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NCT07160244PHASE3RecruitingAccepts Healthy Volunteers

BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies

Pfizer

Start Date

8/25/2025

Completion Date

3/2/2029

Summary

BEATRIX (group B strEptococcus mATeRnal and Infant VaX study) The purpose of this study is to learn about the safety and how the group B streptococcus (GBS) vaccine works in pregnant women and their babies. This study is seeking healthy pregnant participants: * aged 49 or younger who can join. * between 24 and 36 weeks of gestation ("Gestational age" is a medical term used to describe how far along your pregnancy is) * had a fetal ultrasound examination performed with no major fetal abnormalities observed * documented negative for HIV, syphilis and Hepatitis B All participants in this study will receive only 1 shot in an arm. This could either be a group B streptococcus 6-valent polysaccharide conjugate vaccine (GBS6) or placebo. Placebo is an inactive substance used in the study for comparison purposes; in this study, the placebo injection will be saline (saltwater). The pregnant participants may take part in this study for a maximum of 14 months (6 months after delivery) , and their babies for about 12 months after they are born. The pregnant participants will need to visit the research site at least 3 to 4 times with some visits permitted to occur over the telephone. A subset of infants will be asked to take part in the study for up to 19 months. The subset will receive diphtheria toxoid-containing vaccine and/or pneumococcal vaccine following each country's standard immunization plan and have blood drawn 1 month after completion of the primary and/or toddler (booster) doses.

Eligibility Criteria

Age Range: No minimum to 49 years

Key Inclusion criteria- Maternal: * Healthy pregnant women ≤49 years of age who are between 24 0/7 and 36 0/7 weeks of gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, and who have no known increased risk of complications. * Had a fetal anomaly ultrasound examination with no significant fetal abnormalities observed. * Documented negative human immunodeficiency virus (HIV) antibody test, syphilis test, and hepatitis B virus (HBV) surface antigen test during this pregnancy and prior to randomization. * Capable of giving personal signed informed consent. * Willing to give informed consent for her infant to participate in the study. Key Exclusion criteria- Maternal: * Prepregnancy body mass index (BMI) of \>40 kg/m2. * Current pregnancy complications or abnormalities that may increase the risk associated with the participation in and completion of the study. * Prior pregnancy complications or abnormalities that, based on the investigator's judgment, may increase the risk associated with the participation in and completion of the study. * History of microbiologically proven invasive disease caused by GBS in the current pregnancy. * A known or suspected infection during the current pregnancy that may increase the risk of complications in pregnancy (eg, active tuberculosis, syphilis, primary genital herpes simplex, malaria). Key Inclusion criteria- Infant Participants \- Evidence of a signed and dated ICD signed by the parent(s)/legally authorized representative or legal guardian Key Exclusion Criteria - Infant Participants: \- Children or grandchildren who are direct descendants of investigator site staff or sponsor and sponsor delegate employees directly involved in the conduct of the study. Key Exclusion Criteria - Infant immunogenicity subset Participants: \- Children with a known or suspected contraindication to any vaccine administered in the infant vaccine immunogenicity subset. Refer to the study contact for further eligibility details

Interventions

BIOLOGICAL

Multivalent Group B streptococcus vaccine

BIOLOGICAL

Placebo

BIOLOGICAL

Infanrix hexa

BIOLOGICAL

Prevenar 20

BIOLOGICAL

Pediarix

BIOLOGICAL

Prevnar 20

BIOLOGICAL

Infanrix

Interested in This Trial?

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Conditions

Healthy

Locations

Center for Research in Women's Health

Birmingham, Alabama 35233

United States

Children's of Alabama

Birmingham, Alabama 35233

United States

University of Alabama at Birmingham - School of Medicine

Birmingham, Alabama 35233

United States

University of Alabama at Birmingham Women & Infants Center

Birmingham, Alabama 35294

United States

SEC Clinical Research

Dothan, Alabama 36305

United States

USA Health Allen Cox Building

Mobile, Alabama 36604

United States

USA Health Children's and Women's Hospital

Mobile, Alabama 36604

United States

USA Health Mitchell Cancer Institute

Mobile, Alabama 36604

United States

USA Health Strada Patient Care Center

Mobile, Alabama 36604

United States

ClinMed

Phoenix, Arizona 85004

United States

Valleywise Comprehensive Health Center Women's Clinic

Phoenix, Arizona 85008

United States

Valleywise Health Medical Center

Phoenix, Arizona 85008

United States

Genesis OB/GYN

Tucson, Arizona 85741

United States

Eclipse Clinical Research

Tucson, Arizona 85745

United States

Antelope Valley Medical Center

Lancaster, California 93534

United States

Chemidox Clinical Trials

Lancaster, California 93534

United States

Loma Linda University Children's Hospital

Loma Linda, California 92354

United States

Loma Linda University Health System

Loma Linda, California 92354

United States

Loma Linda University Pediatrics Clinic

Loma Linda, California 92354

United States

Lucile Packard Children's Hospital

Palo Alto, California 94304

United States

Stanford Obstetrics Clinic

Palo Alto, California 94304

United States

Stanford University Medical Center

Palo Alto, California 94304

United States

Stanford University

Palo Alto, California 94304

United States

Anschutz Health Sciences Building

Aurora, Colorado 80045

United States

Children's Hospital Colorado

Aurora, Colorado 80045

United States

CU Research Pharmacy

Aurora, Colorado 80045

United States

University of Colorado AO1

Aurora, Colorado 80045

United States

University of Colorado Hospital Outpatient Pavilion

Aurora, Colorado 80045

United States

University of Colorado Hospital

Aurora, Colorado 80045

United States

University of Colorado Research II Building

Aurora, Colorado 80045

United States

South Florida Clinical Research Institute - Margate

Margate, Florida 33063

United States

Citadelle Clinical Research

North Miami Beach, Florida 33162

United States

Emerald Coast OBGYN Clinical Research

Panama City, Florida 32405

United States

HCA Florida Gulf Coast Hospital

Panama City, Florida 32405

United States

Advanced Specialty Research

Boise, Idaho 83702

United States

Express Lab

Garden City, Idaho 83714

United States

Clinical Research Prime

Idaho Falls, Idaho 83404

United States

Eastern Idaho Regional Medical Center

Idaho Falls, Idaho 83404

United States

Mountain View Hospital

Idaho Falls, Idaho 83404

United States

Madison Memorial Hospital

Rexburg, Idaho 83440

United States

Accellacare - McFarland

Ames, Iowa 50010

United States

Mary Greeley Medical Center

Ames, Iowa 50010

United States

McFarland Clinic, PC

Ames, Iowa 50010

United States

Velocity Clinical Research, Covington

Covington, Louisiana 70433

United States

Ochsner Baptist Medical Center

New Orleans, Louisiana 70115

United States

Center for Immunization Research

Baltimore, Maryland 21205

United States

Center for Immunization Research

Baltimore, Maryland 21224

United States

Johns Hopkins Bayview Medical Center

Baltimore, Maryland 21224

United States

Gynecology and Obstetrics at Johns Hopkins Health Care and Surgery Center- White Marsh

Nottingham, Maryland 21236

United States

Boston Medical Center

Boston, Massachusetts 02118

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

Boeson Research GTF

Great Falls, Montana 59405

United States

Great Falls OBGYN Associates

Great Falls, Montana 59405

United States

Origin Health GTF

Great Falls, Montana 59405

United States

Blue Moose Pediatrics

Missoula, Montana 59804

United States

Boeson Research MSO

Missoula, Montana 59804

United States

Origin Health

Missoula, Montana 59804

United States

CHI Health St Francis

Grand Island, Nebraska 68803

United States

Grand Island Regional Medical Center

Grand Island, Nebraska 68803

United States

Velocity Clinical Research, Grand Island

Grand Island, Nebraska 68803

United States

Midwest Children's Health Research Center

Lincoln, Nebraska 68504

United States

Midwest Children's Health Research Center

Lincoln, Nebraska 68505

United States

Bryan Health

Lincoln, Nebraska 68506

United States

Midwest Children's Health Research Institute

Lincoln, Nebraska 68516

United States

Women's Health Care Center of Williamsburg

Lincoln, Nebraska 68516

United States

Midwest Children's Health Research Center

Lincoln, Nebraska 68522

United States

Velocity Clinical Research, Norfolk

Norfolk, Nebraska 68701

United States

Cooper University Health Care

Camden, New Jersey 08103

United States

Cooper University Health Care

Cherry Hill, New Jersey 08034

United States

Family Health Center

New Brunswick, New Jersey 08901

United States

Saint Peter's University Hospital

New Brunswick, New Jersey 08901

United States

Cooper University Health Care

Sewell, New Jersey 08080

United States

Stony Brook Medicine Clinical Research Center

East Setauket, New York 11733

United States

New York-Presbyterian Queens

Flushing, New York 11355

United States

Obstetrical Center

Fresh Meadows, New York 11365

United States

ACGC Research, NYU Ambulatory Care Garden City

Garden City, New York 11530

United States

NYU Langone Ambulatory Care Garden City

Garden City, New York 11530

United States

Jackson Heights Family Health Center

Jackson Heights, New York 11372

United States

NYU Langone Long Island, Clinical Research Center 3-002 (Admin only)

Mineola, New York 11501

United States

Columbia University Irving Medical Center

New York, New York 10032

United States

Weill Cornell Medicine - New York Presbyterian Hospital

New York, New York 10065

United States

Stony Brook University

Stony Brook, New York 11794

United States

Duke Vaccine and Trials Unit

Durham, North Carolina 27703

United States

Duke University - Main Hospital and Clinics

Durham, North Carolina 27705

United States

Duke University - Main Hospital and Clinics

Durham, North Carolina 27710

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio 45206

United States

University of Cincinnati Physicians Midtown

Cincinnati, Ohio 45213

United States

Hoxworth Center

Cincinnati, Ohio 45219

United States

University of Cincinnati Medical Center

Cincinnati, Ohio 45219

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio 45229

United States

University Hospitals

Cleveland, Ohio 44106

United States

Cincinnati Children's Hospital Medical Center Liberty

Liberty Township, Ohio 45044

United States

Cincinnati Children's Hospital Medical Center Mason

Mason, Ohio 45040

United States

Senders Pediatrics

South Euclid, Ohio 44121

United States

University of Cincinnati Medical Center West Chester

West Chester, Ohio 45069

United States

University of Cincinnati Physicians

West Chester, Ohio 45069

United States

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania 15213

United States

UPMC Magee Women's Hospital

Pittsburgh, Pennsylvania 15213

United States

Tribe Clinical Research, LLC- Greer

Greer, South Carolina 29650

United States

Tribe Clinical Research at Parkside Pediatrics Five Forks

Simpsonville, South Carolina 29681

United States

Proactive Clinical Research LLC

Edinburg, Texas 78539

United States

Memorial Hermann Memorial City Hospital

Houston, Texas 77024

United States

The University of Texas Health Science Center at Houston

Houston, Texas 77024

United States

Maximos Ob/Gyn

League City, Texas 77573

United States

Dr. Ruben Aleman and Associates

McAllen, Texas 78504

United States

University of Utah Madsen Health Center - Women's Health

Salt Lake City, Utah 84112

United States

University of Utah

Salt Lake City, Utah 84112

United States

University of Utah Clinical Neuroscience Center

Salt Lake City, Utah 84132

United States

University of Utah Hospital

Salt Lake City, Utah 84132

United States

Inova Fairfax Medical Campus

Falls Church, Virginia 22042

United States

Sentara Leigh Hospital

Norfolk, Virginia 23502

United States

The Group For Women - Kempsville Office

Norfolk, Virginia 23502

United States

Tidewater Physicians for Women

Norfolk, Virginia 23502

United States

Womens Care Center

Norfolk, Virginia 23502

United States

Virginia Physicians For Women (VPFW)

North Chesterfield, Virginia 23235

United States

Clinical Research Partners, LLC

Richmond, Virginia 23226

United States

Seattle Childrens Research Institute

Seattle, Washington 98101

United States

Seattle Childrens Hospital

Seattle, Washington 98105

United States

UW Medical Center Northwest

Seattle, Washington 98133

United States

UW Medical Center Montlake

Seattle, Washington 98195

United States

Marshfield Medical Center - Marshfield-(Hospital)

Marshfield, Wisconsin 54449

United States

Marshfield Medical Center - Marshfield

Marshfield, Wisconsin 54449

United States

Fundación Respirar

Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ABP

Argentina

Clinica Del Niño Y La Madre

Mar del Plata, Buenos Aires 7600

Argentina

Clinica Privada del Sol S.A

Córdoba, Córdoba Province X5000IIH

Argentina

Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L

San Miguel de Tucumán, Tucumán Province 4000

Argentina

Instituto de Maternidad y Ginecología Nuestra Señora de las Mercedes

San Miguel de Tucumán, Tucumán Province 4000

Argentina

Centro de investigación Clínica OSECAC - Sede Jonas Salk

Buenos Aires, 1044

Argentina

Equipo Ciencia

Buenos Aires, C1428BNF

Argentina

Hospital Público Materno Infantil

Salta, 4400

Argentina

Centro de Pesquisa Clínica - Obras Sociais Irmã Dulce

Salvador, Estado de Bahia 41680-430

Brazil

Centro de Estudos e Pesquisa em Molestias Infecciosas - CPCLIN/RN

Natal, Rio Grande do Norte 59025050

Brazil

Universidade Federal de Santa Maria.

Santa Maria, Rio Grande do Sul 97105-900

Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São José do Rio Preto, São Paulo 15090000

Brazil

Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo

São Paulo, São Paulo

Brazil

Canadian Center for Vaccinology

Halifax, Nova Scotia B3K 6R8

Canada

Kingston Health Sciences Centre - Kingston General Site

Kingston, Ontario K7L 2V7

Canada

CHU de Quebec-Universite Laval-Centre hospitalier de l'Universite Laval et Centre mere-enfant Soleil

Québec, Quebec G1V 4G2

Canada

FVR, Kokkolan rokotetutkimusklinikka

Kokkola, Keski-Pohjanmaa 67100

Finland

FVR, Oulun rokotetutkimusklinikka

Oulu, North Ostrobothnia 90220

Finland

FVR, Tampereen rokotetutkimusklinikka

Tampere, Pirkanmaa 33100

Finland

FVR, Seinäjoen rokotetutkimusklinikka

Seinäjoki, South Ostrobothnia 60100

Finland

FVR, Turun rokotetutkimusklinikka

Turku, Southwest Finland 20520

Finland

MeVac - Meilahti Vaccine Research Center

Helsinki, Uusimaa 00290

Finland

St.Mary's Hospital

Kurume, Fukuoka 830-8543

Japan

Sendai City Hospital

Sendai, Miyagi 982-8502

Japan

Beppu Medical Center

Beppu-shi, Oita Prefecture 874-0011

Japan

Osaka Habikino Medical Center

Habikino, Osaka 583-8588

Japan

Taniguchi Hospital

Izumisano, Osaka 598-0043

Japan

Yamanashi Prefectural Central Hospital

Kofu, Yamanashi 400-8506

Japan

Fukui Aiiku Hospital

Fukui, 910-0833

Japan

Rakuwakai Otowa Hospital

Kyoto, 607-8062

Japan

Shizuoka General Hospital

Shizuoka, 420-8527

Japan

Panamerican Clinical Research Mexico S.A de C.V. Guadalajara.

Guadalajara, Jalisco 44670

Mexico

Arké SMO S.A. de C.V.

Mexico City, Mexico City 06700

Mexico

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León 64460

Mexico

Unidad de Medicina Especializada SMA

San Juan del Río, Querétaro 76800

Mexico

Arké SMO S.A de C.V

Veracruz, 91900

Mexico

Jeroen Bosch Hospital

's-Hertogenbosch, North Brabant 5223 GZ

Netherlands

Diakonessenhuis, locatie Utrecht

Utrecht, 3582 KE

Netherlands

UMC Utrecht - Wilhelmina Kinderziekenhuis

Utrecht, 3584

Netherlands

Josha Research

Bloemfontein, Free State 9301

South Africa

REIMED Reiger Park

Boksburg, Gauteng 1459

South Africa

Wits RHI Shandukani Research Centre

Johannesburg, Gauteng 2001

South Africa

Setshaba Research Centre

Pretoria, Gauteng 0152

South Africa

Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit

Soweto, Gauteng 1864

South Africa

MRC Unit on Child And Adolescent Health

Cape Town, Western Cape 7700

South Africa

Gugulethu Green Clinic

Cape Town, Western Cape 7750

South Africa

Kangwon National University Hospital

Chuncheon, Gangwon-do 24289

South Korea

Chonnam National University Hospital

Gwangju, Kwangju-kwangyǒkshi 61469

South Korea

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [seoul] 03080

South Korea

Korea University Guro Hospital

Seoul, Seoul-teukbyeolsi [seoul] 08308

South Korea

Keimyung University Dongsan Hospital

Daegu, Taegu-kwangyǒkshi 42601

South Korea

Kyung Hee University Hospital at Gangdong

Seoul, 05278

South Korea

CHUS - Hospital Clinico Universitario

Santiago de Compostela, A Coruña [LA Coruña] 15706

Spain

Hospital Sant Joan de Déu

Esplugues de Llobregat, Barcelona [barcelona] 08950

Spain

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid 28223

Spain

Hospital Universitario de Torrejón

Torrejón de Ardoz, Madrid 28850

Spain

Hospital Universitario La Paz

Madrid, Madrid, Comunidad de 28046

Spain

Hospital Universitario HM Puerta del Sur

Madrid, Madrid, Comunidad de 28938

Spain

Hospital Antequera

Antequera, 29200

Spain

Hospital Universitario La Zarzuela

Aravaca, 28023

Spain

Hospital General Universitario Gregorio Marañon

Madrid, 28007

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Hospital Quirónsalud Sagrado Corazón

Seville, 41013

Spain

Instituto Hispalense de Pediatria- IHP1

Seville, 41014

Spain

Hsinchu Municipal Mackay Children's Hospital

Hsinchu, Hsinchu 30046

Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 80756

Taiwan

National Taiwan University Hospital

Taipei, 10002

Taiwan

Mackay Memorial Hospital

Taipei, 10449

Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, 333

Taiwan

University Hospitals Bristol NHS Foundation Trust

Bristol, Bristol, CITY of BS1 3NU

United Kingdom

St Michael's Hospital

Bristol, Bristol, CITY of BS2 8EG

United Kingdom

Barnet Hospital

London, England EN5 3DJ

United Kingdom

St. George's Hospital

London, England SW17 0QT

United Kingdom

North Manchester General Hospital

Manchester, England M8 5RB.

United Kingdom

The Royal Cornwall Hospital

Truro, England TR1 3LJ

United Kingdom

Southampton General Hospital

Southampton, Hampshire SO16 6YD

United Kingdom

St Mary's Hospital (Manchester University NHS Foundation Trust)

Manchester, Lancashire M13 9WL

United Kingdom

Imperial College Healthcare NHS Foundation Trust - St Mary's Hospital

London, London, CITY of W2 1NY

United Kingdom

The John Radcliffe Hospital

Oxford, Oxfordshire OX3 9DU

United Kingdom

The Princess Royal Hospital

Shropshire, Telford AND Wrekin TF1 6TF

United Kingdom

Bristol Royal Hospital for Children

Bristol, BS2 8BJ

United Kingdom

Bristol Royal Infirmary

Bristol, BS2 8EX

United Kingdom

St James's University Hospital

Leeds, LS9 7TF

United Kingdom

Royal Free Hospital

London, NW32QG

United Kingdom

Wythenshawe Hospital

Manchester, M23 9LT

United Kingdom