AzTrials
AzTrials

HealthyPhase 3NCT07160244

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

A Phase 3 study testing Multivalent Group B streptococcus vaccine, Infanrix hexa and Prevenar 20 in people with Healthy, run by Pfizer at 216 sites in 15 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 1 day to 49 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Multivalent Group B streptococcus vaccine, Infanrix hexa and Prevenar 20
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6,000 participants
Where
216 sitesin 15 countries
Study dates
25 Aug 2025to 2 Mar 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.
  • Evidence of a signed and dated ICD signed by the parent(s)/legally authorized representative or legal guardian

Who cannot join

  • 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).
  • 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.
Show all 9Show fewer
  • 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

Trial locations and contacts

216 sites in 15 countries. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

216 sites in 15 countries

United States120 sites, 119 recruiting

  • Anschutz Health Sciences Building

    Aurora, Colorado, 80045

    Recruiting

  • Children's Hospital Colorado

    Aurora, Colorado, 80045

    Recruiting

  • CU Research Pharmacy

    Aurora, Colorado, 80045

    Recruiting

  • University of Colorado AO1

    Aurora, Colorado, 80045

    Recruiting

  • University of Colorado Hospital Outpatient Pavilion

    Aurora, Colorado, 80045

    Recruiting

  • University of Colorado Hospital

    Aurora, Colorado, 80045

    Recruiting

  • University of Colorado Research II Building

    Aurora, Colorado, 80045

    Recruiting

  • Center for Immunization Research

    Baltimore, Maryland, 21205

    Recruiting

  • Center for Immunization Research

    Baltimore, Maryland, 21224

    Recruiting

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224

    Recruiting

  • Center for Research in Women's Health

    Birmingham, Alabama, 35233

    Recruiting

  • Children's of Alabama

    Birmingham, Alabama, 35233

    Recruiting

  • University of Alabama at Birmingham - School of Medicine

    Birmingham, Alabama, 35233

    Recruiting

  • University of Alabama at Birmingham Women & Infants Center

    Birmingham, Alabama, 35294

    Recruiting

  • ASR, LLC

    Boise, Idaho, 83702

    Recruiting

  • Boston Medical Center

    Boston, Massachusetts, 02118

    Recruiting

  • Cooper University Health Care

    Camden, New Jersey, 08103

    Not yet recruiting

  • Cooper University Health Care

    Cherry Hill, New Jersey, 08034

    Not yet recruiting

  • Cincinnati Children's Hospital Medical Center Investigational Drug Services

    Cincinnati, Ohio, 45206

    Recruiting

  • Cincinnati Children's Hospital Medical Center Vaccine Research Center

    Cincinnati, Ohio, 45206

    Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

    Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

    Recruiting

  • University Hospitals

    Cleveland, Ohio, 44106

    Recruiting

  • Velocity Clinical Research, Covington

    Covington, Louisiana, 70433

    Recruiting

  • SEC Clinical Research

    Dothan, Alabama, 36305

    Recruiting

  • Duke Vaccine and Trials Unit

    Durham, North Carolina, 27703

    Recruiting

  • Duke University - Main Hospital and Clinics

    Durham, North Carolina, 27705

    Recruiting

  • Duke University - Main Hospital and Clinics

    Durham, North Carolina, 27710

    Recruiting

  • Inova Fairfax Medical Campus

    Falls Church, Virginia, 22042

    Recruiting

  • New York-Presbyterian Queens

    Flushing, New York, 11355

    Recruiting

  • Obstetrical Center

    Fresh Meadows, New York, 11365

    Recruiting

  • Express Lab

    Garden City, Idaho, 83714

    Recruiting

  • ACGC Research, NYU Ambulatory Care Garden City

    Garden City, New York, 11530

    Recruiting

  • NYU Langone Ambulatory Care Garden City

    Garden City, New York, 11530

    Recruiting

  • CHI Health St Francis

    Grand Island, Nebraska, 68803

    Recruiting

  • Grand Island Regional Medical Center

    Grand Island, Nebraska, 68803

    Recruiting

  • Velocity Clinical Research, Grand Island

    Grand Island, Nebraska, 68803

    Recruiting

  • Boeson Research GTF

    Great Falls, Montana, 59405

    Recruiting

  • Great Falls OBGYN Associates

    Great Falls, Montana, 59405

    Recruiting

  • Origin Health GTF

    Great Falls, Montana, 59405

    Recruiting

  • Tribe Clinical Research, LLC- Greer

    Greer, South Carolina, 29650

    Recruiting

  • Memorial Hermann Memorial City Hospital

    Houston, Texas, 77024

    Recruiting

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77024

    Recruiting

  • Clinical Research Prime

    Idaho Falls, Idaho, 83404

    Recruiting

  • Eastern Idaho Regional Medical Center

    Idaho Falls, Idaho, 83404

    Recruiting

  • Mountain View Hospital

    Idaho Falls, Idaho, 83404

    Recruiting

  • Jackson Heights Family Health Center

    Jackson Heights, New York, 11372

    Recruiting

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

    Recruiting

  • Antelope Valley Medical Center

    Lancaster, California, 93534

    Recruiting

  • Chemidox Clinical Trials

    Lancaster, California, 93534

    Recruiting

  • Maximos Ob/Gyn

    League City, Texas, 77573

    Recruiting

  • Cincinnati Children's Hospital Medical Center Liberty

    Liberty Township, Ohio, 45044

    Recruiting

  • Midwest Children's Health Research Center

    Lincoln, Nebraska, 68504

    Recruiting

  • Midwest Children's Health Research Center

    Lincoln, Nebraska, 68505

    Recruiting

  • Bryan Health

    Lincoln, Nebraska, 68506

    Recruiting

  • Midwest Children's Health Research Institute

    Lincoln, Nebraska, 68516

    Recruiting

  • Women's Health Care Center of Williamsburg

    Lincoln, Nebraska, 68516

    Recruiting

  • Midwest Children's Health Research Center

    Lincoln, Nebraska, 68522

    Recruiting

  • Loma Linda University Children's Hospital

    Loma Linda, California, 92354

    Recruiting

  • Loma Linda University Health System

    Loma Linda, California, 92354

    Recruiting

  • Loma Linda University Pediatrics Clinic

    Loma Linda, California, 92354

    Recruiting

  • South Florida Clinical Research Institute - Margate

    Margate, Florida, 33063

    Recruiting

  • Marshfield Medical Center - Marshfield-(Hospital)

    Marshfield, Wisconsin, 54449

    Recruiting

  • Marshfield Medical Center - Marshfield

    Marshfield, Wisconsin, 54449

    Recruiting

  • Cincinnati Children's Hospital Medical Center Mason

    Mason, Ohio, 45040

    Recruiting

  • Dr. Ruben Aleman and Associates

    McAllen, Texas, 78504

    Recruiting

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

    Mineola, New York, 11501

    Recruiting

  • Blue Moose Pediatrics

    Missoula, Montana, 59804

    Recruiting

  • Boeson Research MSO

    Missoula, Montana, 59804

    Recruiting

  • Origin Health

    Missoula, Montana, 59804

    Recruiting

  • USA Health Allen Cox Building

    Mobile, Alabama, 36604

    Recruiting

  • USA Health Children's and Women's Hospital

    Mobile, Alabama, 36604

    Recruiting

  • USA Health Mitchell Cancer Institute

    Mobile, Alabama, 36604

    Recruiting

  • USA Health Strada Patient Care Center

    Mobile, Alabama, 36604

    Recruiting

  • Family Health Center

    New Brunswick, New Jersey, 08901

    Recruiting

  • Saint Peter's University Hospital

    New Brunswick, New Jersey, 08901

    Recruiting

  • Ochsner Baptist Medical Center

    New Orleans, Louisiana, 70115

    Recruiting

  • Columbia University Irving Medical Center

    New York, New York, 10032

    Recruiting

  • Weill Cornell Medicine - New York Presbyterian Hospital

    New York, New York, 10065

    Recruiting

  • Velocity Clinical Research, Norfolk

    Norfolk, Nebraska, 68701

    Recruiting

  • Sentara Leigh Hospital

    Norfolk, Virginia, 23502

    Recruiting

  • The Group For Women - Kempsville Office

    Norfolk, Virginia, 23502

    Recruiting

  • Tidewater Physicians for Women

    Norfolk, Virginia, 23502

    Recruiting

  • Womens Care Center

    Norfolk, Virginia, 23502

    Recruiting

  • Virginia Physicians For Women (VPFW)

    North Chesterfield, Virginia, 23235

    Recruiting

  • Citadelle Clinical Research

    North Miami Beach, Florida, 33162

    Recruiting

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

    Nottingham, Maryland, 21236

    Recruiting

  • Nebraska Medicine

    Omaha, Nebraska, 68105

    Recruiting

  • Children's Physicians - UNMC

    Omaha, Nebraska, 68198

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    Recruiting

  • Lucile Packard Children's Hospital

    Palo Alto, California, 94304

    Recruiting

  • Stanford Obstetrics Clinic

    Palo Alto, California, 94304

    Recruiting

  • Stanford University Medical Center

    Palo Alto, California, 94304

    Recruiting

  • Stanford University

    Palo Alto, California, 94304

    Recruiting

  • Emerald Coast OBGYN Clinical Research

    Panama City, Florida, 32405

    Recruiting

  • Emerald Coast Pediatrics

    Panama City, Florida, 32405

    Recruiting

  • HCA Florida Gulf Coast Hospital

    Panama City, Florida, 32405

    Recruiting

  • ClinMed

    Phoenix, Arizona, 85004

    Recruiting

  • Valleywise Comprehensive Health Center Women's Clinic

    Phoenix, Arizona, 85008

    Recruiting

  • Valleywise Health Medical Center

    Phoenix, Arizona, 85008

    Recruiting

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

    Recruiting

  • UPMC Magee Women's Hospital

    Pittsburgh, Pennsylvania, 15213

    Recruiting

  • Madison Memorial Hospital

    Rexburg, Idaho, 83440

    Recruiting

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23226

    Recruiting

  • University of Utah Clinical Neuroscience Center

    Salt Lake City, Utah, 84108

    Recruiting

  • University of Utah - Obstetrics and Gynecology Department

    Salt Lake City, Utah, 84112

    Recruiting

  • University of Utah Madsen Health Center - Women's Health

    Salt Lake City, Utah, 84112

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84132

    Recruiting

  • Seattle Childrens Research Institute

    Seattle, Washington, 98101

    Recruiting

  • Seattle Childrens Hospital

    Seattle, Washington, 98105

    Recruiting

  • UW Medical Center Northwest

    Seattle, Washington, 98133

    Recruiting

  • UW Medical Center Montlake

    Seattle, Washington, 98195

    Recruiting

  • Cooper University Health Care

    Sewell, New Jersey, 08080

    Not yet recruiting

  • Tribe Clinical Research at Parkside Pediatrics Five Forks

    Simpsonville, South Carolina, 29681

    Recruiting

  • Senders Pediatrics

    South Euclid, Ohio, 44121

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Active, not recruiting

  • Northwest Women's Center

    Tucson, Arizona, 85704

    Recruiting

  • Genesis OB/GYN

    Tucson, Arizona, 85741

    Recruiting

  • Eclipse Clinical Research

    Tucson, Arizona, 85745

    Recruiting

  • University of Cincinnati Medical Center West Chester

    West Chester, Ohio, 45069

    Recruiting

Other trials in United States

United Kingdom16 sites, 16 recruiting

  • St Michael's Hospital

    Bristol, Bristol, CITY of, BS2 8EG

    Recruiting

  • Bristol NHS Foundation Trust

    Bristol, BS1 3NU

    Recruiting

  • Bristol Royal Hospital for Children

    Bristol, BS2 8BJ

    Recruiting

  • Bristol Royal Infirmary

    Bristol, BS2 8EX

    Recruiting

  • St James's University Hospital

    Leeds, LS9 7TF

    Recruiting

  • Barnet Hospital

    London, England, EN5 3DJ

    Recruiting

  • St. George's Hospital

    London, England, SW17 0QT

    Recruiting

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

    London, London, CITY of, W2 1NY

    Recruiting

  • Royal Free Hospital

    London, NW32QG

    Recruiting

  • North Manchester General Hospital

    Manchester, England, M8 5RB.

    Recruiting

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

    Manchester, Lancashire, M13 9WL

    Recruiting

  • Wythenshawe Hospital

    Manchester, M23 9LT

    Recruiting

  • The John Radcliffe Hospital

    Oxford, Oxfordshire, OX3 9DU

    Recruiting

  • The Princess Royal Hospital

    Shropshire, Telford AND Wrekin, TF1 6TF

    Recruiting

  • Southampton General Hospital

    Southampton, Hampshire, SO16 6YD

    Recruiting

  • The Royal Cornwall Hospital

    Truro, England, TR1 3LJ

    Recruiting

Other trials in United Kingdom

Spain12 sites, 12 recruiting

  • Hospital Antequera

    Antequera, 29200

    Recruiting

  • Hospital Universitario La Zarzuela

    Aravaca, 28023

    Recruiting

  • Hospital Sant Joan de Déu

    Esplugues de Llobregat, Barcelona [barcelona], 08950

    Recruiting

  • Hospital Universitario La Paz

    Madrid, Madrid, Comunidad de, 28046

    Recruiting

  • Hospital Universitario HM Puerta del Sur

    Madrid, Madrid, Comunidad de, 28938

    Recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, Madrid, 28223

    Recruiting

  • CHUS - Hospital Clinico Universitario

    Santiago de Compostela, A Coruña [LA Coruña], 15706

    Recruiting

  • Hospital Quirónsalud Sagrado Corazón

    Seville, 41013

    Recruiting

  • Instituto Hispalense de Pediatria- IHP1

    Seville, 41014

    Recruiting

  • Hospital Universitario de Torrejón

    Torrejón de Ardoz, Madrid, 28850

    Recruiting

Other trials in Spain

Brazil10 sites, 10 recruiting

  • Complexo Hospital de Clínicas da Universidade Federal do Paraná

    Curitiba, Paraná, 80.060-900

    Recruiting

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

    Natal, Rio Grande do Norte, 59025050

    Recruiting

  • Hospital Nossa Senhora da Conceicao - Grupo Hospitalar Conceicao

    Porto Alegre, Rio Grande do Sul, 91350-200

    Recruiting

  • Maternidade Climério de Oliveira / Universidade Federal da Bahia

    Salvador, Estado de Bahia, 40055-150

    Recruiting

  • Maternidade e Hospital da Criança Deputado Alan Sanches / Secretaria Municipal da Saúde

    Salvador, Estado de Bahia, 40210-341

    Recruiting

  • Hospital Geral Roberto Santos / Secretaria da Saúde do Estado da Bahia

    Salvador, Estado de Bahia, 41180-780

    Recruiting

  • Centro de Pesquisa Clínica - Obras Sociais Irmã Dulce

    Salvador, Estado de Bahia, 41680-430

    Recruiting

  • Universidade Federal de Santa Maria.

    Santa Maria, Rio Grande do Sul, 97105-900

    Recruiting

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto

    São José do Rio Preto, São Paulo, 15090000

    Recruiting

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

    São Paulo, 05403-000

    Recruiting

Other trials in Brazil

Argentina9 sites, 9 recruiting

  • Centro de investigación Clínica OSECAC - Sede Jonas Salk

    Buenos Aires, 1044

    Recruiting

  • Equipo Ciencia

    Buenos Aires, C1428BNF

    Recruiting

  • Fundación Respirar

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ABP

    Recruiting

  • Clinica Privada del Sol S.A

    Córdoba, Córdoba Province, X5000IIH

    Recruiting

  • Instituto Médico Platense (IMP)

    La Plata, Buenos Aires, 1900

    Recruiting

  • Clinica Del Niño Y La Madre

    Mar del Plata, Buenos Aires, 7600

    Recruiting

  • Hospital Público Materno Infantil

    Salta, 4400

    Recruiting

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

    San Miguel de Tucumán, Tucumán Province, 4000

    Recruiting

  • Instituto de Maternidad y Ginecología Nuestra Señora de las Mercedes

    San Miguel de Tucumán, Tucumán Province, 4000

    Recruiting

Other trials in Argentina

Japan9 sites, 9 recruiting

  • Beppu Medical Center

    Beppu-shi, Oita Prefecture, 874-0011

    Recruiting

  • Fukui Aiiku Hospital

    Fukui, 910-0833

    Recruiting

  • Osaka Habikino Medical Center

    Habikino, Osaka, 583-8588

    Recruiting

  • Taniguchi Hospital

    Izumisano, Osaka, 598-0043

    Recruiting

  • Yamanashi Prefectural Central Hospital

    Kofu, Yamanashi, 400-8506

    Recruiting

  • St.Mary's Hospital

    Kurume, Fukuoka, 830-8543

    Recruiting

  • Rakuwakai Otowa Hospital

    Kyoto, 607-8062

    Recruiting

  • Sendai City Hospital

    Sendai, Miyagi, 982-8502

    Recruiting

  • Shizuoka General Hospital

    Shizuoka, 420-8527

    Recruiting

Other trials in Japan

South Africa8 sites, 8 recruiting

  • Josha Research

    Bloemfontein, Free State, 9301

    Recruiting

  • REIMED Reiger Park

    Boksburg, Gauteng, 1459

    Recruiting

  • FAMCRU

    Cape Town, Western Cape, 7505

    Recruiting

  • MRC Unit on Child And Adolescent Health

    Cape Town, Western Cape, 7700

    Recruiting

  • Gugulethu Green Clinic

    Cape Town, Western Cape, 7750

    Recruiting

  • Wits RHI Shandukani Research Centre

    Johannesburg, Gauteng, 2001

    Recruiting

  • Setshaba Research Centre

    Pretoria, Gauteng, 0152

    Recruiting

  • Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit

    Soweto, Gauteng, 1864

    Recruiting

Other trials in South Africa

Finland6 sites, 6 recruiting

  • MeVac - Meilahti Vaccine Research Center

    Helsinki, Uusimaa, 00290

    Recruiting

  • FVR, Kokkolan rokotetutkimusklinikka

    Kokkola, Keski-Pohjanmaa, 67100

    Recruiting

  • FVR, Oulun rokotetutkimusklinikka

    Oulu, North Ostrobothnia, 90220

    Recruiting

  • FVR, Seinäjoen rokotetutkimusklinikka

    Seinäjoki, South Ostrobothnia, 60100

    Recruiting

  • FVR, Tampereen rokotetutkimusklinikka

    Tampere, Pirkanmaa, 33100

    Recruiting

  • FVR, Turun rokotetutkimusklinikka

    Turku, Southwest Finland, 20520

    Recruiting

Other trials in Finland

South Korea6 sites, 6 recruiting

  • Kangwon National University Hospital

    Chuncheon, Gangwon-do, 24289

    Recruiting

  • Keimyung University Dongsan Hospital

    Daegu, Taegu-kwangyǒkshi, 42601

    Recruiting

  • Chonnam National University Hospital

    Gwangju, Kwangju-kwangyǒkshi, 61469

    Recruiting

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 03080

    Recruiting

  • Korea University Guro Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 08308

    Recruiting

  • Kyung Hee University Hospital at Gangdong

    Seoul, 05278

    Recruiting

Other trials in South Korea

Mexico5 sites, 5 recruiting

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

    Guadalajara, Jalisco, 44670

    Recruiting

  • Arké SMO S.A. de C.V.

    Mexico City, Mexico City, 06700

    Recruiting

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León, 64460

    Recruiting

  • Unidad de Medicina Especializada SMA

    San Juan del Río, Querétaro, 76800

    Recruiting

  • Arké SMO S.A de C.V

    Veracruz, 91900

    Recruiting

Other trials in Mexico

Taiwan5 sites, 5 recruiting

  • Hsinchu Municipal Mackay Children's Hospital

    Hsinchu, Hsinchu, 30046

    Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

    Recruiting

  • National Taiwan University Hospital

    Taipei, 10002

    Recruiting

  • Mackay Memorial Hospital

    Taipei, 10449

    Recruiting

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333

    Recruiting

Other trials in Taiwan

Canada4 sites, 4 recruiting

  • Canadian Center for Vaccinology

    Halifax, Nova Scotia, B3K 6R8

    Recruiting

  • Kingston Health Sciences Centre - Kingston General Site

    Kingston, Ontario, K7L 2V7

    Recruiting

  • CHU Sainte-Justine

    Montreal, Quebec, H3T 1C5

    Recruiting

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

    Québec, Quebec, G1V 4G2

    Recruiting

Other trials in Canada

Netherlands3 sites, 3 recruiting

  • Jeroen Bosch Hospital

    's-Hertogenbosch, North Brabant, 5223 GZ

    Recruiting

  • Diakonessenhuis, locatie Utrecht

    Utrecht, 3582 KE

    Recruiting

  • UMC Utrecht - Wilhelmina Kinderziekenhuis

    Utrecht, 3584

    Recruiting

Other trials in Netherlands

The Gambia2 sites, 2 recruiting

  • Medical Research Council Unit The Gambia at London School of Hygiene and Tropical Medicine

    Fajara, PO Box 273

    Recruiting

  • Sukuta Health Center

    Sukuta, Western 1

    Recruiting

Other trials in The Gambia

Philippines1 site, 1 recruiting

  • Asian Hospital and Medical Center

    Muntinlupa City, National Capital Region, 1780

    Not yet recruiting

Other trials in Philippines

About this study

Official title: A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE IN HEALTHY PREGNANT WOMEN AND THEIR INFANTS

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:

Read more
  • 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
Healthy
Being tested
Multivalent Group B streptococcus vaccine, Placebo, Infanrix hexa, Prevenar 20, Pediarix
Keywords
group B streptococcus, maternal immunization, vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multivalent Group B streptococcus vaccineBiological

    Also called GBS6

    Multivalent Group B streptococcus vaccine

  • PlaceboBiological

    Saline Control

  • Infanrix hexaBiological

    Vaccine administered in a subset of infant participants as per the national immunization schedule

  • Prevenar 20Biological

    Vaccine administered in a subset of infant participants as per the national immunization schedule

  • PediarixBiological

    Vaccine administered in a subset of infant participants as per the national immunization schedule

  • Prevnar 20Biological

    Vaccine administered in a subset of infant participants as per the national immunization schedule

  • InfanrixBiological

    Vaccine administered in a subset of infant participants as per the national immunization schedule

Study groups in NCT07160244
Study groupRoleWhat they receive
GBS6ExperimentalMultivalent group B streptococcus vaccine
Receives: Biological: Multivalent Group B streptococcus vaccine
PlaceboPlacebo comparatorPlacebo
Receives: Biological: Placebo
Infanrix hexaExperimentalCommercially available combination vaccine containing diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio), and Haemophilus influenzae type b (Hib)
Receives: Biological: Infanrix hexa
Prevenar 20ExperimentalCommercially available vaccine that protects against 20 strains of Streptococcus pneumoniae
Receives: Biological: Prevenar 20
PediarixExperimentalCommercially available combination vaccine containing diphtheria, tetanus, pertussis (whooping cough), hepatitis B, and polio
Receives: Biological: Pediarix
Prevnar 20ExperimentalCommercially available vaccine that protects against 20 strains of Streptococcus pneumoniae
Receives: Biological: Prevnar 20
InfanrixExperimentalCommercially available combination vaccine containing diphtheria, tetanus, and pertussis
Receives: Biological: Infanrix

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of maternal participants reporting prespecified local reactions within 7 days following study intervention

    Measured: Within 7 days

  2. The proportion of maternal participants reporting prespecified systemic events within 7 days following study intervention

    Measured: Within 7 days

  3. The proportion of maternal participants reporting adverse events (AEs) through 1 month following study intervention

    Measured: 1 month

  4. The proportion of maternal participants reporting serious adverse events (SAEs) through 6 months after delivery

    Measured: 6 months after delivery

  5. The proportion of maternal participants reporting medically attended adverse events (MAAEs) through 6 months after delivery

    Measured: 6 months after delivery

  6. The proportion of maternal participants reporting adverse events of special interest (AESIs) through 6 months after delivery.

    Measured: 6 months after delivery

  7. The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting adverse events (AEs) from birth through 1 month of age

    Measured: Birth to 1 month of age

  8. The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting serious adverse events (SAEs) from birth through end of the study

    Measured: Through study completion, at least 1 year

  9. The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting medically attended adverse events (MAAEs) from birth through 6 months of age

    Measured: Birth to 6 months of age

  10. The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting adverse events of special interest (AESIs) from birth through end of study

    Measured: Through study completion, at least 1 year

  11. To measure the relative risk reduction in the proportion of infant participants at birth with GBS serotype-specific IgG antibody concentrations below predefined serotype-specific GBS late onset disease thresholds in the GBS6 group to the placebo group

    Measured: Birth

  12. To measure the relative risk reduction in the proportion of infant participants at birth with GBS serotype-specific IgG antibody concentrations below predefined serotype-specific GBS early onset disease thresholds in the GBS6 group to the placebo group

    Measured: Birth

  13. To evaluate the aggregate predicted VE combining all 6 serotypes in GBS6 to provide protection from invasive GBS late onset disease based on serotype specific anti-CPS IgG concentrations measured in infants at birth.

    Measured: Birth

  14. To evaluate the aggregate predicted VE combining all 6 serotypes in GBS6 to provide protection from invasive GBS early onset disease based on serotype specific anti-CPS IgG concentrations measured in infants at birth.

    Measured: Birth

Secondary outcomes (6)

  1. To measure GBS serotype-specific opsonophagocytic titers in infant participants at birth by geometric mean ratio between GBS6 group versus placebo group and by the difference in seroresponse rates between GBS6 group and placebo group

    Measured: Birth

  2. To describe anti-CPS IgG antibody levels predicted to provide protection from invasive GBS disease (all disease) caused by the 6 individual vaccine serotypes in infants when GBS6 is administered to healthy pregnant women.

    Measured: Birth

  3. To describe anti-CPS IgG antibody levels in infant participants born to maternal participants vaccinated with GBS6.

    Measured: Birth

  4. To describe anti-CPS IgG antibody levels predicted to provide protection from invasive GBS LOD and EOD, separately, caused by the 6 individual vaccine serotypes (Ia, Ib, II, III, IV, and V) in infants when GBS6 is administered to healthy pregnant women.

    Measured: Birth

  5. To measure GBS serotype-specific IgG by geometric mean concentration in maternal participants at 1 month after vaccination and at delivery.

    Measured: 1 month after vaccination and at delivery

  6. Compare the proportion of infants with anti-diphtheria toxoid and/or pneumococcal IgG responses at 1 month post-primary and toddler doses between GBS6 and placebo groups, including predefined IgG levels and geometric mean ratios.

    Measured: 1 month after the primary vaccination series and 1 month after the toddler dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2025
  2. Study start25 Aug 2025
  3. Primary completion6 Nov 2028 (estimated)
  4. Study completion2 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
6,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07160244
Sponsor's protocol ID
C1091009
Other IDs
2022-503070-36-00
Status last verified
Sep 2026
First submitted
14 Aug 2025
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Multivalent Group B streptococcus vaccine, Infanrix hexa and Prevenar 20 in people with Healthy, run by Pfizer at 216 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 216 sites in United States, United Kingdom, Spain, Brazil, Argentina and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of maternal participants reporting prespecified local reactions within 7 days following study intervention (time frame: Within 7 days). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07160244.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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Clinical Trial NCT07160244 | AzTrials