[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"immunogenicity-vaccine\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:immunogenicity-vaccine":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":26,"conditions":27,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100658637","phase-3-study-interchangeability-hep-b-vaccine-administered-at-birth-dose-100658637",false,"NCT07854847","Study Interchangeability Hep-B Vaccine Administered at Birth Dose","Randomized, Double-Blind, Interchangeability Study of In-House Recombinant Hepatitis B (Bio Farma) at Birth Dose Followed by RRegistered DTwP-HepB-IPV-Hib (HEXASIIL) Vaccine in Indonesian Infants","Inclusion Criteria:\n\n1. Healthy, full term, newborn infants.\n2. Infant born between 37-42 weeks of pregnancy.\n3. Infant weigh between 2500 - 4000 gram at birth.\n4. Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.\n5. Parents will commit themselves to comply with the indications of the investigator and with the schedule of the trial.\n\nExclusion Criteria:\n\n1. Infants concomitantly enrolled or scheduled to be enrolled in another trial.\n2. Infants evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥ 37.5°C on Day 0).\n3. Infants suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection, based on anamnesis.\n4. Infants received or plans to receive any treatment likely to alter the immune response intravenously (immunoglobulins, blood-derived products or long term corticotherapy (\\> 2 weeks)).\n5. Infants received other vaccinations with the exception of BCG, poliomyelitis, rotavirus, and PCV.\n6. Infants with HbsAg and HIV positive (from cord blood)\n7. Mother suspected of immunodeficiency disease based on anamnesis",true,"ALL","0 Days","3 Days",{"count":21,"type":22},270,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This trial is a randomized, double-blind, two arms parallel groups, prospective intervention study.",[28,29],"Vaccination Adverse Event","Immunogenicity, Vaccine",[31,32],"Vaccine","Hepatitis B","NOT_YET_RECRUITING","2026-09-28",{"date":36,"type":37},"2026-10-02","ACTUAL",{"date":39,"type":22},"2026-10",{"date":41,"type":22},"2027-07",{"name":43,"class":44},"PT Bio Farma","INDUSTRY"]