DTaP-IPV/Hib Vaccine Primary & Booster Vaccinations Versus Co-administration of DTaP-IPV and Hib Vaccine in Japanese Infants

Inclusion Criteria:

• Aged 2 months to 68 months inclusive (recommended 3 to 8 months for Groups A and B; 2months for Group C) on the day of inclusion
• Informed consent form signed by the parent(s) or other legal representative
• Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

• Fever ≥ 37.5°C (axillary temperature) on the day of inclusion
• Any serious disease whether acute or chronic
• Past or current medical history of Guillain-Barre syndrome, acute thrombocytopenicpurpura or encephalopathy
• History of diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzaetype b infections
• History of a life threatening reaction to a vaccine containing the same substances ofthe study vaccine
• History of anaphylaxis to any of the study vaccine components
• Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis orHaemophilus influenzae type b infections with a trial vaccine or another vaccine
• Congenital or current acquired immunodeficiency, immunosuppressive therapy such aslong-term systemic corticosteroids therapy
• Participation in another clinical trial preceding the trial inclusion
• Planned participation in another clinical trial during the present trial period
• Blood or blood-derived products received in the past or current or plannedadministration during the trial (including immunoglobulins)
• Any vaccination with live vaccines within the past 27 days preceding the first trialvaccination
• Any vaccination with inactivated vaccines within the past 6 days preceding the firsttrial vaccination
• Clinical or known serological evidence of systemic illness including Hepatitis B,Hepatitis C and/or HIV infection
• Subject ineligible according to the Investigator's clinical judgment
• Identified as employee of the Investigator or study center, with direct involvement inthe proposed study or other studies under the direction of that investigator or studycenter, as well as family member (i.e., immediate, husband, wife and their children,adopted or natural) of the employees or the Investigator.