Immunogenicity and Safety of Primary and Booster Vaccination With DTPa-HBV-IPV/Hib Vaccine

Inclusion Criteria: Inclusion criteria for enrolment at birth * Written informed consent obtained from the parents or guardians of the subject. * A male or female infant born after a normal gestation period (between 36 and 42 weeks). * Born to a mother seronegative for HBsAg. * Free of obvious health problems as established by clinical examination before entering into the study. Inclusion criteria for administration of the combined vaccine regimen * Between, and including, 6 and 8 weeks of age at the time of the first dose of the three-dose course of vaccination. * Free of obvious health problems as established by medical history and clinical examination before entering into this phase of the study. Inclusion criteria for administration of the booster dose * Between, and including, 15 and 18 months of age at the time of the booster vaccination. * Written informed consent obtained from the parents or guardians of the subject. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Completion of the three-dose primary vaccination course. Exclusion Criteria: Exclusion criteria for enrolment at birth * A family history of congenital or hereditary immunodeficiency. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection. * Major congenital defect(s). Exclusion criteria for administration of the combined vaccine regimen * Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration Immunosuppressants or other immune-modifying drugs since birth. * Any chronic drug therapy to be continued during the study period. * Planned administration/ administration of a vaccine except Bacille Calmette-Guérin vaccine during the period starting from 30 days before each dose of vaccines and ending 30 days after. * Previous vaccination against diphtheria, tetanus, pertussis or Haemophilus influenzae type b disease. * History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B and/or Haemophilus influenzae type b disease. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * Serious chronic illness. * History of any neurologic disorders or seizures. * Acute disease at the time of enrolment. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. Exclusion criteria for administration of the booster dose * Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the booster dose of study vaccines, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months of vaccination. * Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and/or Haemophilus influenzae type b. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * Acute disease at the time of enrolment. * History of any neurologic disorders or seizures. * Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose of study vaccine or planned administration during the study period. * Hypersensitivity reaction due to vaccine in primary course * Encephalopathy within 7 days of previous vaccination with DTP vaccine