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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

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

ArmDescriptionAssigned 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

SEC Clinical Research
Dothan 4059102, Alabama 4829764 36305

ClinMed
Phoenix 5308655, Arizona 5551752 85004

Antelope Valley Medical Center
Lancaster 5364940, California 5332921 93534

Chemidox Clinical Trials
Lancaster 5364940, California 5332921 93534

Emerald Coast OBGYN Clinical Research
Panama City 4167694, Florida 4155751 32405

HCA Florida Gulf Coast Hospital
Panama City 4167694, Florida 4155751 32405

Advanced Specialty Research
Boise 5586437, Idaho 5596512 83702

Express Lab
Garden City 5593814, Idaho 5596512 83714

Clinical Research Prime
Idaho Falls 5596475, Idaho 5596512 83404

Eastern Idaho Regional Medical Center
Idaho Falls 5596475, Idaho 5596512 83404

Mountain View Hospital
Idaho Falls 5596475, Idaho 5596512 83404

Madison Memorial Hospital
Rexburg 5605242, Idaho 5596512 83440

Accellacare - McFarland
Ames 4846834, Iowa 4862182 50010

Mary Greeley Medical Center
Ames 4846834, Iowa 4862182 50010

McFarland Clinic, PC
Ames 4846834, Iowa 4862182 50010

Velocity Clinical Research, Covington
Covington 4321005, Louisiana 4331987 70433

Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110

Boeson Research GTF
Great Falls 5655240, Montana 5667009 59405

Origin Health GTF
Great Falls 5655240, Montana 5667009 59405

Boeson Research MSO
Missoula 5666639, Montana 5667009 59804

Origin Health
Missoula 5666639, Montana 5667009 59804

Velocity Clinical Research, Grand Island
Grand Island 5069297, Nebraska 5073708 68803

Midwest Children's Health Research Center
Lincoln 5072006, Nebraska 5073708 68504

Midwest Children's Health Research Center
Lincoln 5072006, Nebraska 5073708 68505

Bryan Health
Lincoln 5072006, Nebraska 5073708 68506

Midwest Children's Health Research Institute
Lincoln 5072006, Nebraska 5073708 68516

Women's Health Care Center of Williamsburg
Lincoln 5072006, Nebraska 5073708 68516

Midwest Children's Health Research Center
Lincoln 5072006, Nebraska 5073708 68522

Velocity Clinical Research, Norfolk
Norfolk 5073965, Nebraska 5073708 68701

Tribe Clinical Research, LLC- Greer
Greer 4580599, South Carolina 4597040 29650

Tribe Clinical Research at Parkside Pediatrics Five Forks
Simpsonville 4595864, South Carolina 4597040 29681

Maximos Ob/Gyn
League City 4705692, Texas 4736286 77573

Sentara Leigh Hospital
Norfolk 4776222, Virginia 6254928 23502

The Group For Women - Kempsville Office
Norfolk 4776222, Virginia 6254928 23502

Tidewater Physicians for Women
Norfolk 4776222, Virginia 6254928 23502

Womens Care Center
Norfolk 4776222, Virginia 6254928 23502

Virginia Physicians For Women (VPFW)
North Chesterfield 11838958, Virginia 6254928 23235

Clinical Research Partners, LLC
Richmond 4781708, Virginia 6254928 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.