In breve
Clinical trials are studying STREPTOCOCCUS AGALACTIAE, SEROTYPE III, CAPSULAR POLYSACCHARIDE, CONJUGATED TO CRM197 in healthy pregnant women and their infants. These studies look mainly at safety, tolerability, and whether the vaccine can help protect babies against group B streptococcus disease.
Punti chiave
- Clinical trials are studying STREPTOCOCCUS AGALACTIAE, SEROTYPE III, CAPSULAR POLYSACCHARIDE, CONJUGATED TO CRM197 in healthy pregnant women and their infants. The trial is in Phase 3 and is authorized, with a planned enrollment of 12,000 participants. It focuses on group B streptococcus disease, including protection against early-onset and late-onset disease in babies. The main goals are to check safety, tolerability, and whether the vaccine can trigger antibody levels that may help protect infants. Researchers also track local reactions, systemic events, adverse events, serious adverse events, and medically attended adverse events.
Trial overview
This clinical research is an interventional study, which means researchers give a study vaccine or a placebo and then compare the results. The trial studies STREPTOCOCCUS AGALACTIAE, SEROTYPE III, CAPSULAR POLYSACCHARIDE, CONJUGATED TO CRM197 in healthy pregnant women and follows their infants after birth. The condition being studied is group B streptococcus (GBS) disease.
The study title says it is a study to learn about a Group B Streptococcus vaccine in healthy pregnant women and their infants. The brief summary shows that the trial is designed to look at safety, tolerability, and immune response after vaccination during pregnancy.
Who can participate
The trial data identify healthy pregnant women as the main participants. Their infants are also part of the study follow-up, because researchers want to see both safety in babies and antibody levels at birth.
The study compares a placebo with the vaccine given intramuscularly, which means into a muscle. This helps researchers see whether the vaccine group and the placebo group have different results.
What is being measured
The main outcomes include prespecified local reactions, such as redness, swelling, and pain at the injection site. The trial also measures prespecified systemic events, including fever, nausea, vomiting, diarrhea, headache, fatigue, muscle pain, and joint pain.
Researchers will also record adverse events (AEs), serious adverse events (SAEs), and medically attended adverse events (MAAEs). In simple terms, these are any unwanted medical problems, more serious medical problems, and problems that need medical care.
Another important outcome is the level of GBS serotype specific anti-CPS IgG antibody concentrations measured in infants at birth. These antibody levels are used in the study to estimate whether the vaccine may help protect against invasive GBS disease caused by serotypes Ia, Ib, II, III, IV, and V.
The brief summary also says the study aims to estimate protection against both early-onset disease (EOD) and late-onset disease (LOD) in infants. Early-onset disease means disease that appears soon after birth, while late-onset disease appears later in infancy.
Trial phase and status
This study is in Phase 3. Phase 3 trials usually involve larger groups and are used to learn more about safety and how well a vaccine may work in the target population.
The trial status is Authorised. The planned enrollment is 12,000 participants, which shows that this is a large study.
Why this study matters
Group B streptococcus disease is the condition being targeted in this research, and the study is focused on preventing disease in babies through vaccination during pregnancy. The trial looks at both the mother’s safety and the baby’s safety, which is important because the vaccine is given during pregnancy.
The study also tries to predict whether the immune response in the infant may offer protection against several GBS serotypes, including serotype III. This makes the trial especially relevant for understanding whether maternal vaccination could help lower the risk of newborn and infant GBS disease.