Table of Contents
- Trial overview
- Who can participate
- What the study is trying to find out
- Safety and other endpoints
- Phase, status, and size
- Key points from the trial
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.[1] The trial is looking at a Group B streptococcus vaccine compared with placebo, which is an inactive treatment used for comparison.[1]
The study is focused on Group B streptococcus (GBS) disease, a condition that can affect newborn babies.[1] The trial is designed to learn whether vaccination during pregnancy is safe and whether it may help protect infants after birth.[1]
Who can participate
The main participants in this trial are healthy pregnant women.[1] Their infants are also followed after birth so researchers can check safety and immune response in the baby.[1]
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.[1]
What the study is trying to find out
The trial has several goals.[1] 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.[1]
Second, it aims to assess the safety of maternal immunization in infants born to vaccinated pregnant women.[1] 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.[1]
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.[1] 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.[1]
Safety and other endpoints
The main outcomes include prespecified local reactions such as redness, swelling, and pain at the injection site.[1] These are common ways to measure how the body reacts where the vaccine is given.[1]
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.[1] In addition, the study measures adverse events, serious adverse events, and medically attended adverse events.[1]
Another important endpoint is the level of GBS serotype specific anti-CPS IgG antibody concentrations measured at birth in infant participants.[1] These measurements help researchers estimate how strong the immune response may be in newborns.[1]
Phase, status, and size
This study is a Phase 3 trial.[1] Phase 3 studies usually involve many participants and are used to learn more about safety and possible benefit in a larger group.[1]
The trial status is Authorised, and the planned enrollment is 12,000 participants.[1] That makes it a large study, which can help researchers gather more reliable information about the vaccine and the babies born to vaccinated mothers.[1]
Key points from the trial
This trial is an interventional study, meaning researchers are giving a study treatment and comparing it with placebo.[1] The main condition being studied is Group B streptococcus disease, with a focus on preventing disease in newborn infants.[1]
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.[1] These trial results are meant to guide understanding of maternal vaccination and infant protection against GBS disease.[1]
