To Evaluate the Safety, Tolerability, Efficacy and Immunogenicity of BNT162b2 Boosting Strategies Against COVID-19 in Participants ≥12 Years of Age.

PHASE3CompletedINTERVENTIONAL
Enrollment

16,385

Participants

Timeline

Start Date

July 1, 2021

Primary Completion Date

May 25, 2023

Study Completion Date

May 25, 2023

Conditions
SARS-CoV-2 InfectionCOVID-19
Interventions
BIOLOGICAL

BNT162b2

Intramuscular Injection

OTHER

Placebo

Intramuscular Injection

BIOLOGICAL

BNT162b2 OMI

Intramuscular Injection

BIOLOGICAL

Combination BNT162b2 and BNT162b2 OMI

"30-µg (15-µg each) or 60-µg (30-µg each)~Site prepared dosing suspension from 1 vial each of diluted BNT162b2 and BNT162b2 OMI~Intramuscular Injection"

BIOLOGICAL

Combination (Bivalent) BNT162b2 and BNT162b2 OMI

"30-µg (15-µg each) or 60-µg (30-µg each)~Preformulated bivalent mixture (no dilution required) presented in a single vial~Intramuscular Injection"

Trial Locations (168)

1501

Worthwhile Clinical Trials, Benoni

1619

Clinresco Centres, Kempton Park

1685

Dr A Jacovides & Partners Inc., Midrand

2113

Newtown Clinical Research, Johannesburg

5201

Synergy Biomed Research Institute, East London

7500

TREAD Research, Cape Town

7530

Tiervlei Trial Centre, Cape Town

10016

NYU Langone Health, New York

10029

Icahn School of Medicine at Mount Sinai, New York

13215

SUNY Upstate Medical University, Syracuse

13850

Meridian Clinical Research, LLC, Vestal

13901

Meridian Clinical Research LLC, Binghamton

14609

Rochester Clinical Research, Inc., Rochester

14621

Rochester General Hospital Infectious Disease, Rochester

14642

University of Rochester Medical Center- Kari Steinmetz, Rochester

University of Rochester Medical Center, Rochester

University of Rochester, Rochester

18102

Lehigh Valley Health Network/Network Office of Research and Innovation, Allentown

21224

Johns Hopkins Bayview Medical Center, Baltimore

22003

Clinical Alliance for Research & Education - Infectious Diseases (CARE-ID), Annandale

23114

Virginia Research Center, Midlothian

27103

Accellacare, Winston-Salem

27408

PharmQuest Life Sciences, LLC, Greensboro

27518

Accellacare, Cary

27609

Accellacare, Raleigh

27612

M3 Wake Research, Inc., Raleigh

27703

Duke Vaccine and Trials Unit, Durham

28144

Accellacare - Salisbury, Salisbury

28209

Accellacare, Charlotte

28211

Accellacare, Charlotte

28401

Accellacare (formerly PMG Research of Wilmington, LLC), Wilmington

Accellacare, Wilmington

28601

Accellacare, Hickory

29566

Main Street Physician's Care, Little River

30281

Clinical Research Atlanta, Stockbridge

31406

Meridian Clinical Research, LLC, Savannah

31904

IACT Health, Columbus

32216

Jacksonville Center for Clinical Research, Jacksonville

32256

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare, Jacksonville

32801

Clinical Neuroscience Solutions, Inc., Orlando

33012

Indago Research & Health Center, Inc, Hialeah

33024

Research Centers of America ( Hollywood ), Hollywood

33134

Alliance for Multispecialty Research, LLC, Coral Gables

33142

Acevedo Clinical Research Associates, Miami

35216

Accel Research Sites - Birmingham Clinical Research Unit, Birmingham

35611

North Alabama Research Center, Athens

35801

Medical Affiliated Research Center, Huntsville

36608

Alliance for Multispecialty Research, LLC, Mobile

37203

Clinical Research Associates Inc, Nashville

37388

Trinity Clinical Research, Tullahoma

37620

Holston Medical Group, Bristol

37660

Holston Medical Group, Kingsport

37909

Alliance for Multispecialty Research - Weisgarber Medical Park, Knoxville

38119

Clinical Neuroscience Solutions Inc., Memphis

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare, Memphis

39503

MedPharmics, LLC, Gulfport

40004

Kentucky Pediatric/ Adult Research, Bardstown

43213

Aventiv Research Inc, Columbus

44106

University Hospitals Cleveland Medical Center, Cleveland

VA Northeast Ohio Healthcare System, Cleveland

44121

Senders Pediatrics, South Euclid

44122

Velocity Clinical Research, Cleveland, Cleveland

45206

Cincinnati Children's Hospital Medical Center, Cincinnati

45219

Meridian Clinical Research, LLC, Cincinnati

Sterling Research Group, Ltd., Cincinnati

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

Cincinnati Children's Hospital, Cincinnati

45246

Meridian Clinical Research, Cincinnati

45406

Dayton Clinical Research, Dayton

45409

Dayton Clinical Research, Dayton

45419

PriMED Clinical Research, Dayton

45429

PriMED Clinical Research, Dayton

48334

Michigan Center of Medical Research (MICHMER), Farmington Hills

51106

Velocity Clinical Research, Sioux City, Sioux City

52242

University of Iowa, Iowa City

58104

Lillestol Research, Fargo

59715

Bozeman Health Deaconess Hospital d/b/a Bozeman Health Clinical Research, Bozeman

Bozeman Health Deaconess Hospital, Bozeman

60389

Studienzentrum Dr. Keller, Frankfurt

60596

IKF Pneumologie GmbH & Co. KG, Frankfurt

63005

Clinical Research Professionals, Chesterfield

63141

Sundance Clinical Research, St Louis

67114

Alliance for Multispecialty Research, LLC, Newton

67207

Alliance for Multispecialty Research, LLC, Wichita

68025

Methodist Physicians Clinic/CCT Research, Fremont

68114

Quality Clinical Research, Omaha

68134

Velocity Clinical Research, Omaha, Omaha

68701

Meridian Clinical Research, LLC, Norfolk

Meridian Clinical Research, Norfolk

70121

Ochsner Clinic Foundation, New Orleans

71101

Louisiana State University Health Sciences Shreveport, Shreveport

73072

Lynn Institute of Norman, Norman

75149

SMS Clinical Research, Mesquite

75246

North Texas Infectious Diseases Consultants, P.A, Dallas

76104

Ventavia Research Group, Fort Worth

76135

Benchmark Research, Fort Worth

76248

SCR of Texas, LLC, Keller

Ventavia Research Group, Keller

77008

HG Pediatrics, Houston

Renu Garg, MD Pediatrics, Houston

Van Tran Family Practice, Houston

Ventavia Research Group, LLC, Houston

77081

DM Clinical Research-Bellaire, Houston

77375

DM Clinical Research, Tomball

77584

LinQ Research, LLC, Pearland

78229

Clinical Trials of Texas, Inc., San Antonio

Clinical Trials of Texas, LLC, San Antonio

IMA Clinical Research San Antonio, San Antonio

78705

Benchmark Research, Austin

78726

ARC Clinical Research at Four Points, Austin

78745

Tekton Research, Inc, Austin

80012

Lynn Institute of Denver, Aurora

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

85018

HOPE Research Institute, Phoenix

The Pain Center of Arizona, Phoenix

85023

HOPE Research Institute, Phoenix

85281

Alliance for Multispecialty Research, LLC, Tempe

85941

Johns Hopkins Center for American Indian Health, Whiteriver

Whiteriver Indian Hospital- Garrett Building, Whiteriver

Whiteriver Indian Hospital, Whiteriver

86503

Johns Hopkins Center for American Indian Health, Chinle

87301

Gallup Indian Medical Center, Gallup

Johns Hopkins Center for American Indian Health, Gallup

87420

Johns Hopkins Center for American Indian Health, Shiprock

Northern Navajo Medical Center, Shiprock

89104

Clinical Research Center of Nevada, Las Vegas

Wake Research - Clinical Research Center of Nevada, LLC, Las Vegas

89106

Wake Research - Clinical Research Center of Nevada, LLC, Las Vegas

90027

Kaiser Permanente Los Angeles Medical Center, Los Angeles

Kaiser Permanente, Los Angeles

Kaiser Permenente Medical Center Infectious Disease, Los Angeles

90057

Velocity Clinical Research, Westlake, Los Angeles

90806

Collaborative Neuroscience Research, LLC, Long Beach

91606

Velocity Clinical Research, North Hollywood, North Hollywood

91607

Bayview Research Group, LLC, Valley Village

92123

California Research Foundation, San Diego

92801

Anaheim Clinical Trials, LLC, Anaheim

94598

Diablo Clinical Research, Inc., Walnut Creek

94611

Kaiser Permanente Oakland, Oakland

95051

Kaiser Permanente Santa Clara, Santa Clara

95817

UC Davis Medical Center, Sacramento

96001

Paradigm Clinical Research Centers, Inc, Redding

96814

East-West Medical Research Institute, Honolulu

97227

Kaiser Permanente Center for Health Research, Portland

98101

Benaroya Research Institute at Virginia Mason, Seattle

98801

Wenatchee Valley Hospital, Wenatchee

5262100

Sheba Medical Center, Ramat Gan

5265601

The Edmond and Lily Safra Children's Hospital The Chaim Sheba Medical Center Department of Pediatric, Ramat Gan

06460

Clinical Research Consulting, Milford

06510

Yale University School of Medicine, New Haven

06511

Yale-New Haven Hospital, New Haven

06519

Yale Center for Clinical Investigation, New Haven

02118

Boston Medical Center, Boston

01655

University of Massachusetts Chan Medical School, Worcester

08869

Amici Clinical Research LLC, Raritan

08244

South Jersey Infectious Disease, Somers Point

07059

IMA Clinical Research Warren, Warren Township

27612-8104

M3 Wake Research, Inc., Raleigh

45229-3039

Cincinnati Children's Hospital, Cincinnati

02818

Velocity Clinical Research, Providence, East Greenwich

40.415-006

Obras Sociais Irma Dulce, Salvador

04266-010

CEPIC - Centro Paulista de Investigação Clínica, São Paulo

T5H 4B9

MIC Medial Imaging Consultants, Edmonton

0184

Botho Ke Bontle Health Services PTY LTD, Pretoria

0380

Limpopo Clinical Research Initiative, Thabazimbi

0183

Jongaie Research, Pretoria

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

BioNTech SE

INDUSTRY