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])

GlaxoSmithKline3,033 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

3,033

Conditions

Streptococcus Agalactiae

Interventions

Blood samplePROCEDURE

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.

Vaginal swab sampleOTHER

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.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

GSK Investigational Site

Johannesburg, South Africa

Outcomes

Primary Outcomes

Proportion (Percentage) of maternal subjects enrolled in the study relative to the number of pregnant women screened.

Maternal mothers were excluded at screening if: * Age \<18 yrs. * Not planning to deliver at study center. * Did not consent.

Time frame: During routine antenatal visits in the 4 months enrollment period (in antenatal clinics attached to study delivery units or the clinics serving the population delivering at those unit)

Proportion (percentage) of maternal subjects enrolled in ante-natal clinics.

Percentage of maternal mothers who were not excluded at screening and who were presenting in antenatal clinics.

Time frame: During routine antenatal visits in the 4 months enrollment period(in antenatal clinics attached to study delivery units)

Proportion (percentage) of maternal subjects enrolled at delivery.

Percentage of maternal mothers who were not excluded at screening and who were enrolled at delivery visit.

Time frame: At delivery

Proportion (percentage) of mother-infant dyads enrolled with data available to assess early censorship criteria.

Percentage of mothers who were not excluded at screening and with data available to assess Early censoring criteria for defining the final analysis population: * Intravenous intrapartum antibiotics at delivery. * Blood transfusion in the 30 days prior to delivery. * Infant born with life threatening condition/ congenital malformation. * Failure to complete 90 day Follow-Up for potential controls. * Non-homologous serotype in case infants and mothers.

Time frame: At delivery

Proportion (percentage) of enrolled mother-infant dyads with cord blood collected.

Percentage of maternal mother (who were not excluded at screening) -infants dyads and with cord blood sample obtained for serology.

Time frame: At delivery

Data from ClinicalTrials.gov

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Proportion (percentage) of mother-infant dyads with complete data on the defined key clinical variables.

Percentage of maternal mother (who were not excluded at screening) -infants dyads with defined key clinical variables. The key clinical variables have been defined as follows: Maternal subjects * Smoking during pregnancy, * Vaginal douche during pregnancy, * Gestational age at enrolment, * HIV test completed during routine care, * For those with test completed availability of test result and for HIV positive subjects CD4 count and viral load data. * Time between rupture of membranes and delivery, * Intrapartum antibiotic usage at delivery and duration of treatment * Evidence of intra-amniotic uterine infection. Infant subjects: * Birth weight, * Head circumference, * Congenital malformation, * Completion of 90-day follow-up visit in subset of sub-jects (cases and controls) eligible for this visit.

Time frame: Throughout the study, an average of 4 months.