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])

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Streptococcus Agalactiae

Treatments: Other: Vaginal swab sample; Procedure: Blood sample

Study type: Interventional

Funder types: Industry

Identifiers

NCT01888471

V98_22OB (Other Identifier)

205523

Details and patient eligibility

About

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.

Enrollment: 3,033 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• Subjects Refusing to consent to study participation.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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3,033 participants in 2 patient groups

Cases Group

Other group

Description:

Cases Group will be defined as: Maternal subjects identified with invasive GBS disease from the enrolled maternal-newborn dyad Study cohort: Cases will be classified as follows: EOD (Early onset disease): isolation of GBS from the blood or cerebrospinal fluid (CSF) within 0-6 days of birth. LOD (Late onset disease): isolation of GBS from the blood or cerebrospinal fluid (CSF) within 7-90 days of birth.

Treatment:

Procedure: Blood sample

Other: Vaginal swab sample

Controls Group

Other group

Description:

Controls will be defined as newborns to mothers, enrolled into the study and identified as colonized by a serotype which is homologous to that of cases, but who do not develop invasive GBS disease.

Treatment:

Procedure: Blood sample

Other: Vaginal swab sample