[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569151":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":30,"centralContacts":38,"locations":49,"responsibleParty":72,"collaborators":74,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":30,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":30,"studyType":91,"phases":92,"briefSummary":95,"conditions":96,"keywords":30,"overallStatus":99,"whyStopped":30,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"PT Bio Farma","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A","EXPERIMENTAL","0,5 ml of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A injected three-dose regimen with 28 days interval between doses",[13],"Biological: DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A",{"label":15,"type":10,"description":16,"interventionNames":17},"DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B","0,5 ml of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B injected three-dose regimen with 28 days interval between doses.",[18],"Biological: DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B",{"label":20,"type":21,"description":22,"interventionNames":23},"Registered DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac) ®","ACTIVE_COMPARATOR","0,5 ml of DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac)® injected three-dose regimen with 28 days interval between doses.",[24],"Biological: Registered DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac)®",[26,31,34],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"BIOLOGICAL","0,5 ml DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula A injected three-dose regimen with 28 days interval between doses. Vaccine is injected intramuscularly in left anterolateral thigh.",[9],null,{"type":27,"name":15,"description":32,"armGroupLabels":33,"otherNames":30},"0,5 ml injected of DTwP-Hepatitis B-Hib-IPV (Bio Farma) Vaccine Formula B three-dose regimen with 28 days interval between doses. Injected intramuscularly in left anterolateral thigh.",[15],{"type":27,"name":35,"description":36,"armGroupLabels":37,"otherNames":30},"Registered DTwP-Hepatitis B-Hib Vaccine and IPV (Sinovac)®","The control group will receive 0,5 ml of Registered DTwP-Hepatitis B-Hib vaccine and 0,5 ml IPV (Sinovac)® injected in three-dose regimen with 28 days interval between doses. Registered DTwP-Hepatitis B-Hib Vaccine are injected intramuscularly into the left antero-lateral thigh region. IPV (Sinovac)® vaccine are injected intramuscularly into the right mid-lateral thigh region",[20],[39,45],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Rini Mulia Sari, MD","CONTACT","+622033755","14102","rini.mulia@biofarma.co.id",{"name":46,"role":41,"phone":42,"phoneExt":47,"email":48},"Mita Puspita, MD","5045","mita.puspita@biofarma.co.id",[50,62,67],{"facility":51,"status":30,"city":52,"state":53,"zip":30,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":30},"Garuda Primary Health Centre","Bandung","West Java","Indonesia","ID",{"type":57,"coordinates":58},"Point",[59,60],107.60694,-6.92222,{"lat":60,"lon":59},{"facility":63,"status":30,"city":52,"state":53,"zip":30,"country":54,"countryCode":55,"cosmosGeoPoint":64,"geoPoint":66,"contacts":30},"Ibrahim Adjie Priamry Health Centre",{"type":57,"coordinates":65},[59,60],{"lat":60,"lon":59},{"facility":68,"status":30,"city":52,"state":53,"zip":30,"country":54,"countryCode":55,"cosmosGeoPoint":69,"geoPoint":71,"contacts":30},"Puter Primary Health Centre",{"type":57,"coordinates":70},[59,60],{"lat":60,"lon":59},{"type":73,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[75],{"name":76,"class":77},"Faculty of Medicine Universitas Padjadjaran","UNKNOWN","100569151","phase-1-phase-iii-open-label-randomized-safety-and-immunogenicity-following-dtwp-hepatitis-b-hib-ipv-vaccine-bio-farma-in-indonesian-infants-100569151",false,"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.",true,"ALL","6 Weeks","11 Weeks",{"count":89,"type":90},465,"ESTIMATED","INTERVENTIONAL",[93,94],"PHASE1","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.",[97,98],"Vaccine Adverse Reaction","Vaccine Reaction","NOT_YET_RECRUITING","2024-11-13",{"date":102,"type":103},"2024-11-15","ACTUAL",{"date":105,"type":90},"2025-03-01",{"date":107,"type":90},"2026-09-30",{"name":5,"class":6},3]