Protectivity and Safety Following Recombinant Hepatitis B Vaccine
Tahapan Penelitian : Initial
PT Bio Farma
Fakultas Kedokteran Universitas Diponegoro
Tanggal Input Registry : 27-08-2019
|Tanggal Antisipasi Studi
|To asses the protectivity of investigational product after three doses of vaccine in children, adolescents and adults.
|• To describe immunogenicity of investigational product in all subjects. • To assess the safety of investigational product in all subjects. • To evaluate immunogenicity and safety after primary series of investigational product compare to control • To evaluate immunogenicity and safety in three consecutive batches of investigational product in all subjects
|Judul Penelitian Popular
|Protectivity and Safety Following Recombinant Hepatitis B Vaccine
|Judul Penelitian Ilmiah
|Protectivity and Safety Following Recombinant Hepatitis B Vaccine with different source of Hepatitis B bulk compared to Hepatitis B (Bio Farma) vaccine in Indonesian Population
|3 doses of Recombinant Hepatitis B
|Jumlah Subyek Penelitian
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
|No. 80/EC/FK UNDIP/III/2019
|Nomor Persetujuan Material Transfer Agreement
|Nomor Persetujuan Pelaksanaan Uji Klinik
|Other Study ID Numbers
|Hep B 0218