności od danych dotyczących bezpieczeństwa i/lub immunogenności uzyskanych w trakcie tego badania, możliwe jest, że poziomy dawek mogą nie zostać rozpoczęte, mogą zostać zakończone wcześniej i/lub mogą zostać dodane z poziomami dawek poniżej najniższej podanej dawki.

Aktualizacja w ramach poprawki 6 protokołu: Wszyscy uczestnicy otrzymają trzecią dawkę BNT162b2. W przypadku uczestników w wieku od ≥6 miesięcy do <5 lat trzecia dawka zostanie podana co najmniej 8 tygodni po drugiej dawce. U uczestników w wieku od ≥5 do <12 lat trzecia dawka zostanie podana co najmniej 6 miesięcy po drugiej dawce. Przerwa między drugą a trzecią dawką będzie oparta na wieku uczestnika w momencie rejestracji. Poziom dawki trzeciej dawki BNT162b2 będzie oparty na wieku w momencie szczepienia: uczestnicy w wieku <5 lat w momencie podania trzeciej dawki otrzymają poziom dawki 3 µg, uczestnicy w wieku od ≥5 do <12 lat wiek w momencie podania trzeciej dawki otrzyma dawkę 10 µg, a uczestnicy w wieku ≥12 lat w momencie podania trzeciej dawki otrzymają dawkę 30 µg.

Uczestnikom zostanie pobrana krew przed zarówno Dawką 1, jak i Dawką 2 oraz 7 dni po Dawce 2, aby ocenić immunogenność w celu określenia wybranego poziomu dawki BNT162b2 dla fazy 2/3. Uczestnikom zostanie również pobrana krew przed podaniem dawki 3 oraz 1, 6 i 12 miesięcy po dawce 3.

Faza 1. Ocena niższych dawek

Jest otwartą częścią badania, w której oceniana jest niższa dawka, która oceni bezpieczeństwo, tolerancję i immunogenność 10 µg BNT162b2 z 2 schematów w 2 grupach wiekowych (uczestnicy w wieku od 12 do <16 lat i od 16 do <18 lat) .

Celem fazy 1 oceny niższych dawek jest ocena bezpieczeństwa i immunogenności BNT162b2 z 2 różnych schematów dawkowania w każdej grupie wiekowej: (1) 2 dawki w odstępie około 21 dni i (2) 2 dawki w odstępie około 8 tygodni .

Uczestnikom zostanie pobrana krew przed Dawką 1, przed Dawką 2, 7 dni po Dawce 2 i 1 miesiąc po Dawce 2 w celu oceny immunogenności w celu określenia wybranego schematu dawkowania BNT162b2 dla fazy 2/3 fazy oceny niższej dawki części badanie. Ponadto, uczestnikom zostanie pobrana krew w 6 i 12 miesięcy po dawce 2, aby określić utrzymywanie się odpowiedzi immunologicznej.

Faza 2/3 Wybrana dawka

Jest częścią badania, która oceni bezpieczeństwo, tolerancję i immunogenność w każdej grupie wiekowej przy wybranym poziomie dawki z części badania fazy 1 dotyczącej ustalania dawki. Skuteczność zostanie oceniona w obrębie lub między grupami wiekowymi, w których pomostowanie immunologiczne jest skuteczne, w zależności od zgromadzenia wystarczającej liczby przypadków w tych grupach wiekowych.

Uczestnikom zostanie pobrana krew na początku badania przed Dawką 1 i 6 miesięcy po Dawce 2. Immunomostkowanie uczestników w wieku od 16 do 25 lat w badaniu C4591001 będzie oparte na danych dotyczących immunogenności zebranych na (1) poziomie wyjściowym i 1 miesiąc po Dawce 2 i (2) wartość wyjściowa i 1 miesiąc po dawce 3. Utrzymywanie się odpowiedzi immunologicznej będzie oparte na danych dotyczących immunogenności zebranych u uczestników w (1) wartości wyjściowej oraz 1 i 6 miesięcy po dawce 2 oraz (2) wartości początkowej i 1, 6, 12 i 18 miesięcy po dawce 3. Ponadto skuteczność przeciwko potwierdzonemu COVID-19 i bezobjawowemu zakażeniu zostanie również oceniona u uczestników w wieku ≥5 do <12 lat.

W wyznaczonych ośrodkach w USA dodatkowa, opcjonalna próbka krwi pełnej o objętości około 10 ml zostanie pobrana przed podaniem dawki 1 oraz 7 dni i 6 miesięcy po dawce 2 od maksymalnie około 60 uczestników w wieku ≥10 lat. Dodatkowe próbki zostaną pobrane przed Dawką 3 i 1 miesiąc po Dawce 3 (tylko oryginalna grupa BNT162b2). Próbki te zostaną użyte eksploracyjnie do zbadania komórkowej odpowiedzi immunologicznej po szczepieniu w tych punktach czasowych.

Podczas 6-miesięcznej wizyty kontrolnej wszyscy uczestnicy zostaną odślepieni. Uczestnicy, którzy pierwotnie otrzymywali placebo, będą mieli możliwość otrzymania BNT162b2 w ramach badania. Uczestnicy, którzy pierwotnie otrzymywali placebo i kwalifikują się do otrzymania BNT162b2 lub innej szczepionki przeciwko COVID-19 zgodnie z lokalnymi lub krajowymi zaleceniami przed wizytą kontrolną po 6 miesiącach (wizyta 5 lub 405) (szczegóły wyszczególnione oddzielnie i dostępne w elektronicznym portalu referencyjnym dotyczącym badań ) będą miały możliwość otrzymania BNT162b2 (10 µg lub 3 µg) w zależności od wieku w momencie szczepienia.

Aktualizacja w ramach poprawki 6 protokołu: Wszyscy uczestnicy otrzymają trzecią dawkę BNT162b2. W przypadku uczestników w wieku od ≥6 miesięcy do <5 lat trzecia dawka zostanie podana co najmniej 8 tygodni po drugiej dawce. U uczestników w wieku od ≥5 do <12 lat trzecia dawka zostanie podana co najmniej 6 miesięcy po drugiej dawce. Przerwa między drugą a trzecią dawką będzie oparta na wieku uczestnika w momencie rejestracji. Poziom dawki drugiej i trzeciej dawki BNT162b2 będzie oparty na wieku w momencie szczepienia: uczestnicy w wieku <5 lat w momencie podania drugiej/trzeciej dawki otrzymają poziom dawki 3 µg, uczestnicy w wieku ≥5 do <12 lat w momencie podania drugiej/trzeciej dawki otrzyma dawkę 10 µg, a uczestnicy w wieku ≥12 lat w momencie podania drugiej/trzeciej dawki otrzymają dawkę 30 µg.

Ocena niższej dawki fazy 2/3

Jest otwartą częścią badania, która oceni bezpieczeństwo, tolerancję i immunogenność wybranego schematu dawkowania w każdej grupie wiekowej z fazy 1 oceny niższych dawek, z łączną liczbą około 600 aktywnych uczestników.

Około 300 aktywnych uczestników w każdej grupie wiekowej w tej fazie weźmie udział w analizie pomostowania immunologicznego po 1 miesiącu od podania 2. dawki oraz ogólnej analizie utrzymywania się odpowiedzi immunologicznej po 6 i 12 miesiącach od podania 2. dawki.

Faza 2/3 Pobieranie próbek surowicy do potencjalnego badania troponiny I

Jeśli badanie poziomu troponiny I u osób, które nie otrzymały BNT162b2 wskazuje, że poziom troponiny I może być wiarygodnym wskaźnikiem potencjalnego subklinicznego zapalenia mięśnia sercowego, uzyskanie próbek surowicy do potencjalnego oznaczenia troponiny I w okresie zwiększonego ryzyka klinicznego zapalenia mięśnia sercowego może pomóc scharakteryzować brak /obecność i częstość subklinicznego zapalenia mięśnia sercowego. Do oceny zostanie włączona dodatkowa grupa uczestników: w wieku od 5 do <12 lat: losowo przydzieleni w stosunku 2:1 do grupy otrzymującej BNT162b2 10 µg lub placebo oraz w wieku od ≥12 do <16 lat: otwarta grupa otrzymująca BNT162b2 w dawce 30 µg.

Aktualizacja w ramach poprawki 7 protokołu: Wszyscy uczestnicy otrzymają trzecią dawkę BNT162b2. W przypadku wszystkich uczestników (w wieku od ≥5 do <12 i od ≥12 do <16 lat) trzecia dawka zostanie podana co najmniej 5 miesięcy po dawce 2.

Poziom dawki drugiej i trzeciej dawki BNT162b2 będzie oparty na wieku w momencie szczepienia: uczestnicy w wieku ≥5 do <12 lat w momencie podania drugiej/trzeciej dawki otrzymają poziom dawki 10 µg, oraz uczestnicy w wieku ≥12 lat w momencie podania drugiej/trzeciej dawki otrzymają poziom dawki 30 µg.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

11837

Faza

Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

6 miesięcy do 18 lat (Dziecko)

Akceptuje zdrowych ochotników

Tak

Opis

Kryteria przyjęcia

Uczestnicy płci męskiej lub żeńskiej w wieku od ≥6 miesięcy do <12 lat w momencie randomizacji podczas wizyty 1 w celu ustalenia dawki/oceny wybranej dawki oraz uczestnicy w wieku od ≥12 do <18 lat w czasie randomizacji , podczas wizyty 1 w celu oceny niższej dawki. Część badania polegająca na pobieraniu próbek surowicy do badania potencjalnej troponiny I: uczestnicy płci męskiej lub żeńskiej w wieku od ≥5 do <16 lat.
Rodzice/opiekunowie prawni uczestników i uczestnicy, stosownie do wieku, którzy chcą i są w stanie przestrzegać wszystkich zaplanowanych wizyt, planu leczenia, badań laboratoryjnych, względów związanych ze stylem życia i innych procedur badawczych.
Zdrowi uczestnicy, których historia medyczna, badanie fizykalne i ocena kliniczna badacza kwalifikują się do włączenia do badania.
Uwaga: Zdrowi uczestnicy z istniejącą wcześniej stabilną chorobą, zdefiniowaną jako choroba niewymagająca znaczącej zmiany terapii lub hospitalizacji z powodu pogorszenia choroby w ciągu 6 tygodni przed włączeniem, mogą zostać włączeni.
Oczekuje się, że uczestnicy będą dostępni przez cały czas trwania badania, a z ich rodzicami/opiekunami prawnymi można się kontaktować telefonicznie podczas uczestnictwa w badaniu.
Negatywny test ciążowy z moczu dla kobiet, które są biologicznie zdolne do posiadania dzieci.
Uczestnik płci żeńskiej w wieku rozrodczym lub uczestnik płci męskiej zdolny do spłodzenia dzieci, który jest skłonny stosować wysoce skuteczną metodę antykoncepcji zgodnie z niniejszym protokołem przez co najmniej 28 dni po przyjęciu ostatniej dawki interwencji w ramach badania, jeśli istnieje ryzyko zajścia w ciążę ze swoim partnerem ; lub uczestnik płci żeńskiej, który nie może zajść w ciążę lub uczestnik płci męskiej, który nie jest w stanie spłodzić dzieci.
Uczestnik lub rodzic/rodzice/opiekun prawny uczestnika jest w stanie wyrazić podpisaną świadomą zgodę, co obejmuje przestrzeganie wymagań i ograniczeń wymienionych w ICD oraz w niniejszym protokole. W zależności od wieku uczestnika i lokalnych wymagań, uczestnicy zostaną również poproszeni o wyrażenie stosownej zgody (ustnej lub pisemnej).

Kryteria wyłączenia

Tylko faza 1: Przeszłość kliniczna (na podstawie samych objawów COVID-19, jeśli wynik SARS CoV 2 NAAT nie był dostępny) lub mikrobiologiczna (na podstawie objawów COVID-19 i dodatniego wyniku SARS-CoV-2 NAAT) diagnoza COVID19.
Tylko faza 1: Znane zakażenie wirusem HIV, HCV lub HBV.
Odbiór leków mających zapobiegać COVID-19.
Wcześniejsza lub aktualna diagnoza MIS-C.
Inny stan medyczny lub psychiatryczny, w tym niedawne (w ciągu ostatniego roku) lub czynne myśli/zachowania samobójcze lub nieprawidłowości w wynikach badań laboratoryjnych, które mogą zwiększać ryzyko udziału w badaniu lub, w ocenie badacza, czynić uczestnika nieodpowiednim do udziału w badaniu. Uwaga: Obejmuje to zarówno stany, które mogą zwiększać ryzyko związane z podawaniem interwencji w badaniu, jak i stan, który może zakłócać interpretację wyników badania
Historia ciężkich działań niepożądanych związanych ze szczepionką i/lub ciężka reakcja alergiczna (np. anafilaksja) na jakikolwiek składnik interwencji w ramach badania.
Osoby z obniżoną odpornością ze stwierdzonym lub podejrzewanym niedoborem odporności, na podstawie wywiadu i/lub badania laboratoryjnego/fizycznego.
Osoby z chorobą autoimmunologiczną w wywiadzie lub czynną chorobą autoimmunologiczną wymagającą interwencji terapeutycznej, w tym między innymi toczeń rumieniowaty układowy. Uwaga: stabilna cukrzyca typu 1 i niedoczynność tarczycy są dozwolone.
Skaza krwotoczna lub stan związany z przedłużającym się krwawieniem, który w opinii badacza stanowiłby przeciwwskazanie do wstrzyknięcia domięśniowego.
Kobieta w ciąży lub karmiąca piersią.
Wcześniejsze szczepienie jakąkolwiek szczepionką przeciwko koronawirusowi.
Osoby, które otrzymują leczenie za pomocą terapii immunosupresyjnej, w tym środków cytotoksycznych lub kortykosteroidów ogólnoustrojowych, np. z powodu raka lub choroby autoimmunologicznej, lub planowane przyjęcie w trakcie badania. Jeśli ogólnoustrojowe kortykosteroidy były podawane krótkoterminowo (<14 dni) w leczeniu ostrej choroby, uczestników nie należy włączać do badania, dopóki kortykosteroidy nie zostaną przerwane na co najmniej 28 dni przed podaniem interwencji w ramach badania. Dozwolone są kortykosteroidy wziewne/nebulizowane, dostawowe, dokaletkowe lub miejscowe (na skórę lub do oczu).
Otrzymanie produktów z krwi/osocza, immunoglobulin lub przeciwciał monoklonalnych na 60 dni przed interwencją w badaniu lub otrzymanie dowolnej terapii przeciwciałami biernymi swoistymi dla COVID-19 na 90 dni przed podaniem interwencji w ramach badania lub planowany odbiór w trakcie badania.
Udział w innych badaniach obejmujących interwencję w badaniu w ciągu 28 dni przed rozpoczęciem badania i/lub w trakcie udziału w badaniu.
Wcześniejszy udział w innych badaniach obejmujących interwencję badawczą zawierającą LNP.
Uczestnicy będący bezpośrednimi potomkami (dziećmi lub wnukami) członków personelu ośrodka badawczego lub pracowników firmy Pfizer/BioNTech bezpośrednio zaangażowanych w prowadzenie badania, personel ośrodka nadzorowany w inny sposób przez badacza oraz członkowie ich rodzin.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Główny cel: Zapobieganie
Przydział: Nielosowe
Model interwencyjny: Przydział równoległy
Maskowanie: Brak (otwarta etykieta)

Liczba ramion

Broń i interwencje

Grupa uczestników / Arm	Interwencja / Leczenie
Eksperymentalny: Niska/średnia dawka, ≥5 do <12 lat Niska/średnia dawka (10mcg), 2 dawki w odstępie 21 dni	Biologiczny: Biologiczne/szczepionka: BNT162b2 10mcg BNT162b2 Poziom niskiej/średniej dawki (10mcg).
Eksperymentalny: Średnia dawka, ≥5 do <12 lat Średnia dawka (20mcg), 2 dawki w odstępie 21 dni	Biologiczny: BNT162b2 20mcg Poziom średniej dawki BNT162b2 (20 mcg).
Eksperymentalny: Wysoka dawka, ≥5 do <12 lat Wysoka dawka (30mcg), 2 dawki w odstępie 21 dni	Biologiczny: BNT162b2 30mcg Poziom BNT162b2 w wysokiej dawce (30mcg).
Eksperymentalny: Niska/średnia dawka, ≥2 do <5 lat Niska/średnia dawka (10mcg), 2 dawki w odstępie 21 dni	Biologiczny: Biologiczne/szczepionka: BNT162b2 10mcg BNT162b2 Poziom niskiej/średniej dawki (10mcg).
Eksperymentalny: Średnia dawka, ≥2 do <5 lat Średnia dawka (20mcg), 2 dawki w odstępie 21 dni	Biologiczny: BNT162b2 20mcg Poziom średniej dawki BNT162b2 (20 mcg).
Eksperymentalny: Wysoka dawka, ≥2 do <5 lat Wysoka dawka (30mcg), 2 dawki w odstępie 21 dni	Biologiczny: BNT162b2 30mcg Poziom BNT162b2 w wysokiej dawce (30mcg).
Eksperymentalny: Niska/średnia dawka, od ≥6 miesięcy do <2 lat Niska/średnia dawka (10mcg), 2 dawki w odstępie 21 dni	Biologiczny: Biologiczne/szczepionka: BNT162b2 10mcg BNT162b2 Poziom niskiej/średniej dawki (10mcg).
Eksperymentalny: Średnia dawka, od ≥6 miesięcy do <2 lat Średnia dawka (20mcg), 2 dawki w odstępie 21 dni	Biologiczny: BNT162b2 20mcg Poziom średniej dawki BNT162b2 (20 mcg).
Eksperymentalny: Wysoka dawka, ≥6 miesięcy do <2 lat Wysoka dawka (30mcg), 2 dawki w odstępie 21 dni	Biologiczny: BNT162b2 30mcg Poziom BNT162b2 w wysokiej dawce (30mcg).
Komparator placebo: Placebo, od ≥6 miesięcy do <2 lat	Inny: Placebo Wstrzyknięcie domięśniowe
Komparator placebo: Placebo, ≥2 do <5 lat	Inny: Placebo Wstrzyknięcie domięśniowe
Komparator placebo: Placebo, ≥5 do <12 lat	Inny: Placebo Wstrzyknięcie domięśniowe
Eksperymentalny: Niska dawka, od ≥6 miesięcy do <2 lat Niska dawka (3mcg), 2 dawki w odstępie 21 dawek	Biologiczny: Biologiczne/szczepionka: BNT162b2 3mcg Niska dawka BNT162b2 (3mcg).
Eksperymentalny: Niska dawka, ≥2 do <5 lat Niska dawka (3mcg), 2 dawki w odstępie 21 dni	Biologiczny: Biologiczne/szczepionka: BNT162b2 3mcg Niska dawka BNT162b2 (3mcg).
Eksperymentalny: Wysoka dawka, od 12 do <16 lat (badanie troponiny I) Wysoka dawka (30mcg), 3 dawki	Biologiczny: BNT162b2 30mcg Poziom BNT162b2 w wysokiej dawce (30mcg).
Eksperymentalny: Niska/średnia dawka, ≥5 do <12 lat (badanie troponiny I) Niska/średnia dawka (10mcg), 3 dawki	Biologiczny: Biologiczne/szczepionka: BNT162b2 10mcg BNT162b2 Poziom niskiej/średniej dawki (10mcg).
Eksperymentalny: Placebo, ≥5 do <12 lat (badanie troponiny I)	Inny: Placebo Wstrzyknięcie domięśniowe
Eksperymentalny: Mała dawka, od ≥6 miesięcy do <2 lat (schemat 3-dawkowy) Niska dawka (3mcg), 3 dawki	Biologiczny: Biologiczne/szczepionka: BNT162b2 3mcg Niska dawka BNT162b2 (3mcg).
Eksperymentalny: Mała dawka, ≥2 do <5 lat (schemat 3-dawkowy) Niska dawka (3mcg), 3 dawki	Biologiczny: Biologiczne/szczepionka: BNT162b2 3mcg Niska dawka BNT162b2 (3mcg).
Komparator placebo: Placebo, ≥6 miesięcy do <2 lat (schemat 3-dawkowy)	Inny: Placebo Wstrzyknięcie domięśniowe
Komparator placebo: Placebo, ≥2 do <5 lat (schemat 3-dawkowy)	Inny: Placebo Wstrzyknięcie domięśniowe

Co mierzy badanie?

Podstawowe miary wyniku

Miary wyników drugorzędnych

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

BioNTech SE

Współpracownicy

Pfizer

Śledczy

Dyrektor Studium: Pfizer CT.gov Call Center, Pfizer

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

24 marca 2021

Zakończenie podstawowe (Rzeczywisty)

4 października 2023

Ukończenie studiów (Rzeczywisty)

8 grudnia 2023

Daty rejestracji na studia

Pierwszy przesłany

19 marca 2021

Pierwszy przesłany, który spełnia kryteria kontroli jakości

24 marca 2021

Pierwszy wysłany (Rzeczywisty)

25 marca 2021

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

28 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

26 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

C4591007
2020-005442-42 (Numer EudraCT)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Zakażenie SARS-CoV-2, COVID-19

Pfizer

Aktywny, nie rekrutujący

Badanie, aby dowiedzieć się, jak dobrze coroczne aktualizacje szczepionek Covid-19 w celu ochrony ludzi przed Covid-19 oraz ile pieniędzy wydają ludzi na opiekę zdrowotną na Covid-19

COVID-19 | Choroba koronawirusowa 2019 (COVID-19) | Covid-19 infekcja | Covid-19 szczepionki | Zakażenie SARS-CoV-2, COVID19 | Szczepienie na COVID-19 | Zakażenie SARS-CoV-2, COVID-19 | COVID-19 (choroba koronawirusowa 2019) | Zakażenie COVID-19 SARS-CoV-2

Stany Zjednoczone
The Institute of Molecular and Translational Medicine...
University Hospital Olomouc; Palacky University

Zakończony

Badanie SARS-CoV-2-CZ-PREVAL-II – Region Olomoucki

SARS-CoV-2 | Zakażenie SARS-CoV-2 (COVID-19).

Czechy
AstraZeneca

Zakończony

Badanie AZD3152 we wstrzyknięciu domięśniowym lub infuzji dożylnej u zdrowych dorosłych japońskich uczestników

COVID-19, SARS-CoV-2

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

Zakończony

Czy przeciwciała specyficzne dla SARS-CoV-2 są korelatem ochrony? (ImmCoV)

COVID-19 | SARS-CoV-2

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

Zakończony

Bezpieczeństwo, tolerancja i farmakokinetyka SAB-185 u zdrowych uczestników

COVID-19 | SARS-CoV-2

Stany Zjednoczone
University of Wisconsin, Madison
National Institutes of Health (NIH)

Zakończony

Powtórzyć testy na obecność SARS-CoV-2

COVID-19 | SARS-CoV-2

Stany Zjednoczone
Syneos Health
US Specialty Formulations, LLC

Zakończony

Pierwsze badanie na ludziach dotyczące doustnie podawanego CoV2-OGEN1 zdrowym osobom

SARS-CoV-2 (COVID-19)

Nowa Zelandia
Mayo Clinic

Zakończony

Seroprevalence of SARS CoV 2 Antibodies in Previously Undiagnosed Healthcare Workers

COVID-19 | SARS-CoV-2

Stany Zjednoczone
Interna Therapeutics Ltd.

Aktywny, nie rekrutujący

Bezpieczeństwo, tolerancja i systemowa ekspozycja APO-SI-K170A-C76 u zdrowych wolontariuszy (BID)

Zakażenie SARS-CoV-2 (COVID-19).

Izrael
University of Valladolid

Zakończony

Wpływ maski treningowej w CrossFit® Post-SARS-COV-2 zakażenie. (ETMEXCOVID)

Zakażenie SARS-CoV-2 (objawowe) | Powikłania płucne COVID-19 | SARS-CoV-2 Pacjenci z pozytywnym wynikiem | COVID19- Zakażenie wirusem SARS-COV-2

Hiszpania

Badania kliniczne na Placebo

Galderma R&D

Zakończony

Wpływ żelu CD07805/47 na trądzik różowaty

Trądzik różowaty

Niemcy
SamA Pharmaceutical Co., Ltd

Nieznany

Badania kliniczne oceniające skuteczność i bezpieczeństwo HLIM

Ostre zapalenie oskrzeli | Ostra infekcja górnych dróg oddechowych

Republika Korei
National Institute on Drug Abuse (NIDA)

Zakończony

Wpływ dróg podawania konopi indyjskich na wydajność i farmakokinetykę człowieka

Używanie konopi indyjskich

Stany Zjednoczone
AstraZeneca
Parexel; Spandauer Damm 130; 14050; Berlin, Germany

Zakończony

Ocena bezpieczeństwa, tolerancji i farmakodynamiki po podaniu jednej dawki AZD8601 pacjentom płci męskiej z cukrzycą typu II (T2DM)

Mężczyźni z cukrzycą typu II (T2DM)

Niemcy
Akeso

Jeszcze nie rekrutacja

Badanie kliniczne AK120 u młodzieży z umiarkowanym do ciężkiego atopowym zapaleniem skóry

Atopowe zapalenie skóry

Chiny
Heptares Therapeutics Limited

Zakończony

Farmakokinetyka kapsułki doustnej u zdrowych osób z Japonii i rasy kaukaskiej (HTL0018318)

Farmakokinetyka | Problemy z bezpieczeństwem

Zjednoczone Królestwo
Cellmedis
Medical Network Sp. z o.o.

Jeszcze nie rekrutacja

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 (choroba refluksowa przełyku) | NERD

Polska
Soroka University Medical Center

Zakończony

Effect of Probiotics in Childhood Abdominal Pain

Ból brzucha

Izrael
Regado Biosciences, Inc.

Zakończony

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

Zdrowy ochotnik

Stany Zjednoczone
West Penn Allegheny Health System

Zakończony

Badanie wzrostu Sunovion u dzieci z łagodną astmą i alergicznym nieżytem nosa

Astma | Alergiczny nieżyt nosa

Stany Zjednoczone

Miara wyniku	Opis środka	Ramy czasowe
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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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)

Miara wyniku	Opis środka	Ramy czasowe
Phase 1: Percentage of Participants With Local Reactions Within 7 Days After Dose 1: >=5 to <12 Years of Age Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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 Ramy czasowe: 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

Badanie fazy 1/2/3 oceniające bezpieczeństwo, tolerancję i immunogenność kandydata na szczepionkę RNA przeciwko COVID-19 u zdrowych dzieci i młodych dorosłych

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Bada produkt leczniczy regulowany przez amerykańską FDA

Bada produkt urządzenia regulowany przez amerykańską FDA

Badania kliniczne na Zakażenie SARS-CoV-2, COVID-19

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