Safety and Preliminary of Immunogenicity Following Recombinant Hepatitis B (Bio Farma) Vaccine in Adults & Children

Tahapan Penelitian : Awal
Sponsor:
Mitra Pelaksana:
Dept Ilmu Kesehatan Anak Universitas Padjadjaran/RSUP dr. Hasan Sadikin, Bandung
No Registry
INA-DPS3T9B
Tanggal Input Registry : 28-11-2019

03-12-2019
The main evaluation criteria are number and percentage of subjects with at least one immediate reaction (local reaction or systemic event) within 30 minutes after one dose or three doses of Hepatitis B vaccination
Safety • Number and percentage of subjects with at least one of these adverse events, solicited or not, within 24 h, 48h, 72h and 28 days after each dose of vaccination. • Number and percentage of subjects with serious adverse event from inclusion until 28 day after each dose of vaccination. • Any deviation from routine laboratory evaluation that probably related to the vaccination (adults subject) • Description of safety data between groups Immunogenicity: Preliminary assessment of immunogenicity of anti-HBs following 1 dose of vaccination • Number and percentage of subjects with anti HbsAg ≥10mIU/ml, 28 days after 1 doses of vaccination.
 
Safety and Preliminary of Immunogenicity Following Recombinant Hepatitis B (Bio Farma) Vaccine in Adults & Children
Safety and Preliminary of Immunogenicity Following Recombinant Hepatitis B (Bio Farma) Vaccine in Adults & Children
Eksperimental
Investigational Product Recombinant Hepatitis B (Bio Farma) Vaccine Form Liquid (in uniject) Dose 1 mL Route Intramuscular injection (deltoid) Batch Number 3660318UK Expiry Date September 2020 Active Comparator Recombinant Hepatitis B (Bio Farma) Vaccine® Form Liquid (in uniject) Dose 1 mL Route Intramuscular injection (deltoid) Batch Number 3660718 Expiry Date 31 August 2020
100
 

Inclusion Criteria:

Inclusion criteria Adult: 1. Healthy individu as determined by clinical judgment, including a medical history, physical exam, rontgen thorax and laboratory results, which confirms the absence of a current or past disease state considered significant by the investigator. 2. Subjects have been informed properly regarding the study and signed the informed consent form 3. Subjects will commit to comply with the instructions of the investigator and the schedule of the trial. Children: 1. Healthy individu as determined by clinical judgment, including a medical history, physical exam and rontgen thorax 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 and 3. Subject/parents/guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial

Exclusion Criteria:

Exclusion criteria: 1. Subject concomitantly enrolled or scheduled to be enrolled in another trial 2. Any direct relatives relationship with the study team. 3. Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C) within the 48 hours preceding enrollment. 4. Known history of allergy to any component of the vaccines (based on anamnesis) 5. Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy) 6. History of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy. 7. 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). 8. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives. 9. Pregnancy or planning a pregnancy within the next 3 months & lactation. (for Adults) 10. Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization. 11. HbsAg positive 12. Subjects with known history of Hepatitis B infection. 13. Subjects who have received Hepatitis B vaccination which proven by vaccination records. 14. Subject planning to move from the study area before the end of study period.
 
1030/UN6.KEP/EC/2019
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R6.01.06.321.11.19.4609
Hep B 0119
Asep Irham