Hepatitis B seroprotection rate (primary objective)
The investigational DTwP-HepB-Hib vaccine formulation (group 1) was non-inferior to the comparator DTwP-HepB-Hib vaccine formulation (group 2) for anti HBsAg in terms of post-dose 3 seroprotection rates in the PPAS population. Seroprotection against HepB at post-dose 3 was observed in 99.1% (95% CI, 96.6–99.9) and 99.0% (95% CI, 96.5–99.9) of subjects in the groups 1 and 2 respectively. The difference in seroprotection rates between the two groups was 0.1% (95% CI, -2.47 to 2.68). The lower limit of the 2-sided 95% CI of the difference between the 2 vaccine groups was -2.4% which was well above the lower limit of the 2-sided 95% CI of the difference defined for demonstration of non-inferiority, i.e. above -10% (minus delta).