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

STUDY BASICS

Are you the parent of a teenager who is pregnant? Your teen may be eligible for a research study looking at an investigational maternal vaccine that is designed to protect pregnant women and their babies from the 6 most common types of Group B streptococcus (GBS). If your teenager joins this study, they will receive 1 dose of the study vaccine or placebo between weeks 24 and 36 of their pregnancy.

STUDY PURPOSE

Group B streptococcus (GBS) is a leading cause of serious bacterial infection in newborns, with over 300,000 cases each year. It may cause dangerous complications during pregnancy as well.  This study is researching an investigational maternal vaccine that is designed to protect pregnant women and their babies from the 6 most common types of GBS. The purpose of this study is to learn how the investigational vaccine, GBS6, works in women who are pregnant and their babies.

COULD THIS STUDY BE RIGHT FOR YOU?

Parent of a teen that is less than 36 weeks pregnant

WHAT PARTICIPANTS CAN EXPECT

• If your teen joins this study, they will receive 1 dose of the study vaccine or placebo between weeks 24 and 36 of their pregnancy. A placebo looks like the study vaccine but has no active ingredients.
• Your teen will be in the study until about 6 months after their baby is born and will have at least 5-6 study visits. Their baby will be in the study until they are 12 months old and will have at least 4 study visits. Some of these visits may occur by phone.
• Your teen may also be invited to enroll their baby in an optional phase of the study where they would receive other childhood vaccines and have additional study visits.