Actively Recruiting
BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies
Led by Pfizer · Updated on 2026-05-14
6000
Participants Needed
177
Research Sites
183 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy pregnant women 49 years or younger between 24 0/7 and 36 0/7 weeks of gestation with an uncomplicated, singleton pregnancy and no known increased risk of complications
- Fetal anomaly ultrasound examination showing no significant fetal abnormalities
- Documented negative HIV antibody test, syphilis test, and hepatitis B surface antigen test during this pregnancy prior to randomization
- Able to give signed informed consent personally
- Willing to provide informed consent for infant participation
You will not qualify if you...
- Prepregnancy body mass index (BMI) greater than 40 kg/m2
- Current pregnancy complications or abnormalities that increase risk for study participation
- Previous pregnancy complications or abnormalities increasing risk for study participation based on investigator judgment
- History of microbiologically confirmed invasive GBS disease during current pregnancy
- Known or suspected infection during current pregnancy that may increase risk of complications (eg, active tuberculosis, syphilis, primary genital herpes simplex, malaria)
- Infant descendants of investigator site staff or sponsor employees involved in study conduct
- Contraindication or suspected contraindication to any vaccine given in infant immunogenicity subset
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 177 locations
1
Center for Research in Women's Health
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Children's of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
3
University of Alabama at Birmingham - School of Medicine
Birmingham, Alabama, United States, 35233
Actively Recruiting
4
University of Alabama at Birmingham Women & Infants Center
Birmingham, Alabama, United States, 35294
Actively Recruiting
5
SEC Clinical Research
Dothan, Alabama, United States, 36305
Actively Recruiting
6
ClinMed
Phoenix, Arizona, United States, 85004
Actively Recruiting
7
Valleywise Comprehensive Health Center Women's Clinic
Phoenix, Arizona, United States, 85008
Not Yet Recruiting
8
Valleywise Health Medical Center
Phoenix, Arizona, United States, 85008
Not Yet Recruiting
9
Genesis OB/GYN
Tucson, Arizona, United States, 85741
Actively Recruiting
10
Eclipse Clinical Research
Tucson, Arizona, United States, 85745
Actively Recruiting
11
Antelope Valley Medical Center
Lancaster, California, United States, 93534
Actively Recruiting
12
Chemidox Clinical Trials
Lancaster, California, United States, 93534
Actively Recruiting
13
Lucile Packard Children's Hospital
Palo Alto, California, United States, 94304
Not Yet Recruiting
14
Stanford Obstetrics Clinic
Palo Alto, California, United States, 94304
Not Yet Recruiting
15
Stanford University Medical Center
Palo Alto, California, United States, 94304
Not Yet Recruiting
16
Stanford University
Palo Alto, California, United States, 94304
Not Yet Recruiting
17
Anschutz Health Sciences Building
Aurora, Colorado, United States, 80045
Not Yet Recruiting
18
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Not Yet Recruiting
19
CU Research Pharmacy
Aurora, Colorado, United States, 80045
Not Yet Recruiting
20
University of Colorado AO1
Aurora, Colorado, United States, 80045
Not Yet Recruiting
21
University of Colorado Hospital Outpatient Pavilion
Aurora, Colorado, United States, 80045
Not Yet Recruiting
22
University of Colorado Hospital
Aurora, Colorado, United States, 80045
Not Yet Recruiting
23
University of Colorado Research II Building
Aurora, Colorado, United States, 80045
Not Yet Recruiting
24
South Florida Clinical Research Institute - Margate
Margate, Florida, United States, 33063
Actively Recruiting
25
Citadelle Clinical Research
North Miami Beach, Florida, United States, 33162
Not Yet Recruiting
26
Emerald Coast OBGYN Clinical Research
Panama City, Florida, United States, 32405
Actively Recruiting
27
HCA Florida Gulf Coast Hospital
Panama City, Florida, United States, 32405
Actively Recruiting
28
Advanced Specialty Research
Boise, Idaho, United States, 83702
Actively Recruiting
29
Express Lab
Garden City, Idaho, United States, 83714
Actively Recruiting
30
Clinical Research Prime
Idaho Falls, Idaho, United States, 83404
Actively Recruiting
31
Eastern Idaho Regional Medical Center
Idaho Falls, Idaho, United States, 83404
Actively Recruiting
32
Mountain View Hospital
Idaho Falls, Idaho, United States, 83404
Actively Recruiting
33
Madison Memorial Hospital
Rexburg, Idaho, United States, 83440
Actively Recruiting
34
Accellacare - McFarland
Ames, Iowa, United States, 50010
Actively Recruiting
35
Mary Greeley Medical Center
Ames, Iowa, United States, 50010
Actively Recruiting
36
McFarland Clinic, PC
Ames, Iowa, United States, 50010
Actively Recruiting
37
Velocity Clinical Research, Covington
Covington, Louisiana, United States, 70433
Actively Recruiting
38
Center for Immunization Research
Baltimore, Maryland, United States, 21205
Actively Recruiting
39
Center for Immunization Research
Baltimore, Maryland, United States, 21224
Actively Recruiting
40
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Actively Recruiting
41
Gynecology and Obstetrics at Johns Hopkins Health Care and Surgery Center- White Marsh
Nottingham, Maryland, United States, 21236
Actively Recruiting
42
Boston Medical Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
43
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
44
Boeson Research GTF
Great Falls, Montana, United States, 59405
Actively Recruiting
45
Great Falls OBGYN Associates
Great Falls, Montana, United States, 59405
Actively Recruiting
46
Origin Health GTF
Great Falls, Montana, United States, 59405
Actively Recruiting
47
Blue Moose Pediatrics
Missoula, Montana, United States, 59804
Actively Recruiting
48
Boeson Research MSO
Missoula, Montana, United States, 59804
Actively Recruiting
49
Origin Health
Missoula, Montana, United States, 59804
Actively Recruiting
50
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, United States, 68803
Actively Recruiting
51
Midwest Children's Health Research Center
Lincoln, Nebraska, United States, 68504
Actively Recruiting
52
Midwest Children's Health Research Center
Lincoln, Nebraska, United States, 68505
Actively Recruiting
53
Bryan Health
Lincoln, Nebraska, United States, 68506
Actively Recruiting
54
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States, 68516
Actively Recruiting
55
Women's Health Care Center of Williamsburg
Lincoln, Nebraska, United States, 68516
Actively Recruiting
56
Midwest Children's Health Research Center
Lincoln, Nebraska, United States, 68522
Actively Recruiting
57
Velocity Clinical Research, Norfolk
Norfolk, Nebraska, United States, 68701
Actively Recruiting
58
Stony Brook Medicine Clinical Research Center
East Setauket, New York, United States, 11733
Actively Recruiting
59
ACGC Research, NYU Ambulatory Care Garden City
Garden City, New York, United States, 11530
Actively Recruiting
60
NYU Langone Ambulatory Care Garden City
Garden City, New York, United States, 11530
Actively Recruiting
61
NYU Langone Long Island, Clinical Research Center 3-002 (Admin only)
Mineola, New York, United States, 11501
Actively Recruiting
62
Weill Cornell Medicine - New York Presbyterian Hospital
New York, New York, United States, 10065
Not Yet Recruiting
63
Stony Brook University
Stony Brook, New York, United States, 11794
Actively Recruiting
64
Duke Vaccine and Trials Unit
Durham, North Carolina, United States, 27703
Actively Recruiting
65
Duke University - Main Hospital and Clinics
Durham, North Carolina, United States, 27705
Actively Recruiting
66
Duke University - Main Hospital and Clinics
Durham, North Carolina, United States, 27710
Actively Recruiting
67
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45206
Actively Recruiting
68
University of Cincinnati Physicians Midtown
Cincinnati, Ohio, United States, 45213
Actively Recruiting
69
Hoxworth Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
70
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
71
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
72
University Hospitals
Cleveland, Ohio, United States, 44106
Actively Recruiting
73
Cincinnati Children's Hospital Medical Center Liberty
Liberty Township, Ohio, United States, 45044
Actively Recruiting
74
Cincinnati Children's Hospital Medical Center Mason
Mason, Ohio, United States, 45040
Actively Recruiting
75
Senders Pediatrics
South Euclid, Ohio, United States, 44121
Actively Recruiting
76
University of Cincinnati Medical Center West Chester
West Chester, Ohio, United States, 45069
Actively Recruiting
77
University of Cincinnati Physicians
West Chester, Ohio, United States, 45069
Actively Recruiting
78
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Not Yet Recruiting
79
UPMC Magee Women's Hospital
Pittsburgh, Pennsylvania, United States, 15213
Not Yet Recruiting
80
Tribe Clinical Research, LLC- Greer
Greer, South Carolina, United States, 29650
Actively Recruiting
81
Tribe Clinical Research at Parkside Pediatrics Five Forks
Simpsonville, South Carolina, United States, 29681
Actively Recruiting
82
Proactive Clinical Research LLC
Edinburg, Texas, United States, 78539
Not Yet Recruiting
83
Memorial Hermann Memorial City Hospital
Houston, Texas, United States, 77024
Actively Recruiting
84
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77024
Actively Recruiting
85
Maximos Ob/Gyn
League City, Texas, United States, 77573
Actively Recruiting
86
Inova Fairfax Medical Campus
Falls Church, Virginia, United States, 22042
Actively Recruiting
87
Sentara Leigh Hospital
Norfolk, Virginia, United States, 23502
Actively Recruiting
88
The Group For Women - Kempsville Office
Norfolk, Virginia, United States, 23502
Actively Recruiting
89
Tidewater Physicians for Women
Norfolk, Virginia, United States, 23502
Actively Recruiting
90
Womens Care Center
Norfolk, Virginia, United States, 23502
Actively Recruiting
91
Virginia Physicians For Women (VPFW)
North Chesterfield, Virginia, United States, 23235
Actively Recruiting
92
Clinical Research Partners, LLC
Richmond, Virginia, United States, 23226
Actively Recruiting
93
Seattle Childrens Research Institute
Seattle, Washington, United States, 98101
Not Yet Recruiting
94
Seattle Childrens Hospital
Seattle, Washington, United States, 98105
Not Yet Recruiting
95
UW Medical Center Northwest
Seattle, Washington, United States, 98133
Not Yet Recruiting
96
UW Medical Center Montlake
Seattle, Washington, United States, 98195
Not Yet Recruiting
97
Fundación Respirar
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1426ABP
Actively Recruiting
98
Clinica Del Niño Y La Madre
Mar del Plata, Buenos Aires, Argentina, 7600
Not Yet Recruiting
99
Clinica Privada del Sol S.A
Córdoba, Córdoba Province, Argentina, X5000IIH
Not Yet Recruiting
100
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
San Miguel de Tucumán, Tucumán Province, Argentina, 4000
Actively Recruiting
101
Instituto de Maternidad y Ginecología Nuestra Señora de las Mercedes
San Miguel de Tucumán, Tucumán Province, Argentina, 4000
Actively Recruiting
102
Centro de investigación Clínica OSECAC - Sede Jonas Salk
Buenos Aires, Argentina, 1044
Actively Recruiting
103
Equipo Ciencia
Buenos Aires, Argentina, C1428BNF
Actively Recruiting
104
Centro de Pesquisa Clínica - Obras Sociais Irmã Dulce
Salvador, Estado de Bahia, Brazil, 41680-430
Actively Recruiting
105
Universidade Federal de Santa Maria.
Santa Maria, Rio Grande do Sul, Brazil, 97105-900
Not Yet Recruiting
106
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil, 15090000
Actively Recruiting
107
Canadian Center for Vaccinology
Halifax, Nova Scotia, Canada, B3K 6R8
Not Yet Recruiting
108
Kingston Health Sciences Centre - Kingston General Site
Kingston, Ontario, Canada, K7L 2V7
Not Yet Recruiting
109
CHU de Quebec-Universite Laval-Centre hospitalier de l'Universite Laval et Centre mere-enfant Soleil
Québec, Quebec, Canada, G1V 4G2
Actively Recruiting
110
FVR, Kokkolan rokotetutkimusklinikka
Kokkola, Keski-Pohjanmaa, Finland, 67100
Not Yet Recruiting
111
FVR, Oulun rokotetutkimusklinikka
Oulu, North Ostrobothnia, Finland, 90220
Not Yet Recruiting
112
FVR, Tampereen rokotetutkimusklinikka
Tampere, Pirkanmaa, Finland, 33100
Not Yet Recruiting
113
FVR, Seinäjoen rokotetutkimusklinikka
Seinäjoki, South Ostrobothnia, Finland, 60100
Not Yet Recruiting
114
FVR, Turun rokotetutkimusklinikka
Turku, Southwest Finland, Finland, 20520
Not Yet Recruiting
115
MeVac - Meilahti Vaccine Research Center
Helsinki, Uusimaa, Finland, 00290
Actively Recruiting
116
St.Mary's Hospital
Kurume, Fukuoka, Japan, 830-8543
Actively Recruiting
117
Sendai City Hospital
Sendai, Miyagi, Japan, 982-8502
Actively Recruiting
118
Beppu Medical Center
Beppu-shi, Oita Prefecture, Japan, 874-0011
Actively Recruiting
119
Osaka Habikino Medical Center
Habikino, Osaka, Japan, 583-8588
Actively Recruiting
120
Taniguchi Hospital
Izumisano, Osaka, Japan, 598-0043
Actively Recruiting
121
Yamanashi Prefectural Central Hospital
Kofu, Yamanashi, Japan, 400-8506
Actively Recruiting
122
Fukui Aiiku Hospital
Fukui, Japan, 910-0833
Actively Recruiting
123
Rakuwakai Otowa Hospital
Kyoto, Japan, 607-8062
Actively Recruiting
124
Shizuoka General Hospital
Shizuoka, Japan, 420-8527
Actively Recruiting
125
Panamerican Clinical Research Mexico S.A de C.V. Guadalajara.
Guadalajara, Jalisco, Mexico, 44670
Not Yet Recruiting
126
Arké SMO S.A. de C.V.
Mexico City, Mexico City, Mexico, 06700
Not Yet Recruiting
127
Unidad de Medicina Especializada SMA
San Juan del Río, Querétaro, Mexico, 76800
Not Yet Recruiting
128
Arké SMO S.A de C.V
Veracruz, Mexico, 91900
Not Yet Recruiting
129
Jeroen Bosch Hospital
's-Hertogenbosch, North Brabant, Netherlands, 5223 GZ
Not Yet Recruiting
130
Diakonessenhuis, locatie Utrecht
Utrecht, Netherlands, 3582 KE
Not Yet Recruiting
131
Josha Research
Bloemfontein, Free State, South Africa, 9301
Not Yet Recruiting
132
REIMED Reiger Park
Boksburg, Gauteng, South Africa, 1459
Actively Recruiting
133
Wits RHI Shandukani Research Centre
Johannesburg, Gauteng, South Africa, 2001
Not Yet Recruiting
134
Setshaba Research Centre
Pretoria, Gauteng, South Africa, 0152
Not Yet Recruiting
135
Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit
Soweto, Gauteng, South Africa, 1864
Actively Recruiting
136
MRC Unit on Child And Adolescent Health
Cape Town, Western Cape, South Africa, 7700
Not Yet Recruiting
137
Gugulethu Green Clinic
Cape Town, Western Cape, South Africa, 7750
Not Yet Recruiting
138
Kangwon National University Hospital
Chuncheon, Gangwon-do, South Korea, 24289
Actively Recruiting
139
Chonnam National University Hospital
Gwangju, Kwangju-kwangyǒkshi, South Korea, 61469
Not Yet Recruiting
140
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea, 03080
Not Yet Recruiting
141
Korea University Guro Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea, 08308
Actively Recruiting
142
Keimyung University Dongsan Hospital
Daegu, Taegu-kwangyǒkshi, South Korea, 42601
Actively Recruiting
143
Kyung Hee University Hospital at Gangdong
Seoul, South Korea, 05278
Not Yet Recruiting
144
CHUS - Hospital Clinico Universitario
Santiago de Compostela, A Coruña [LA Coruña], Spain, 15706
Actively Recruiting
145
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona [barcelona], Spain, 08950
Actively Recruiting
146
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain, 28223
Actively Recruiting
147
Hospital Universitario de Torrejón
Torrejón de Ardoz, Madrid, Spain, 28850
Actively Recruiting
148
Hospital Universitario La Paz
Madrid, Madrid, Comunidad de, Spain, 28046
Actively Recruiting
149
Hospital Universitario HM Puerta del Sur
Madrid, Madrid, Comunidad de, Spain, 28938
Actively Recruiting
150
Hospital Costa del Sol
Marbella, Malaga, Spain, 29603
Actively Recruiting
151
Hospital Antequera
Antequera, Spain, 29200
Actively Recruiting
152
Hospital Universitario La Zarzuela
Aravaca, Spain, 28023
Actively Recruiting
153
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Actively Recruiting
154
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
155
Hospital Quirónsalud Sagrado Corazón
Seville, Spain, 41013
Actively Recruiting
156
Instituto Hispalense de Pediatria- IHP1
Seville, Spain, 41014
Actively Recruiting
157
Hsinchu Municipal Mackay Children's Hospital
Hsinchu, Hsinchu, Taiwan, 30046
Actively Recruiting
158
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 80756
Actively Recruiting
159
National Taiwan University Hospital
Taipei, Taiwan, 10002
Actively Recruiting
160
Mackay Memorial Hospital
Taipei, Taiwan, 10449
Not Yet Recruiting
161
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, Taiwan, 333
Actively Recruiting
162
University Hospitals Bristol NHS Foundation Trust
Bristol, Bristol, CITY of, United Kingdom, BS1 3NU
Actively Recruiting
163
St Michael's Hospital
Bristol, Bristol, CITY of, United Kingdom, BS2 8EG
Actively Recruiting
164
Barnet Hospital
London, England, United Kingdom, EN5 3DJ
Not Yet Recruiting
165
St. George's Hospital
London, England, United Kingdom, SW17 0QT
Not Yet Recruiting
166
North Manchester General Hospital
Manchester, England, United Kingdom, M8 5RB.
Actively Recruiting
167
The Royal Cornwall Hospital
Truro, England, United Kingdom, TR1 3LJ
Actively Recruiting
168
Southampton General Hospital
Southampton, Hampshire, United Kingdom, SO16 6YD
Actively Recruiting
169
St Mary's Hospital (Manchester University NHS Foundation Trust)
Manchester, Lancashire, United Kingdom, M13 9WL
Actively Recruiting
170
Imperial College Healthcare NHS Foundation Trust - St Mary's Hospital
London, London, CITY of, United Kingdom, W2 1NY
Actively Recruiting
171
The John Radcliffe Hospital
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Actively Recruiting
172
The Princess Royal Hospital
Shropshire, Telford AND Wrekin, United Kingdom, TF1 6TF
Actively Recruiting
173
Bristol Royal Hospital for Children
Bristol, United Kingdom, BS2 8BJ
Actively Recruiting
174
Bristol Royal Infirmary
Bristol, United Kingdom, BS2 8EX
Actively Recruiting
175
St James's University Hospital
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
176
Royal Free Hospital
London, United Kingdom, NW32QG
Not Yet Recruiting
177
Wythenshawe Hospital
Manchester, United Kingdom, M23 9LT
Actively Recruiting
Research Team
P
Pfizer CT.gov Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
7
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