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])

NACompletedINTERVENTIONAL
Enrollment

3,033

Participants

Timeline

Start Date

December 11, 2013

Primary Completion Date

July 14, 2014

Study Completion Date

July 14, 2014

Conditions
Streptococcus Agalactiae
Interventions
PROCEDURE

Blood sample

Blood sample will be obtained from enrolled mothers at delivery(either immediately before or after delivery) Both original blood sample and cord blood sample will be obtained for serology.

OTHER

Vaginal swab sample

Vaginal swab will be collected at delivery from a pre-defined subset of enrolled mothers for the identification of controls, for determining GBS maternal colonization status and serotype.

Trial Locations (1)

Unknown

GSK Investigational Site, Johannesburg

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01888471 - 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]) | Biotech Hunter | Biotech Hunter