TABLE 1.

Noninferiority Analysis for DTwP-IPV-HB-PRP~T versus DTwP-HB-PRP~T+bOPV+IPV at 1 Month After the Three-dose Primary Vaccination Sseries (PP analysis set)

				DTwP-IPV-HB-PRP~T versus DTwP-HB-PRP~T+bOPV+IPV
Antigen	Seroprotection Threshold*	DTwP-IPV-HB-PRP~T	DTwP-HB-PRP~T+bOPV+IPV	Difference or Ratio† (95% CI)	Delta	Noninferiority
Anti-D	≥0.01 IU/mL	100 (98.3;100)	100 (98.3;100)	0.00 (−1.74;1.72)	−10%	Yes
Anti-T	≥0.01 IU/mL	100 (98.3;100)	100 (98.3;100)	0.00 (−1.74;1.72)	−10%	Yes
Anti-PRP	≥0.15 µg/mL	100 (98.3;100)	99.5 (97.5;100)	0.46 (−1.32;2.54)	−10%	Yes
Anti-HBs	≥10 mIU/mL	98.6 (96.0;99.7)	98.6 (96.0;99.7)	−0.01 (−2.77;2.72)	−10%	Yes
Anti-polio 1	≥8 (1/dil)	100 (98.3;100)	100 (98.3;100)	0.00 (−1.74;1.72)	−10%	Yes
Anti-polio 2	≥8 (1/dil)	100 (98.3;100)	98.2 (95.4;99.5)	1.83 (−0.25;4.60)	−10%	Yes
Anti-polio 3	≥8 (1/dil)	100 (98.3;100)	100 (98.3;100)	0.00 (−1.76;1.72)	−10%	Yes
Anti-PT	aGMC	44.6 (37.3;53.3)	64.7 (54.1;77.3)	0.690 (0.536;0.888)	0.5	Yes
Anti-FIM	aGMC	937.3 (807.6;1087.7)	1150.4 (992.0;1334.2)	0.815 (0.660;1.01)	0.5	Yes

^*Not applicable for pertussis antigens (aGMC presented for anti-PT and anti-FIM).

^†Difference for anti-D, anti-T, anti-PRP, anti-HBs, anti-polio 1, 2, 3; ratio for anti-PT and anti-FIM.

Data are % (95% CI) (anti-D, anti-T, anti-HBs, anti-polio 1, 2, 3, and anti-PRP) or aGMC (95% CI) (anti-PT and anti-FIM).

For anti-D, anti-T, and anti-PRP, anti-HB, anti-polio 1, 2, 3, non-inferiority was concluded if the lower limit of the 2-sided CI for the difference was greater than 10%.

For anti-PT and anti-FIM, non-inferiority was concluded if the lower limit of the 2-sided 95% CI of the ratio was greater than 0.5.