Status:
COMPLETED
GBS Sero-correlate of Protection
Lead Sponsor:
University of Witwatersrand, South Africa
Collaborating Sponsors:
Novartis Vaccines
Conditions:
Invasive Group B Streptococcus Disease
Eligibility:
FEMALE
18+ years
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 level...
Detailed Description
Group B Streptococcus (GBS) is a leading cause of invasive disease during the neonatal period in developed and developing countries. The global incidence of disease is 0.53 per 1000 live births, thoug...
Eligibility Criteria
Inclusion
- (i) Pregnant women attending participating community/hospital antenatal clinics and/or delivering at participating delivery centers.
- (ii) Subjects aged ≥18 years. (iii) Able to understand and comply with planned study procedures. (iv) Provides written informed consent.
Exclusion
- (i) Refuses to consent to study participation.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2016
Estimated Enrollment :
35274 Patients enrolled
Trial Details
Trial ID
NCT02215226
Start Date
July 1 2014
End Date
December 31 2016
Last Update
September 13 2018
Active Locations (1)
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1
Respiratory and Meningeal Pathogen Research Unit
Soweto, Johannesburg, Gauteng, South Africa, 2013