A Phase III Open-label Randomised Study to Evaluate the Immunogenicity and Safety of the Concomitant Administration of a New Hexavalent DTaP-IPV-HepB-PRP-T Combined Vaccine (Hexavalent Vaccine) Given at 2, 3, and 4 Months of Age With a Meningococcal Serogroup C Conjugate (MenC) Vaccine Given at 2 and 4 Months of Age

Date de début de l'étude : 1 avril 2013

Inclusion Criteria: Healthy infant 46 to 74 days of age (both inclusive) Born at full term of pregnancy (≥37 weeks) and/or with a birth weight≥2.5 kg Subject's parent(s) or legal representative able to comply with the study procedures Exclusion Criteria: Participation in another clinical study investigating a vaccine, drug, medical device, or medical procedure Receipt of any vaccine in the 4 weeks preceding each study vaccination Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, meningococcal, pneumococcal, rotavirus infection Know or suspected congenital, hereditary or acquired immunodeficiency History of seizures or encephalopathy Known thrombocytopenia Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection Chronic illness that could interfere with trial conduct or completion Known or suspected hypersensitivity to any of the study vaccines' active substance or excipients or history of a life-threatening reaction to a vaccine(s) containing the same substances as the study vaccines Contraindication to any of the study vaccines Known personal or maternal history of hepatitis B or hepatitis C seropositivity History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, Haemophilus influenzae type b or meningococcal serogroup C infection Receipt of immune globulin, blood or blood-derived products, immunosuppressive drugs, systemic corticosteroid since birth Identified as a natural or adopted child of the investigator or employee with direct involvement in the current study.