[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"group-b-streptococcus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:group-b-streptococcus":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100580181","preparing-for-maternal-gbs-vaccine-trials-in-africa-100580181",false,"NCT06833957","Preparing for Maternal GBS Vaccine Trials in Africa","PReparing for OptimalPhase III\u002FIV maTErnal Group B StreptococCal Vaccine Trials in Africa (PROTECT)","PROTECT","Inclusion Criteria:\n\n* WP2 Pregnancy Exposure Registries inclusion criteria:\n\nAll women and their infants attending for antenatal and\u002For delivery and postpartum services at the study sites in Uganda, Malawi, Mozambique, and Kenya.\n\nWP3 GBS Surveillance inclusion criteria:\n\n* Infants aged less than 90 days old with laboratory-confirmed GBS infection admitted at participating health facilities in Uganda, Malawi, Mozambique, and Kenya.\n* Infants whose parents or guardians provided written informed consent for their participation.\n* Residents in the catchment area of participating health facilities.\n\nWP4 Vaccine Confidence inclusion criteria:\n\n* In Uganda, Kenya and Mozambique, pregnant women at any gestation period aged 18 years and above (reproductive age).\n* In Malawi, pregnant women aged 16 years are eligible to be included in the study because they are considered emancipated minors.\n* Pregnant women who consent to the study and give written consent.\n* Stakeholders who include pregnant women, health workers, women leaders, community leaders, national stakeholders, cultural and religious leaders who are willing to take part and can give written informed consent.\n\nExclusion Criteria:\n\nWP4 Vaccine Confidence exclusion criteria:\n\n* Pregnant women who are visiting\u002Fnon-resident in the research area.\n* Those who may be unwell and unable to consent to take part in the study.",true,"ALL",{"count":20,"type":21},18100,"ESTIMATED","8 Months","OBSERVATIONAL","Infections are one of the key causes of newborn deaths. Among them, Group B Streptococcus (GBS) is the leading cause of sepsis and bacterial meningitis in the first 90 days of life.\n\nFortunately, GBS vaccines for pregnant women, a powerful tool for fighting infections, are currently in development. Once vaccine trials are completed, these vaccines can stop preventable newborn deaths.\n\nThe PReparing for Optimal Phase III\u002FIV maTErnal Group B StreptococCal vaccine Trials in Africa (PROTECT) project, funded by the European \\& Developing Countries Clinical Trials Partnership (EDCTP) and European Commission, is supporting medical sites in Kenya, Malawi, Mozambique, and Uganda to establish uniform pregnancy and infant health data collection processes. It is also establishing surveillance of GBS in newborns to determine incidence rates and measure the burden of disease. With better reporting systems, medical sites can participate in vaccine trials and monitor vaccine safety. At the same time, the consortium is working to understand the drivers of vaccine hesitancy and to develop culturally appropriate communication tools to facilitate engagement with vaccines.\n\nThe end goal is to set up a network of sites that can monitor vaccine safety for current and future vaccines.",[26,27,28],"Group B Streptococcus","Invasive Bacterial Diseases (IBD)","Maternal Immunization",[30,31,32,33,26,34,35,36],"Child health","Clinical research","Clinical trials","Infectious diseases","vaccines","maternal immunisation","maternal health","RECRUITING","2026-05-19",{"date":40,"type":41},"2026-05-20","ACTUAL",{"date":43,"type":41},"2025-03-01",{"date":45,"type":21},"2027-02-28",{"name":47,"class":48},"Barcelona Institute for Global Health","OTHER",10,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":57,"enrollmentInfo":58,"targetDuration":57,"studyType":23,"phases":4,"briefSummary":60,"conditions":61,"keywords":67,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":4},"100584989","comprehensive-outcomes-monitoring-for-peri--and-postnatal-invasive-group-b-strep-sequelae-comppass-registry-100584989","NCT06896526","Comprehensive Outcomes Monitoring for Peri- and Postnatal Invasive Group B Strep Sequelae (COMPPASS) Registry","COMPPASS","Inclusion Criteria:\n\n1. A child below the age of 19 who was either diagnosed with or received a lab test result confirming an iGBS infection, or being able to describe their child's condition and experience with iGBS infection at, or within 90 days of, birth.\n\n   or A child who was diagnosed as having invasive Group B Strep infection within the first 90 days after delivery and later passed away because of the infection or Parent who has experienced a stillbirth due to iGBS infection\n2. A sibling(s) from a multi-gestation pregnancy where at least one child was diagnosed as having invasive Group B Strep infection\n3. Parent or caregiver who understands and electronically signs the inform consent document\n4. In addition to parental or caregiver consent, children between the ages of 13-17 years who are able to understand and provide assent to take part in the study, as confirmed by an electronic signature by their consenting parent or caregiver.\n\nExclusion Criteria:\n\n1\\. A child affected by iGBS infection currently over the age of 18.","18 Years",{"count":59,"type":21},10000,"The goal of this registry is to collect and store important medical and non-health information on children from 0 to 18 years of age affected by early- (up to 24 hours after birth) and late-onset (up to 90 days after birth) invasive Group B Streptococcus (iGBS) and their families. Data collected from families of children affected by perinatal iGBS will support further research to understand the short- and long-term impact of iGBS disease on affected children and its impact on their families. Participants will be invited to complete obstetric and pregnancy-related questionnaires as well as validated neurodevelopmental surveys at various timepoints throughout their participation in the registry.",[62,26,63,64,65,66],"Invasive Group B Streptococcus Disease","Group B Streptococcal Infection","Group B Streptococcus (GBS) Disease","Group B Streptococcal Infection, Early-Onset","Group B Streptococcal Infection, Late-Onset",[62,68],"Invasive Group B Streptococcus Registry","NOT_YET_RECRUITING","2025-03-19",{"date":72,"type":41},"2025-03-26",{"date":74,"type":21},"2025-04-01",{"date":76,"type":21},"2035-03-31",{"name":78,"class":79},"Precia Group","INDUSTRY"]