In short
Clinical trials are studying STREPTOCOCCUS AGALACTIAE, SEROTYPE V, CAPSULAR POLYSACCHARIDE, CONJUGATED TO CRM197 in healthy pregnant women and their infants. The main goals are to check safety and tolerability and to see whether the vaccine can help protect babies against group B streptococcus disease.
Key points
- One clinical trial is studying STREPTOCOCCUS AGALACTIAE, SEROTYPE V, CAPSULAR POLYSACCHARIDE, CONJUGATED TO CRM197 in healthy pregnant women and their infants. It is a Phase 3 interventional study with 12,000 participants and is currently authorised. The study is focused on Group B streptococcus disease, including early-onset and late-onset disease in babies. Researchers are measuring safety, tolerability, adverse events, and antibody levels in infants at birth. The trial also looks at whether these antibody levels may predict protection against disease caused by several GBS serotypes, including serotype V.
Trial overview
This article covers one authorised Phase 3 clinical trial of STREPTOCOCCUS AGALACTIAE, SEROTYPE V, CAPSULAR POLYSACCHARIDE, CONJUGATED TO CRM197 in healthy pregnant women and their infants. The study is an interventional study, which means researchers give a study treatment and then measure outcomes. The condition being studied is Group B streptococcus (GBS) disease.
Who is being studied
The trial is designed for healthy pregnant women and their infants. The brief summary says the study also checks the safety of maternal immunization in infants born to pregnant participants who were vaccinated during pregnancy. No other detailed eligibility rules are provided in the source data.
What is being measured
The main outcomes focus on safety and on whether the vaccine can lead to antibody levels in infants that may predict protection. The trial measures prespecified local reactions such as redness, swelling, and pain at the injection site. It also measures prespecified systemic events, which are symptoms that affect the whole body, such as fever, nausea, vomiting, diarrhea, headache, fatigue, muscle pain, and joint pain.
Trial design and phase
This is a large Phase 3 trial with an enrollment of 12,000 participants. The study compares a placebo with STREPTOCOCCUS AGALACTIAE, SEROTYPE V, CAPSULAR POLYSACCHARIDE, CONJUGATED TO CRM197 given by intramuscular injection. A placebo is a look-alike treatment with no active vaccine, used to compare results fairly.
Safety endpoints
The safety endpoints include adverse events (AEs), serious adverse events (SAEs), and medically attended adverse events (MAAEs). An adverse event is any unwanted medical problem seen during a study, while a serious adverse event is a more severe problem that may need urgent care. Medically attended adverse events are problems that lead to medical attention.
Immune response endpoints
The study also measures GBS serotype specific anti-CPS IgG antibody concentrations in infants at birth. Anti-CPS IgG means antibodies against the capsular polysaccharide, which is part of the bacterial surface. The brief summary says the trial looks at whether these antibody levels may predict protection from early-onset disease (EOD) and late-onset disease (LOD) caused by the six vaccine serotypes Ia, Ib, II, III, IV, and V.
What this means for patients
For families, this trial is mainly about whether vaccination during pregnancy can help protect newborn babies from GBS disease. The study does not report results in the source data, so it is not yet possible to say how well the vaccine works. The available information shows that researchers are carefully checking both safety in mothers and babies and the immune response in infants at birth.