[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100578909":3},{"organization":4,"outcomesModule":7,"designInfo":56,"detailedDescription":68,"studyPopulation":55,"armGroups":69,"interventions":79,"overallOfficials":55,"centralContacts":89,"locations":98,"responsibleParty":110,"collaborators":114,"id":124,"slug":125,"hasResults":126,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":126,"sex":132,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":55,"studyType":138,"phases":139,"briefSummary":141,"conditions":142,"keywords":148,"overallStatus":156,"whyStopped":55,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},{"fullName":5,"class":6},"Menzies School of Health Research","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":55},[9],{"measure":10,"description":11,"timeFrame":12},"Serotype-specific immunoglobulin G (IgG) antibodies","Pneumosil serotype-specific (1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F, 23F) immunoglobulin G (IgG) geometric mean concentrations (GMCs).","4 weeks after vaccination",[14,18,21,24,26,29,32,36,40,44,48,51],{"measure":15,"description":16,"timeFrame":17},"Serotype-specific IgG antibodies","Pneumosil serotype-specific IgG GMCs","4 weeks and 3 months after vaccination",{"measure":19,"description":20,"timeFrame":17},"Proportion of participants with serotype-specific IgG antibody responses ≥ 0.35 μg\u002FmL","Proportion of participants with Pneumosil serotype-specific IgG concentrations ≥ 0.35μg\u002FmL",{"measure":22,"description":23,"timeFrame":17},"Functional antibody responses","Pneumosil serotype-specific pneumococcal geometric mean opsonisation indices (GMOIs)",{"measure":22,"description":25,"timeFrame":17},"Proportion of participants with Pneumosil serotye-specfiic pneumococcal opsonisation indices (OIs) \\>8",{"measure":27,"description":28,"timeFrame":17},"Salivary IgG antibodies","Serotype-specific salivary IgG (μg\u002Fml) for Pneumosil serotypes and non-vaccine types 3, 4, 11A, and 18C",{"measure":30,"description":31,"timeFrame":17},"Salivary immunoglobulin A (IgA) antibodies","Serotype-specific salivary IgA (μg\u002Fml) for Pneumosil serotypes and non-vaccine types 3, 4, 11A, and 18C",{"measure":33,"description":34,"timeFrame":35},"Nasopharyngeal carriage of pneumococcus","Proportion of participants with nasopharyngeal carriage of Pneumosil vaccine-type pneumococci and their antimicrobial resistance patterns","3 months after vaccination",{"measure":37,"description":38,"timeFrame":39},"Severe acute malnutrition recovery","Weight-for-height\u002Flength z-score \\>= -2 or MUAC \\>12.5cm","Reviewed at all study visits until completion (12 months after vaccination)",{"measure":41,"description":42,"timeFrame":43},"Re-hospitalisation","Any repeat admission to hospital as confirmed by medical records","3 months and 12 months after vaccination",{"measure":45,"description":46,"timeFrame":47},"Mortality","Deaths as reported. Cause of death determined from review of medial records.","3 and 12 months after vaccination",{"measure":49,"description":50,"timeFrame":39},"Composite illness or mortality","Repeat hospitalisation(s) or death.",{"measure":52,"description":53,"timeFrame":54},"Salmonella Typhi antibodies","Proportion of paticipants with \\>4 fold rise (compared to pre-vaccination) of Salmonella Typhi anti-Vi IgG geometric mean titres (GMTs)","4 weeks and 3 months after vaccination for all participants, plus 4 months and 6 months after vaccination for participants in the control arm",null,{"allocation":57,"interventionModel":58,"interventionModelDescription":59,"primaryPurpose":60,"observationalModel":55,"timePerspective":55,"maskingInfo":61},"RANDOMIZED","PARALLEL","A prospective, single-centre, double-blind, phase 4, randomised, controlled trial in children aged 6-59 months hospitalised with severe acute malnutrition.","PREVENTION",{"masking":62,"maskingDescription":55,"whoMasked":63},"QUADRUPLE",[64,65,66,67],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","This is a prospective, single-centre, double-blind, randomised controlled trial in 264 children aged 6-59 months hospitalised with severe acute malnutrition.\n\nParticipants will be randomised (1:1) to receive either a dose of a pneumococcal conjugate vaccine (Pneumosil, the intervention group) or a dose of a Typhoid conjugate vaccine (Typbar TCV, the control group). Stratification for randomisation will be done on (a) prior immunisation with a PCV (confirmed or unknown\u002Funvaccinated); and (b) severity of malnurition (weight-for-height\u002Flength z-score \\\u003C-4 or \\>=-4). Participants will be enrolled as soon as practical after admission to hospital, while randomisation and vaccine administration will occur once the participant is medically stable in the 'transition phase' of SAM care.\n\nThe primary objective is to demonstrate that immune responses to the 10 pneumococcal serotypes in Pneumosil are better in participants who receive Pneumosil, compared to those who receive Typbar TCV, when measured 28 days after vaccination.",[70,75],{"label":71,"type":72,"description":55,"interventionNames":73},"Treatment Arm: Pneumosil","EXPERIMENTAL",[74],"Biological: Pneumococcal conjugate vaccine",{"label":76,"type":6,"description":55,"interventionNames":77},"Control Arm: Typbar TCV",[78],"Biological: Typhoid conjugate vaccine",[80,85],{"type":81,"name":82,"description":83,"armGroupLabels":84,"otherNames":55},"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.",[71],{"type":81,"name":86,"description":87,"armGroupLabels":88,"otherNames":55},"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.",[76],[90,95],{"name":91,"role":92,"phone":93,"phoneExt":55,"email":94},"Nicholas S. S. Fancourt, PhD","CONTACT","+61889468600","nick.fancourt@menzies.edu.au",{"name":96,"role":92,"phone":93,"phoneExt":55,"email":97},"Jane N Nelson, Bachelor of Nursing","jane.nelson@menzies.edu.au",[99],{"facility":100,"status":55,"city":101,"state":102,"zip":55,"country":102,"countryCode":103,"cosmosGeoPoint":104,"geoPoint":109,"contacts":55},"Guido Valadares National Hospital (HNGV)","Dili","Timor-Leste","TL",{"type":105,"coordinates":106},"Point",[107,108],125.57361,-8.55861,{"lat":108,"lon":107},{"type":111,"investigatorFullName":112,"investigatorTitle":113,"investigatorAffiliation":5,"oldNameTitle":55,"oldOrganization":55},"SPONSOR_INVESTIGATOR","Nick Fancourt","Senior Research Fellow",[115,117,119,121],{"name":116,"class":6},"Murdoch Childrens Research Institute",{"name":118,"class":6},"The University of Western Australia",{"name":120,"class":6},"University of Edinburgh",{"name":122,"class":123},"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":136,"type":137},214,"ESTIMATED","INTERVENTIONAL",[140],"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.",[143,144,145,146,147],"Severe Acute Malnutrition in Childhood","Pneumococcal Disease","Pneumococcal Vaccines","Pneumococcal Infection","Pneumonia in Children",[149,150,151,152,153,154,155],"Pneumococcal","Severe Acute Malnutrition in childhood","Pneumococcal vaccine","Pneumosil","Pneumococcal disease","Pneumococcal infection","Pneumonia","NOT_YET_RECRUITING","2025-12-10",{"date":159,"type":160},"2025-12-18","ACTUAL",{"date":162,"type":137},"2026-01",{"date":164,"type":137},"2029-02",{"name":112,"class":6},1]