Pertussis immune responses (primary objective)
hepatitis B
HEPATITIS B, PERTUSSIS
The investigational DTwP-HepB-Hib vaccine formulation (group 1) was non-inferior to the comparator DTwP-HepB-Hib vaccine formulation (group 2) for anti-pertussis responses in terms of post-dose 3 aGMCs in the PPAS population. The aGMC for anti-PT at day 84 were 76.7 EU/mL (95% CI, 62.1–94.7) and 63.3 EU/mL (95% CI, 50.9–78.6) for groups 1 and 2 respectively. The ratio of the aGMC for anti-PT antibodies at day 84 between the 2 study groups was 1.21 (95% CI, 0.89–1.64). The lower limit of the 95% CI of the ratio of aGMC for anti-PT (0.89) was above the lower limit defined for demonstration of non-inferiority for anti-PT, i.e. above 0.5.The aGMC for anti-FIM at day 84 were 1079 EU/mL (95% CI, 898–1296) and 1129 EU/mL (95% CI, 935–1362) for Groups 1 and 2 respectively. The ratio of the aGMC for anti-FIM antibodies at day 84 between the 2 study groups was 0.95 (95% CI, 0.73–1.24). The lower limit of the 95% CI of the ratio of aGMC for anti-FIM (0.73) was above the lower limit defined for demonstration of non-inferiority for anti-FIM, i.e. above 0.5.The immunogenicity of the investigational DTwP-HepB-Hib vaccine formulation was demonstrated to be non-inferior to the comparator DTwP-HepB-Hib vaccine formulation for HepB and pertussis antigens.The results were similar in the FAS population for both hepatitis B seroprotection rate and pertussis immune responses.