Testing Multivalent Group B streptococcus against a placebo for healthy
Official title: BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies
A PHASE 3, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE IN HEALTHY PREGNANT WOMEN AND THEIR INFANTS
- Phase 3
- 7 groups
- Sites in Halifax, Kingston and 1 more city
- Recruiting
Interventions (7)
- Biological therapy
Multivalent Group B streptococcus vaccine
Multivalent Group B streptococcus vaccine
- Biological therapy
Placebo
Saline Control
- Biological therapy
Infanrix hexa
Vaccine administered in a subset of infant participants as per the national immunization schedule
- Biological therapy
Prevenar 20
Vaccine administered in a subset of infant participants as per the national immunization schedule
- Biological therapy
Pediarix
Vaccine administered in a subset of infant participants as per the national immunization schedule
- Biological therapy
Prevnar 20
Vaccine administered in a subset of infant participants as per the national immunization schedule
- Biological therapy
Infanrix
Vaccine administered in a subset of infant participants as per the national immunization schedule
Canadian Sites (3)
3 of 3 recruiting
- Recruiting
Canadian Center for Vaccinology
Halifax, Nova Scotia
- Recruiting
Kingston Health Sciences Centre - Kingston General Site
Kingston, Ontario
- Recruiting
CHU de Quebec-Universite Laval-Centre hospitalier de l'Universite Laval et Centre mere-enfant Soleil
Québec, Quebec
Eligibility Criteria
See who this study is looking for30 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Had a fetal anomaly ultrasound examination with no significant fetal abnormalities observed.
- +Capable of giving personal signed informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
- +Willing to give informed consent for her infant to participate in the study.
- +Key Exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →- Maternal:
- +Prepregnancy body mass index (BMI) of \>40 kg/m2.
- +Key Inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →- 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 investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → siteTrial siteA hospital or clinic where a study is actually run.Read more → staff or sponsorSponsorThe organisation responsible for the study overall.Read more → 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 eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → details
- +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.
- +Documented negative human immunodeficiency virus (HIV) antibody test, syphilis test, and hepatitis B virus (HBV) surface antigen test during this pregnancy and prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- +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).
Exclusion
- −Prepregnancy body mass index (BMI) of \>40 kg/m2.
- −Key Inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →- Infant Participants
- −\- Evidence of a signed and dated ICD signed by the parent(s)/legally authorized representative or legal guardian
- −Key Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → - Infant Participants:
- −\- Children or grandchildren who are direct descendants of investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → siteTrial siteA hospital or clinic where a study is actually run.Read more → staff or sponsorSponsorThe organisation responsible for the study overall.Read more → 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 eligibilityEligibility criteriaThe full list of requirements for taking part in a study.Read more → details
- −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).
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to prevent a condition from developing.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 7 groups in this study.
Group A receives Multivalent Group B streptococcus vaccine.
Registry label: A: GBS6
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo.
Registry label: B: Placebo
Group C receives Infanrix hexa.
Registry label: C: Infanrix hexa
Group D receives Prevenar 20.
Registry label: D: Prevenar 20
Group E receives Pediarix.
Registry label: E: Pediarix
Group F receives Prevnar 20.
Registry label: F: Prevnar 20
Group G receives Infanrix.
Registry label: G: Infanrix
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 1 day to 49 years.
The study is open to people of any sex.
The study accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 6,000 people.
The study is currently expected to finish around March 2029.
The main measurement is taken over: Within 7 days.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
The proportion of maternal participants reporting prespecified local reactions within 7 days following study intervention — measured over Within 7 days.
The proportion of maternal participants reporting prespecified systemic events within 7 days following study intervention — measured over Within 7 days.
The proportion of maternal participants reporting adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AEs) through 1 month following study intervention — measured over 1 month.
The proportion of maternal participants reporting serious adverse eventsSerious adverse eventAn adverse event meeting a formal severity threshold, such as requiring hospital admission.Read more → (SAEs) through 6 months after delivery — measured over 6 months after delivery.
The study lists 10 further main measurements.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07160244 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Multivalent Group B streptococcus vaccineBiological
Multivalent Group B streptococcus vaccine
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About PlaceboBiological
Saline Control
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About Infanrix hexaBiological
Vaccine administered in a subset of infant participants as per the national immunization schedule
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About Prevenar 20Biological
Vaccine administered in a subset of infant participants as per the national immunization schedule
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About PediarixBiological
Vaccine administered in a subset of infant participants as per the national immunization schedule
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About Prevnar 20Biological
Vaccine administered in a subset of infant participants as per the national immunization schedule
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About InfanrixBiological
Vaccine administered in a subset of infant participants as per the national immunization schedule
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 1 day to 49 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 1 day to 49 years.
It is open to people of any sex.
It accepts healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more → as well as people with the condition.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Within 7 days.
The study as a whole is currently expected to finish around 2029-03-02.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 6,000 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 14 locations, including: Halifax, Nova Scotia, Canada; Kingston, Ontario, Canada; Québec, Quebec, Canada; Great Falls, Montana, United States; Missoula, Montana, United States; East Setauket, New York, United States, and 8 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
Other Sites (20)
Boeson Research GTF
Great Falls, Montana, United States
Great Falls OBGYN Associates
Great Falls, Montana, United States
Origin Health GTF
Great Falls, Montana, United States
Blue Moose Pediatrics
Missoula, Montana, United States
Boeson Research MSO
Missoula, Montana, United States
Origin Health
Missoula, Montana, United States
Stony Brook Medicine Clinical Research Center
East Setauket, New York, United States
New York-Presbyterian Queens
Flushing, New York, United States
Obstetrical Center
Fresh Meadows, New York, United States
ACGC Research, NYU Ambulatory Care Garden City
Garden City, New York, United States
NYU Langone Ambulatory Care Garden City
Garden City, New York, United States
Jackson Heights Family Health Center
Jackson Heights, New York, United States
NYU Langone Long Island, Clinical Research Center 3-002 (Admin only)
Mineola, New York, United States
Columbia University Irving Medical Center
New York, New York, United States
Weill Cornell Medicine - New York Presbyterian Hospital
New York, New York, United States
Stony Brook University
Stony Brook, New York, United States
Seattle Childrens Research Institute
Seattle, Washington, United States
Seattle Childrens Hospital
Seattle, Washington, United States
UW Medical Center Northwest
Seattle, Washington, United States
UW Medical Center Montlake
Seattle, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.