Antibody Levels Associated With Reduced Risk of Invasive Group B Streptococcus Disease in Infants Aged Less Than 90 Days

N/AWithdrawnNCT02099149

Novartis

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Invasive Group B Streptococcus Disease

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Pregnant women attending participating community/hospital antenatal clinics and/or delivering at participating delivery centers. * Subjects aged ≥18 years. * Able to understand and comply with planned study procedures. * Provides written informed consent. Exclusion Criteria: * Refuses to consent to study participation.

Locations (1)

Respiratory and Meningeal Pathogen Research Unit

Soweto, Gauteng, South Africa

Outcomes

Primary Outcomes

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

Time frame: 0-6 days

Secondary Outcomes

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

Time frame: 7-90 days

Data from ClinicalTrials.gov

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