Table of contents
- Trial overview
- Who is being studied
- What is being measured
- Trial phase and design
- Main goals of the research
- Trial status and size
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.[1] The study is focused on group B streptococcus (GBS) disease and is designed to learn about safety, tolerability, and possible protection for babies.[1]
Who is being studied
The trial targets healthy pregnant women and their infants.[1] 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.[1]
The study also includes a placebo group, which is a comparison group that does not receive the active vaccine.[1] This helps researchers compare outcomes between vaccinated and non-vaccinated participants in a fair way.[1]
What is being measured
The main safety outcomes include prespecified local reactions such as redness, swelling, and pain at the injection site.[1] 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.[1]
Other important measures are adverse events, serious adverse events, and medically attended adverse events.[1] These terms mean any unwanted health problem, any severe health problem, and any problem that needs medical care.[1]
The trial also measures GBS serotype specific anti-CPS IgG antibody concentrations in infant participants at birth.[1] In simple terms, this checks whether babies have blood levels of antibodies that may suggest protection against different GBS types.[1]
Trial phase and design
This study is a Phase 3 clinical trial.[1] Phase 3 trials are large studies that help researchers confirm safety and assess whether a vaccine may work as expected.[1]
The trial is interventional, meaning the researchers give a study treatment and then observe the results.[1] In this case, participants receive either the vaccine or placebo by intramuscular injection, which means an injection into the muscle.[1]
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.[1]
Second, it wants to assess the safety of maternal immunization in infants born to vaccinated pregnant people.[1] Maternal immunization means vaccination during pregnancy so the mother may pass protection to the baby.[1]
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.[1] Invasive disease means a serious infection that spreads into the blood or other normally sterile parts of the body.[1]
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.[1]
Trial status and size
The trial status is Authorised.[1] 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.[1]
The available data focus on one major study record with the identifier 2022-503070-36-00.[1] The study title says it is a study to learn about the vaccine in healthy pregnant women and their infants.[1]
