At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Multivalent Group B streptococcus vaccine (biological), Placebo (biological), Infanrix hexa (biological), Prevenar 20 (biological)
- How long the study runs
- Study runs about 43 months (dates as stated)
- About the drug or intervention
- 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
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 1 Day to 49 Years
- Who
- All
- Number of participants
- 6,000
- Started
- 2025-08-25
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for healthy
- • Phase3 - 6,000 participants
- • 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
Who can take part?
- • Ages 1 Day to 49 Years
- • Diagnosed with healthy
Where?
- • Bristol - St Michael's Hospital
- • London - Barnet Hospital
- • London - St. George's Hospital
- • Manchester - North Manchester General Hospital
- • +12 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 1 Day - 49 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Key Inclusion criteria- Maternal:
- ✓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)...
- ✓Capable of giving personal signed agreement to take part.
- ✓Willing to give agreement to take part for her infant to participate in the study.
See the full criteria
Where Is This Study? (16 UK sites)
St Michael's Hospital
Bristol BS2 8EG, United Kingdom
Barnet Hospital
London EN5 3DJ, United Kingdom
St. George's Hospital
London SW17 0QT, United Kingdom
North Manchester General Hospital
Manchester M8 5RB., United Kingdom
The Royal Cornwall Hospital
Truro TR1 3LJ, United Kingdom
Southampton General Hospital
Southampton SO16 6YD, United Kingdom
St Mary's Hospital (Manchester University NHS Foundation Trust)
Manchester M13 9WL, United Kingdom
Imperial College Healthcare NHS Foundation Trust - St Mary's Hospital
London W2 1NY, United Kingdom
The John Radcliffe Hospital
Oxford OX3 9DU, United Kingdom
The Princess Royal Hospital
Shropshire TF1 6TF, United Kingdom
Bristol NHS Foundation Trust
Bristol BS1 3NU, United Kingdom
Bristol Royal Hospital for Children
Bristol BS2 8BJ, United Kingdom
Bristol Royal Infirmary
Bristol BS2 8EX, United Kingdom
St James's University Hospital
Leeds LS9 7TF, United Kingdom
Royal Free Hospital
London NW32QG, United Kingdom
Wythenshawe Hospital
Manchester M23 9LT, United Kingdom
How to Get in Touch
Pfizer CT.gov Call Center
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