Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III)
Tahapan Penelitian : Initial
Sponsor:
PT. Bio Farma
Mitra Pelaksana:
Department of Child Health Medical Faculty of Universitas Udayana Prof. Dr. I.G.N.G Ngoerah
Hospital Bali Indonesia
No Registry
INA-2PM9N5HT
Tanggal Input Registry : 01-08-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 01-09-2025 |
| Outcome Primer | Protectivity of In-House Recombinant Hepatitis B vaccine 28 days after 3 doses immunization |
| Outcome Skunder | Immunogenicity: Serological response |
| Descriptive Information | |
| Judul Penelitian Popular | Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III) |
| Judul Penelitian Ilmiah | Immunogenicity and Safety Following In-House Recombinant Hepatitis B (Bio Farma) vaccine compared to Registered Hepatitis B vaccine in Indonesian Population (Phase III) |
| Jenis Penelitian | Interventional |
| Intervensi | In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 1, In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 2, In-House Recombinant Hepatitis B (Bio Farma) vaccine Batch 3 |
| Jumlah Subyek Penelitian | 540 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: 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, Subjects/parents/guardian(s) have been informed properly regarding the study and signed the informed consent form/ informed assent form, Subject/parents/guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial.Exclusion Criteria: Subject concomitantly enrolled or scheduled to be enrolled in another trial, Subjects with known history of Hepatitis B contained vaccination in the last 10 years, Evolving severe illness and/or chronic disease and fever (axillary temperature >= 37.5 C) within the 48 hours preceding enrollment, Known history of allergy to any component of the vaccines (based on anamnesis), HBsAg positive, Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy), History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection, 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 immunosuppresant, Pregnancy & Lactation (Adult), Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization |
| Administrative Information | |
| Nomor Persetujuan Etik | 1922/UN14.2.2.VII.14/LT/2025 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | HepB 0322 |
| Contact Person | Dr. dr. I Gusti Ayu Trisna Windiani, SpA(K) |