BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies
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
Interventions
Multivalent Group B streptococcus vaccine
Placebo
Infanrix hexa
Prevenar 20
Pediarix
Prevnar 20
Infanrix
Conditions
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