[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627248":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":49,"collaborators":51,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":21,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":83,"whyStopped":21,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"University of Birmingham","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"All participants","EXPERIMENTAL","All participants will receive the same interventions.",[13,14],"Diagnostic Test: Point of care, saliva-based lateral flow test","Diagnostic Test: Blood based immunoassay",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DIAGNOSTIC_TEST","Point of care, saliva-based lateral flow test","Measurement of anti-tetanus toxoid antibody concentration in saliva",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Blood based immunoassay","Measurement of anti-tetanus toxoid antibody concentration in blood",[9],[27],{"name":28,"role":29,"phone":30,"phoneExt":21,"email":31},"Karishma Gokani","CONTACT","+44(0)121 414 4069","k.gokani@bham.ac.uk",[33],{"facility":34,"status":21,"city":35,"state":21,"zip":21,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Center for Family Health Research","Kigali","Rwanda","RW",{"type":39,"coordinates":40},"Point",[41,42],30.05885,-1.94995,{"lat":42,"lon":41},[45],{"name":46,"role":29,"phone":47,"phoneExt":21,"email":48},"Julien Nyombayire","+250 252 503 233","jnyombayire@rzhrg-mail.org",{"type":50,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR",[52,54],{"name":53,"class":6},"Rwanda Biomedical Centre",{"name":55,"class":56},"Center for Family Health Research\u002FProjet San Francisco","UNKNOWN","100627248","tetanus-antibody-detection-in-saliva-study-100627248",false,"NCT07446166","TETANUS Antibody Detection in Saliva Study","Development of Novel Diagnostics That Use Point-of-care Lateral Flow Testing Technology for Non-invasive, Individual Assessment of Antibody Protection to Tetanus and Vaccine Need","TETANUS","Inclusion Criteria:\n\n* Able and willing to provide informed consent to take part in the study; either directly or from a parent\u002Fguardian, where appropriate\n* \\[Group A\\] Aged 5-10 years inclusive, and determined as healthy by a member of the study team\n* \\[Group B\\] Aged 18-25yrs inclusive, and determined as healthy by a member of the study team\n* \\[Group C\\] Currently pregnant at any stage of pregnancy, prior to receipt of a tetanus booster vaccine in pregnancy, and determined as healthy by a member of the study team and safe to provide a blood sample\n* \\[Group D\\] Adults aged 18-45 years with one or more of the medical conditions that may affect antibody response to vaccination.\n\nExclusion Criteria:\n\n* Participants or parents\u002Fguardians unwilling or unable to provide informed consent to take part\n* Unwilling or unable to comply with study procedures\n* Have a bleeding disorder deemed significant by study doctor\n* \\[Groups A, B and C only\\] Any health condition which, in the opinion of a study physician which could\n\n  1. mean blood sampling has the potential for harm and\u002For\n  2. affect immune response to a vaccine for example known\u002Fsuspected impairment of immune function (with the exception of Group D)",true,"ALL","5 Years","45 Years",{"count":70,"type":71},390,"ESTIMATED","INTERVENTIONAL",[74],"NA","This study aims to design, develop and optimise a non-invasive, saliva sample-based point-of-care lateral flow test for use in low and middle income settings that can return a qualitative result on whether an individual has or has not immunity to tetanus within 10-15mins. If successful, this approach would not require blood sampling or laboratory facilities, empower personalised decision making on vaccine needs and support the development of population level data-driven public health policies.",[77],"Tetanus",[79,80,81,82],"point-of-care","Lateral Flow Test","Rapid Diagnostic","Immune Diagnostic","NOT_YET_RECRUITING","2026-02-25",{"date":86,"type":87},"2026-03-03","ACTUAL",{"date":89,"type":71},"2026-02-01",{"date":91,"type":71},"2028-02-01",{"name":5,"class":6},1]