This study is looking at Group B streptococcus disease, which is an infection that can affect newborn babies. Group B streptococcus, often called GBS, is a type of bacteria that can be passed from mothers to their babies during pregnancy or birth. The study will use Group B Streptococcus 6-Valent Polysaccharide Conjugate Vaccine (GBS6), which is a vaccine designed to protect against six different types of GBS bacteria. Some pregnant women in this study will receive this vaccine while others will receive placebo. The vaccine is given as a solution for injection into the muscle.
The purpose of this study is to learn about the safety of the GBS vaccine in pregnant women and their babies, and to measure how well the vaccine helps the mother’s body create protective substances called antibodies that can be passed to the baby. These antibodies are measured to see if they could protect infants from GBS infections that can occur in the first days after birth, called early-onset disease, or infections that happen later in the first months of life, called late-onset disease. The study will look at whether the vaccine can create enough antibodies against all six types of GBS bacteria included in the vaccine.
During the study, pregnant women between 24 and 36 weeks of pregnancy will receive either the vaccine or placebo. The study will monitor the pregnant women for any reactions at the injection site such as redness, swelling, or pain, as well as general symptoms like fever, nausea, vomiting, diarrhea, headache, tiredness, muscle pain, and joint pain. Blood samples will be taken from mothers and their babies at different times to measure antibody levels. The babies will be followed after birth to check their health and safety, and to measure the antibodies they received from their mothers through the vaccine.
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