Assess the Feasibility of an Investigational Vaccination Regimen, Compared to a 3-dose Primary Vaccination With GSK Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib Vaccine) Following Hepatitis B Vaccination at Birth. Primary Vaccination is Followed in the 2nd Year of Life by a Booster Dose of Infanrix-hexa

Number of seroprotected subjects for anti-polyribosyl ribitol phosphate (anti-PRP)

时间窗: At Month 1 post-booster vaccination

A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.15 g/mL.

Antibody concentrations for anti-polyribosyl ribitol phosphate (anti-PRP)

时间窗: At Month 1 post-booster vaccination

Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 g/mL.

Number of seroprotected subjects for anti-Hepatitis B surface antigen (anti-HBs) antibodies

时间窗: At Month 1 post-booster vaccination

A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.

Antibody concentrations for anti-Hepatitis B surface antigen (anti-HBs) antibodies

时间窗: At Month 1 post-booster vaccination

Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 10 mIU/mL.

Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

时间窗: At Month 1 Post-Booster

Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.

Modified vaccine response for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

时间窗: At Month 1 Post-Booster

Modified vaccine response was defined as: For initially seronegative subjects, antibody concentration 5 EL.U/mL at one month after the third dose of Infanrix hexa™. For initially seropositive subjects: antibody concentration at one month post vaccination 0.25 fold the pre-vaccination antibody concentration.

Antibody concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies

时间窗: At Month 1 post-booster vaccination

Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL.

Number of subjects with solicited general symptoms

时间窗: During the 8-day (Day 0-Day 7) follow-up period after the any dose and booster vaccination

The solicited local symptoms assessed were Drowsiness, Temperature (Fever), Irritability and Loss of appetite. Temperature = Fever ≥ 38.0 °C. Grade 3 drowsiness = drowsiness that prevented normal activity; Grade 3 irritability = crying that could not be comforted/prevented normal activity; Grade 3 loss of appetite = not eating at all; Grade 3 Temperature = \> 39.5 °C. Related = symptoms considered by the investigator to have a causal relationship to vaccination.

Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies

时间窗: At Month 1 Post-Booster

A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL.

Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies

时间窗: At Month 1 post-booster vaccination

A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.

Number of subjects with unsolicited adverse events (AES)

时间窗: Occurring within Day 0-30 following primary and booster vaccination

An AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.