[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"invasive-bacterial-diseases-ibd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:invasive-bacterial-diseases-ibd":27},{"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":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":18,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100540857","epidemiological-study-on-invasive-bacterial-diseases-100540857","NCT06322290","Epidemiological Study on Invasive Bacterial Diseases","Epidemiological Study on Invasive Bacterial Diseases (IBD)","Inclusion Criteria:\n\n* Pediatric and adult patients diagnosed with pneumococcal, meningococcal, and hemophilus MBI\n\nExclusion Criteria:\n\n* Other type of bacterial infections.","1 Day","70 Years",{"count":60,"type":21},5000,"Streptococcus pneumoniae (pneumococcus), Neisseria meningitidis (meningococcus), and Haemophilus influenzae (hemophilus) are among the main bacteria responsible for invasive bacterial diseases (MBIs) that result in severe clinical pictures also characterized by a high frequency of serious complications. Surveillance of infections caused by these pathogens and their distribution by serotypes\u002Fserogroups is essential to guide public health interventions, assess epidemiologic trends, monitor any secondary cases, estimate the proportion of preventable cases, identify any vaccine failures, and evaluate the impact of vaccine strategies.The present study aims to study the epidemiology of invasive bacterial diseases, characterize the circulating strains also in order to plan treatment and prevention strategies.",[27],"2024-03-18",{"date":65,"type":41},"2024-03-21",{"date":67,"type":41},"2021-12-09",{"date":69,"type":21},"2032-03-30",{"name":71,"class":48},"Meyer Children's Hospital IRCCS",38]