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])

July 17, 2019 updated by: GlaxoSmithKline

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3033

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Johannesburg, South Africa
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cases Group

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.
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.
Other: Controls Group
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion (Percentage) of maternal subjects enrolled in the study relative to the number of pregnant women screened.
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)

Maternal mothers were excluded at screening if:

  • Age <18 yrs.
  • Not planning to deliver at study center.
  • Did not consent.
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.
Time Frame: During routine antenatal visits in the 4 months enrollment period(in antenatal clinics attached to study delivery units)
Percentage of maternal mothers who were not excluded at screening and who were presenting in antenatal clinics.
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.
Time Frame: At delivery
Percentage of maternal mothers who were not excluded at screening and who were enrolled at delivery visit.
At delivery
Proportion (percentage) of mother-infant dyads enrolled with data available to assess early censorship criteria.
Time Frame: At delivery

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.
At delivery
Proportion (percentage) of enrolled mother-infant dyads with cord blood collected.
Time Frame: At delivery
Percentage of maternal mother (who were not excluded at screening) -infants dyads and with cord blood sample obtained for serology.
At delivery
Proportion (percentage) of enrolled mother-infant dyads with both maternal and cord blood collected.
Time Frame: At delivery
Percentage of maternal mother (who were not excluded at screening) -infants dyads and with both maternal and cord blood sample obtained for serology.
At delivery
Proportion (percentage) of mother-infant dyads with complete data on the defined key clinical variables.
Time Frame: Throughout the study, an average of 4 months.

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.
Throughout the study, an average of 4 months.
Percentage of subjects who completed the 90-day follow up visit in subset of subjects eligible for this visit.
Time Frame: At 90 day follow up visit
At 90 day follow up visit
Percentage of maternal subjects, with vaginal swab samples, culture positive for GBS.
Time Frame: Throughout the study, an average of 4 months.
Throughout the study, an average of 4 months.
Percentage of maternal subjects who had culture positive for GBS, classified by serotype.
Time Frame: Throughout the study, an average of 4 months.
Throughout the study, an average of 4 months.
GBS anti-capsular antibody concentration (serotype-specific anti capsular antibody) in maternal subjects, vaginally colonized with GBS.
Time Frame: At delivery
At delivery
GBS anti-capsular antibody concentration (serotype-specific anticapsular antibody) in infant subjects.
Time Frame: At birth
At birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2013

Primary Completion (Actual)

July 14, 2014

Study Completion (Actual)

July 14, 2014

Study Registration Dates

First Submitted

June 25, 2013

First Submitted That Met QC Criteria

June 26, 2013

First Posted (Estimate)

June 27, 2013

Study Record Updates

Last Update Posted (Actual)

July 19, 2019

Last Update Submitted That Met QC Criteria

July 17, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 205523
  • V98_22OB (Other Identifier: Novartis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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