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| Name | Class |
|---|---|
| Novartis Vaccines | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controls | Infants born to GBS colonized mother who do not develop GBS disease | ||
| Cases | Infants with culture confirmed GBS disease |
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| Measure | Description | Time Frame |
|---|---|---|
| Early onset Group B Streptococcus Disease due to serotypes Ia or III | 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 | 0-6 days |
| Measure | Description | Time Frame |
|---|---|---|
| Late onset Group B Streptococcus Disease due to serotype III | Risk of late onset Group B Streptococcus disease (due to serotypes III) with respect to maternal or newborn anticapsular antibody levels at delivery | 7-90 days |
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Inclusion Criteria:
Exclusion Criteria:
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Pregnant women aged 18 years or older attending for antenatal care or delivery at 3 academic hospital centers in the Johannesburg area and the antenatal clinics serving those hospital centers.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Vaccines | Novartis Vaccines | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Respiratory and Meningeal Pathogen Research Unit | Soweto | Gauteng | 2013 | South Africa |
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| ID | Term |
|---|---|
| D000067562 | Late Onset Disorders |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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