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

Each study age group/arm will be divided into two groups of treatment. One group will receive investigational product and one other group will receive active comparator. This Study is sequential age de-escalation. To be conducted in heathy adults (18-40 years old) and followed by children (10-17 years old) ). Before the study started, the subjects will be assessed for anti HBs Antibody. For subjects with anti-HBs not protective (< 10mIU/mL) before immunization, additional 2 doses will be required with 1 month interval.

Inclusion criteria

Adult

• 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.
• Subjects have been informed properly regarding the study and signed the informed consent form
• Subjects will commit to comply with the instructions of the investigator and the schedule of the trial

Children:

• 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.
• Subjects/parents/guardian(s) have been informed properly regarding the study and signed the informed consent form and
• 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
• Any direct relatives relationship with the study team.
• Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C) within the 48 hours preceding enrollment.
• Known history of allergy to any component of the vaccines (based on anamnesis)
• Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy)
• History of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy.
• 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).
• Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
• Pregnancy or planning a pregnancy within the next 3 months & lactation. (for Adults)
• Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.
• HbsAg positive
• Subjects with known history of Hepatitis B infection.
• Subjects who have received Hepatitis B vaccination which proven by vaccination records.
• Subject planning to move from the study area before the end of study period.