Europas førende søgning efter kliniske forsøg

GROUP B STREPTOCOCCUS CAPSULAR POLYSACCHARIDE IB CONJUGATED TO DIPHTHERIA TOXIN CRM197

Clinical trials are studying GROUP B STREPTOCOCCUS CAPSULAR POLYSACCHARIDE IB CONJUGATED TO DIPHTHERIA TOXIN CRM197 in healthy pregnant women and their infants. The trials mainly look at safety, tolerability, and whether the vaccine can help protect babies from group B streptococcal disease. The main focus is on pregnancy and newborn outcomes.

Table of contents

Overview of the trial program

The available trial is a study in healthy pregnant women and their infants, and it is listed as Authorised.[1] It is an interventional study, which means participants receive a study treatment rather than only being observed.[1]

The study is testing GROUP B STREPTOCOCCUS CAPSULAR POLYSACCHARIDE IB CONJUGATED TO DIPHTHERIA TOXIN CRM197 against placebo.[1] The condition being studied is Group B streptococcus (GBS) disease.[1]

Who can take part

This trial is designed for pregnant people who are healthy at the time of the study.[1] The babies born to these participants are also followed after birth so researchers can study safety and immune response in infants.[1]

The study does not describe other groups in the source data, so the main target population is healthy pregnant women and their infants.[1]

Trial phase and study design

The study is in Phase 3, which is a late stage of clinical research.[1] Phase 3 studies usually include many participants and help researchers learn more about safety and how well a study treatment may work.[1]

The enrollment listed for this trial is 12,000 participants.[1] That large number suggests the trial is designed to collect a broad set of safety and immune-response data.[1]

What the trials measure

The main outcomes include prespecified local reactions such as redness, swelling, and pain at the injection site.[1] The study also measures systemic events, which are body-wide symptoms such as fever, nausea, vomiting, diarrhea, headache, fatigue, muscle pain, and joint pain.[1]

Researchers also track adverse events (AEs), serious adverse events (SAEs), and medically attended adverse events (MAAEs).[1] These terms mean any unwanted health problem, a serious health problem, or a problem that needs medical care.[1]

In infants, the study measures GBS serotype specific anti-CPS IgG antibody concentrations at birth.[1] This is a blood-test measure that helps researchers see how much immune response the baby has after maternal vaccination.[1]

What the study hopes to show

The brief summary says the study aims to describe the safety and tolerability of GBS6 in maternal participants.[1] It also aims to assess the safety of maternal immunization in the infants born to vaccinated pregnant participants.[1]

Another goal is to see whether the vaccine can induce antibody levels predicted to protect infants from invasive GBS early-onset disease (EOD) and late-onset disease (LOD) caused by the listed serotypes Ia, Ib, II, III, IV, and V.[1] The study also looks at the combined predicted vaccine effectiveness across all 6 serotypes for both early-onset and late-onset disease.[1]

Key terms explained

Maternal immunization means vaccination during pregnancy, with the goal of helping protect the baby after birth.[1] Serotype means a specific type within the GBS family, and this study includes six serotypes.[1]

Anti-CPS IgG is a type of antibody measured in the study, and higher levels may suggest better immune protection for the infant.[1] The trial uses these measurements to estimate whether the vaccine may help prevent GBS disease in newborns.[1]

Trial ID Phase Condition studied Status Enrollment
2022-503070-36-00 Phase 3 Group B streptococcus (GBS) disease Authorised 12000

FAQ

  • Who can take part in these clinical trials? The trial shown here is for healthy pregnant women. It also follows their infants after birth to check safety and immune response.
  • What is being studied in these trials? The trials study GROUP B STREPTOCOCCUS CAPSULAR POLYSACCHARIDE IB CONJUGATED TO DIPHTHERIA TOXIN CRM197 as a maternal vaccine. Researchers want to see if it is safe and if it can help protect infants from group B streptococcal disease.
  • What phase is the trial? The trial is in Phase 3. This means it is a late-stage study that usually looks at safety and effectiveness in a larger group of people.
  • What condition is the trial focused on? The trial focuses on group B streptococcus disease, also called GBS disease. It looks at ways to help prevent early-onset and late-onset disease in babies.
  • What outcomes are measured? The study measures local reactions, such as redness, swelling, and pain at the injection site, and systemic events like fever and fatigue. It also measures adverse events, serious adverse events, medically attended adverse events, and antibody levels in infants at birth.

Igangværende kliniske forsøg for GROUP B STREPTOCOCCUS CAPSULAR POLYSACCHARIDE IB CONJUGATED TO DIPHTHERIA TOXIN CRM197

  • Undersøgelse af gruppe B-streptokokvaccine hos raske gravide kvinder og deres spædbørn for at forebygge infektion

    Rekrutterer

    1 1
    Undersøgte lægemidler:
    Finland Holland Spanien

Ordliste

  • Group B streptococcus (GBS): A type of bacteria that can cause serious infection in newborn babies. The trials study ways to help prevent this disease.
  • Vaccine: A treatment given to help the body build protection against a disease. In this trial, the vaccine is given to pregnant women.
  • Healthy pregnant women: Pregnant participants who do not have the illness being studied and are well enough to join the trial.
  • Infants: Babies after birth. In this study, infants are followed to see if the mother’s vaccination affects their safety and protection.
  • Phase 3: A late stage of clinical research with a larger number of participants. It is used to learn more about safety and how well the treatment may work.
  • Safety: Whether the study treatment causes unwanted medical problems.
  • Tolerability: How well participants can handle the study treatment.
  • Adverse event (AE): Any unwanted health problem that happens during the study, whether or not it is caused by the treatment.
  • Serious adverse event (SAE): A serious health problem during the study that may need urgent care or cause major harm.
  • Medically attended adverse event (MAAE): A health problem that leads the participant to get medical care.
  • Antibody: A protein made by the immune system to help fight infection. The trial measures antibody levels in infants at birth.
  • Serotype: A specific type within a germ group. This trial measures responses to several GBS serotypes, including Ia, Ib, II, III, IV, and V.

Referencer

  1. https://clinicaltrials.gov/study/2022-503070-36-00