[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593700":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":10,"centralContacts":34,"locations":44,"responsibleParty":120,"collaborators":10,"id":122,"slug":123,"hasResults":124,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":10,"eligibilityCriteria":128,"healthyVolunteers":129,"sex":130,"minAge":131,"maxAge":10,"enrollmentInfo":132,"targetDuration":10,"studyType":135,"phases":10,"briefSummary":136,"conditions":137,"keywords":140,"overallStatus":47,"whyStopped":10,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"Serum Institute of India Pvt. Ltd.","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Case control study of Clinical malaria",null,"Clinical Malaria case definition: Presence of axillary temperature ≥ 37.5°C and\u002F or history of fever within the last 48 hours before the diagnosis is made AND P. falciparum asexual parasitaemia \\>5000 parasites\u002FμL detected by microscopy.\n\nThis is a case-control study to assess the effectiveness of the R21\u002FMatrix-M Vaccine against clinical malaria in children aged ≥ 5 months of age.\n\nSurveillance and detection of cases: Cases qualifying the case definitions of clinical, cases will be recruited from the hospitals, clinics or the sub-sites as per the respective case definitions. The required laboratory investigations will be conducted if not already done to ensure the child meets the respective case definition example: e.g. microscopy with parasite density will be conducted in the suspected cases of clinical malaria.\n\nFor clinical malaria cases in high-transmission perennial areas, the ratio of case: control will be 1:1. Controls will be matched for age and neighborhood.",[13],"Other: Case control study of clinical malaria",{"label":15,"type":10,"description":16,"interventionNames":17},"Case control study of Severe malaria","Severe Malaria case definition: Presence of P. falciparum parasitaemia detected by microscopy AND one or more of the disease severity criteria.\n\nThis is a case-control study to assess the effectiveness of the R21\u002FMatrix-M Vaccine against severe malaria in children aged ≥ 5 months of age. Surveillance and detection of cases: Cases qualifying the case definitions of severe malaria, cases will be recruited from the hospitals, clinics or the sub-sites as per the respective case definitions. The required laboratory investigations will be conducted if not already done to ensure the child meets the respective case definition. For severe malaria cases, the ratio of case: control will be 1:4. Controls will be matched for age and neighborhood.",[18],"Other: Case control study of severe malaria",{"label":20,"type":10,"description":21,"interventionNames":22},"Case control study of death (all cause)","Death (all-cause) case definition: Children who died, of any cause excluding trauma or elective surgery, who were eligible to have received the R21\u002FMatrix-M vaccine based on their date of birth.\n\nThis is a case-control study to assess if the R21 vaccine recipients are at an increased risk due to (all cause) mortality in children aged ≥ 5 months of age. Surveillance and detection of cases: For deaths, cases will be recruited from the hospital or the community (house visits). Cause of death can be ascertained from hospital or available medical records as well as discussions with family or healthcare professionals who may have been involved. For death (all cause) cases, the ratio of case: control will be 1:4. living controls will be enrolled and matched for age and neighborhood.",[23],"Other: Case control study of death (all cause)",[25,29,32],{"type":26,"name":27,"description":27,"armGroupLabels":28,"otherNames":10},"OTHER","Case control study of clinical malaria",[9],{"type":26,"name":30,"description":30,"armGroupLabels":31,"otherNames":10},"Case control study of severe malaria",[15],{"type":26,"name":20,"description":20,"armGroupLabels":33,"otherNames":10},[20],[35,40],{"name":36,"role":37,"phone":38,"phoneExt":10,"email":39},"Dr. Prasad Kulkarni, MD, FRCP","CONTACT","+91-20-7194-6820","drpsk@seruminstitute.com",{"name":41,"role":37,"phone":42,"phoneExt":10,"email":43},"Dr. Sandesh M Bharati, MD","+91- 20-7194-6825","sandesh.bharati@seruminstitute.com",[45,62,76,92,107],{"facility":46,"status":47,"city":48,"state":49,"zip":10,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Unité de Recherche Clinique de Nanoro (URCN), Institut de Recherche en Sciences de la Santé, Direction Régionale du Centre-Ouest (IRSS-DRCO), Bousse","RECRUITING","Bousse","Burkina Faso","BF",{"type":52,"coordinates":53},"Point",[54,55],-1.89515,12.66121,{"lat":55,"lon":54},[58],{"name":59,"role":37,"phone":60,"phoneExt":10,"email":61},"Prof Halidou Tinto","+226 70346354","halidoutinto@gmail.com",{"facility":63,"status":47,"city":64,"state":10,"zip":10,"country":65,"countryCode":10,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Centre de Recherche et de Lutte contre le Paludisme Institut National de Santé Publique, boulevard Nangui Abrogoua près État Major des Armées","Toumodi","Côte d’Ivoire",{"type":52,"coordinates":67},[68,69],-5.01769,6.55799,{"lat":69,"lon":68},[72],{"name":73,"role":37,"phone":74,"phoneExt":10,"email":75},"Prof William Yavo","+225 05 05 17 53 53","yavowilliam@yahoo.fr",{"facility":77,"status":47,"city":78,"state":79,"zip":10,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"University of Ilorin Department of Pediatrics University of Ilorin Teaching Hospital, Ilorin, Nigeria","Yenagoa","Bayesla","Nigeria","NG",{"type":52,"coordinates":83},[84,85],6.26764,4.92675,{"lat":85,"lon":84},[88],{"name":89,"role":37,"phone":90,"phoneExt":10,"email":91},"Prof Olugbenga Mokuolu","+234-803-713-7407","mokuolu@unilorin.edu.ng",{"facility":93,"status":47,"city":94,"state":95,"zip":10,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Infectious Diseases Research Collaboration (IDRC), Uganda","Busia","Uganda","UG",{"type":52,"coordinates":98},[99,100],34.09221,0.46588,{"lat":100,"lon":99},[103],{"name":104,"role":37,"phone":105,"phoneExt":10,"email":106},"Prof. Moses Kamya, MD","+256-414-530020","mkamya@irdc-uganda.org",{"facility":108,"status":47,"city":109,"state":10,"zip":10,"country":95,"countryCode":96,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Makerere University College of Health Sciences","Mukono",{"type":52,"coordinates":111},[112,113],32.75528,0.35333,{"lat":113,"lon":112},[116],{"name":117,"role":37,"phone":118,"phoneExt":10,"email":119},"Dr Victoria Nankabirwa","+256-755-757-460","vnankabirwa@musph.ac.ug",{"type":121,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100593700","an-observational-study-to-assess-effectiveness-and-safety-of-the-r21matrix-m-malaria-vaccine-100593700",false,"NCT07009847","An Observational Study to Assess Effectiveness and Safety of The R21\u002FMatrix-M Malaria Vaccine","A Case Control Study to Assess Effectiveness and Safety of The R21\u002FMatrix-M Malaria Vaccine","Inclusion Criteria:\n\nFor Cases- A male or female child eligible to have received R21\u002FMatrix-M Vaccine based on age. 2 Parent\u002Flegal guardian\u002F caregiver of the child willing to provide the written informed consent for their child's participation in the study.\n\n3 Parent\u002Flegal guardian\u002F caregiver willing to comply with the study requirements and share or allow access to the data regarding the vaccination status and medical records with the study personnel.\n\n4 Resident of the R21\u002FMatrix-M vaccine implementation area and brought to the study hospital \u002Fclinic or sub-site with clinical complaints. 5 Child meeting the respective case definition (Severe Malaria, Clinical Malaria or Death due to any cause).\n\nFor Controls- A male or female child eligible to have received R21\u002FMatrix-M Vaccine based on age. The matched control should have a date of birth within 60 days of that of the case.\n\n2\\. Parent\u002Flegal guardian\u002F caregiver of the child willing to provide the informed consent for their child's participation in the study.\n\n3\\. Parent\u002F legal guardian\u002F caregiver willing to comply with the study requirements and share or allow access to the data regarding the vaccination status and medical records with the study personnel 4. Resident of the R21\u002FMatrix-M vaccine implementation area and who would have sought treatment at the same hospital if they had developed symptoms. Resident will be defined as child and\u002For child's parents\u002F guardian\u002Fcaregiver eating and sleeping in a household in the location for most days of the week from past 6 months. The matched control should be residing in the same neighborhood as the respective case, but not from the same household.\n\nExclusion Criteria:\n\nFor Cases-\n\n1. Parent\u002Flegal guardian\u002F caregiver not consenting to let the child participate or not permitting to access the data related to vaccination or other medical records.\n2. Child not meeting the respective case definition (Severe Malaria, Clinical Malaria or Death due to any cause).\n3. Received one or more doses of RTS,S\u002FAS01 vaccine in the past.\n\nFor Controls-\n\n1. Parent\u002Flegal guardian\u002F caregiver not consenting to let the child participate or not permitting to access the data related to vaccination or other medical records.\n2. Child meeting any of the case definitions (Severe Malaria, Clinical Malaria).\n3. Child having history suggestive of clinical malaria in past 30 days (applicable for clinical malaria and severe malaria case-control studies only).\n4. Received one or more doses of RTS,S\u002FAS01 vaccine\u002Fs in the past.",true,"ALL","5 Months",{"count":133,"type":134},2308,"ESTIMATED","OBSERVATIONAL","This is an observational case-control study to assess the effectiveness of the R21\u002FMatrix-M vaccine against severe malaria, clinical malaria (in high transmission perennial areas), and to assess if the R21 vaccine recipients are at an increased risk of deaths (all-cause). Clinical malaria, severe malaria and death (all-cause) cases will be enrolled in study. For each case (severe or death) 4 controls matched for age and neighborhood will be enrolled whereas for clinical malaria case, 1 matched control will be enrolled.\n\n1. Proportion of vaccinated and unvaccinated children amongst Severe Malaria Cases caused by P. falciparum.\n2. Proportion of vaccinated and unvaccinated children amongst Clinical Malaria Cases in high-transmission perennial areas caused by P. falciparum.\n3. Proportion of vaccinated and unvaccinated children in cases of death (all cause)\n4. Exploratory effectiveness endpoint: Proportion of vaccinated and unvaccinated children in the hospitalized clinical and severe malaria cases.",[138,139],"Malaria,Falciparum","Morality",[141,142,143],"clinical malaria","severe malaria","death (all cause)","2025-08-12",{"date":146,"type":147},"2025-08-13","ACTUAL",{"date":149,"type":147},"2025-06-16",{"date":151,"type":134},"2026-12-31",{"name":5,"class":6},5]