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

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.