Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsPhase3

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

Sponsor: Pfizer

NCT ID: NCT07160244

View on ClinicalTrials.gov ↗

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.

Healthy

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

Documented negative

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
Key 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. Key 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

Where Is This Study? (16 UK sites)

St Michael's Hospital

Bristol BS2 8EG, United Kingdom

Recruiting

Barnet Hospital

London EN5 3DJ, United Kingdom

Recruiting

St. George's Hospital

London SW17 0QT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mr Subhir Bedi

researchgovernance@sgul.ac.uk020 8725 4986

North Manchester General Hospital

Manchester M8 5RB., United Kingdom

Recruiting
Hospital R&D contact (matched)

Elizabeth Mainwaring

R&D.applications@mft.nhs.uk0161 276 3340

The Royal Cornwall Hospital

Truro TR1 3LJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Abi Weeks

rch-tr.CornwallResearch@nhs.net01872 25 6424

Southampton General Hospital

Southampton SO16 6YD, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

St Mary's Hospital (Manchester University NHS Foundation Trust)

Manchester M13 9WL, United Kingdom

Recruiting
Hospital R&D contact (matched)

Elizabeth Mainwaring

R&D.applications@mft.nhs.uk0161 276 3340

Imperial College Healthcare NHS Foundation Trust - St Mary's Hospital

London W2 1NY, United Kingdom

Recruiting
Hospital R&D contact (matched)

Donna Copeland

donna.copeland@nhs.net---

The John Radcliffe Hospital

Oxford OX3 9DU, United Kingdom

Recruiting

The Princess Royal Hospital

Shropshire TF1 6TF, United Kingdom

Recruiting

Bristol NHS Foundation Trust

Bristol BS1 3NU, United Kingdom

Recruiting
Hospital R&D contact (matched)

Helen Lewis-White

Research@nbt.nhs.uk0117 41 49330

Bristol Royal Hospital for Children

Bristol BS2 8BJ, United Kingdom

Recruiting

Bristol Royal Infirmary

Bristol BS2 8EX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Colleen Bowthorpe

colleen.bowthorpe@nhs.scot01387 241815

St James's University Hospital

Leeds LS9 7TF, United Kingdom

Recruiting
Hospital R&D contact (matched)

R&I Team

leedsth-tr.researchfacilitation@nhs.net0113 2060469

Royal Free Hospital

London NW32QG, United Kingdom

Recruiting
Hospital R&D contact (matched)

Natasha Ajraam

rf-tr.randd@nhs.net020 375 82150

Wythenshawe Hospital

Manchester M23 9LT, United Kingdom

Recruiting

How to Get in Touch

Pfizer CT.gov Call Center

Sponsor contact

CONTACT

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09