Immunogenicity and Safety of DTPa-HBV-IPV/Hib Compared to DTPa-IPV/Hib and HBV Administered Concomitantly

Inclusion Criteria: * A male or female between 12 and 16 weeks of age at the time of the first vaccination. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Written informed consent obtained from the parents or guardians of the subject after they have been advised of the risks and benefits of the study in a language which they clearly understood, and before performance of any study procedure. Exclusion Criteria: * Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine. * Administration of chronic immunosuppressants or immune-modifying drugs during the study period. * Administration of a vaccine not foreseen by the study protocol during the period starting from one month before each dose and ending one month after each dose. * Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib diseases. * History of/or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio and/or Hib disease. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. * History of allergic disease or reaction likely to be exacerbated by any component of the vaccine, including allergic reactions to neomycin and polymyxin B. * Major congenital defects or serious chronic illness. * Progressive neurological disorders. * Administration of immunoglobulins and/or any blood products since birth and during the study period. * Acute febrile illness at the time of planned vaccination.