A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

11,837

Participants

Timeline

Start Date

March 24, 2021

Primary Completion Date

October 4, 2023

Study Completion Date

December 8, 2023

Conditions
SARS-CoV-2 Infection, COVID-19
Interventions
BIOLOGICAL

Biological/Vaccine: BNT162b2 10mcg

BNT162b2 Low/Mid-Dose (10mcg) level

BIOLOGICAL

BNT162b2 20mcg

BNT162b2 Mid-Dose (20mcg) level

BIOLOGICAL

BNT162b2 30mcg

BNT162b2 High-Dose (30mcg) level

OTHER

Placebo

Intramuscular injection

BIOLOGICAL

Biological/Vaccine: BNT162b2 3mcg

BNT162b2 Low-Dose (3mcg) level

Trial Locations (146)

11725

Advanced Specialty Care, Commack

11733

Clinical Research Center, East Setauket

11794

Stony Brook University, Stony Brook

13210

SUNY Upstate Medical University, Syracuse

13901

Meridian Clinical Research LLC, Binghamton

Meridian Clinical Research, LLC, Binghamton

13905

Meridian Clinical Research LLC, Binghamton

14609

Rochester Clinical Research, Inc., Rochester

14642

University of Rochester Medical Center, Rochester

15706

CHUS - Hospital Clinico Universitario, Santiago de Compostela

Hospital Clinico Universitario Santiago de Compostela, Santiago de Compostela

16506

AHN Erie Health + Wellness Pavillion: West, Erie

20009

Emerson Clinical Research Institute - Washington - Connecticut Avenue, Washington D.C.

20010

Children's National Medical Center, Washington D.C.

20011

Emerson Clinical Research Institute, Washington D.C.

20016

Meridian Clinical Research, LLC, Washington D.C.

20520

FVR, Turku Clinic, Turku

21224

Johns Hopkins Bayview Medical Center, Baltimore

22902

Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice), Charlottesville

Pediatric Research of Charlottesville, LLC, Charlottesville

23114

Virginia Research Center, Midlothian

27703

Duke University - Main Hospital and Clinics, Durham

Duke Vaccine And Trials Unit, Durham

28041

Hospital Universitario 12 de Octubre, Madrid

28100

FVR, Pori Clinic, Pori

28105

Atrium Health-STRIVE Vaccine Research Clinic (study visits), Matthews

28207

Atrium Health-STRIVE Vaccine Research Clinic, Charlotte

28211

Teen Health Connection (study visits), Charlotte

28660

Hospital Universitario HM Monteprincipe, Boadilla del Monte

28938

Hospital Universitario HM Puerta del Sur, Madrid

Hospital HM Puerta del Sur, Móstoles

29015

Grupo Pediatrico Uncibay, Málaga

29200

Hospital de Antequera, Antequera

Hospital de Antequera, Antequera

29414

Coastal Pediatric Research, Charleston

29486

Coastal Pediatric Research, Summerville

29607

Tribe Clinical Research, LLC, Greenville

30291

Rophe Adult and Pediatric Medicine/SKYCRNG, Union City

30322

Emory Children's Center Illness POD, Atlanta

Emory University School of Medicine, Atlanta

30331

Atlanta Center for Medical Research, Atlanta

31210

Meridian Clinical Research, LLC, Macon

32256

Clinical Neuroscience Solutions, Inc., Jacksonville

32801

Clinical Neuroscience Solutions, Orlando

33100

Tampere Vaccine Research Clinic, Tampere

FVR, Tampere Clinic, Tampere

33142

Acevedo Clinical Research Associates, Miami

35233

University of Alabama at Birmingham - School of Medicine, Birmingham

37203

Clinical Research Associates Inc, Nashville

38105

St. Jude Children's Research Hospital, Memphis

39157

Quinn Healthcare/SKYCRNG, Ridgeland

SKY Integrative Medical Center/SKYCRNG, Ridgeland

40004

Kentucky Pediatric/ Adult Research, Bardstown

40202

Novak Center for Children's Health, Louisville

41012

Instituto Hispalense de Pediatria, Seville

43213

Aventiv Research Inc., Columbus

Centricity Research Columbus Ohio Multispecialty, Columbus

44121

Senders Pediatrics, South Euclid

45206

Cincinnati Children's Hospital Medical Center, Cincinnati

45229

Cincinnati Childrens Hospital Medical Center, Cincinnati

45419

PriMed Clinical Research, Dayton

45429

PriMed Clinical Research, Dayton

48025

Michigan Center of Medical Research, Bingham Farms

60100

FVR, Seinäjoki Clinic, Seinäjoki

63005

Clinical Research Professionals, Chesterfield

64108

Children's Mercy Hospital, Kansas City

67100

FVR, Kokkola Clinic, Kokkola

67114

Alliance for Multispecialty Research, LLC, Newton

67207

Alliance for Multispecialty Research, LLC, Wichita

68114

Children's Hospital & Medical Center, Omaha

68117

Children's Physician's Clinic, Spring Valley, Omaha

68510

Velocity Clinical Research, Lincoln, Lincoln

68901

Meridian Clinical Research, LLC, Hastings

70121

Ochsner Clinic Foundation, New Orleans

71101

Louisiana State University Health Sciences Shreveport, Shreveport

75024

ACRC Trials (Administrative Site), Plano

75033

Village Health Partners (Patient Seen Address), Frisco

75251

Cedar Health Research, Dallas

77008

Helios Clinical Research - HOU, Houston

Van Tran Family Practice, Houston

77030

Texas Children's Hospital - Clinical Research Center, Houston

77055

West Houston Clinical Research Services, Houston

77065

DM Clinical Research, Houston

77087

Pediatric Associates, Houston

77539

Bay Colony Pediatrics, Dickinson

78411

Driscoll Children's Hospital, Corpus Christi

78539

Proactive Clinical Research, LLC, Edinburg

78726

ARC Clinical Research at Four Points, Austin

ARC Clinical Research at Wilson Parke, Austin

80045

Children's Hospital Colorado, Aurora

83404

Clinical Research Prime, Idaho Falls

83646

Solaris Clinical Research, Meridian

84109

J. Lewis Research, Inc. / Foothill Family Clinic, Salt Lake City

84121

J. Lewis Research, Inc. / Foothill Family Clinic South, Salt Lake City

85016

Phoenix Children's Hospital, Phoenix

90027

Kaiser Permanente Los Angeles Medical Center, Los Angeles

SCPMG/Kaiser Permanente Los Angeles Medical Center, Los Angeles

90057

Matrix Clinical Research, Los Angeles

90220

FVR, Oulu Clinic, Oulu

90274

Peninsula Research Associates, Rolling Hills Estates

90723

Center for Clinical Trials, LLC, Paramount

Center for Clinical Trials, Paramount

91607

Bayview Research Group, LLC, Valley Village

93637

Madera Family Medical Group, Madera

94304

Clinical & Translational Research Unit (CTRU) & Spectrum BioBank, Stanford University, Palo Alto

Lucile Packard Children's Hospital Stanford, Palo Alto

94305

Stanford Health Care Investigational Drug Service, Stanford

Stanford Health Care, Stanford

94611

Kaiser Permanente Oakland, Oakland

95051

Kaiser Permanente Santa Clara, Santa Clara

95815

Kaiser Permanente Sacramento, Sacramento

97030

Cyn3rgy Research, Gresham

97070

Kohler & Milstein Research S.A. de C.V., Mérida

97130

Centro Multidisciplinario Para El Desarrollo Especializado De La Investigacion, Mérida

98105

Seattle Children's Hospital, Seattle

06519

Yale Center for Clinical Investigation, New Haven

02118

Boston Medical Center, Boston

08903

Rutgers University, New Brunswick

02818

Velocity Clinical Research-Providence, East Greenwich

40415-006

Hospital Santo Antônio - Obras Sociais Irmã Dulce/ Centro de Pesquisa Clínica - CPEC, Salvador

30150-221

Santa Casa De Misericórdia de Belo Horizonte, Belo Horizonte

80810-050

Serviço de Infectologia e Controle de Infecção Hospitalar de Curitiba/ Centro Médico São Franci, Curitiba

59025-050

CePCLIN - Centro de Estudos e Pesquisas em Moléstias Infecciosas Ltda, Natal

04266-010

CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos Ltda., São Paulo

00930

FVR, Helsinki East Clinic, Helsinki

FVR, Helsinki East Clinic, Helsinki

FVR, Helsinki East Clinic, Helsinki

04400

FVR, Järvenpää Clinic, Järvenpää

02230

FVR, Espoo Clinic, Espoo

00100

FVR, Helsinki South Clinic, Helsinki

00290

MeVac - Meilahti Vaccine Research Center, Helsinki

C.P. 64060

CHRISTUS - LATAM HUB Center of excellence and innovation S.C., Monterrey

C.P. 91900

Sociedad de Metabolismo y Corazón S.C., Veracruz

87-100

MICS Centrum Medyczne Torun, Torun

85-048

IN-VIVO Bydgoszcz, Bydgoszcz

30-348

Centrum Badan Klinicznych JCI, Krakow

90-349

Osrodek Badan Klinicznych Appletreeclinics, Lodz

91-347

GRAVITA Diagnostyka i Leczenie nieplodnosci, Lodz

62-030

Rodzinne Centrum Medyczne LUBMED, Luboń

41-103

Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Jarosz i Partnerzy Spolka Lekarska, Siemianowice Śląskie

02-647

Provita 001, Warsaw

08540

EAP Centelles, Centelles

EBA Centelles, Centelles

08950

Hospital Sant Joan de Deu, Esplugues de Llobregat

Hospital Sant Joan de Deu, Esplugues de Llobregrat

08195

Hospital Universitari General de Catalunya, Sant Cugat del Vallès

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

BioNTech SE

INDUSTRY

NCT04816643 - A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children | Biotech Hunter | Biotech Hunter