[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diarrhoea\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diarrhoea":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"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":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100617599","phase-2-long-term-immunogenicity-of-the-altsonflex1-2-3-shigella-vaccine-in-african-children-100617599",false,"NCT07320716","Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children","A Phase 2, Open-Label, Single-Center, Long-Term Immunogenicity Follow-Up Study of the GVGH altSonflex1-2-3 Shigella Vaccine 1, 2 and 3 Years After Vaccination in African Children","H06_04TP","Inclusion Criteria:\n\n* Children who, as infants, previously participated in two completed studies (H06\\_01TP or H06\\_02TP) and were vaccinated with 3 or 2 doses of altSonflex1-2-3 or control vaccines, respectively, completed all previous vaccinations and are 12±1 months after the last altSonflex1-2-3 vaccination.\n* Individuals in good health as determined by medical history since last study visit and clinical judgment of the investigator.\n\nExclusion Criteria:\n\n* Serious and significant progressive, unstable, or uncontrolled clinical condition(s).\n* Any confirmed or suspected immunosuppressive or immunodeficient condition.\n* Clinical condition(s) representing a contraindication to blood draws.\n* Any behavioural or cognitive impairment or psychiatric disease.\n* Acute disease and\u002For fever at the time of enrollment.\n* Individuals with known or suspected HIV infection or HIV-related disease, with history of an autoimmune disorder or any other known or suspected impairment\u002Falteration of the immune system, or under immunosuppressive therapy.\n* Receipt of immunoglobulins and\u002For any blood products or plasma derivatives, during the period starting 3 months before each study visit.",true,"ALL","26 Months","55 Months",{"count":22,"type":23},528,"ESTIMATED","INTERVENTIONAL",[26],"PHASE2","The current study is a follow-up to 2 previous parent studies, a dose-selection study with 3 different dose-levels of the altSonflex1-2-3 vaccine in a schedule of 3 vaccinations (H06\\_01TP study \\[NCT05073003, 212149\\]) and a study with an alternate 2 vaccination schedule H06\\_02TP study \\[NCT06663436, 219449\\]). The current study aims to assess the longevity of the immune response to the selected dose of the altSonflex1-2-3 vaccine 1, 2, and 3 years after the last vaccination in African children. The study involves no new vaccinations but will collect immunogenicity blood samples from participants.",[29],"Diarrhoea",[31,32,33,34,35],"Shigella sonnei","Shigella flexneri","Shigella vaccine","altSonflex1-2-3","Shigelllosis","NOT_YET_RECRUITING","2025-12-22",{"date":39,"type":40},"2026-01-06","ACTUAL",{"date":42,"type":23},"2026-01-02",{"date":44,"type":23},"2028-10-31",{"name":46,"class":47},"GlaxoSmithKline","INDUSTRY",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":18,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":24,"phases":60,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100556775","phase-1-racecadotril-versus-standard-treatment-in-decreasing-the-duration-of-acute-diarrhoea-in-children-100556775","NCT06529497","Racecadotril Versus Standard Treatment in Decreasing the Duration of Acute Diarrhoea in Children","Efficacy of Racecadotril in Addition to Standard Treatment i in Decreasing the Duration of Acute Diarrhoea in Children as Compared to Standard of Treatment Alone","ERADICATE","Inclusion Criteria:\n\n* Hospitalized Patients with acute watery diarrhea of both genders who are\n\n  1. Age: 03 months to 05 years\n  2. Present in first 24 hours of onset of disease.\n\n     Exclusion Criteria:\n\n  \u003C!-- -->\n\n  1. Parenteral Diarrhea\n  2. Chronic Diarrhea like Coeliac disease, Lactose intolerance\n  3. Mal-absorption Syndromes\n  4. Diarrhea related to food poisoning, dysentery as suggested by history\n  5. Severe dehydration patents who are vitally unstable.\n  6. Diarrhea associated with measles.\n  7. Persistent vomiting\n  8. Abdominal distention\n  9. Patients allergic to racecadotril\n  10. Patients managed before enrolled to study","3 Months","5 Years",{"count":59,"type":23},260,[61,26],"PHASE1","Acute watery diarrhea is defined as the passage of 3 or more loose or liquid stools per day for 3 or more days but less than 14 days, including patients with mild to moderate dehydration per WHO classification. The study's outcome variables are stool frequency, measured by the total number of stools passed during 24 and 48 hours from the initiation of treatment, and hospital duration, measured by the total duration of hospital stay in hours. The null hypothesis states that racecadotril combined with standard treatment has no effect on reducing the mean number of stools passed during 48 hours compared to standard treatment alone in pediatric patients with acute watery diarrhea, while the alternate hypothesis suggests that racecadotril combined with standard treatment will significantly reduce the mean number of stools passed during 48 hours compared to standard treatment alone in these patients.",[29],[65,29,66],"Stool","Paediatrics","2024-07-30",{"date":69,"type":40},"2024-07-31",{"date":71,"type":23},"2024-08-02",{"date":73,"type":23},"2024-12-02",{"name":75,"class":76},"Liaquat National Hospital & Medical College","OTHER"]