Recruiting NCT07160244

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

Phase III Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Multivalent Group B streptococcus vaccine, Placebo, Infanrix hexa, Prevenar 20.
Who it may be relevant to: Registry conditions: Healthy. Basic parameters: 1 Day — 49 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Brazil, Canada, Finland +8
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

Biological Multivalent Group B streptococcus vaccine
Multivalent Group B streptococcus vaccine
Biological Placebo
Saline Control
Biological Infanrix hexa
Vaccine administered in a subset of infant participants as per the national immunization schedule
Biological Prevenar 20
Vaccine administered in a subset of infant participants as per the national immunization schedule
Biological Pediarix
Vaccine administered in a subset of infant participants as per the national immunization schedule
Biological Prevnar 20
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

Primary outcome measures

The proportion of maternal participants reporting prespecified local reactions within 7 days following study intervention [Time frame: Within 7 days]
The proportion of maternal participants reporting prespecified systemic events within 7 days following study intervention [Time frame: Within 7 days]
The proportion of maternal participants reporting adverse events (AEs) through 1 month following study intervention [Time frame: 1 month]
The proportion of maternal participants reporting serious adverse events (SAEs) through 6 months after delivery [Time frame: 6 months after delivery]
The proportion of maternal participants reporting medically attended adverse events (MAAEs) through 6 months after delivery [Time frame: 6 months after delivery]
The proportion of maternal participants reporting adverse events of special interest (AESIs) through 6 months after delivery. [Time frame: 6 months after delivery]
The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting adverse events (AEs) from birth through 1 month of age [Time frame: Birth to 1 month of age]
The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting serious adverse events (SAEs) from birth through end of the study [Time frame: Through study completion, at least 1 year]
The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting medically attended adverse events (MAAEs) from birth through 6 months of age [Time frame: Birth to 6 months of age]
The proportion of infant participants born to pregnant women who were vaccinated with GBS6 during pregnancy reporting adverse events of special interest (AESIs) from birth through end of study [Time frame: Through study completion, at least 1 year]

Secondary outcome measures (6)

To measure GBS serotype-specific opsonophagocytic titers in infant participants at birth by geometric mean ratio between GBS6 group versus placebo group and by the difference in seroresponse rates between GBS6 group and placebo group [Time frame: Birth]
To describe anti-CPS IgG antibody levels predicted to provide protection from invasive GBS disease (all disease) caused by the 6 individual vaccine serotypes in infants when GBS6 is administered to healthy pregnant women. [Time frame: Birth]
To describe anti-CPS IgG antibody levels in infant participants born to maternal participants vaccinated with GBS6. [Time frame: Birth]
To describe anti-CPS IgG antibody levels predicted to provide protection from invasive GBS LOD and EOD, separately, caused by the 6 individual vaccine serotypes (Ia, Ib, II, III, IV, and V) in infants when GBS6 is administered to healthy pregnant women. [Time frame: Birth]
To measure GBS serotype-specific IgG by geometric mean concentration in maternal participants at 1 month after vaccination and at delivery. [Time frame: 1 month after vaccination and at delivery]
Compare the proportion of infants with anti-diphtheria toxoid and/or pneumococcal IgG responses at 1 month post-primary and toddler doses between GBS6 and placebo groups, including predefined IgG levels and geometric mean ratios. [Time frame: 1 month after the primary vaccination series and 1 month after the toddler dose]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Prevention