In short
Clinical trials are studying STREPTOCOCCUS AGALACTIAE, SEROTYPE II, CAPSULAR POLYSACCHARIDE, CONJUGATED TO CRM197 in healthy pregnant women and their infants. These studies mainly look at safety, tolerability, and whether the vaccine can help protect babies from Group B streptococcus disease.
Key points
- Clinical trials are studying STREPTOCOCCUS AGALACTIAE, SEROTYPE II, CAPSULAR POLYSACCHARIDE, CONJUGATED TO CRM197 in healthy pregnant women and their infants. The main goal is to learn about safety, tolerability, and whether the vaccine may help protect babies from Group B streptococcus disease. The listed study is a Phase 3 interventional trial with 12,000 participants and is currently authorised. Researchers are also checking whether infants have antibody levels that may predict protection against early-onset and late-onset disease. The trial compares the vaccine with placebo and measures local reactions, systemic events, adverse events, and serious adverse events.
Trial overview
This clinical research is studying STREPTOCOCCUS AGALACTIAE, SEROTYPE II, CAPSULAR POLYSACCHARIDE, CONJUGATED TO CRM197 in a study of healthy pregnant women and their infants. The trial is looking at a Group B streptococcus vaccine compared with placebo, which is an inactive treatment used for comparison.
The study is focused on Group B streptococcus (GBS) disease, a condition that can affect newborn babies. The trial is designed to learn whether vaccination during pregnancy is safe and whether it may help protect infants after birth.
Who can participate
The main participants in this trial are healthy pregnant women. Their infants are also followed after birth so researchers can check safety and immune response in the baby.
This is important because the study is not only about the pregnant participant, but also about the baby who may receive indirect protection if the vaccine works as expected.
What the study is trying to find out
The trial has several goals. First, it aims to describe the safety and tolerability of the vaccine in maternal participants, meaning how well it is accepted and what side effects or reactions may happen.
Second, it aims to assess the safety of maternal immunization in infants born to vaccinated pregnant women. Third, it checks whether the vaccine can raise anti-CPS IgG antibody levels in infants, which are blood proteins linked with protection against invasive GBS disease.
The study also looks at predicted protection against both early-onset disease and late-onset disease caused by the vaccine serotypes Ia, Ib, II, III, IV, and V. In simple terms, researchers want to know if the immune response in the baby may help prevent illness soon after birth and later in infancy.
Safety and other endpoints
The main outcomes include prespecified local reactions such as redness, swelling, and pain at the injection site. These are common ways to measure how the body reacts where the vaccine is given.
Researchers are also tracking prespecified systemic events, which are body-wide symptoms such as fever, nausea, vomiting, diarrhea, headache, fatigue, muscle pain, and joint pain. In addition, the study measures adverse events, serious adverse events, and medically attended adverse events.
Another important endpoint is the level of GBS serotype specific anti-CPS IgG antibody concentrations measured at birth in infant participants. These measurements help researchers estimate how strong the immune response may be in newborns.
Phase, status, and size
This study is a Phase 3 trial. Phase 3 studies usually involve many participants and are used to learn more about safety and possible benefit in a larger group.
The trial status is Authorised, and the planned enrollment is 12,000 participants. That makes it a large study, which can help researchers gather more reliable information about the vaccine and the babies born to vaccinated mothers.
Key points from the trial
This trial is an interventional study, meaning researchers are giving a study treatment and comparing it with placebo. The main condition being studied is Group B streptococcus disease, with a focus on preventing disease in newborn infants.
The most important patient-centered questions in this research are whether vaccination during pregnancy is safe, whether it is tolerated well, and whether it leads to antibody levels in infants that may predict protection. These trial results are meant to guide understanding of maternal vaccination and infant protection against GBS disease.