Development of a Serocorrelate of Protection Against Invasive Group B Streptococcus Disease
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY
A multicentre study to provide evidence that the relationship between an immune marker value (anti-GBS IgG concentration) and the probability of invasive GBS (iGBS) disease in infants less than 90 days of age is sufficiently strong that a vaccine able to induce an immune response will lead to a meaningful decrease in the probability of iGBS disease.
Eligibility
Participation Requirements
Sex: All
View:
• \-
Locations
Other Locations
United Kingdom
St George's University of London
RECRUITING
London
Contact Information
Primary
Nadia Azzouzi
nazzouzi@sgul.ac.uk
02082666488
Time Frame
Start Date: 2021-12-01
Estimated Completion Date: 2024-03-30
Participants
Target number of participants: 400
Treatments
Cases
Cases are defined as infants who develop invasive GBS disease (iGBS disease= isolation of GBS from a normally sterile site, i.e. blood or CSF) in the first 90 days of life.
Controls
Controls are defined as infants who are exposed to the same serotype of GBS at birth as the case - but who do not develop iGBS disease in the first 90 days of life.
Related Therapeutic Areas
Sponsors
Collaborators: Public Health England, Medical Research Council, University of Nottingham
Leads: St George's, University of London