[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632081":3},{"organization":4,"armGroups":7,"interventions":39,"overallOfficials":63,"centralContacts":67,"locations":76,"responsibleParty":96,"collaborators":98,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":44,"eligibilityCriteria":110,"healthyVolunteers":111,"sex":112,"minAge":113,"maxAge":114,"enrollmentInfo":115,"targetDuration":44,"studyType":118,"phases":119,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":79,"whyStopped":44,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"International Vaccine Institute","OTHER",[8,14,18,24,30,35],{"label":9,"type":10,"description":11,"interventionNames":12},"OSP:rTTHc CCV 25 ㎍ with Aluminum phosphate","EXPERIMENTAL","0.5 mL per dose; dosing schedule\u002Fduration: 1 dose or 2 doses at 168-days interval administered intramuscularly",[13],"Biological: OSP:rTTHc CCV 25 ㎍ with Aluminum phosphate",{"label":15,"type":10,"description":11,"interventionNames":16},"OSP:rTTHc CCV 25 ㎍ without Aluminum phosphate",[17],"Biological: OSP:rTTHc CCV 25 ㎍ without Aluminum phosphate",{"label":19,"type":20,"description":21,"interventionNames":22},"Euvichol®-Plus","ACTIVE_COMPARATOR","1.5 mL per dose; dosing schedule\u002Fduration: 2 doses at 14-days interval administered orally",[23],"Biological: Euvichol®-Plus",{"label":25,"type":26,"description":27,"interventionNames":28},"Isotonic Sodium Chloride injection","PLACEBO_COMPARATOR","0.5 mL per dose; dosing schedule\u002Fduration: 2 doses at 168-days interval administered intramuscularly",[29],"Other: Placebo",{"label":31,"type":10,"description":32,"interventionNames":33},"OSP:rTTHc CCV 25 ㎍ with Aluminum phosphate and Euvichol®-Plus","0.5 mL per dose of CCV administered intramuscularly and 1.5 mL dose of Euvichol®-Plus administered orally at 168-days interval",[34],"Biological: CCV with Aluminum, Euvichol®-Plus",{"label":36,"type":10,"description":32,"interventionNames":37},"OSP:rTTHc CCV 25 ㎍ without Aluminum phosphate and Euvichol®-Plus",[38],"Biological: CCV without Aluminum, Euvichol®-Plus",[40,45,48,51,55,59],{"type":41,"name":9,"description":42,"armGroupLabels":43,"otherNames":44},"BIOLOGICAL","OSP:rTTHc Cholera Conjugate with Aluminum phosphate Cohort Arms A1, A3, B1, B3, C1, C3, C10",[9],null,{"type":41,"name":15,"description":46,"armGroupLabels":47,"otherNames":44},"OSP:rTTHc Cholera Conjugate without Aluminum phosphate Cohort Arms A2, A4, B2, B4, C2, C4",[15],{"type":41,"name":19,"description":49,"armGroupLabels":50,"otherNames":44},"V. cholerae O1 and O139 bivalent inactivated oral cholera vaccine cohort Arm C6",[19],{"type":6,"name":52,"description":53,"armGroupLabels":54,"otherNames":44},"Placebo","Sterile 0.9% sodium chloride cohort Arms A5, B5, C5",[25],{"type":41,"name":56,"description":57,"armGroupLabels":58,"otherNames":44},"CCV with Aluminum, Euvichol®-Plus","1. OSP:rTTHc CCV 25 # with Aluminum phosphate OSP:rTTHc Cholera Conjugate with Aluminum phosphate\n2. Euvichol®-Plus V. cholerae O1 and O139 bivalent inactivated oral cholera vaccine\n\nCohort Arms C7, C9",[31],{"type":41,"name":60,"description":61,"armGroupLabels":62,"otherNames":44},"CCV without Aluminum, Euvichol®-Plus","1. OSP:rTTHc CCV 25 # without Aluminum phosphate OSP:rTTHc Cholera Conjugate without Aluminum phosphate\n2. Euvichol®-Plus V. cholerae O1 and O139 bivalent inactivated oral cholera vaccine\n\nCohort Arms C8, C10",[36],[64],{"name":65,"affiliation":5,"role":66},"Julia Lynch, MD","PRINCIPAL_INVESTIGATOR",[68,73],{"name":69,"role":70,"phone":71,"phoneExt":44,"email":72},"Naveena D'Cor, MD","CONTACT","+82 2 8811 000","naveena.dcor@ivi.int",{"name":74,"role":70,"phone":71,"phoneExt":44,"email":75},"Tarun Saluja, MD","Tarun.Saluja@ivi.int",[77],{"facility":78,"status":79,"city":80,"state":81,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"KAVI-Institute of Clinical Research, University","RECRUITING","Nairobi","Kenyatta National Hospital Complex","19676","Kenya","KE",{"type":86,"coordinates":87},"Point",[88,89],36.81667,-1.28333,{"lat":89,"lon":88},[92],{"name":93,"role":70,"phone":94,"phoneExt":44,"email":95},"Jaoko Walter Godfrey","+254-727-555-254","wjaoko@kaviuon.org",{"type":97,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR",[99,102],{"name":100,"class":101},"EuBiologics Co.,Ltd","INDUSTRY",{"name":103,"class":6},"Massachusetts General Hospital","100632081","phase-2-age-descending-study-to-evaluate-the-safety-and-immunogenicity-of-the-cholera-conjugate-vaccine-in-adults-and-children-100632081",false,"NCT07509047","Age-descending Study to Evaluate the Safety and Immunogenicity of the Cholera Conjugate Vaccine in Adults and Children","A Phase II, Randomized, Controlled, Age-descending Study in Adults and Children to Evaluate the Safety and Immunogenicity of the OSP:rTTHc Cholera Conjugate Vaccine in Cholera-endemic Region","Inclusion Criteria:\n\n1. Individuals aged 1 to 45 years at consent\n2. Participants\u002F Participants' legally authorized representative (LAR) willing to provide written informed consent to participate in the study voluntarily\n3. Participants who can comply with the study requirements\n4. Individuals in good health as determined by the outcome of medical history, physical examination, and the clinical judgment of the investigator\n\nExclusion Criteria:\n\n1. Known history or allergy to investigational vaccine components or other medications, or any other allergies\n2. Individuals with major congenital abnormalities\n3. Known history of immune function disorders including immunodeficiency diseases (known HIV infection¥ or other immune function disorders)\n4. Use of systemic steroids within past 6 months (\\>10 mg\u002Fday prednisone equivalent for periods exceeding 2 consecutive weeks), or receive chemotherapy, radiation therapy or other immunosuppressive drugs within the past 6 months.\n5. Any abnormality or chronic disease which in the opinion of the investigator might be detrimental for the safety of the participant and interfere with the assessment of the study objectives\n6. Individuals with behavioral or cognitive impairment or psychiatric disease or neural disorders that, in the opinion of the investigator, could interfere with the participant's ability to participate in the trial\n7. Individuals with splenectomy\n8. Individuals with known bleeding disorders\n9. Receipt of blood, blood-derived products, or immunoglobulin products in the past 3 months\n10. Individuals who have received other vaccines from 4 weeks prior to the first dose of test vaccination or planned to receive any vaccine within 4 weeks of the last dose of the investigational product.\n11. Individuals with active or known previous Vibrio cholerae infection\n12. Individuals with a history of severe diarrhea in the last 6 months requiring care at a medical facility lasting 24 hours or more\n13. Individuals with prior receipt of a cholera vaccine in the last 5 years\n14. Any female participant who is lactating or pregnant\n15. Females of childbearing potential who do not agree to use an effective birth control method for at least 4 weeks before the screening and up to 12 weeks after the study vaccination.\n16. Individuals enrolled in another clinical trial within 6 months prior to enrollment, concomitantly enrolled or scheduled to be enrolled in another trial during study period\n17. Individuals who are research staff involved with the clinical trial or family\u002Fhousehold members of research staff\n18. As per Investigator's medical judgement, an individual could also be excluded from the study despite meeting all inclusion\u002Fexclusion criteria mentioned above\n19. Children below 5 years old with Weight for Height Z score and\u002For Height for Age Z score of less than -2",true,"ALL","1 Year","45 Years",{"count":116,"type":117},390,"ESTIMATED","INTERVENTIONAL",[120],"PHASE2","This phase II study is intended to determine the immunogenicity and safety of single dose and two doses of OSP:rTTHc cholera conjugate vaccine (CCV) with or without alum adjuvant. The study will guide the future dosing schedule and formulation of CCV (with or without Aluminum phosphate adjuvant) expected to be needed in adults and children in cholera-endemic region.",[123],"Cholera Vaccination",[125,126,127,128],"Cholera Conjugate Vaccine","O Specific Polysaccharide","Recombinant Tetanus Toxoid Heavy Chain Fragment","Cholera Vaccine","2026-03-27",{"date":131,"type":132},"2026-04-03","ACTUAL",{"date":134,"type":132},"2026-01-13",{"date":136,"type":117},"2027-12",{"name":5,"class":6},1]