Dysautonomia International

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

Purpose

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.

Condition

Healthy

Eligibility

Eligible Ages: Between 1 Day and 49 Years
Eligible Sex: All
Accepts Healthy Volunteers: Yes

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.

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

Study Design

Phase: Phase 3
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental GBS6	Multivalent group B streptococcus vaccine	Biological: Multivalent Group B streptococcus vaccine Multivalent Group B streptococcus vaccine Other names: GBS6
Placebo Comparator Placebo	Placebo	Biological: Placebo Saline Control
Experimental Infanrix hexa	Commercially available combination vaccine containing diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio), and Haemophilus influenzae type b (Hib)	Biological: Infanrix hexa Vaccine administered in a subset of infant participants as per the national immunization schedule
Experimental Prevenar 20	Commercially available vaccine that protects against 20 strains of Streptococcus pneumoniae	Biological: Prevenar 20 Vaccine administered in a subset of infant participants as per the national immunization schedule
Experimental Pediarix	Commercially available combination vaccine containing diphtheria, tetanus, pertussis (whooping cough), hepatitis B, and polio	Biological: Pediarix Vaccine administered in a subset of infant participants as per the national immunization schedule
Experimental Prevnar 20	Commercially available vaccine that protects against 20 strains of Streptococcus pneumoniae	Biological: Prevnar 20 Vaccine administered in a subset of infant participants as per the national immunization schedule
Experimental Infanrix	Commercially available combination vaccine containing diphtheria, tetanus, and pertussis	Biological: Infanrix hexa Vaccine administered in a subset of infant participants as per the national immunization schedule Biological: Infanrix Vaccine administered in a subset of infant participants as per the national immunization schedule

Recruiting Locations

Center for Research in Women's Health
Birmingham, Alabama 35233

Children's of Alabama
Birmingham, Alabama 35233

University of Alabama at Birmingham - School of Medicine
Birmingham, Alabama 35233

University of Alabama at Birmingham Women & Infants Center
Birmingham, Alabama 35294

SEC Clinical Research
Dothan, Alabama 36305

ClinMed
Phoenix, Arizona 85004

Genesis OB/GYN
Tucson, Arizona 85741

Eclipse Clinical Research
Tucson, Arizona 85745

Antelope Valley Medical Center
Lancaster, California 93534

Chemidox Clinical Trials
Lancaster, California 93534

South Florida Clinical Research Institute - Margate
Margate, Florida 33063

Emerald Coast OBGYN Clinical Research
Panama City, Florida 32405

HCA Florida Gulf Coast Hospital
Panama City, Florida 32405

Advanced Specialty Research
Boise, Idaho 83702

Express Lab
Garden City, Idaho 83714

Clinical Research Prime
Idaho Falls, Idaho 83404

Eastern Idaho Regional Medical Center
Idaho Falls, Idaho 83404

Mountain View Hospital
Idaho Falls, Idaho 83404

Madison Memorial Hospital
Rexburg, Idaho 83440

Accellacare - McFarland
Ames, Iowa 50010

Mary Greeley Medical Center
Ames, Iowa 50010

McFarland Clinic, PC
Ames, Iowa 50010

Velocity Clinical Research, Covington
Covington, Louisiana 70433

Center for Immunization Research
Baltimore, Maryland 21205

Center for Immunization Research
Baltimore, Maryland 21224

Johns Hopkins Bayview Medical Center
Baltimore, Maryland 21224

Gynecology and Obstetrics at Johns Hopkins Health Care and Surgery Center- White Marsh
Nottingham, Maryland 21236

Boston Medical Center
Boston, Massachusetts 02118

Washington University School of Medicine
St Louis, Missouri 63110

Boeson Research GTF
Great Falls, Montana 59405

Origin Health GTF
Great Falls, Montana 59405

Boeson Research MSO
Missoula, Montana 59804

Origin Health
Missoula, Montana 59804

Velocity Clinical Research, Grand Island
Grand Island, Nebraska 68803

Midwest Children's Health Research Center
Lincoln, Nebraska 68504

Midwest Children's Health Research Center
Lincoln, Nebraska 68505

Bryan Health
Lincoln, Nebraska 68506

Midwest Children's Health Research Institute
Lincoln, Nebraska 68516

Women's Health Care Center of Williamsburg
Lincoln, Nebraska 68516

Midwest Children's Health Research Center
Lincoln, Nebraska 68522

Velocity Clinical Research, Norfolk
Norfolk, Nebraska 68701

Stony Brook Medicine Clinical Research Center
East Setauket, New York 11733

ACGC Research, NYU Ambulatory Care Garden City
Garden City, New York 11530

NYU Langone Ambulatory Care Garden City
Garden City, New York 11530

NYU Langone Long Island, Clinical Research Center 3-002 (Admin only)
Mineola, New York 11501

Stony Brook University
Stony Brook, New York 11794

Duke Vaccine and Trials Unit
Durham, North Carolina 27703

Duke University - Main Hospital and Clinics
Durham, North Carolina 27705

Duke University - Main Hospital and Clinics
Durham, North Carolina 27710

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45206

University of Cincinnati Physicians Midtown
Cincinnati, Ohio 45213

Hoxworth Center
Cincinnati, Ohio 45219

University of Cincinnati Medical Center
Cincinnati, Ohio 45219

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229

University Hospitals
Cleveland, Ohio 44106

Cincinnati Children's Hospital Medical Center Liberty
Liberty Township, Ohio 45044

Cincinnati Children's Hospital Medical Center Mason
Mason, Ohio 45040

Senders Pediatrics
South Euclid, Ohio 44121

University of Cincinnati Medical Center West Chester
West Chester, Ohio 45069

University of Cincinnati Physicians
West Chester, Ohio 45069

Tribe Clinical Research, LLC- Greer
Greer, South Carolina 29650

Tribe Clinical Research at Parkside Pediatrics Five Forks
Simpsonville, South Carolina 29681

Memorial Hermann Memorial City Hospital
Houston, Texas 77024

The University of Texas Health Science Center at Houston
Houston, Texas 77024

Maximos Ob/Gyn
League City, Texas 77573

Inova Fairfax Medical Campus
Falls Church, Virginia 22042

Sentara Leigh Hospital
Norfolk, Virginia 23502

The Group For Women - Kempsville Office
Norfolk, Virginia 23502

Tidewater Physicians for Women
Norfolk, Virginia 23502

Womens Care Center
Norfolk, Virginia 23502

Virginia Physicians For Women (VPFW)
North Chesterfield, Virginia 23235

Clinical Research Partners, LLC
Richmond, Virginia 23226

More Details

Status: Recruiting
Sponsor: Pfizer

Study Contact

Pfizer CT.gov Call Center
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.