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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Pfizer • ClinicalTrials.gov ID: NCT07160244

Registry updated: 2026-09-25
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Description

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.

Interventions

  • Multivalent Group B streptococcus vaccine (Biological)
    Multivalent Group B streptococcus vaccine
  • Placebo (Biological)
    Saline Control
  • Infanrix hexa (Biological)
    Vaccine administered in a subset of infant participants as per the national immunization schedule
  • Prevenar 20 (Biological)
    Vaccine administered in a subset of infant participants as per the national immunization schedule
  • Pediarix (Biological)
    Vaccine administered in a subset of infant participants as per the national immunization schedule
  • Prevnar 20 (Biological)
    Vaccine administered in a subset of infant participants as per the national immunization schedule
  • Infanrix (Biological)
    Vaccine administered in a subset of infant participants as per the national immunization schedule

Eligibility criteria

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

Conditions

Healthy

Locations

  • Center for Research in Women's Health — Birmingham, Alabama, United States
  • Children's of Alabama — Birmingham, Alabama, United States
  • University of Alabama at Birmingham - School of Medicine — Birmingham, Alabama, United States
  • University of Alabama at Birmingham Women & Infants Center — Birmingham, Alabama, United States
  • SEC Clinical Research — Dothan, Alabama, United States
  • USA Health Allen Cox Building — Mobile, Alabama, United States
  • USA Health Children's and Women's Hospital — Mobile, Alabama, United States
  • USA Health Mitchell Cancer Institute — Mobile, Alabama, United States
  • USA Health Strada Patient Care Center — Mobile, Alabama, United States
  • ClinMed — Phoenix, Arizona, United States
  • Valleywise Comprehensive Health Center Women's Clinic — Phoenix, Arizona, United States
  • Valleywise Health Medical Center — Phoenix, Arizona, United States
  • Northwest Women's Center — Tucson, Arizona, United States
  • Genesis OB/GYN — Tucson, Arizona, United States
  • Eclipse Clinical Research — Tucson, Arizona, United States
  • Antelope Valley Medical Center — Lancaster, California, United States
  • Chemidox Clinical Trials — Lancaster, California, United States
  • Loma Linda University Children's Hospital — Loma Linda, California, United States
  • Loma Linda University Health System — Loma Linda, California, United States
  • Loma Linda University Pediatrics Clinic — Loma Linda, California, United States
  • Lucile Packard Children's Hospital — Palo Alto, California, United States
  • Stanford Obstetrics Clinic — Palo Alto, California, United States
  • Stanford University Medical Center — Palo Alto, California, United States
  • Stanford University — Palo Alto, California, United States
  • Anschutz Health Sciences Building — Aurora, Colorado, United States
  • Children's Hospital Colorado — Aurora, Colorado, United States
  • CU Research Pharmacy — Aurora, Colorado, United States
  • University of Colorado AO1 — Aurora, Colorado, United States
  • University of Colorado Hospital Outpatient Pavilion — Aurora, Colorado, United States
  • University of Colorado Hospital — Aurora, Colorado, United States
  • University of Colorado Research II Building — Aurora, Colorado, United States
  • South Florida Clinical Research Institute - Margate — Margate, Florida, United States
  • Citadelle Clinical Research — North Miami Beach, Florida, United States
  • Emerald Coast OBGYN Clinical Research — Panama City, Florida, United States
  • Emerald Coast Pediatrics — Panama City, Florida, United States
  • HCA Florida Gulf Coast Hospital — Panama City, Florida, United States
  • ASR, LLC — Boise, Idaho, United States
  • Express Lab — Garden City, Idaho, United States
  • Clinical Research Prime — Idaho Falls, Idaho, United States
  • Eastern Idaho Regional Medical Center — Idaho Falls, Idaho, United States
  • Mountain View Hospital — Idaho Falls, Idaho, United States
  • Madison Memorial Hospital — Rexburg, Idaho, United States
  • Velocity Clinical Research, Covington — Covington, Louisiana, United States
  • Ochsner Baptist Medical Center — New Orleans, Louisiana, United States
  • Center for Immunization Research — Baltimore, Maryland, United States
  • Center for Immunization Research — Baltimore, Maryland, United States
  • Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
  • Gynecology and Obstetrics at Johns Hopkins Health Care and Surgery Center- White Marsh — Nottingham, Maryland, United States
  • Boston Medical Center — Boston, Massachusetts, United States
  • Washington University School of Medicine — St Louis, Missouri, United States
  • Boeson Research GTF — Great Falls, Montana, United States
  • Great Falls OBGYN Associates — Great Falls, Montana, United States
  • Origin Health GTF — Great Falls, Montana, United States
  • Blue Moose Pediatrics — Missoula, Montana, United States
  • Boeson Research MSO — Missoula, Montana, United States
  • Origin Health — Missoula, Montana, United States
  • CHI Health St Francis — Grand Island, Nebraska, United States
  • Grand Island Regional Medical Center — Grand Island, Nebraska, United States
  • Velocity Clinical Research, Grand Island — Grand Island, Nebraska, United States
  • Midwest Children's Health Research Center — Lincoln, Nebraska, United States
  • Midwest Children's Health Research Center — Lincoln, Nebraska, United States
  • Bryan Health — Lincoln, Nebraska, United States
  • Midwest Children's Health Research Institute — Lincoln, Nebraska, United States
  • Women's Health Care Center of Williamsburg — Lincoln, Nebraska, United States
  • Midwest Children's Health Research Center — Lincoln, Nebraska, United States
  • Velocity Clinical Research, Norfolk — Norfolk, Nebraska, United States
  • Nebraska Medicine — Omaha, Nebraska, United States
  • Children's Physicians - UNMC — Omaha, Nebraska, United States
  • University of Nebraska Medical Center — Omaha, Nebraska, United States
  • Cooper University Health Care — Camden, New Jersey, United States
  • Cooper University Health Care — Cherry Hill, New Jersey, United States
  • Family Health Center — New Brunswick, New Jersey, United States
  • Saint Peter's University Hospital — New Brunswick, New Jersey, United States
  • Cooper University Health Care — Sewell, New Jersey, United States
  • New York-Presbyterian Queens — Flushing, New York, United States
  • Obstetrical Center — Fresh Meadows, New York, United States
  • ACGC Research, NYU Ambulatory Care Garden City — Garden City, New York, United States
  • NYU Langone Ambulatory Care Garden City — Garden City, New York, United States
  • Jackson Heights Family Health Center — Jackson Heights, New York, United States
  • NYU Langone Long Island, Clinical Research Center 3-002 (Admin only) — Mineola, New York, United States
  • Columbia University Irving Medical Center — New York, New York, United States
  • Weill Cornell Medicine - New York Presbyterian Hospital — New York, New York, United States
  • Duke Vaccine and Trials Unit — Durham, North Carolina, United States
  • Duke University - Main Hospital and Clinics — Durham, North Carolina, United States
  • Duke University - Main Hospital and Clinics — Durham, North Carolina, United States
  • Cincinnati Children's Hospital Medical Center Investigational Drug Services — Cincinnati, Ohio, United States
  • Cincinnati Children's Hospital Medical Center Vaccine Research Center — Cincinnati, Ohio, United States
  • University of Cincinnati Medical Center — Cincinnati, Ohio, United States
  • Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
  • University Hospitals — Cleveland, Ohio, United States
  • Cincinnati Children's Hospital Medical Center Liberty — Liberty Township, Ohio, United States
  • Cincinnati Children's Hospital Medical Center Mason — Mason, Ohio, United States
  • Senders Pediatrics — South Euclid, Ohio, United States
  • University of Cincinnati Medical Center West Chester — West Chester, Ohio, United States
  • UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
  • UPMC Magee Women's Hospital — Pittsburgh, Pennsylvania, United States
  • Tribe Clinical Research, LLC- Greer — Greer, South Carolina, United States
  • Tribe Clinical Research at Parkside Pediatrics Five Forks — Simpsonville, South Carolina, United States
  • University of Tennessee Medical Center — Knoxville, Tennessee, United States
  • Memorial Hermann Memorial City Hospital — Houston, Texas, United States
  • The University of Texas Health Science Center at Houston — Houston, Texas, United States
  • Maximos Ob/Gyn — League City, Texas, United States
  • Dr. Ruben Aleman and Associates — McAllen, Texas, United States
  • University of Utah Clinical Neuroscience Center — Salt Lake City, Utah, United States
  • University of Utah - Obstetrics and Gynecology Department — Salt Lake City, Utah, United States
  • University of Utah Madsen Health Center - Women's Health — Salt Lake City, Utah, United States
  • University of Utah — Salt Lake City, Utah, United States
  • Inova Fairfax Medical Campus — Falls Church, Virginia, United States
  • Sentara Leigh Hospital — Norfolk, Virginia, United States
  • The Group For Women - Kempsville Office — Norfolk, Virginia, United States
  • Tidewater Physicians for Women — Norfolk, Virginia, United States
  • Womens Care Center — Norfolk, Virginia, United States
  • Virginia Physicians For Women (VPFW) — North Chesterfield, Virginia, United States
  • Clinical Research Partners, LLC — Richmond, Virginia, United States
  • Seattle Childrens Research Institute — Seattle, Washington, United States
  • Seattle Childrens Hospital — Seattle, Washington, United States
  • UW Medical Center Northwest — Seattle, Washington, United States
  • UW Medical Center Montlake — Seattle, Washington, United States
  • Marshfield Medical Center - Marshfield-(Hospital) — Marshfield, Wisconsin, United States
  • Marshfield Medical Center - Marshfield — Marshfield, Wisconsin, United States
  • Fundación Respirar — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
  • Instituto Médico Platense (IMP) — La Plata, Buenos Aires, Argentina
  • Clinica Del Niño Y La Madre — Mar del Plata, Buenos Aires, Argentina
  • Clinica Privada del Sol S.A — Córdoba, Córdoba Province, Argentina
  • Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L — San Miguel de Tucumán, Tucumán Province, Argentina
  • Instituto de Maternidad y Ginecología Nuestra Señora de las Mercedes — San Miguel de Tucumán, Tucumán Province, Argentina
  • Centro de investigación Clínica OSECAC - Sede Jonas Salk — Buenos Aires, Argentina
  • Equipo Ciencia — Buenos Aires, Argentina
  • Hospital Público Materno Infantil — Salta, Argentina
  • Maternidade Climério de Oliveira / Universidade Federal da Bahia — Salvador, Estado de Bahia, Brazil
  • Maternidade e Hospital da Criança Deputado Alan Sanches / Secretaria Municipal da Saúde — Salvador, Estado de Bahia, Brazil
  • Hospital Geral Roberto Santos / Secretaria da Saúde do Estado da Bahia — Salvador, Estado de Bahia, Brazil
  • Centro de Pesquisa Clínica - Obras Sociais Irmã Dulce — Salvador, Estado de Bahia, Brazil
  • Complexo Hospital de Clínicas da Universidade Federal do Paraná — Curitiba, Paraná, Brazil
  • Centro de Estudos e Pesquisa em Molestias Infecciosas - CPCLIN/RN — Natal, Rio Grande do Norte, Brazil
  • Hospital Nossa Senhora da Conceicao - Grupo Hospitalar Conceicao — Porto Alegre, Rio Grande do Sul, Brazil
  • Universidade Federal de Santa Maria. — Santa Maria, Rio Grande do Sul, Brazil
  • Fundação Faculdade Regional de Medicina de São José do Rio Preto — São José do Rio Preto, São Paulo, Brazil
  • Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo — São Paulo, Brazil
  • Canadian Center for Vaccinology — Halifax, Nova Scotia, Canada
  • Kingston Health Sciences Centre - Kingston General Site — Kingston, Ontario, Canada
  • CHU Sainte-Justine — Montreal, Quebec, Canada
  • CHU de Quebec-Universite Laval-Centre hospitalier de l'Universite Laval et Centre mere-enfant Soleil — Québec, Quebec, Canada
  • FVR, Kokkolan rokotetutkimusklinikka — Kokkola, Keski-Pohjanmaa, Finland
  • FVR, Oulun rokotetutkimusklinikka — Oulu, North Ostrobothnia, Finland
  • FVR, Tampereen rokotetutkimusklinikka — Tampere, Pirkanmaa, Finland
  • FVR, Seinäjoen rokotetutkimusklinikka — Seinäjoki, South Ostrobothnia, Finland
  • FVR, Turun rokotetutkimusklinikka — Turku, Southwest Finland, Finland
  • MeVac - Meilahti Vaccine Research Center — Helsinki, Uusimaa, Finland
  • St.Mary's Hospital — Kurume, Fukuoka, Japan
  • Sendai City Hospital — Sendai, Miyagi, Japan
  • Beppu Medical Center — Beppu-shi, Oita Prefecture, Japan
  • Osaka Habikino Medical Center — Habikino, Osaka, Japan
  • Taniguchi Hospital — Izumisano, Osaka, Japan
  • Yamanashi Prefectural Central Hospital — Kofu, Yamanashi, Japan
  • Fukui Aiiku Hospital — Fukui, Japan
  • Rakuwakai Otowa Hospital — Kyoto, Japan
  • Shizuoka General Hospital — Shizuoka, Japan
  • Panamerican Clinical Research Mexico S.A de C.V. Guadalajara. — Guadalajara, Jalisco, Mexico
  • Arké SMO S.A. de C.V. — Mexico City, Mexico City, Mexico
  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez" — Monterrey, Nuevo León, Mexico
  • Unidad de Medicina Especializada SMA — San Juan del Río, Querétaro, Mexico
  • Arké SMO S.A de C.V — Veracruz, Mexico
  • Jeroen Bosch Hospital — 's-Hertogenbosch, North Brabant, Netherlands
  • Diakonessenhuis, locatie Utrecht — Utrecht, Netherlands
  • UMC Utrecht - Wilhelmina Kinderziekenhuis — Utrecht, Netherlands
  • Asian Hospital and Medical Center — Muntinlupa City, National Capital Region, Philippines
  • Josha Research — Bloemfontein, Free State, South Africa
  • REIMED Reiger Park — Boksburg, Gauteng, South Africa
  • Wits RHI Shandukani Research Centre — Johannesburg, Gauteng, South Africa
  • Setshaba Research Centre — Pretoria, Gauteng, South Africa
  • Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit — Soweto, Gauteng, South Africa
  • FAMCRU — Cape Town, Western Cape, South Africa
  • MRC Unit on Child And Adolescent Health — Cape Town, Western Cape, South Africa
  • Gugulethu Green Clinic — Cape Town, Western Cape, South Africa
  • Kangwon National University Hospital — Chuncheon, Gangwon-do, South Korea
  • Chonnam National University Hospital — Gwangju, Kwangju-kwangyǒkshi, South Korea
  • Seoul National University Hospital — Seoul, Seoul-teukbyeolsi [seoul], South Korea
  • Korea University Guro Hospital — Seoul, Seoul-teukbyeolsi [seoul], South Korea
  • Keimyung University Dongsan Hospital — Daegu, Taegu-kwangyǒkshi, South Korea
  • Kyung Hee University Hospital at Gangdong — Seoul, South Korea
  • CHUS - Hospital Clinico Universitario — Santiago de Compostela, A Coruña [LA Coruña], Spain
  • Hospital Sant Joan de Déu — Esplugues de Llobregat, Barcelona [barcelona], Spain
  • Hospital Universitario Quironsalud Madrid — Pozuelo de Alarcón, Madrid, Spain
  • Hospital Universitario de Torrejón — Torrejón de Ardoz, Madrid, Spain
  • Hospital Universitario La Paz — Madrid, Madrid, Comunidad de, Spain
  • Hospital Universitario HM Puerta del Sur — Madrid, Madrid, Comunidad de, Spain
  • Hospital Antequera — Antequera, Spain
  • Hospital Universitario La Zarzuela — Aravaca, Spain
  • Hospital General Universitario Gregorio Marañon — Madrid, Spain
  • Hospital Universitario 12 de Octubre — Madrid, Spain
  • Hospital Quirónsalud Sagrado Corazón — Seville, Spain
  • Instituto Hispalense de Pediatria- IHP1 — Seville, Spain
  • Hsinchu Municipal Mackay Children's Hospital — Hsinchu, Hsinchu, Taiwan
  • Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan
  • National Taiwan University Hospital — Taipei, Taiwan
  • Mackay Memorial Hospital — Taipei, Taiwan
  • Chang Gung Medical Foundation-Linkou Branch — Taoyuan, Taiwan
  • Sukuta Health Center — Sukuta, Western 1, The Gambia
  • Medical Research Council Unit The Gambia at London School of Hygiene and Tropical Medicine — Fajara, The Gambia
  • St Michael's Hospital — Bristol, Bristol, CITY of, United Kingdom
  • Barnet Hospital — London, England, United Kingdom
  • St. George's Hospital — London, England, United Kingdom
  • North Manchester General Hospital — Manchester, England, United Kingdom
  • The Royal Cornwall Hospital — Truro, England, United Kingdom
  • Southampton General Hospital — Southampton, Hampshire, United Kingdom
  • St Mary's Hospital (Manchester University NHS Foundation Trust) — Manchester, Lancashire, United Kingdom
  • Imperial College Healthcare NHS Foundation Trust - St Mary's Hospital — London, London, CITY of, United Kingdom
  • The John Radcliffe Hospital — Oxford, Oxfordshire, United Kingdom
  • The Princess Royal Hospital — Shropshire, Telford AND Wrekin, United Kingdom
  • Bristol NHS Foundation Trust — Bristol, United Kingdom
  • Bristol Royal Hospital for Children — Bristol, United Kingdom
  • Bristol Royal Infirmary — Bristol, United Kingdom
  • St James's University Hospital — Leeds, United Kingdom
  • Royal Free Hospital — London, United Kingdom
  • Wythenshawe Hospital — Manchester, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record