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
Status: Recruiting
Location: See all (71) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
BEATRIX (group B strEptococcus mATeRnal and Infant VaX study) The purpose of this study is to learn about the safety and how the group B streptococcus (GBS) vaccine works in pregnant women and their babies. This study is seeking healthy pregnant participants: * aged 49 or younger who can join. * between 24 and 36 weeks of gestation (Gestational age is a medical term used to describe how far along your pregnancy is) * had a fetal ultrasound examination performed with no major fetal abnormalities observed * documented negative for HIV, syphilis and Hepatitis B All participants in this study will receive only 1 shot in an arm. This could either be a group B streptococcus 6-valent polysaccharide conjugate vaccine (GBS6) or placebo. Placebo is an inactive substance used in the study for comparison purposes; in this study, the placebo injection will be saline (saltwater). The pregnant participants may take part in this study for a maximum of 14 months (6 months after delivery) , and their babies for about 12 months after they are born. The pregnant participants will need to visit the research site at least 3 to 4 times with some visits permitted to occur over the telephone. A subset of infants will be asked to take part in the study for up to 19 months. The subset will receive diphtheria toxoid-containing vaccine and/or pneumococcal vaccine following each country's standard immunization plan and have blood drawn 1 month after completion of the primary and/or toddler (booster) doses.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 49
Healthy Volunteers: t
View:
• 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
Locations
United States
Alabama
SEC Clinical Research
NOT_YET_RECRUITING
Dothan
Arizona
ClinMed
RECRUITING
Phoenix
Eclipse Clinical Research
NOT_YET_RECRUITING
Tucson
Genesis OB/GYN
NOT_YET_RECRUITING
Tucson
California
Antelope Valley Medical Center
RECRUITING
Lancaster
Chemidox Clinical Trials
RECRUITING
Lancaster
Florida
South Florida Clinical Research Institute - Margate
NOT_YET_RECRUITING
Margate
Emerald Coast OBGYN Clinical Research
NOT_YET_RECRUITING
Panama City
HCA Florida Gulf Coast Hospital
NOT_YET_RECRUITING
Panama City
Iowa
Mary Greeley Medical Center
NOT_YET_RECRUITING
Ames
McFarland Clinic, PC
NOT_YET_RECRUITING
Ames
Idaho
Advanced Specialty Research
RECRUITING
Boise
Express Lab
RECRUITING
Garden City
Clinical Research Prime
RECRUITING
Idaho Falls
Eastern Idaho Regional Medical Center
RECRUITING
Idaho Falls
Mountain View Hospital
RECRUITING
Idaho Falls
Madison Memorial Hospital
RECRUITING
Rexburg
Louisiana
Velocity Clinical Research, Covington
NOT_YET_RECRUITING
Covington
Massachusetts
Boston Medical Center
NOT_YET_RECRUITING
Boston
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Montana
Boeson Research GTF
RECRUITING
Great Falls
Origin Health GTF
RECRUITING
Great Falls
Boeson Research MSO
RECRUITING
Missoula
Origin Health
RECRUITING
Missoula
Nebraska
Velocity Clinical Research, Grand Island
RECRUITING
Grand Island
Bryan Health
RECRUITING
Lincoln
Midwest Children's Health Research Center
RECRUITING
Lincoln
Midwest Children's Health Research Center
RECRUITING
Lincoln
Midwest Children's Health Research Center
RECRUITING
Lincoln
Midwest Children's Health Research Institute
RECRUITING
Lincoln
Women's Health Care Center of Williamsburg
RECRUITING
Lincoln
Velocity Clinical Research, Norfolk
RECRUITING
Norfolk
South Carolina
Tribe Clinical Research, LLC- Greer
NOT_YET_RECRUITING
Greer
Tribe Clinical Research at Parkside Pediatrics Five Forks
NOT_YET_RECRUITING
Simpsonville
Texas
Proactive Clinical Research LLC
NOT_YET_RECRUITING
Edinburg
Maximos Ob/Gyn
NOT_YET_RECRUITING
League City
Virginia
Sentara Leigh Hospital
NOT_YET_RECRUITING
Norfolk
The Group For Women - Kempsville Office
NOT_YET_RECRUITING
Norfolk
Tidewater Physicians for Women
NOT_YET_RECRUITING
Norfolk
Womens Care Center
NOT_YET_RECRUITING
Norfolk
Virginia Physicians For Women (VPFW)
RECRUITING
North Chesterfield
Clinical Research Partners, LLC
RECRUITING
Richmond
Other Locations
Argentina
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
NOT_YET_RECRUITING
San Miguel De Tucumán
Finland
FVR, Kokkolan rokotetutkimusklinikka
NOT_YET_RECRUITING
Kokkola
FVR, Oulun rokotetutkimusklinikka
NOT_YET_RECRUITING
Oulu
FVR, Seinäjoen rokotetutkimusklinikka
NOT_YET_RECRUITING
Seinäjoki
FVR, Tampereen rokotetutkimusklinikka
NOT_YET_RECRUITING
Tampere
FVR, Turun rokotetutkimusklinikka
NOT_YET_RECRUITING
Turku
Japan
Beppu Medical Center
RECRUITING
Beppu-shi
Fukui Aiiku Hospital
RECRUITING
Fukui
Osaka Habikino Medical Center
RECRUITING
Habikino
Taniguchi Hospital
RECRUITING
Izumisano
Yamanashi Prefectural Central Hospital
RECRUITING
Kofu
St.Mary's Hospital
NOT_YET_RECRUITING
Kurume
Rakuwakai Otowa Hospital
RECRUITING
Kyoto
Sendai City Hospital
NOT_YET_RECRUITING
Sendai
Shizuoka General Hospital
RECRUITING
Shizuoka
Spain
Hospital Universitario HM Puerta del Sur
NOT_YET_RECRUITING
Madrid
Hospital Universitario Quironsalud Madrid
NOT_YET_RECRUITING
Pozuelo De Alarcón
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
NOT_YET_RECRUITING
Kaohsiung City
National Taiwan University Hospital
RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou Branch
NOT_YET_RECRUITING
Taoyuan District
United Kingdom
St Michael's Hospital
NOT_YET_RECRUITING
Bristol
University Hospitals Bristol NHS Foundation Trust
NOT_YET_RECRUITING
Bristol
Imperial College Healthcare NHS Foundation Trust - St Mary's Hospital
NOT_YET_RECRUITING
London
St. George's Hospital
NOT_YET_RECRUITING
London
North Manchester General Hospital
NOT_YET_RECRUITING
Manchester
St Mary's Hospital (Manchester University NHS Foundation Trust)
NOT_YET_RECRUITING
Manchester
Wythenshawe Hospital
NOT_YET_RECRUITING
Manchester
The Princess Royal Hospital
RECRUITING
Shropshire
Southampton General Hospital
NOT_YET_RECRUITING
Southampton
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date:2025-08-25
Estimated Completion Date:2029-03-02
Participants
Target number of participants:6000
Treatments
Experimental: GBS6
Multivalent group B streptococcus vaccine
Placebo_comparator: Placebo
Placebo
Experimental: Infanrix hexa
Commercially available combination vaccine containing diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio), and Haemophilus influenzae type b (Hib)
Experimental: Prevenar 20
Commercially available vaccine that protects against 20 strains of Streptococcus pneumoniae
Experimental: Pediarix
Commercially available combination vaccine containing diphtheria, tetanus, pertussis (whooping cough), hepatitis B, and polio
Experimental: Prevnar 20
Commercially available vaccine that protects against 20 strains of Streptococcus pneumoniae
Experimental: Infanrix
Commercially available combination vaccine containing diphtheria, tetanus, and pertussis