Assessment of the Immunogenicity and Safety of PENTAXIM™ in Philippines

Open, randomized, multicentric, controlled trial. Infants will be randomly allocated in one of the two study groups as follows:

Group A: 212 subjects will receive the PENTAXIM™ vaccine at 6, 10 and 14 weeks of age, and the recombinant 10 µg hepatitis B vaccine at 0, 6 and 14 weeks of age.

Group B: 212 subjects will receive the PENTAXIM™ and the recombinant 10 µg hepatitis B vaccines at 6, 10 and 14 weeks of age.

All infants included in the study will receive a booster dose of PENTAXIM™ vaccine at 18-19 months of age.

Inclusion criteria

• Informed consent signed by one or both parent(s) and/or by a legally accepted representative prior to the first study intervention
• Healthy male or female newborn
• Age ranging from birth to 48 hours of life (included)
• Birth weight >2.5 kg and gestational age >37 weeks
• Born to HBs antigen-negative mother

Exclusion criteria

• Known previous therapy of the mother with cadaveric pituitary derived human growth hormone
• Infant presently enrolled or scheduled to be enrolled in another clinical trial
• Infant with moderate or severe illness, mainly infectious diseases
• Infant with fever (rectal temperature > 38°C or axillary temperature > 37.5°C)
• Infant with severe congenital defects or abnormalities
• Uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
• Known immunological deficiency (including a known HIV seropositive mother)
• Administration of vaccine since birth (other than BCG)
• Previous or planned administration of immunosuppressive therapy, immunoglobulins and /or any blood-derived products (inhaled and topical corticoids are allowed)