[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100521356":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":39,"centralContacts":44,"locations":53,"responsibleParty":83,"collaborators":27,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":87,"sex":93,"minAge":94,"maxAge":27,"enrollmentInfo":95,"targetDuration":27,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":56,"whyStopped":27,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"University of Oxford","OTHER",[8,15,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"MDA + Vaccine","ACTIVE_COMPARATOR","The participants in MVDA villages will receive R21\u002FMatrix M at M0, M1, M2, and a booster M12 plus DHA\u002Fpiperaquine and a SLD-PQ at M0, M1, and M2",[13,14],"Drug: DHA\u002Fpiperaquine and a SLD-PQ","Biological: Study vaccine R21\u002FMatrix-M™",{"label":16,"type":10,"description":17,"interventionNames":18},"MDA only","The participants in MDA only villages will receive DHA\u002Fpiperaquine and a SLD-PQ at M0, M1, and M2",[13],{"label":20,"type":10,"description":21,"interventionNames":22},"Vaccine only","The participants in vaccine only villages will receive R21\u002FMatrix M at M0, M1, M2, and a booster M12",[14],{"label":24,"type":25,"description":26,"interventionNames":27},"Control","NO_INTERVENTION","The participants in control will receive MVDA at the end of the 24th month assuming that MVDA is found to be safe and effective. During M0 to M24, the comparison villages will receive the standard of care as per national malaria treatment guidelines.",null,[29,34],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":27},"DRUG","DHA\u002Fpiperaquine and a SLD-PQ","Participants in Arms 1 and 2 will receive three rounds of antimalarial drugs - each round starting on the day of vaccination (Day 0) at Study Months 0, 1, and 2. Each round consists of three daily doses of co-formulated dihydroartemisinin\u002Fpiperaquine on Day 0, 1, and 2 (i.e. the day of vaccination and each day for 2 days after). The drug dose is based on the weight of the participant at the first visit (M0D0). Dihydroartemisinin\u002Fpiperaquine tablets (Shanghai Fosun Pharmaceutical Co., Ltd.) for adult participants each contain 40 mg dihydroartemisinin and 320 mg piperaquine with a therapeutic dose range between 2-10 mg\u002Fkg\u002Fday dihydroartemisinin and 16-26 mg\u002Fkg\u002Fdose piperaquine. In addition, each participant will receive a single low dose primaquine on the day of vaccination (Day 0; Table 4). One single low dose primaquine of approximately 0.25 mg\u002Fkg (Thai Government Pharmaceutical Organisation) will be administered. Children under 10kg do not receive PQ.",[9,16],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":27},"BIOLOGICAL","Study vaccine R21\u002FMatrix-M™","The mixing prior to administration strategy will involve withdrawal of 0.5 mL antigen from one vial of R21 Malaria vaccine and adding it to Matrix-M1 vial. 0.5 mL of R21 antigen shall be withdrawn from another vial of R21 Malaria vaccine and be added to the same Matrix-M1 vial. The total volume in Matrix-M1 vial will be 1.5 mL. After addition the content will be mixed gently, and 0.75 mL of the mixture will be withdrawn and administered to participants. Each dose of 0.75mL (after mixing of R21 with Matrix-M1) will contain 10 µg of R21 and 50 µg for participants 14 years and older. In children up to 14 years a 5 μg will be used.",[9,20],[40],{"name":41,"affiliation":42,"role":43},"Lorenz von Seidlein","Mahidol University","PRINCIPAL_INVESTIGATOR",[45,49],{"name":41,"role":46,"phone":47,"phoneExt":27,"email":48},"CONTACT","+66926486322","Lorenz@tropmedres.ac",{"name":50,"role":46,"phone":51,"phoneExt":27,"email":52},"Rupam Tripura","+8801572288558","Rupam@tropmedres.ac",[54,72],{"facility":55,"status":56,"city":57,"state":27,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Alikadam Upazila Health Complex","RECRUITING","Bāndarban","4650","Bangladesh","BD",{"type":62,"coordinates":63},"Point",[64,65],92.21946,22.19534,{"lat":65,"lon":64},[68],{"name":69,"role":46,"phone":70,"phoneExt":27,"email":71},"Mohammad Abul Faiz","+008801613008857","drmafaiz@gmail.com",{"facility":73,"status":56,"city":74,"state":27,"zip":75,"country":59,"countryCode":60,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Lama Upazila Health Complex","Lāma","4641",{"type":62,"coordinates":77},[78,79],92.21907,21.77439,{"lat":79,"lon":78},[82],{"name":69,"role":46,"phone":70,"phoneExt":27,"email":71},{"type":84,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100521356","phase-4-mass-vaccine-and-drug-administration-bangladesh-100521356",false,"NCT06068530","Mass Vaccine and Drug Administration, Bangladesh","A Cluster-randomised, Open-label Trial to Compare the Impact of Combined Mass Vaccine and Drug Administrations, Mass Drug Administration, Mass Vaccinations, or no Intervention on Plasmodium Falciparum Malaria Transmission","MVDA","Inclusion Criteria:\n\n* Current residence in a study village irrespective of permanence\n* Age 6 months and above (no upper age limit)\n* Written informed consent provided by participants (or a parent\u002Fguardian in case the participant is under 18 years old)\n\nExclusion Criteria:\n\n* Pregnancy, plan to get pregnant, or breastfeeding.\n* Acute illness requiring intervention\n* A history of an adverse reaction to study drugs\u002Fvaccine and prior receipt of any other malaria vaccine or enrolment in another intervention trial.","ALL","6 Months",{"count":96,"type":97},10000,"ESTIMATED","INTERVENTIONAL",[100],"PHASE4","This is an open i.e. not blinded, cluster-randomised, controlled intervention study. The study will use a factorial design to estimate the protective effectiveness of mass drug administrations, mass vaccinations, combined mass vaccinations and drug administrations versus the current standard of care.",[103],"Plasmodium Falciparum Malaria",[103,105,106],"Malaria Vaccine","Malaria Drug Administrations","2025-12-11",{"date":109,"type":110},"2025-12-18","ACTUAL",{"date":112,"type":110},"2025-02-15",{"date":114,"type":97},"2028-02-01",{"name":5,"class":6},2]