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| ID | Type | Description | Link |
|---|---|---|---|
| V98_22OB | Other Identifier | Novartis |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases Group | Other | 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:
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| Controls Group | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion (Percentage) of maternal subjects enrolled in the study relative to the number of pregnant women screened. | Maternal mothers were excluded at screening if:
| 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. | 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. | 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:
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
• Subjects Refusing to consent to study participation.
Pregnant women (irrespective of gestational age staging or underlying comorbidities) attending for antenatal care at CHBAH or an allied antenatal clinic and/or delivering at the participating delivery center (CHBAH).
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Johannesburg | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26409812 | Derived | 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. |
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| Vaginal swab sample | Other | 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. |
|
| At delivery |
| 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 |
| 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
Infant subjects:
| 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. | At 90 day follow up visit |
| Percentage of maternal subjects, with vaginal swab samples, culture positive for GBS. | Throughout the study, an average of 4 months. |
| Percentage of maternal subjects who had culture positive for GBS, classified by serotype. | 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. | At delivery |
| GBS anti-capsular antibody concentration (serotype-specific anticapsular antibody) in infant subjects. | At birth |
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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