[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617599":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":56,"centralContacts":57,"locations":56,"responsibleParty":66,"collaborators":56,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":56,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":95,"whyStopped":56,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":56},{"fullName":5,"class":6},"GlaxoSmithKline","INDUSTRY",[8,14,21,25],{"label":9,"type":10,"description":11,"interventionNames":12},"H06_01TP Study_Infants_Selected dose","EXPERIMENTAL","Infants who received 3 doses of the altSonflex1-2-3 vaccine on Day 1, Day 85, and Day 253 in the H06\\_01TP parent study.",[13],"Biological: AltSonflex1-2-3",{"label":15,"type":16,"description":17,"interventionNames":18},"H06_01TP Study_ ST2_Infants_Control","ACTIVE_COMPARATOR","Infants who received 2 doses of the Menveo vaccine on Day 1 and Day 85, and 1 dose of the Infanrix hexa vaccine on Day 281 in the H06\\_01TP parent study.",[19,20],"Biological: Menveo","Biological: Infanrix hexa",{"label":22,"type":10,"description":23,"interventionNames":24},"H06_02TP Study_Infants_Selected dose","Infants who received 2 doses of the altSonflex1-2-3 vaccine on Day 1 and Day 169 in the H06\\_02TP parent study.",[13],{"label":26,"type":16,"description":27,"interventionNames":28},"H06_02TP Study_ Infants_Control","Infants who received 1 dose of the TYPHIBEV vaccine on Day 1 and 1 dose of the Infanrix hexa vaccine on Day 169 in the H06\\_02TP parent study.",[20,29],"Biological: TYPHIBEV",[31,38,44,50],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"BIOLOGICAL","AltSonflex1-2-3","No intervention is administered in this extension study. The selected dose of altSonflex1-2-3 vaccine was administered intramuscularly in the participants' thigh during the H06\\_01TP (212149) parent study on Day 1, Day 85, and Day 253; or on Day 1 and Day 169 during the H06\\_02TP (219449) study.",[9,22],[37],"GSK's Shigella vaccine",{"type":32,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Menveo","No intervention is administered in this extension study. The Menveo vaccine was administered intramuscularly in the participants' thigh on Day 1 and Day 85 during the H06\\_01TP (212149) parent study.",[15],[43],"GSKs Meningococcal A, C, Y and W-135 conjugate vaccine",{"type":32,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Infanrix hexa","No intervention is administered in this extension study. The Infanrix hexa vaccine was administered intramuscularly in the participants' thigh on Day 281 during the H06\\_01TP (212149) study; or on Day 169 during the H06\\_02TP (219449) parent study.",[15,26],[49],"GSKs Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b vaccine",{"type":32,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"TYPHIBEV","No intervention is administered in this extension study. The TYPHIBEV vaccine was administered intramuscularly in the participants' thigh on Day 1 during the H06\\_02TP (219449) parent study.",[26],[55],"Biological E. Limiteds Typhoid Vi-CRM197 conjugate vaccine",null,[58,63],{"name":59,"role":60,"phone":61,"phoneExt":56,"email":62},"US GSK Clinical Trials Call Center","CONTACT","877-379-3718","GSKClinicalSupportHD@gsk.com",{"name":64,"role":60,"phone":65,"phoneExt":56,"email":62},"EU GSK Clinical Trials Call Center","+44 (0) 20 89904466",{"type":67,"investigatorFullName":56,"investigatorTitle":56,"investigatorAffiliation":56,"oldNameTitle":56,"oldOrganization":56},"SPONSOR","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":81,"type":82},528,"ESTIMATED","INTERVENTIONAL",[85],"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.",[88],"Diarrhoea",[90,91,92,93,94],"Shigella sonnei","Shigella flexneri","Shigella vaccine","altSonflex1-2-3","Shigelllosis","NOT_YET_RECRUITING","2025-12-22",{"date":98,"type":99},"2026-01-06","ACTUAL",{"date":101,"type":82},"2026-01-02",{"date":103,"type":82},"2028-10-31",{"name":5,"class":6}]