Antibody Levels Associated With Reduced Risk of Invasive Group B Streptococcus Disease in Infants Aged Less Than 90 Days

Establishing a Sero-correlate of Protection Against Invasive Group B Streptococcus Disease in Newborns and Young Infants Aged Less Than 90 Days.

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02099149

Enrollment

Registered

2014-03-28

Start date

2014-05-31

Completion date

2015-08-31

Last updated

2014-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive Group B Streptococcus Disease

Keywords

Group B Streptococcus, early onset disease, late onset disease, anticapsular antibodies, serotype specific

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 levels associated with reductions in risk of GBS disease in infants aged less than 90 days.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Pregnant women attending participating community/hospital antenatal clinics and/or delivering at participating delivery centers. * Subjects aged ≥18 years. * Able to understand and comply with planned study procedures. * Provides written informed consent.

Exclusion criteria

* Refuses to consent to study participation.

Design outcomes

Primary

Measure	Time frame	Description
Early onset Group B Streptococcus Disease due to serotypes Ia or III	0-6 days	Risk of early onset Group B Streptococcus disease (due to serotypes Ia or III) with respect to maternal or newborn anticapsular antibody levels at delivery

Secondary

Measure	Time frame	Description
Late onset Group B Streptococcus Disease due to serotype III	7-90 days	Risk of late onset Group B Streptococcus disease (due to serotypes III) with respect to maternal or newborn anticapsular antibody levels at delivery

Countries

South Africa

Outcome results