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])

Streptococcus Agalactiae Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01888471
• Other study ID #: 205523
• Secondary ID: V98_22OB
• Status: Completed
• Phase: N/A
• Start date: December 11, 2013
• Est. completion date: July 14, 2014

Study information

• Verified date: July 2019
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3033
• Est. completion date: July 14, 2014
• Est. primary completion date: July 14, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Streptococcus Agalactiae

Intervention

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.

Locations

Country	Name	City	State
South Africa	GSK Investigational Site	Johannesburg

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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)
Primary	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.	During routine antenatal visits in the 4 months enrollment period(in antenatal clinics attached to study delivery units)
Primary	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.	At delivery
Primary	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.	At delivery
Primary	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.	At delivery
Primary	Proportion (percentage) of enrolled mother-infant dyads with both maternal and cord blood collected.	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
Primary	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.	Throughout the study, an average of 4 months.
Primary	Percentage of subjects who completed the 90-day follow up visit in subset of subjects eligible for this visit.		At 90 day follow up visit
Primary	Percentage of maternal subjects, with vaginal swab samples, culture positive for GBS.		Throughout the study, an average of 4 months.
Primary	Percentage of maternal subjects who had culture positive for GBS, classified by serotype.		Throughout the study, an average of 4 months.
Primary	GBS anti-capsular antibody concentration (serotype-specific anti capsular antibody) in maternal subjects, vaginally colonized with GBS.		At delivery
Primary	GBS anti-capsular antibody concentration (serotype-specific anticapsular antibody) in infant subjects.		At birth

External Links

•   Results Summary for this study can be found on the Novartis clinical study register