The Safety and Immunogenicity of DTP/Hepatitis B 10ug Hib Vaccine (Bio Farma)

Phase 1 of DTP/Hepatitis B 10ug Hib Vaccine

The objective of this study was to know the safety of DTP/Hepatitis B and Hib/PRP-T vaccine and immediate reactions within the first 30 minutes after injection.

This trial was an open-label study, no randomization, and no placebo or control group. Total 30 healthy infants (age 6-11 weeks) followed this trial. The safety was assessed within 24 hours, 48 hours, 72 hours, and 28 days after injection.

Inclusion Criteria:

• Infant 6-11 week of age
• Infant born after 37-42 week of pregnancy
• Infant weighting more than 2.5 kg at birth
• Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form
• Parents commit themselves to comply with the indication of the investigator and with the schedule of the trial

Exclusion Criteria:

• Child concomitantly enroll or schedule to be enroll in another trial
• Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature >=37.5 Celsius on Day 0)
• Known history of allergy to any component of the vaccine component (e.g.formaldehyde)
• History of uncontrolled coagulopathy or blood disorder contraindicating intramuscular injection
• Known history of congenital or acquired immunodeficiency (including HIV infection)
• Child who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulin, blood derived product or long term corticotherapy (>2 minggu)
• Other vaccination within the 7 days prior to inclusion 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 objective
• Infant with a known history of diphteria, tetanus, pertussis, Hib, Hepatitis B infection