[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580181":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":18,"centralContacts":23,"locations":33,"responsibleParty":127,"collaborators":129,"id":148,"slug":149,"hasResults":150,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":156,"sex":157,"minAge":10,"maxAge":10,"enrollmentInfo":158,"targetDuration":161,"studyType":162,"phases":10,"briefSummary":163,"conditions":164,"keywords":168,"overallStatus":36,"whyStopped":10,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},{"fullName":5,"class":6},"Barcelona Institute for Global Health","OTHER",[8,12,15],{"label":9,"type":10,"description":11,"interventionNames":10},"WP2: Pregnancy Episode Registries",null,"This work package (WP2) will develop systems to determine background pregnancy and infancy outcomes, as defined by Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA), in preparation for maternal vaccine clinical trials and post-implementation studies. WP2 will assess the utility of existing medical records data to accurately determine pregnancy events following immunisation and, using patient data related to atleast 4000 pregnancies in each country, to establish an easy to use pregnancy episodes registry (PER) that can be used for future Phase III\u002FIV trials. The PER will be developed using freely available code developed under EDCTP2 so that it can be used in other African settings in the future.\n\nThe WP2 group consists of pregnant women and their infants up to hospital discharge at the chosen health facilities in Uganda, Malawi, Mozambique, and Kenya.",{"label":13,"type":10,"description":14,"interventionNames":10},"WP3: GBS disease sentinel site surveillance","WP3 will conduct a prospective observational GBS surveillance study among infants less than 90 days old who are admitted with laboratory confirmed GBS at sentinel sites in Kenya, Uganda, Malawi and Mozambique. The WP3 study team will develop and strengthen IBD surveillance, with a focus on GBS in each site. All of the proposed sites have access to microbiological capacity that will be leveraged to monitor microbiologically confirmed neonatal sepsis burden. In doing so, WP3 will improve the nations' ability to participate in late phase clinical trials and post-licensure effectiveness studies in preparation for phase III\u002FIV GBS maternal vaccine clinical trials and vaccine decision making.\n\nThe WP3 group consists of all infants less than 90 days old admitted with GBS infection detected in blood or cerebrospinal fluid (CSF) by culture, or GBS detected in CSF by quantitative polymerase chain reaction, at the health facilities in the four countries during a period of at least 12 months.",{"label":16,"type":10,"description":17,"interventionNames":10},"WP4: Vaccine confidence","Many low- and middle-income countries face significant challenges regarding vaccine implementation including vaccine confidence and participation in vaccine clinical trials, especially for vaccines targeting pregnant women. Through a mixed-methods study, WP4 will assess the knowledge, attitudes and practices of pregnant women, health care providers, community members and other relevant stakeholders towards maternal vaccines, and assess the understanding and willingness to participate in maternal vaccine trials in Kenya, Malawi, Mozambique and Uganda. WP4 will also co-create a communication\u002Feducation toolkit to enhance understanding of the importance of maternal vaccines and participation in maternal vaccine trials.\n\nThe WP4 group therefore consists of pregnant women and health care workers at the identified health facilities at the time of fieldwork. It will also consist of stakeholders such as Ministries of Health, community leaders, religious, political, or cultural leaders.",[19],{"name":20,"affiliation":21,"role":22},"Eve Nakabembe","MU-JHU CARE","STUDY_DIRECTOR",[24,30],{"name":25,"role":26,"phone":27,"phoneExt":28,"email":29},"Azucena Bardají","CONTACT","+34 93 2275 400","4145","azucena.bardaji@isglobal.org",{"name":31,"role":26,"phone":27,"phoneExt":28,"email":32},"Lucy Walmsley","lucy.walmsley@isglobal.org",[34,48,58,67,79,84,89,101,109,120],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":10},"Mariakani Sub-County Hospital","RECRUITING","Mariakani","Coast","80113","Kenya","KE",{"type":43,"coordinates":44},"Point",[45,46],39.47458,-3.86261,{"lat":46,"lon":45},{"facility":49,"status":36,"city":50,"state":51,"zip":52,"country":40,"countryCode":41,"cosmosGeoPoint":53,"geoPoint":57,"contacts":10},"Malindi Sub County Hospital in Malindi","Malindi","Kilifi County","80200",{"type":43,"coordinates":54},[55,56],40.11692,-3.21799,{"lat":56,"lon":55},{"facility":59,"status":36,"city":60,"state":51,"zip":61,"country":40,"countryCode":41,"cosmosGeoPoint":62,"geoPoint":66,"contacts":10},"Rabai Sub County Hospital","Rabai","80114",{"type":43,"coordinates":63},[64,65],39.57041,-3.93168,{"lat":65,"lon":64},{"facility":68,"status":36,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":78,"contacts":10},"Queen Elizabeth Central Hospital","Blantyre","Blantyre District","Box 95","Malawi","MW",{"type":43,"coordinates":75},[76,77],35.00854,-15.78499,{"lat":77,"lon":76},{"facility":80,"status":36,"city":69,"state":70,"zip":10,"country":72,"countryCode":73,"cosmosGeoPoint":81,"geoPoint":83,"contacts":10},"Lirangwe Health Centre",{"type":43,"coordinates":82},[76,77],{"lat":77,"lon":76},{"facility":85,"status":36,"city":69,"state":69,"zip":10,"country":72,"countryCode":73,"cosmosGeoPoint":86,"geoPoint":88,"contacts":10},"Ndirande Health Centre",{"type":43,"coordinates":87},[76,77],{"lat":77,"lon":76},{"facility":90,"status":36,"city":91,"state":92,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":100,"contacts":10},"Hospital Geral De Mavalane","Maputo","Cidade de Maputo","1100","Mozambique","MZ",{"type":43,"coordinates":97},[98,99],32.58322,-25.96553,{"lat":99,"lon":98},{"facility":102,"status":36,"city":103,"state":103,"zip":10,"country":94,"countryCode":95,"cosmosGeoPoint":104,"geoPoint":108,"contacts":10},"Manhiça District Hospital","Manhiça",{"type":43,"coordinates":105},[106,107],32.80722,-25.40222,{"lat":107,"lon":106},{"facility":110,"status":36,"city":111,"state":111,"zip":112,"country":113,"countryCode":114,"cosmosGeoPoint":115,"geoPoint":119,"contacts":10},"Kawempe National Referral Hospital","Kampala","P. O Box 3253","Uganda","UG",{"type":43,"coordinates":116},[117,118],32.58219,0.31628,{"lat":118,"lon":117},{"facility":121,"status":36,"city":111,"state":122,"zip":123,"country":113,"countryCode":114,"cosmosGeoPoint":124,"geoPoint":126,"contacts":10},"Komamboga Health Centre III","Komamboga","4126",{"type":43,"coordinates":125},[117,118],{"lat":118,"lon":117},{"type":128,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[130,132,134,137,139,141,143,144,146],{"name":131,"class":6},"Fundação Manhiça",{"name":133,"class":6},"Universiteit Antwerpen",{"name":135,"class":136},"LINQ Management GMBH","UNKNOWN",{"name":138,"class":6},"Aga Khan University",{"name":140,"class":6},"University of Liverpool",{"name":142,"class":6},"Kamuzu University of Health Sciences",{"name":21,"class":6},{"name":145,"class":6},"St George's, University of London",{"name":147,"class":6},"University of Oxford","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":159,"type":160},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.",[165,166,167],"Group B Streptococcus","Invasive Bacterial Diseases (IBD)","Maternal Immunization",[169,170,171,172,165,173,174,175],"Child health","Clinical research","Clinical trials","Infectious diseases","vaccines","maternal immunisation","maternal health","2026-05-19",{"date":178,"type":179},"2026-05-20","ACTUAL",{"date":181,"type":179},"2025-03-01",{"date":183,"type":160},"2027-02-28",{"name":5,"class":6},10]