Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B

Comparison of Immunogenicity and Safety of DTP-HB-Hib (Bio Farma) with Pentabio® vaccine Primed with Recombinant Hepatitis B at Birth dose (using different source of Hepatitis B), in Indonesian Infants

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Child concomitantly enrolled or scheduled to be enrolled in another trial.
• Mother with HBsAg positive.
• Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature >37.5C on Day 0).
• Suspected of allergy to any component of the vaccines (e.g. formaldehyde).
• Suspected of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
• Newborn suspected of congenital or acquired immunodeficiency (including HIV infection).
• Received or plans to receive any treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (> 2 weeks)).
• Received other vaccination with the exception of BCG and poliomyelitis.
• Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.

Randomized, double blind, 2 arms parallel group, prospective intervention study This study will do the lot to lot consistency and will be compared to registered product