This study will only include infants born to mothers who are tested as seronegative for human immunodeficiency virus (HIV) & hepatitis B surface antigen (HBsAg). The purpose of this study is to demonstrate in infants who received a birth dose of hepatitis B vaccine that Tritanrix™-HepB/Hib-MenAC vaccine is at least as good as Tritanrix™-HepB/Hiberix™ with respect to immunogenicity of the hepatitis B antigen.

Randomized study with two groups to receive one of the following vaccination regimens:

• GSK Biologicals' Tritanrix™-HepB/Hib-MenAC
• GSK Biologicals' Tritanrix™-HepB/Hiberix™

Inclusion criteria:

• Healthy infants aged 7 days +/- 3 days old born to mothers who are tested as seronegative for HIV & HBsAg, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.

Exclusion criteria:

• Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease since birth.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
• A family history of congenital or hereditary immunodeficiency.
• Major congenital defects or serious illness.
• 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.
• A birth dose of hepatitis B vaccine given outside the frame of this study.

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.