Clinical trial NCT01888471: 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])
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Streptococcus Agalactiae
Keywords: Streptococcal disease
Feasibility
Infants
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-06-27
Enrollment: 3033
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.


Eligibility 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.

Primary outcomes:
measure: 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)
measure: 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)
measure: Proportion (percentage) of maternal subjects enrolled at delivery.
timeFrame: At delivery
measure: Proportion (percentage) of mother-infant dyads enrolled with data available to assess early censorship criteria.
timeFrame: At delivery
measure: Proportion (percentage) of enrolled mother-infant dyads with cord blood collected.
timeFrame: At delivery
measure: Proportion (percentage) of enrolled mother-infant dyads with both maternal and cord blood collected.
timeFrame: At delivery
measure: Proportion (percentage) of mother-infant dyads with complete data on the defined key clinical variables.
timeFrame: Throughout the study, an average of 4 months.
measure: 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
measure: Percentage of maternal subjects, with vaginal swab samples, culture positive for GBS.
timeFrame: Throughout the study, an average of 4 months.
measure: Percentage of maternal subjects who had culture positive for GBS, classified by serotype.
timeFrame: Throughout the study, an average of 4 months.
measure: GBS anti-capsular antibody concentration (serotype-specific anti capsular antibody) in maternal subjects, vaginally colonized with GBS.
timeFrame: At delivery
measure: GBS anti-capsular antibody concentration (serotype-specific anticapsular antibody) in infant subjects.
timeFrame: At birth
Secondary outcomes:
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Cutland CL, Cunnington M, Olugbosi M, Jones SA, Hugo A, Maharaj K, Slobod K, Madhi SA. Lessons learnt from enrolment and follow up of pregnant women and their infants in clinical trials in South Africa, a low-middle income country. Vaccine. 2015 Nov 25;33(47):6406-12. doi: 10.1016/j.vaccine.2015.08.040. Epub 2015 Sep 26.