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])

Feasibility Study for Identifying a Sero-correlate of Protection Against Invasive Group B Streptococcus Disease in Newborns and Young Infants Aged Less ≤90 Days

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,033 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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 as well as infants of age less than 90 days age.

Conditions

• Streptococcus Agalactiae

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-12-11
• Primary completion: 2014-07-14
• Completion: 2014-07-14
• First posted: 2013-06-27
• Last updated: 2019-07-19

Locations

1 site across 1 country: South Africa