Immunogenicity assessment
FHA
SECONDARY, PERTUSSIS
All subjects provided a pre-vaccination (baseline) blood sample at day 0 and a post-vaccination sample 28 days after administration of the third dose (day 84). The serological primary endpoints were assessed 28 days after the third dose of the primary series for the non-inferiority analyses. HepB seroprotection status was defined as anti-HbsAg antibody concentration ≥ 10 mIU/mL. The serological secondary endpoints assessed at baseline (day 0) and 28 days after the third dose of the primary series were antibody concentrations for each valence at each time point and above the following cut-offs: anti-D antibody concentrations ≥ 0.01 IU/mL, ≥ 0.1 IU/mL and ≥ 1.0 IU/mL; anti-T antibody concentrations ≥ 0.01 IU/ mL, ≥ 0.1 IU/mL and ≥ 1.0 IU/mL; anti-HBs antibody concentrations ≥ 10 mIU/mL and ≥ 100 mIU/mL; and anti-PRP antibody concentrations ≥ 0.15 μ/mL and ≥ 1.0 μ/mL. For the pertussis antigens, vaccine responses against PT, filamentous hemagglutinin (FHA), PRN (pertactin) and FIM antigens, were defined as subjects with post-dose 3 vaccination concentrations ≥ 4 x LLOQ if their pre-vaccination concentrations were <4 x LLOQ or with post-dose 3 vaccination concentrations ≥ the pre-vaccination concentrations if their pre-vaccination concentration were ≥ 4 x LLOQ. Vaccine seroconversion status for anti-PT, anti-FHA, anti-PRN and anti-FIM antibodies was defined as subjects with a ≥ 4-fold rise in their respective PT, FHA, PRN, FIM antibody concentrations between pre-dose 1 and post-dose 3. The ratio (post dose 3 /pre-primary) of individual Ab concentration for all Abs were also assessed.All immunological assays were carried out at one central laboratory (Global Clinical Immunology (GCI), Sanofi, Swiftwater, Pennsylvania, USA). The assays were performed on pre-dose 1 and post-dose 3 samples obtained from all the subjects. The method used for D, T, and 