[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"malaria-vaccines\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:malaria-vaccines":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100583669","phase-2-infant-malaria-vaccine-schedule-optimization-100583669",false,"NCT06879327","Infant Malaria Vaccine Schedule Optimization","A Phase 2b Multicenter Randomized, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of R21\u002FMatrix-M Malaria Vaccine in African Infants With Different Immunization Schedules","Inclusion Criteria:\n\n* Signed informed consent or thumb-printed and witnessed informed consent obtained from the parent\u002Flegal guardian of the infant.\n* Infants must have been born full-term (at ≥37 weeks of gestation) and \\> 2500 grams at birth.\n* Immunization schedule Cohorts 1, 2, and 3: Male and female infants 42-49 days (inclusive) of age at time of enrollment.\n* Prior to group randomization, for infants in Cohort 1 randomization to receive vaccine dose 1 (Groups 1 and 2 of R21\u002FMM or placebo, respectively) will occur at 42-49 days of age. Infants in Cohorts 2 and 3 will not be randomized to R21\u002FMM or placebo; placebo will no longer be given. Rather infants in these cohorts will receive open-label R21\u002FMM according to the immunization schedule category to which they have been randomized. Infants in Cohort 2, will receive their open-label R21\u002FMM vaccine dose 1 (Group 3) at 2 months (56-63 days of age). Infants in Cohort 3, will receive their open-label R21\u002FMM vaccine dose 1 (Group 5) at 3 months (84-91 days of age).\n* The participant's parent\u002Fguardian must be willing to avoid travel, particularly in the 28 days after each study vaccination, must confirm willingness to contact the study team in the event of unexpected\u002Funavoidable travel and, for the safety cohort, must confirm availability for the home visits to be conducted by a field worker or nurse to collect solicited AEs over the 7 days (day of vaccination and 6 subsequent days) following each study vaccine.\n* The participant's parent\u002Fguardian must confirm willingness to bring their child to the study clinic \u002F local health care clinic, and capacity to contact the study team in the event the subject has any illnesses or other health concerns during the study.\n* Participants who the investigator believes that their parent\u002Fguardian can and will comply with the requirements of the protocol (e.g. return for follow-up visits) may be enrolled in the study.\n\nExclusion Criteria:\n\n• Acute disease at the time of enrolment (acute disease is defined as the presence of a moderate or severe illness with or without fever). This does not include minor illnesses such as diarrhea, mild upper respiratory infection, without low-grade febrile illness, i.e. axillary temperature \\\u003C 37.5°C or tympanic temperature \\\u003C 38°C.\n\n(Note: In case of acute disease, participants may be re-assessed by a study physician for resolution of the condition and enrolled if eligible and still within the visit window).\n\n* Clinically significant pulmonary, cardiovascular, gastrointestinal, endocrine, neurological, skin, hepatic or renal functional abnormality, as determined by medical history, physical examination or laboratory tests which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial.\n* At time of enrollment, any infant who has received any dose of the hexavalent\u002Fpentavalent vaccines, pneumococcal vaccine, rotavirus vaccine, IPV or has received more than one dose of oral polio virus or more than one dose of hepatitis B vaccine.\n* Weight-for-length\u002Fheight Z score of less than -3 or other clinical signs of malnutrition.\n* Infant with major congenital defects.\n* The infant has anaemia associated with clinical signs of symptoms of decompensation, or a haemoglobin of ≤ 5.0 g\u002FdL.\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.\n* Any confirmed or suspected immunosuppressive or immunodeficient state (including HIV or asplenia) or known maternal HIV infection (no HIV testing will be routinely done by the study team).\n* Administration of immunoglobulins and\u002For any blood products\u002Fblood transfusion from birth to time of planned administration of the vaccine candidate.\n* Previous vaccination of participant or biological mother with a malaria vaccine.\n* Participation in another research study involving receipt of an investigational product or planned use during the study period.\n* Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.",true,"ALL","42 Days","49 Days",{"count":21,"type":22},964,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The aim of this study is to identify an optimal infant vaccine schedule for a malaria vaccine which is better aligned with the timing of other vaccine interventions.",[28],"Malaria Vaccines",[30,31],"Plasmodium falciparum","R21\u002FMatrix-M Malaria Vaccine","RECRUITING","2026-05-13",{"date":35,"type":36},"2026-05-15","ACTUAL",{"date":38,"type":36},"2025-05-30",{"date":40,"type":22},"2027-09-27",{"name":42,"class":43},"PATH","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":16,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100595929","phase-4-comparison-of-two-strategies-for-administering-the-r21-matrix-m-vaccine-in-a-context-of-seasonal-malaria-transmission-in-chad-100595929","NCT07038837","Comparison of Two Strategies for Administering the R21-Matrix M Vaccine in a Context of Seasonal Malaria Transmission in Chad","Cluster Randomised Non-inferiority Trial Comparing Malaria Incidence When Implementing R21\u002FMatrix-M Synchronized With Seasonal Malaria Chemoprevention Distribution Versus R21\u002FMatrix-M Given Routinely Through the EPI in Two Health Districts in Chad (CoSAV-R21)","COSAV-R21","Inclusion Criteria:\n\n* • Routine arm\n\n  1. Aged 6 to 11 months at the time of the first R21\u002FMM vaccination (dose 1).\n  2. Residing in a village participating in the study and randomized to the routine arm.\n  3. Oral consent provided by the child's parent\u002Fguardian.\n\n     * Synchronised arm\n\n  \u003C!-- -->\n\n  1. Aged 6 to 59 months at the time of the first R21\u002FMM vaccination (dose 1) during the first 3 rounds of SMC (2025).\n  2. Residing in a village participating in the study and randomized to the synchronized arm.\n  3. Oral consent provided by the child's parent\u002Fguardian.\n\nExclusion Criteria:\n\n* Exclusion criteria for both arms according to Chad national EPI guidelines\n\nMalaria vaccine is not recommended for children with known severe hypersensitivity:\n\n* To a previous dose of a malaria vaccine\n* To a previous dose of hepatitis B vaccine\n* One of the components of the R21\u002FMM vaccine\n\nMild illness - including respiratory tract infections, mild diarrhoea and fever below 38.5° C - is not a contraindication to R21\u002FMM vaccination. Malnutrition and being HIV-seropositive are also not contraindications to R21\u002FMM vaccination.","6 Months","59 Months",{"count":55,"type":22},70000,[57],"PHASE4","This is a two-arm, cluster-randomised, phase IV trial conducted in Chad to assess the protective efficacy and impact in real-life conditions of a new strategy for administering the R21\u002FMM malaria vaccine, synchronized within a seasonal malaria chemoprevention (SMC) campaign, among children living in areas of high seasonal malaria transmission.\n\nIn this study, a cluster is defined as the catchment area of a primary care health centre. In Chad, each catchment area is known as a 'zone of responsibility' (French: Zone de Responsibilité' \\[ZR\\]).\n\nTwenty-six (26) of the total 27 ZRs in the districts of Moïssala and Dembo will be randomized in a 1:1 ratio to receive a 4-dose (3 primary doses + 1 booster) R21\u002FMM schedule either (1) integrated into the routine EPI vaccination program (the \"Routine\" control arm), or (2) synchronized with an annual seasonal malaria chemoprevention (SMC) campaign (the \"Synchronized\" intervention arm).\n\nMalaria incidence: R21\u002FMM effectiveness will be assessed using the incidence of biologically confirmed clinical malaria (trial primary endpoint). The incidence of clinical malaria will be determined through enhanced surveillance of malaria cases in health centres and hospitals over a 17-month period (August 2025 - December 2026).\n\nCoverage surveys: Cross-sectional surveys (cluster sampling) will be carried out to measure R21\u002FMM vaccine coverage, SMC coverage, coverage of other malaria prevention measures, and coverage of other EPI vaccines.\n\nNested case-control study: A sub-sample of children admitted to Moïssala District Hospital with severe clinical malaria will be offered the opportunity to participate in a nested case-control study designed to estimate the individual protective efficacy of R21\u002FMM against severe malaria.\n\nAditionnaly, the INTEGREVAC ancillary study's objective is to evaluate the cost-effectiveness, acceptability and feasibility of the synchronised vaccination strategy in the context of the ongoing COSAV-R21 trial, to inform policy decisions for the effective deployment of malaria vaccines in SMC implementation areas.\n\nMethodology and planned work:\n\n(i) A qualitative study using in-depth interviews (IDIs) and group discussions with key stakeholders at the national, health facility, and community levels, including caregivers of children eligible for vaccination, in Chad, at several points during the trial. We will explore stakeholders' and beneficiaries' perceptions and experiences of the synchronised SMC vaccination strategy (trial intervention arm) compared to age-based vaccine administration under the routine immunisation programme (trial control arm), as well as considerations for implementing these strategies. Interviews with healthcare providers, including those administering R21 and SMC, and community members will assess the feasibility of implementing the integrated vaccination strategy via SMC.\n\n(ii) An economic evaluation including a cost-effectiveness analysis and a nested equity analysis will be conducted. The economic evaluation will include a cost analysis to carefully identify and measure the additional costs associated with adding malaria vaccination to the EPI delivery platform and, separately, to the SMC delivery channel. Analysis of key cost drivers will enable us to identify potential efficiency savings, provide evidence for country funding requests (e.g., to GAVI and the Global Fund) and for the malaria vaccine strategy budgeting\u002Fplanning process. Cost-effectiveness and equity analyses of each vaccine delivery strategy will provide evidence to help national programmes plan future malaria vaccine delivery and inform global guidance and on methods of delivering these vaccines, while providing valuable evidence on the real-world cost-effectiveness of malaria vaccination.\n\n(iii) Impact modelling will estimate the costs, impact, and cost-effectiveness of scaling up the intervention approach to the whole of Chad, under different temporal and spatial scenarios.",[60,28],"Malaria Infection",[62,63,64,65,66,67,68,69,70,71,72,73,74,75],"Vaccine","Malaria","Implementation strategy","Children","Pediatric","synchronized","coverage","prevention","incidence","prevalence","qualitative","mixed methods","cost effectiveness","Seasonal Malaria Chemoprevention","2026-04-10",{"date":78,"type":36},"2026-04-15",{"date":80,"type":36},"2025-06-16",{"date":82,"type":22},"2028-06",{"name":84,"class":43},"Epicentre",1]