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

Condition(s) studied

Investigational drug(s) / intervention(s)

Multivalent Group B streptococcus vaccine: Multivalent Group B streptococcus vaccine

Placebo: Saline Control

Infanrix hexa: Vaccine administered in a subset of infant participants as per the national immunization schedule

Prevenar 20: Vaccine administered in a subset of infant participants as per the national immunization schedule

Pediarix: Vaccine administered in a subset of infant participants as per the national immunization schedule

Prevnar 20: Vaccine administered in a subset of infant participants as per the national immunization schedule

Infanrix: Vaccine administered in a subset of infant participants as per the national immunization schedule

Study summary

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.

Eligibility

Primary outcome measure(s)

• The proportion of maternal participants reporting prespecified local reactions within 7 days following study intervention — Within 7 days
• The proportion of maternal participants reporting prespecified systemic events within 7 days following study intervention — Within 7 days
• The proportion of maternal participants reporting adverse events (AEs) through 1 month following study intervention — 1 month
• The proportion of maternal participants reporting serious adverse events (SAEs) through 6 months after delivery — 6 months after delivery
• The proportion of maternal participants reporting medically attended adverse events (MAAEs) through 6 months after delivery — 6 months after delivery
• The proportion of maternal participants reporting adverse events of special interest (AESIs) through 6 months after delivery. — 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 — 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 — 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 — 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 — Through study completion, at least 1 year
• 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 — 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 — 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. — 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. — Birth

Trial sites (216)

+ 176 more sites — see the full list on the official registry below.

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