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

Exclusion Criteria

• •1. Child concomitantly enrolled or scheduled to be enrolled in another trial.
• •2. Child evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature 37.5 celcius degrees on Day 0).
• •3. Child suspected of allergy to any component of the vaccines (e.g. formaldehyde), based on anamnesis.
• •4. Child suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection, based on anamnesis
• •5. Newborn suspected of congenital or acquired immunodeficiency, based on anamnesis
• •6. 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)).
• •7. Child received other vaccination with the exception of BCG and poliomyelitis.
• •8. Child has any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
• •9. Mother with HbsAg and HIV positive (by rapid test within 30 days prior subject's birth)
• •10. Mother suspected of immunodeficiency disease based on anamnesis