Immunogenicity and Safety Following In-House Recombinant Hepatitis B Vaccine in Indonesian Population (Phase III)

This is a phase 3, experimental, randomized, observer-blind, lot to lot consistency study. A total of 540 subjects will be involved in this study.

The primary objective of this study is to assess the protectivity of In-House Recombinant Hepatitis B vaccine 28 days after 3 doses immunization.

Inclusion criteria

• Healthy individual aged 10 - 50 years old, 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 >= 37.5 C) 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 immunosuppressant.
• Pregnancy & Lactation (Adult).
• Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization.