Antibody Levels Associated With Reduced Risk of Invasive Group B Streptococcus Disease in Infants Aged Less Than 90 Days
Withdrawn
- Conditions
- Invasive Group B Streptococcus Disease
- Registration Number
- NCT02099149
- Lead Sponsor
- Novartis
- Brief Summary
Compare anticapsular antibody levels against Group B Streptococcus at delivery in mothers and their infants who develop disease versus those who do not. Use this comparison to establish antibody levels associated with reductions in risk of GBS disease in infants aged less than 90 days.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
- Pregnant women attending participating community/hospital antenatal clinics and/or delivering at participating delivery centers.
- Subjects aged β₯18 years.
- Able to understand and comply with planned study procedures.
- Provides written informed consent.
Exclusion Criteria
- Refuses to consent to study participation.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Early onset Group B Streptococcus Disease due to serotypes Ia or III 0-6 days Risk of early onset Group B Streptococcus disease (due to serotypes Ia or III) with respect to maternal or newborn anticapsular antibody levels at delivery
- Secondary Outcome Measures
Name Time Method Late onset Group B Streptococcus Disease due to serotype III 7-90 days Risk of late onset Group B Streptococcus disease (due to serotypes III) with respect to maternal or newborn anticapsular antibody levels at delivery
Trial Locations
- Locations (1)
Respiratory and Meningeal Pathogen Research Unit
πΏπ¦Soweto, Gauteng, South Africa