To Evaluate the Safety, Tolerability, and Immunogenicity of BNT162b2 Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

726

Participants

Timeline

Start Date

February 16, 2021

Primary Completion Date

July 15, 2022

Study Completion Date

July 15, 2022

Conditions
SARS-CoV-2 InfectionCOVID-19Maternal Immunization
Interventions
BIOLOGICAL

BNT162b2

Intramuscular Injection

OTHER

Placebo

Intramuscular Injection

Trial Locations (90)

1500

WorthWhile Clinical Trials, Benoni

2001

Wits Reproductive Health and HIV Institute (Wits RHI) Shandukani Research Centre, Johannesburg

2013

Vaccines and Infectious Diseases Analytics (VIDA), Soweto

7500

Dr Tobias de Villiers, Cape Town

7530

Tiervlei Trial Centre CC, Cape Town

16506

Allegheny Health and Wellness Pavilion, Erie

16507

OBGYN Associates of Erie, Erie

16508

Central Erie Primary Care, Erie

Liberty Family Practice, Erie

16544

Saint Vincent Hospital, Erie

23502

The Group for Women- MAWC, Norfolk

Tidewater Physicians for Women- MAWC, Norfolk

28660

Hospital Universitario HM Monteprincipe, Boadilla del Monte

28938

Hospital Madrid Puerta del Sur Mostoles, Móstoles

29200

Hospital de Antequera, Antequera

33470

Axcess Medical Research, Loxahatchee Groves

35233

Children's of Alabama, Birmingham

University of Alabama at Birmingham Women & Infant Center, Birmingham

University of Alabama at Birmingham/Center for Women's Reproductive Health, Birmingham

36608

Velocity Clinical Research, Gulfport, Mobile

41012

Instituto Hispalense de Pediatria- IHP1, Seville

41013

Hospital Materno-Infantil Quirón, Seville

Servicio de Ginecología del Hospital Quirón Salud Sagrado Corazón, Seville

48604

Covenant Healthcare, Saginaw

Saginaw Valley Medical Research Group, LLC, Saginaw

59701

Boeson Research (BUT), Butte

SCL St. James Healthcare Hospital, Butte

59711

Community Hospital of Anaconda, Anaconda

59802

Providence St. Patrick Hospital, Missoula

59803

The Birth Center, Missoula

59804

Boeson Research, Missoula

Community Medical Center, Missoula

Community Physicians Group-Maternal Fetal Medicine, Missoula

59840

Marcus Daly Memorial Hospital, Hamilton

59864

St. Luke Community Healthcare Hospital, Ronan

68701

Meridian Clinical Research, LLC, Norfolk

68901

Meridian Clinical Research, LLC, Hastings

75093

Ventavia Research Group, LLC, Plano

75231

Ventavia Research Group LLC, Dallas

76022

Texas Health Harris Methodist Hospital Hurst-Euless-Bedford, Bedford

76086

Ventavia Research Group, LLC, Weatherford

Weatherford OBGYN, Weatherford

76104

8th Avenue Obstetrics & Gynecology, Fort Worth

Baylor Scott & White All Saints Medical Center, Fort Worth

Ventavia Research Group, LLC, Fort Worth

78504

Dr. Ruben Aleman & Associates, McAllen

78539

DHR Health Institute for Research and Development, Edinburg

78705

St. David's Medical Center, Austin

Tekton Research, Inc., Austin

78745

Tekton Research, Inc., Austin

83221

Bingham Memorial Hospital, Blackfoot

83402

Idaho Falls Pediatrics, Idaho Falls

83404

Clinical Research Prime, Idaho Falls

Eastern Idaho Regional Medical Center, Idaho Falls

Mountain View Hospital, Idaho Falls

83406

Idaho Falls Pediatrics, Ammon

84132

University of Utah Hospital, Salt Lake City

University of Utah, Salt Lake City

85013

St. Joseph Hospital, Phoenix

85015

MedPharmics, LLC, Phoenix

85308

Arrowhead Hospital, Glendale

85395

Abrazo West Campus Hospital, Goodyear

90023

East LA Doctors Hospital, Los Angeles

90057

Matrix Clinical Research, Los Angeles

90255

Matrix Clinical Research., Huntington Park

Matrix Clinical Research, Huntington Park

93534

Chemidox Clinical Trials Inc., Lancaster

30.130-100

Faculdade de Medicina da Universidade Federal de Minas Gerais, Belo Horizonte

30130-100

Hospital das Clínicas da Universidade Federal de Minas Gerais, Belo Horizonte

09624-000

HMU SBC - Hospital Municipal Universitário de São Bernardo, São Bernardo do Campo

09715 - 090

CEMEC - Centro Multidisciplinar de Estudos Clínicos, São Bernardo do Campo

18013-000

Hospital Santa Casa de Misericordia de Sorocaba, Sorocaba

18040-425

Clinica de Alergia Martti Antila S/S Ltda./ CMPC - Consultoria Medica e Pesquisa Clinica, Sorocaba

18052-210

Unimed Sorocaba-Hospital Dr. Miguel Soeiro (HMS), Sorocaba

0122

Botho Ke Bontle Health Services, Pretoria

08916

Hospital Universitari Germans Trias i Pujol, Badalona

08950

Hospital Sant Joan de Deu, Esplugues de Llobregat

Clinica Diagonal, Barcelona

08023

Hospital Quironsalud Barcelona, Barcelona

08035

Hospital Universitari Vall d'Hebron, Barcelona

08041

Hospital de la Santa Creu i Sant Pau, Barcelona

SO14 0YG

Hampshire Research Hub, Royal South Hants Hospital, Southampton

SO16 6YD

University Hospital Southampton NHS Foundation Trust, Southampton

ME7 5NY

Medway NHS Foundation Trust, Gillingham

LS9 7TF

Leeds Teaching Hospitals NHS Trust, Leeds

NW1 2PG

University College London Hospitals, London

W1T 7HA

University College London Hospitals, London

WC1E 6EB

University College London Hospitals, London

NE1 4LP

Royal Victoria Infirmary, Newcastle upon Tyne

OX3 9DU

John Radcliffe Hospital, Oxford

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

lead

BioNTech SE

INDUSTRY