Immunogenicity and Safety Following In-House Recombinant Hepatitis B (Bio Farma) vaccine compared to Hepatitis B (Bio Farma) ® vaccine in Indonesian Population (Phase III)
Tahapan Penelitian : Initial
PT. Bio Farma
Department of Child Health, Medical Faculty of Universitas Udayana, Prof. Dr. I.G.N.G Ngoerah Hospital, Bali, Indonesia.
Tanggal Input Registry : 06-02-2023
|Tanggal Antisipasi Studi||06-03-2023|
|Outcome Primer||To assess the protectivity of In-House Recombinant Hepatitis B vaccine 28 days after 3 doses immunization.|
|Outcome Skunder||To describe immunogenicity of In-House Recombinant Hepatitis B vaccine. To assess the safety of In-House Recombinant Hepatitis B vaccine. To evaluate immunogenicity and safety in three consecutive batches of In-House Recombinant Hepatitis B vaccine. To evaluate immunogenicity and safety after primary series of investigational product compare to control.|
|Judul Penelitian Popular||Immunogenicity and Safety Following In-House Recombinant Hepatitis B (Bio Farma) vaccine compared to Hepatitis B (Bio Farma) ® vaccine in Indonesian Population (Phase III)|
|Judul Penelitian Ilmiah||Immunogenicity and Safety Following In-House Recombinant Hepatitis B (Bio Farma) vaccine compared to Hepatitis B (Bio Farma) ® vaccine in Indonesian Population (Phase III)|
|Intervensi||Treatment Group: In-House Recombinant Hepatitis B Bio Farma Vaccine, three doses vaccine, intramuscular injection. Control Group: Recombinant Hepatitis B (Bio Farma) Vaccine, three doses vaccine, intramuscular injection.|
|Jumlah Subyek Penelitian||540|
Inclusion Criteria:1. Healthy individu 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. 2. Subjects/parents/guardian(s) have been informed properly regarding the study and signed the informed consent form/ informed assent form. 3. Subject/parents/guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial.
Exclusion Criteria:1. Subject concomitantly enrolled or scheduled to be enrolled in another trial. 2. Subjects with known history of Hepatitis B contained vaccination in the last 10 years. 3. Evolving severe illness and/or chronic disease and fever (axillary temperature 37.5C) within the 48 hours preceding enrollment. 4. Known history of allergy to any component of the vaccines (based on anamnesis). 5. HBsAg positive. 6. Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy). 7. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection. 8. 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. 9. Pregnancy & Lactation (Adult). 10. Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.
|Nomor Persetujuan Etik||2738/UN.14.2.2.VII.14/LT/2022|
|Nomor Persetujuan Material Transfer Agreement|
|Nomor Persetujuan Pelaksanaan Uji Klinik|
|Other Study ID Numbers||Hep B 0322|
|Contact Person||Dr. dr. I Gusti Ayu Trisna Windiani, SpA(K)|