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Official title BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies
ClinicalTrials.gov ID: NCT07160244
What this study is testing
What is Multivalent Group B streptococcus vaccine?
Multivalent Group B streptococcus vaccine is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for healthy.
Also referred to as GBS6.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 19 months
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 49. Healthy volunteers may be eligible.
You may be able to join if
- Key - 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...
- 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...
- Capable of giving personal signed informed consent.
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
- Key - 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...
- 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
- 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-...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Dothan, Alabama, United States
- Mobile, Alabama, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Lancaster, California, United States
- Loma Linda, California, United States
- Palo Alto, California, United States
- Aurora, Colorado, United States
- Margate, Florida, United States
- North Miami Beach, Florida, United States
- Panama City, Florida, United States
- Boise, Idaho, United States
- Garden City, Idaho, United States
- Idaho Falls, Idaho, United States
- Rexburg, Idaho, United States
- Ames, Iowa, United States
- Covington, Louisiana, United States
- New Orleans, Louisiana, United States
- Baltimore, Maryland, United States
+ 114 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 19 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 1 day to 49 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Dothan, Alabama, United States; Mobile, Alabama, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Lancaster, California, United States and 128 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.