Last updated: 07/18/2020 12:13:38

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])

GSK study ID
205523
Clinicaltrials.gov ID
NCT01888471
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Feasibility study for identifying a sero-correlate of protection against invasive Group B Streptococcus disease in newborns and young infants aged less ≤90 days
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

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

Timeframe: 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.

Timeframe: 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.

Timeframe: At delivery

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

Timeframe: At delivery

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

Timeframe: At delivery

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

Timeframe: At delivery

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

Timeframe: 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.

Timeframe: At 90 day follow up visit

Percentage of maternal subjects, with vaginal swab samples, culture positive for GBS.

Timeframe: Throughout the study, an average of 4 months.

Percentage of maternal subjects who had culture positive for GBS, classified by serotype.

Timeframe: 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.

Timeframe: At delivery

GBS anti-capsular antibody concentration (serotype-specific anticapsular antibody) in infant subjects.

Timeframe: At birth

Secondary outcomes:
Not applicable
Interventions:
  • Procedure/surgery: Blood sample
  • Other: Vaginal swab sample
    • Enrollment:
    3033
    Primary completion date:
    2014-14-07
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Streptococcus agalactiae
    Product
    GSK3536855A
    Collaborators
    Not applicable
    Study date(s)
    December 2013 to July 2014
    Type
    Interventional
    Phase
    Not applicable

    Participation criteria

    Sex
    Female
    Age
    18+ years
    Accepts healthy volunteers
    Yes
    • 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.
    • Subjects Refusing to consent to study participation.
    Inclusion and exclusion criteria
    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 location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Johannesburg, South Africa
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Study complete
    Actual primary completion date
    2014-14-07
    Actual study completion date
    2014-14-07

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Participate in clinical trial
    Additional information
    Results Summary for this study can be found on the Novartis clinical study register
    Click here
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