[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578909":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":28,"locations":37,"responsibleParty":49,"collaborators":53,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":11,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":87,"overallStatus":95,"whyStopped":11,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Menzies School of Health Research","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Arm: Pneumosil","EXPERIMENTAL",null,[13],"Biological: Pneumococcal conjugate vaccine",{"label":15,"type":6,"description":11,"interventionNames":16},"Control Arm: Typbar TCV",[17],"Biological: Typhoid conjugate vaccine",[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"BIOLOGICAL","Pneumococcal conjugate vaccine","10-valent pneumococcal polysaccharide conjugate vaccine at a dosage of 2μg for each serotype polysaccharide for 1, 5, 6A, 7F, 9V, 14, 19A, 19F, 23F, and 4μg for serotype 6B, conjugated to a carrier protein (CRM197), polysorbate 20 and aluminium phosphate as an adjuvant. Administered as an intramuscular injection of 0.5mL.",[9],{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Typhoid conjugate vaccine","Typhoid conjugate vaccine at a dosage of 25μg purified Vi capsular polysaccharide of Salmonella typhi Ty2 conjugated to Tetanus Toxoid with preservative (2-Phenoxyethanol). Administered as an intramuscular injection of 0.5mL.",[15],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Nicholas S. S. Fancourt, PhD","CONTACT","+61889468600","nick.fancourt@menzies.edu.au",{"name":35,"role":31,"phone":32,"phoneExt":11,"email":36},"Jane N Nelson, Bachelor of Nursing","jane.nelson@menzies.edu.au",[38],{"facility":39,"status":11,"city":40,"state":41,"zip":11,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":11},"Guido Valadares National Hospital (HNGV)","Dili","Timor-Leste","TL",{"type":44,"coordinates":45},"Point",[46,47],125.57361,-8.55861,{"lat":47,"lon":46},{"type":50,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Nick Fancourt","Senior Research Fellow",[54,56,58,60],{"name":55,"class":6},"Murdoch Childrens Research Institute",{"name":57,"class":6},"The University of Western Australia",{"name":59,"class":6},"University of Edinburgh",{"name":61,"class":62},"Timor-Leste Ministry of Health","UNKNOWN","100578909","phase-4-opportunistic-pneumococcal-immunisation-trial-in-malnutrition-100578909",false,"NCT06817421","Opportunistic Pneumococcal Immunisation Trial in MALnutrition","Immunogenicity of Opportunistic Pneumococcal Conjugate Vaccination (Pneumosil®) Versus Control (Typhoid Conjugate Vaccine, Typbar TCV®) in Children Aged 6-59 Months Hospitalised With Severe Acute Malnutrition: a Single-centre, Double-blind, Randomised Controlled Trial in Timor-Leste","OPTIMAL","Inclusion Criteria:\n\n1. Aged 6-59 months at the time of hospitalisation\n2. Hospitalised with severe acute malnutrition (SAM, defined as any one of a, b, or c):\n\n   1. weight-for-length\u002Fheight z-score \\\u003C-3; or\n   2. middle upper arm circumference \\\u003C11.5cm; or\n   3. bilateral pitting pedal oedema unexplained by other causes\n3. Parent\u002Fcarer is willing for their child to participate in the study and has provided written informed consent\n4. Parent\u002Fcarer is willing to comply with all study procedures outlined in the protocol, including specimen collection, for the duration of the study\n\nExclusion Criteria:\n\n1. Known history of allergy or hypersensitivity to any component of either study vaccine, including diphtheria toxoid, or a history of anaphylactic shock.\n2. Treatment with another investigational drug or other intervention in the 30 days prior to randomisation, or ongoing participation in another clinical trial.\n3. Suspected primary or secondary immunodeficiency or prolonged administration (\\>14 days) of an immune modifying drug (including oral glucocorticoids) in the past 3 months.\n4. Known terminal illness expected to result in death within 6 months.\n5. Participants who, in the opinion of the site Principal Investigator, are unable to comply with the study protocol, including scheduled visits, assessments, and any other protocol-required procedures.\n6. Previously enrolled in this trial.","ALL","6 Months","59 Months",{"count":75,"type":76},214,"ESTIMATED","INTERVENTIONAL",[79],"PHASE4","The goal of the OPTIMAL clinical trial is to learn if a dose of a pneumococcal conjugate vaccine (PCV) generates a good immune response in young children who are in hospital with severe acute malnutrition.\n\nResearchers will compare an intervention group who get a dose of a PCV (Pneumosil) to a control group who get a dose of a Typhoid conjugate vaccine (Typbar TCV). To ensure all participants receive timely potential benefits, at 3 months participants in the intervention group with receive a dose of Typbar TCV, and those in the conrol group will receive a dose of Pneumosil.\n\nParticipants will be visited 4 times at their homes over six months after vaccination, with a phone review at 12 months after vaccination.",[82,83,84,85,86],"Severe Acute Malnutrition in Childhood","Pneumococcal Disease","Pneumococcal Vaccines","Pneumococcal Infection","Pneumonia in Children",[88,89,90,91,92,93,94],"Pneumococcal","Severe Acute Malnutrition in childhood","Pneumococcal vaccine","Pneumosil","Pneumococcal disease","Pneumococcal infection","Pneumonia","NOT_YET_RECRUITING","2025-12-10",{"date":98,"type":99},"2025-12-18","ACTUAL",{"date":101,"type":76},"2026-01",{"date":103,"type":76},"2029-02",{"name":51,"class":6},1]