In short
Clinical trials are studying GROUP B STREPTOCOCCUS CAPSULAR POLYSACCHARIDE IB CONJUGATED TO DIPHTHERIA TOXIN CRM197 in healthy pregnant women and their infants. These trials mainly look at safety, tolerability, and whether the vaccine can help protect babies from group B streptococcal disease.
Key points
- Clinical trials of GROUP B STREPTOCOCCUS CAPSULAR POLYSACCHARIDE IB CONJUGATED TO DIPHTHERIA TOXIN CRM197 are studying a GBS vaccine in healthy pregnant women and their infants. The main trial is a Phase 3 interventional study with 12,000 participants. Researchers are checking safety, tolerability, and immune responses, including antibody levels in infants at birth. The study also looks at whether the vaccine may help protect babies from early-onset and late-onset group B streptococcal disease. Key safety measures include local reactions, general symptoms, adverse events, serious adverse events, and medically attended adverse events.
Trial overview
The clinical trial data describe an interventional study of GROUP B STREPTOCOCCUS CAPSULAR POLYSACCHARIDE IB CONJUGATED TO DIPHTHERIA TOXIN CRM197 in healthy pregnant women and their infants. The study is focused on group B streptococcus (GBS) disease and is designed to learn about safety, tolerability, and possible protection for babies.
Who is being studied
The trial targets healthy pregnant women and their infants. This means the research is not mainly about treating people who are already sick, but about studying vaccination during pregnancy and the effect on babies after birth.
The study also includes a placebo group, which is a comparison group that does not receive the active vaccine. This helps researchers compare outcomes between vaccinated and non-vaccinated participants in a fair way.
What is being measured
The main safety outcomes include prespecified local reactions such as redness, swelling, and pain at the injection site. The study also measures prespecified systemic events, which are body-wide symptoms such as fever, nausea, vomiting, diarrhea, headache, fatigue, muscle pain, and joint pain.
Other important measures are adverse events, serious adverse events, and medically attended adverse events. These terms mean any unwanted health problem, any severe health problem, and any problem that needs medical care.
The trial also measures GBS serotype specific anti-CPS IgG antibody concentrations in infant participants at birth. In simple terms, this checks whether babies have blood levels of antibodies that may suggest protection against different GBS types.
Trial phase and design
This study is a Phase 3 clinical trial. Phase 3 trials are large studies that help researchers confirm safety and assess whether a vaccine may work as expected.
The trial is interventional, meaning the researchers give a study treatment and then observe the results. In this case, participants receive either the vaccine or placebo by intramuscular injection, which means an injection into the muscle.
Main goals of the research
The study has several clear goals. First, it wants to describe the safety and tolerability of the vaccine in pregnant participants.
Second, it wants to assess the safety of maternal immunization in infants born to vaccinated pregnant people. Maternal immunization means vaccination during pregnancy so the mother may pass protection to the baby.
Third, the study looks at whether the vaccine can induce antibody levels predicted to protect infants from invasive GBS early-onset disease and late-onset disease caused by the six vaccine serotypes: Ia, Ib, II, III, IV, and V. Invasive disease means a serious infection that spreads into the blood or other normally sterile parts of the body.
The trial also evaluates the combined predicted vaccine effectiveness across all six serotypes for protection against both early-onset and late-onset disease, using antibody levels measured in infants at birth.
Trial status and size
The trial status is Authorised. The planned enrollment is 12,000 participants, which shows that this is a large study designed to collect enough data for safety and immune response analysis.
The available data focus on one major study record with the identifier 2022-503070-36-00. The study title says it is a study to learn about the vaccine in healthy pregnant women and their infants.