This trial is open label, comparative, randomized, phase I/II study, experimental, randomized, open-label, three arm parallel group study. The primary objective for phase I is to evaluate the safety of the DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine within 7 days after each dose. The primary objective for phase II is to evaluate protectivity of DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine.
Infant 6-11 weeks of age.
Infant born after 37-42 weeks of pregnancy.
Infant weighing more than 2.5 kg at birth.
Father or mother, or legally acceptable representative properly informed about the study and signed the informed consent form.
Child concomitantly enrolled or scheduled to be enrolled in another trial.
Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥37.5°C on Day 0).
Known history of allergy to any component of the vaccines.
History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
PT Bio Farma
Lead sponsor
Faculty of Medicine Universitas Padjadjaran
Collaborator