Immunogenicity and Safety of DTP-HB-Hib Using New Hepatitis B Bulk (Bio Farma)

Prior treatment

• Child received or plans to receive any treatment likely to alter the immune response intravenous (immunoglobulins, blood-derived products or long term corticotherapy (> 2 weeks)).
• Child received other vaccination with the exception of BCG and poliomyelitis.
• Mother with HbsAg and HIV positive (by rapid test within 30 days prior subject's birth)

Other illness

• Child evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature 37.5 celcius degrees on Day 0).
• Child suspected of allergy to any component of the vaccines (e.g. formaldehyde), based on anamnesis.
• Child suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection, based on anamnesis
• Child has any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
• Mother suspected of immunodeficiency disease based on anamnesis

Other

• Child concomitantly enrolled or scheduled to be enrolled in another trial.
• Newborn suspected of congenital or acquired immunodeficiency, based on anamnesis

• Healthy, full term, newborns infants.
• Infant born after 37-42 weeks of pregnancy.
• Infant weighing 2500 gram or more at birth.
• Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
• Parents will commit themselves to comply with the indications of the investigator and with the schedule of the trial.