[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617599":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":18,"studyPopulation":18,"armGroups":26,"interventions":49,"overallOfficials":18,"centralContacts":75,"locations":18,"responsibleParty":84,"collaborators":18,"id":86,"slug":18,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":18,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":112,"whyStopped":18,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":18},{"fullName":5,"class":6},"GlaxoSmithKline","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":18,"otherOutcomes":18},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Anti-serotype specific Shigella lipopolysaccharide (LPS)\u002FO-antigen (OAg) serum immunoglobulin G (IgG), as measured by GVGH enzyme-linked immunosorbent assay . (ELISA)","S. sonnei, S. flexneri 1b, S. flexneri 2a, and S. flexneri 3a serotypes will be tested.","At Visit 1 of the current study (12 months after last vaccination in the parent studies)",{"measure":14,"description":11,"timeFrame":15},"Anti-serotype specific Shigella LPS\u002FOAg serum IgG, as measured by GVGH ELISA","At Visit 2 of the current study (24 months after last vaccination in the parent studies)",{"measure":14,"description":11,"timeFrame":17},"At Visit 3 of the current study (36 months after last vaccination in the parent studies)",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":24,"maskingDescription":25,"whoMasked":18},"NONE","This is an open-label study.",[27,33,40,44],{"label":28,"type":29,"description":30,"interventionNames":31},"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.",[32],"Biological: AltSonflex1-2-3",{"label":34,"type":35,"description":36,"interventionNames":37},"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.",[38,39],"Biological: Menveo","Biological: Infanrix hexa",{"label":41,"type":29,"description":42,"interventionNames":43},"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.",[32],{"label":45,"type":35,"description":46,"interventionNames":47},"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.",[39,48],"Biological: TYPHIBEV",[50,57,63,69],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":55},"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.",[28,41],[56],"GSK's Shigella vaccine",{"type":51,"name":58,"description":59,"armGroupLabels":60,"otherNames":61},"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.",[34],[62],"GSKs Meningococcal A, C, Y and W-135 conjugate vaccine",{"type":51,"name":64,"description":65,"armGroupLabels":66,"otherNames":67},"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.",[34,45],[68],"GSKs Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b vaccine",{"type":51,"name":70,"description":71,"armGroupLabels":72,"otherNames":73},"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.",[45],[74],"Biological E. Limiteds Typhoid Vi-CRM197 conjugate vaccine",[76,81],{"name":77,"role":78,"phone":79,"phoneExt":18,"email":80},"US GSK Clinical Trials Call Center","CONTACT","877-379-3718","GSKClinicalSupportHD@gsk.com",{"name":82,"role":78,"phone":83,"phoneExt":18,"email":80},"EU GSK Clinical Trials Call Center","+44 (0) 20 89904466",{"type":85,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","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":98,"type":99},528,"ESTIMATED","INTERVENTIONAL",[102],"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.",[105],"Diarrhoea",[107,108,109,110,111],"Shigella sonnei","Shigella flexneri","Shigella vaccine","altSonflex1-2-3","Shigelllosis","NOT_YET_RECRUITING","2025-12-22",{"date":115,"type":116},"2026-01-06","ACTUAL",{"date":118,"type":99},"2026-01-02",{"date":120,"type":99},"2028-10-31",{"name":5,"class":6}]