Actively Recruiting

Phase 3
Age: 1Day - 49Years
All Genders
Healthy Volunteers
NCT07160244

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

Age: 1Day - 49Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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