[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658637":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":42,"studyPopulation":30,"armGroups":43,"interventions":56,"overallOfficials":66,"centralContacts":71,"locations":30,"responsibleParty":82,"collaborators":84,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":30,"eligibilityCriteria":94,"healthyVolunteers":95,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":30,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":109,"overallStatus":112,"whyStopped":30,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":30},{"fullName":5,"class":6},"PT Bio Farma","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Protectivity of primary series In-House Recombinant Hepatitis B vaccine","Percentage of subjects with anti HBsAg \\> 10mIU\u002Fml after the completion of the primary series of recombinant hepatitis B and Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine for each group","28 days after administration of third dose of DTwP-HepB-IPV-Hib (HEXASIIL) vaccine",[14,18,22,26],{"measure":15,"description":16,"timeFrame":17},"Immunogenicity of birth dose In-House Recombinant Hepatitis B vaccine","GMT and percentage of infants with increasing antibody titer ≥ 4 times and\u002F or percentage of infants with transition of seronegative to seropositive after birth dose Hep B vaccine","28 days after administration of Hep B birth dose vaccine",{"measure":19,"description":20,"timeFrame":21},"Immunogenicity of In-House recombinant Hepatitis B vaccine after the completion of Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine","GMT and percentage of infants with increasing antibody titer ≥ 4 times and\u002F or percentage of infants with transition of seronegative to seropositive after completion of Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine","28 days after the third dose of DTwP-HepB-IPV-Hib (HEXASIIL) vaccine",{"measure":23,"description":24,"timeFrame":25},"Safety of In-House Recombinant Hepatitis B vaccine","Percentage of subjects with solicited and unsolicited adverse events after each dose","30 minutes, 7 days, 28 days after each dose",{"measure":27,"description":28,"timeFrame":29},"Serious Adverse Events","Percentage of infants with at least one serious adverse events","28 days after third dose of Registered DTwP-HepB-IPV-Hib (HEXASIIL) vaccine administration",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":34,"primaryPurpose":35,"observationalModel":30,"timePerspective":30,"maskingInfo":36},"RANDOMIZED","PARALLEL","Randomized, double-blind, two arms parallel groups, prospective intervention study.","PREVENTION",{"masking":37,"maskingDescription":38,"whoMasked":39},"DOUBLE","Inclusion number will be allocated in the chronological order of the subject inclusion in the trial. The subject will be randomized by treatment group. The randomization list will be provided by unblinded personnel of the study team. The unblinded team will keep the list until Sponsor formally issues the result of the study.",[40,41],"PARTICIPANT","INVESTIGATOR","This trial is a randomized, double-blind, two arms parallel groups, prospective intervention study.\n\nApproximately 270 newborns will be enrolled in this trial, divided into 2 arms, with the ratio 1:1. The subject will receive one dose of In-House Recombinant Hepatitis B at birth or registered monovalent Hepatitis B as a control then followed by registered DTwP-HepB-IPVHib (HEXASIIL) vaccine",[44,50],{"label":45,"type":46,"description":47,"interventionNames":48},"Hep B vaccine in-house","EXPERIMENTAL","0,5 ml of In-house Recombinant Hepatitis B (Bio Farma) vaccine injected at birth",[49],"Biological: In-house Hepatitis B Vaccine",{"label":51,"type":52,"description":53,"interventionNames":54},"Registered Hep B vaccine","ACTIVE_COMPARATOR","0,5 ml of Regstered Hepatitis B (Bio Farma) vaccine injected at birth",[55],"Biological: Registered Hepatitis B Vaccine",[57,62],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":30},"BIOLOGICAL","In-house Hepatitis B Vaccine","0,5 ml In-House Recombinant Hepatitis B (Bio Farma) vaccine injected approximately at birth. The vaccines will be injected intramuscularly into the right anterolateral thigh",[45],{"type":58,"name":63,"description":64,"armGroupLabels":65,"otherNames":30},"Registered Hepatitis B Vaccine","0,5 ml Registered Recombinant Hepatitis B (Bio Farma) vaccine injected approximately at birth. The vaccines will be injected intramuscularly into the right anterolateral thigh",[51],[67],{"name":68,"affiliation":69,"role":70},"Rodman Tarigan Girsang, MD","Faculty of Medicine, Padjadjaran University, Bandung","PRINCIPAL_INVESTIGATOR",[72,78],{"name":73,"role":74,"phone":75,"phoneExt":76,"email":77},"Rini Mulia Sari, MD","CONTACT","+622033755","14102","rini.mulia@biofarma.co.id",{"name":79,"role":74,"phone":75,"phoneExt":80,"email":81},"Mita Puspita, MD","5045","mita.puspita@biofarma.co.id",{"type":83,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[85],{"name":86,"class":87},"Faculty of Medicine Universitas Padjadjaran","UNKNOWN","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":100,"type":101},270,"ESTIMATED","INTERVENTIONAL",[104],"PHASE3","This trial is a randomized, double-blind, two arms parallel groups, prospective intervention study.",[107,108],"Vaccination Adverse Event","Immunogenicity, Vaccine",[110,111],"Vaccine","Hepatitis B","NOT_YET_RECRUITING","2026-09-28",{"date":115,"type":116},"2026-10-02","ACTUAL",{"date":118,"type":101},"2026-10",{"date":120,"type":101},"2027-07",{"name":5,"class":6}]