NIPH Clinical Trials Search

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

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Healthy pregnant women and their infants
Date of first enrollment	20/10/2025
Target sample size	6000
Countries of recruitment	Argentina,Japan,Finland,Japan,Spain,Japan,Taiwan,Japan,United Kingdom,Japan,United States,Japan
Study type	Interventional
Intervention(s)	*Biological: Multivalent Group B streptococcus vaccine -Multivalent Group B streptococcus vaccine -Other Names: #GBS6 *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

Outcome(s)

Primary Outcome

*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 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 events (MAAEs) from birth through 6 months of age [Time Frame: Birth to 6 months of age] *To measure the relative risk reduction in the proportion of infant participants at birth with GBS serotype-specific IgG antibody concentrations below predefined serotype-specific GBS late onset disease thresholds in the GBS6 group to the placebo group [Time Frame: Birth] *To measure the relative risk reduction in the proportion of infant participants at birth with GBS serotype-specific IgG antibody concentrations below predefined serotype-specific GBS early onset disease thresholds in the GBS6 group to the placebo group [Time Frame: Birth] *To evaluate the aggregate predicted VE combining all 6 serotypes in GBS6 to provide protection from invasive GBS late onset disease based on serotype specific anti-CPS IgG concentrations measured in infants at birth. [Time Frame: Birth] *To evaluate the aggregate predicted VE combining all 6 serotypes in GBS6 to provide protection from invasive GBS early onset disease based on serotype specific anti-CPS IgG concentrations measured in infants at birth. [Time Frame: Birth]

Secondary Outcome

*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 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]

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	<= 49age old
Gender	Both
Include 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 Inclusion criteria- Infant Participants - Evidence of a signed and dated ICD signed by the parent(s)/legally authorized representative or legal guardian
Exclude criteria	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 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