Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine in Indian Infants Previously Given a Dose of Hepatitis B Vaccine at Birth

Inclusion Criteria: * Aged between 42-56 days (6 to 8 weeks) on the day of inclusion * Born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg * Informed consent form signed by the parent(s) or any other legally acceptable representative * Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures * Born to known hepatitis B surface antigen (HBsAg) seronegative mother (documented laboratory result of HBsAg assay from maternal blood sample performed during last trimester of pregnancy available) * Have received one documented dose of Hep B vaccine and oral poliovirus vaccine (OPV) from birth as per national recommendations. Exclusion Criteria: * Participation in another clinical trial in the 4 weeks preceding the trial inclusion or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure * Receipt of any vaccine in the 4 weeks preceding the first trial vaccination (except Bacillus Calmette-Guerin \[BCG\] vaccine) or planned receipt of any other vaccine within the period from 8 days before to 8 days after each subsequent trial vaccination * Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis (expect the birth dose of OPV as per national recommendations) and hepatitis B (except the birth dose of Hep B vaccine) diseases or Hib infection with the trial vaccine or another vaccine * Past or current receipt of immune globulins, blood or blood-derived products or planned administration during the trial * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy since birth; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth) * History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, or Hib infections (confirmed either clinically, serologically or microbiologically) * Known personal or maternal history of Human Immunodeficiency Virus (HIV) or hepatitis C seropositivity * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances * Known thrombocytopenia, as reported by the parent/legally acceptable representative * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination * In an emergency setting, or hospitalized involuntarily * Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion * Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (axillary temperature ≥38°C) on the day of inclusion (a prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided) * Identified as a natural or adopted child of the Investigator, relatives or employee with direct involvement in the proposed study * History of seizures.