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™
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
192
GSK Investigational Site
Brits, South Africa
GSK Investigational Site
Brits, South Africa
GSK Investigational Site
Centurion, South Africa
GSK Investigational Site
Ga-Rankuwa, South Africa
One month after the third dose of the primary vaccination, measurement of anti-HBs antibody concentrations.
Immunogenicity: One month after the third dose of the primary vaccination, antibody concentrations or titres against all other vaccine antigens.
Reactogenicity and safety: after each dose: solicited (day 0-3, local & general) & unsolicited (day 0-30) symptoms. Over the full course of the study: serious adverse events (SAEs)"
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