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) logo

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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