Assessment of the Immunogenicity and Safety of PENTAXIM™ in Philippines

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)