Protectivity and Safety Following Recombinant Hepatitis B Vaccine

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.

Experimental, randomized, double blind, four arm parallel group study, lot to lot consistency study.

Inclusion criteria

• 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.
• Subjects/parents/guardian(s) have been informed properly regarding the study and signed the informed consent form/ informed assent form.
• 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.
• Subjects with known history of Hepatitis B contained vaccination in the last 10 years
• Evolving severe illness and/or chronic disease and fever (axillary temperature more than37.5oC) within the 48 hours preceding enrollment.
• Known history of allergy to any component of the vaccines (based on anamnesis)
• HBsAg positive
• Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy).
• History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
• 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.
• Pregnancy & Lactation (Adult)
• Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.