[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"PT Bio Farma\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":117},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,72,94],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":14,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100642208","phase-1-a-phase-i-study-of-lipovaxin-tuberculosis-vaccine-in-adult-healthy-populations-100642208",false,"NCT07647107","A Phase I Study of Lipovaxin Tuberculosis Vaccine in Adult Healthy Populations","A Phase I, Double-Blind, Randomized, Placebo Controlled Trial to Evaluate Safety and Immunogenicity of Lipovaxin Tuberculosis Vaccine (Bio Farma) in Healthy Populations Aged 18-40 Years in Indonesia","Inclusion Criteria\n\n1. Clinically Healthy participants aged 18-40 years;\n2. Participants have been informed properly regarding the study and signed the informed consent form.\n3. Participants will commit to comply with the instructions of the investigator and the schedule of the trial;\n4. Participants must have a negative IGRA and sputum.\n5. Clinically normal laboratory values for ureum, creatinine, SGOT, SGPT, complete blood count (CBC), urinalysis, coagulation test (PT, aPTT), total cholesterol, Globulin\u002FAlbumin ratio and CRP\n\nExclusion Criteria:\n\n1. Those who are currently diagnosed with tuberculosis or have a history of tuberculosis (positive IGRA or GenXpert sputum test or chest Xray suggestive of TB) and\u002For history of tuberculosis treatment; including TB Preventive Treatment (TPT);\n2. There are serious chronic diseases, or the disease is in the advanced stage that cannot be controlled smoothly, such as diabetes and thyroid disease;\n3. Currently suffering from or within 2 years of any of the following serious diseases, such as: advanced tumor, autoimmune disease, progressive atherosclerosis, acute exacerbation of the chronic obstructive pulmonary disease, acute or progressive liver or kidney disease, congestive heart failure, etc.; based on interview with participants\n4. Those with known or suspected (or high-risk) immune function impairments or abnormalities, such as those receiving more than 20mg\u002Fday of systemic glucocorticoids for 14 consecutive days within the last 4 weeks, immunosuppressants within 3 months, and Those who received protein preparations or blood products or plasma extracts outside the gastrointestinal tract within 3 months;\n5. People with allergic constitution, such as those with a history of allergy to two or more drugs or foods; a history of severe allergy to any component of the test vaccine, such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenia Purpura, dyspnea, angioedema, etc.; or a history of the above-mentioned serious side effects after using any vaccine or drug in the past; history of bronchial asthma;\n6. Current patients with HIV antibody positive for human immunodeficiency virus;\n7. Women who are pregnant, breastfeeding, or have a positive urine pregnancy test during the screening period, or before vaccination, or who have childbearing plans during the study period;\n8. Subjects receive any vaccination within 1 month before and after dosing;\n9. Those who have participated in any other clinical research and used the investigational drug within 3 months before this clinical research;\n10. Any other situation that the researcher believes may affect the evaluation of the research.",true,"ALL","18 Years","40 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1",[27,28],"Tuberculosis","TB Infection",[30,27,31],"TB vaccine","Lipovaksin TB","NOT_YET_RECRUITING","2026-06-09",{"date":35,"type":36},"2026-06-15","ACTUAL",{"date":38,"type":22},"2026-08",{"date":40,"type":22},"2027-08",{"name":42,"class":43},"PT Bio Farma","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":16,"sex":17,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":4},"100476312","phase-3-immunogenicity-and-safety-following-in-house-recombinant-hepatitis-b-vaccine-in-indonesian-population-phase-iii-100476312","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. Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy).\n7. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.\n8. Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or corticosteroid therapy and other immunosuppressant.\n9. Pregnancy \\& Lactation (Adult).\n10. Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.","10 Years","50 Years",{"count":55,"type":22},540,[57],"PHASE3","This is a phase 3, experimental, randomized, observer-blind, lot to lot consistency study. The primary objective of this study is to assess the protectivity of In-House Recombinant Hepatitis B vaccine 28 days after 3 doses immunization.",[60,61],"Vaccine Reaction","Vaccine Adverse Reaction",[63],"Hepatitis B vaccine, Vaccine","2025-06-03",{"date":66,"type":36},"2025-06-06",{"date":68,"type":22},"2025-09",{"date":70,"type":22},"2026-05",{"name":42,"class":43},{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":16,"sex":17,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":79,"studyType":83,"phases":4,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":44},"100586905","long-term-protection-of-vi-antibodies-induced-by-bio-tcv-in-indonesian-population-compared-to-pqed-tcv-100586905","NCT06921460","Long-Term Protection of Vi Antibodies Induced by Bio TCV in Indonesian Population Compared to PQed TCV","Long-Term Protection of Vi Antibodies Induced by Vi-DT Conjugate Vaccines (Bio TCV) in Indonesian Population Compared to PQed TCV","Inclusion Criteria:\n\n* Healthy\n* Subject\u002FParents\u002Flegal guardian(s) have been informed properly regarding the study and signed the informed consent form\u002Fand informed assent form.\n* Subject\u002Fparents\u002Flegal guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial.\n\nExclusion Criteria:\n\n* History of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.","6 Months","60 Years",{"count":82,"type":22},624,"OBSERVATIONAL","Typhoid fever is a serious systemic infection caused by the enteric pathogen Salmonella enterica serovar typhi. S typhi is spread by the fecal-oral route. Although largely an endemic disease, S. typhi has epidemic potential. This research aims to determine the long-term immune response after administration of one dose of Bio TCV and PQed TCV vaccines in the population in Indonesia. Research participants will be taken from research participants who complete the Bio TCV (Typhoid 0319) Phase III clinical trial research included in the Main Study Group I.",[86],"Antibody Typhoid Vaccine","2025-06-02",{"date":64,"type":36},{"date":90,"type":22},"2025-06-15",{"date":92,"type":22},"2025-12-31",{"name":42,"class":43},{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":16,"sex":17,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":23,"phases":104,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},"100569151","phase-1-phase-iii-open-label-randomized-safety-and-immunogenicity-following-dtwp-hepatitis-b-hib-ipv-vaccine-bio-farma-in-indonesian-infants-100569151","NCT06690515","Phase I\u002FII, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in Indonesian Infants","Inclusion Criteria:\n\n1. Infant 6-11 weeks of age.\n2. Infant born after 37-42 weeks of pregnancy.\n3. Infant weighing more than 2.5 kg at birth.\n4. Father or mother, or legally acceptable representative properly informed about the study and signed the informed consent form.\n5. Parents will commit themselves to comply with the indications of the investigators and with the schedule of the trial.\n\nExclusion Criteria:\n\n1. Child concomitantly enrolled or scheduled to be enrolled in another trial.\n2. Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥37.5°C on Day 0).\n3. Known history of allergy to any component of the vaccines.\n4. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.\n5. Known history of congenital or acquired immunodeficiency (including HIV infection).\n6. Child who has received in the previous 4 weeks of a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (\\> 2 weeks).\n7. Other vaccination within the 7 days prior to inclusion with the exception of BCG and poliomyelitis.\n8. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.\n9. Infant with a known history of diphtheria, tetanus, pertussis, Hib, hepatitis B infection.","6 Weeks","11 Weeks",{"count":103,"type":22},465,[25,105],"PHASE2","This trial is open label, comparative, randomized, phase I\u002FII study, experimental, randomized, open-label, three arm parallel group study. The primary objective for phase I is to evaluate the safety of the DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine within 7 days after each dose. The primary objective for phase II is to evaluate protectivity of DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine.",[61,60],"2024-11-13",{"date":110,"type":36},"2024-11-15",{"date":112,"type":22},"2025-03-01",{"date":114,"type":22},"2026-09-30",{"name":42,"class":43},3,""]