[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100476312":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":36,"centralContacts":41,"locations":32,"responsibleParty":52,"collaborators":54,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":32,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":32,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":81,"whyStopped":32,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":32},{"fullName":5,"class":6},"PT Bio Farma","INDUSTRY",[8,14,17,20],{"label":9,"type":10,"description":11,"interventionNames":12},"In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 1","EXPERIMENTAL","3 doses In-House Recombinant Hepatitis B (Bio Farma) vaccine",[13],"Biological: In-House Recombinant Hepatitis B (Bio Farma) vaccine",{"label":15,"type":10,"description":11,"interventionNames":16},"In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 2",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 3",[13],{"label":21,"type":22,"description":23,"interventionNames":24},"Registered Hepatitis B vaccine recombinant (Engerix-B)","ACTIVE_COMPARATOR","3 doses Registered Hepatitis B vaccine recombinant (Engerix-B)",[25],"Biological: Registered Hepatitis B vaccine recombinant (Engerix-B)",[27,33],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"BIOLOGICAL","In-House Recombinant Hepatitis B (Bio Farma) vaccine","3 doses of In-House Recombinant Hepatitis B (Bio Farma) vaccine",[9,15,18],null,{"type":28,"name":21,"description":34,"armGroupLabels":35,"otherNames":32},"3 doses of Registered Hepatitis B vaccine recombinant (Engerix-B)",[21],[37],{"name":38,"affiliation":39,"role":40},"Trisna Windiani, MD","RSUP Prof. dr. I.G.N.G. Ngoerah","PRINCIPAL_INVESTIGATOR",[42,48],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"Rini Mulia Sari, MD","CONTACT","0222033755","14102","rini.mulia@biofarma.co.id",{"name":49,"role":44,"phone":45,"phoneExt":50,"email":51},"Mita Puspita, MD","5045","mita.puspita@biofarma.co.id",{"type":53,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[55],{"name":56,"class":57},"RS Prof. Dr. I.G.N.G Ngoerah","UNKNOWN","100476312","phase-3-immunogenicity-and-safety-following-in-house-recombinant-hepatitis-b-vaccine-in-indonesian-population-phase-iii-100476312",false,"NCT05482295","Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III)","Immunogenicity and Safety Following In-House Recombinant Hepatitis B (Bio Farma) Vaccine Compared to Registered Hepatitis B Vaccine in Indonesian Population (Phase III)","Inclusion Criteria:\n\n1. Healthy individual aged 10 - 50 years old, as determined by clinical judgment, including a medical history and physical exam which confirms the absence of a current or past disease state considered significant by the investigator.\n2. Subjects\u002Fparents\u002Fguardian(s) have been informed properly regarding the study and signed the informed consent form\u002F informed assent form.\n3. Subject\u002Fparents\u002Fguardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial.\n\nExclusion Criteria:\n\n1. Subject concomitantly enrolled or scheduled to be enrolled in another trial.\n2. Subjects with known history of Hepatitis B contained vaccination in the last 10 years.\n3. Evolving severe illness and\u002For chronic disease and fever (axillary temperature \\>= 37.5 C) within the 48 hours preceding enrollment.\n4. Known history of allergy to any component of the vaccines (based on anamnesis).\n5. HBsAg positive.\n6. 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