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STREPTOCOCCUS AGALACTIAE, SEROTYPE V, CAPSULAR POLYSACCHARIDE, CONJUGATED TO CRM197

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.

Table of contents

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.[1] The study is an interventional study, which means researchers give a study treatment and then measure outcomes.[1] The condition being studied is Group B streptococcus (GBS) disease.[1]

Who is being studied

The trial is designed for healthy pregnant women and their infants.[1] The brief summary says the study also checks the safety of maternal immunization in infants born to pregnant participants who were vaccinated during pregnancy.[1] No other detailed eligibility rules are provided in the source data.[1]

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.[1] The trial measures prespecified local reactions such as redness, swelling, and pain at the injection site.[1] 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.[1]

Trial design and phase

This is a large Phase 3 trial with an enrollment of 12,000 participants.[1] The study compares a placebo with STREPTOCOCCUS AGALACTIAE, SEROTYPE V, CAPSULAR POLYSACCHARIDE, CONJUGATED TO CRM197 given by intramuscular injection.[1] A placebo is a look-alike treatment with no active vaccine, used to compare results fairly.[1]

Safety endpoints

The safety endpoints include adverse events (AEs), serious adverse events (SAEs), and medically attended adverse events (MAAEs).[1] 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.[1] Medically attended adverse events are problems that lead to medical attention.[1]

Immune response endpoints

The study also measures GBS serotype specific anti-CPS IgG antibody concentrations in infants at birth.[1] Anti-CPS IgG means antibodies against the capsular polysaccharide, which is part of the bacterial surface.[1] 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.[1]

What this means for patients

For families, this trial is mainly about whether vaccination during pregnancy can help protect newborn babies from GBS disease.[1] The study does not report results in the source data, so it is not yet possible to say how well the vaccine works.[1] The available information shows that researchers are carefully checking both safety in mothers and babies and the immune response in infants at birth.[1]

Trial IDPhaseCondition studiedStatusEnrollment
2022-503070-36-00Phase 3Group B streptococcus (GBS) diseaseAuthorised12000

FAQ

  • What is being studied in these trials? The trials are studying a Group B Streptococcus vaccine in pregnant women and looking at the effects in their infants. The goals include safety, tolerability, and whether antibody levels in babies may predict protection.
  • Who can take part in the study? The study is for healthy pregnant women and their infants. The trial data do not give more detailed eligibility rules.
  • What phase is this trial? This trial is in Phase 3. That usually means the study is testing the vaccine in a large group of people to learn more about safety and how well it may work.
  • What condition is this trial focused on? The trial focuses on Group B streptococcus, also called GBS disease. It looks at ways to help prevent early-onset and late-onset disease in infants.
  • What safety outcomes are being measured? The study measures local reactions such as redness, swelling, and pain at the injection site. It also tracks fever, nausea, vomiting, diarrhea, headache, fatigue, muscle pain, joint pain, and more serious adverse events.

Ongoing Clinical Trials on STREPTOCOCCUS AGALACTIAE, SEROTYPE V, CAPSULAR POLYSACCHARIDE, CONJUGATED TO CRM197

  • A Study of Group B Streptococcus 6-Valent Polysaccharide Conjugate Vaccine in Healthy Pregnant Women and Their Infants

    Recruiting

    1 1
    Investigated drugs:
    Finland The Netherlands Spain

Glossary

  • Group B streptococcus (GBS): A type of bacteria that can cause disease, especially in newborn babies.
  • Vaccine: A product given to help the body build protection against a disease.
  • Pregnant women: Women who are carrying a baby during pregnancy.
  • Infants: Babies, especially newborns and very young children.
  • Phase 3: A late-stage clinical trial done in a larger group of people to study safety and possible benefit.
  • Interventional study: A study where researchers give a treatment or vaccine and then measure what happens.
  • Placebo: A look-alike treatment with no active vaccine, used for comparison.
  • Adverse event: Any unwanted medical problem that happens during a study.
  • Serious adverse event: A more severe unwanted medical problem that may need urgent medical care.
  • Antibody: A protein made by the immune system that helps fight infection.
  • Serotype: A subgroup of a germ that is identified by its surface features.
  • Early-onset disease (EOD): Disease that starts soon after birth.
  • Late-onset disease (LOD): Disease that starts later after birth.

References

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