Status:
COMPLETED
Feasibility Study for Identifying Anti Capsular Antibody Protection Against Invasive Group B Streptococcus (GBS) Disease in Newborns of 0-6 Days Age (Early Onset Disease [EOD]) as Well as Among Infants of 7-90 Days Age (Late Onset Disease [LOD])
Lead Sponsor:
GlaxoSmithKline
Conditions:
Streptococcus Agalactiae
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate antibody levels against Group B streptococcus in mothers and the risk of developing invasive Group B streptococcus disease in newborns of less than 6 days age ...
Eligibility Criteria
Inclusion
- Pregnant women (irrespective of gestational age staging or underlying comorbidities) attending for antenatal care at Chris Hani Baragwanath Academic Hospital (CHBAH) or an allied antenatal clinic and/or delivering at the participating delivery center (CHBAH)
- Subjects aged ≥18 years.
- Able to understand and comply with planned study procedures.
- Provides written informed consent.
Exclusion
- • Subjects Refusing to consent to study participation.
Key Trial Info
Start Date :
December 11 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2014
Estimated Enrollment :
3033 Patients enrolled
Trial Details
Trial ID
NCT01888471
Start Date
December 11 2013
End Date
July 14 2014
Last Update
July 19 2019
Active Locations (1)
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1
GSK Investigational Site
Johannesburg, South Africa