[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Serum Institute of India Pvt. Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":98},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,71],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":24,"studyType":25,"phases":4,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100622094","evaluation-of-the-antibody-persistence-beyond-five-years-after-immunization-with-menfivetm-nmcv-5-a-pentavalent-meningococcal-acywx-conjugate-vaccine-100622094",false,"NCT07379151","Evaluation of the Antibody Persistence Beyond Five Years After Immunization With MenFiveTM (NmCV-5), a Pentavalent Meningococcal ACYWX Conjugate Vaccine","Evaluation of the Antibody Persistence in African Participants Beyond Five Years After Immunization With MenFiveTM (NmCV-5), a Pentavalent Meningococcal ACYWX Conjugate Vaccine","PERS-ACYWX-03","Inclusion Criteria:\n\n* Written informed consent and assent (if applicable)\n\nExclusion Criteria:\n\n* Current or previous, confirmed disease caused by Neisseria meningitidis at any given time since meningococcal vaccination\n* Any condition or criteria that in the opinion of the investigator might compromise the well-being of the participant or the compliance with study procedures or interfere with the outcome of the study",true,"ALL","7 Years","36 Years",{"count":22,"type":23},450,"ESTIMATED","1 Day","OBSERVATIONAL","This study will measure immune persistence of the NmCV-5 more than 5 years after a single dose vaccination in participants 2-29 years of age in Mali and The Gambia.",[28],"Meningoccocal Disease",[30,31],"Seropersistence","Meningococcal","RECRUITING","2026-05-29",{"date":35,"type":36},"2026-06-03","ACTUAL",{"date":38,"type":36},"2026-05-05",{"date":40,"type":23},"2026-12",{"name":42,"class":43},"Serum Institute of India Pvt. Ltd.","INDUSTRY",2,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":17,"sex":18,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100604275","phase-2-pfs230d1--r21-in-matrix-m1-in-african-school-children-and-adults-100604275","NCT07147400","Pfs230D1 + R21 in Matrix-M1 in African School Children and Adults","Phase 2 Randomized, Double-blind, Controlled Study of Pfs230D1-CRM197 With R21 in Matrix-M1 in Healthy African School Children and Adults","Inclusion Criteria:\n\n1. Age:\\>\u002F= 9 years old and \\\u003C\u002F= 50 years old.\n2. Provides written informed consent if \\>\u002F=18 years of age.\n3. Provides written informed consent of parent\u002Fguardian if \\\u003C18 years of age, with additional participant written assent obtained from children \\> 12 years of age.\n4. Known resident or long-term resident (more than 1 year) of trial site or surrounding villages.\n5. Available for the duration of the trial.\n6. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.\n7. In good general health and without clinically significant medical history in the opinion of the investigator.\n8. Permission for long term storage of blood samples.\n\n   • Note: If a participant withdraws consent or at the time of study completion or end of participation wishes to withdraw permission for long term storage of blood samples, this can be requested, and sample destruction will be documented.\n9. Females of reproductive potential aged 12 years and above who have attained menarche and are sexually active must be willing to use reliable contraception from 21 days prior to Study Day 1 and 21 days prior to Study Day 392 (booster dose) and until 1 month after the last vaccination in primary series and after booster dose.\n\n   * A reliable method of birth control includes one of the following:\n\n     * Confirmed pharmacologic contraceptives (parenteral) delivery.\n     * Intrauterine or implantable device.\n     * Barrier methods.\n\nEXCLUSION CRITERIA:\n\n1. Pregnant and breastfeeding females. Pregnant, as determined by a positive urine or serum beta human choriogonadotropin (βhCG) test.\n\n   NOTE: Pregnancy is also a criterion for discontinuation of any further vaccine dosing\n2. Menstruating females less than 12 years of age. (In order to avoid cultural implications of further assessing pregnancy potential i.e. sexual activity in this age group).\n\n   NOTE: If a female less than 12 years of age starts menarche while on study it will not be exclusionary for them to continue participation, but will undergo pregnancy testing prior to each vaccination.\n3. Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and comply with the study protocol at a level appropriate for the participant's age.\n4. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and\u002For laboratory studies including urinalysis.\n5. Current or planned participation in an investigational product study until the time period of the last required study visit under this protocol.\n6. Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.\n7. History of a severe allergic reaction or anaphylaxis.\n8. Known:\n\n   * Severe asthma, defined as asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past 2 years, or that has required the use of oral or parenteral corticosteroids at any time during the past 2 years.\n   * Autoimmune or antibody-mediated disease including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, or autoimmune thrombocytopenia.\n   * Immunodeficiency.\n   * Seizure disorder (exception: history of simple febrile seizures).\n   * Asplenia or functional asplenia.\n   * Use of chronic (≥14 days) oral or intravenous (IV) corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone \\>10 mg\u002Fday) or immunosuppressive drugs within 30 days of enrollment.\n   * Hypersensitivity reaction to rabies vaccine in the past.\n9. Receipt of:\n\n   * Live vaccine within 4 weeks prior to enrollment or a killed vaccine within 2 weeks prior to enrollment.\n   * Immunoglobulins and\u002For blood products within the past 3 months.\n   * Any malaria vaccine in the past.\n   * Any investigational product in the last 6 months\n10. Any other condition that in the opinion of the investigator might jeopardize the safety or rights of a participant participating in the trial, interfere with the evaluation of the study objectives, or might render the participant unable to comply with the protocol.","9 Years","50 Years",{"count":55,"type":23},1200,"INTERVENTIONAL",[58],"PHASE2","This is a Phase 2, randomized, double-blind, controlled study designed to evaluate the safety, tolerability, immunogenicity, vaccine efficacy, and functional activity of Pfs230D1-CRM197 conjugate vaccine with R21 nanoparticle vaccine formulated on Matrix-M1. Participants (9-50 years of age) will be drawn from Bancoumana, Mali and the surrounding areas.",[61],"Prevention of Malaria Transmission and Clinical Malaria","2025-11-16",{"date":64,"type":36},"2025-11-19",{"date":66,"type":36},"2025-08-22",{"date":68,"type":23},"2027-11",{"name":42,"class":43},1,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":17,"sex":18,"minAge":78,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100593700","an-observational-study-to-assess-effectiveness-and-safety-of-the-r21matrix-m-malaria-vaccine-100593700","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.","5 Months",{"count":80,"type":23},2308,"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.",[83,84],"Malaria,Falciparum","Morality",[86,87,88],"clinical malaria","severe malaria","death (all cause)","2025-08-12",{"date":91,"type":36},"2025-08-13",{"date":93,"type":36},"2025-06-16",{"date":95,"type":23},"2026-12-31",{"name":42,"class":43},5,""]