TABLE 2.
Seroprotection Rates, Vaccine Response Rates, Geometric Mean Concentrations, and Geometric Mean Titers for DTwP-IPV-HB-PRP~T and DTwP-HB-PRP~T+bOPV+IPV Pre-first Vaccination and Post-third Vaccination (PP Analysis Set)
| DTwP-IPV-HB-PRP~T | DTwP-HB-PRP~T+bOPV+IPV | ||||
|---|---|---|---|---|---|
| Antigen | Variable | Pre-first Vaccination | Post-third Vaccination | Pre-first Vaccination | Post-third Vaccination |
| Anti-D | ≥0.01 IU/mL | 95.9 (92.3;98.1) | 100 (98.3;100) | 95.0 (91.2;97.5) | 100 (98.3;100) |
| ≥0.1 IU/mL | 55.8 (48.9;62.5) | 99.1 (96.7;99.9) | 50.2 (43.4;57.0) | 100 (98.3;100) | |
| ≥1.0 IU/mL | 5.1 (2.6;8.9) | 82.0 (76.3;86.9) | 1.8 (0.5;4.6) | 85.4 (80.0;89.8) | |
| GMC | 0.104 (0.088;0.124) | 1.86 (1.65;2.09) | 0.093 (0.077;0.111) | 2.09 (1.89;2.31) | |
| GMCR | NA | 17.8 (14.0;22.7) | NA | 22.6 (17.6;28.9) | |
| Anti-T | ≥0.01 IU/mL | 100 (98.3;100) | 100 (98.3;100) | 100 (98.3;100) | 100 (98.3;100) |
| ≥0.1 IU/mL | 99.1 (96.7;99.9) | 100 (98.3;100) | 97.3 (94.1;99.0) | 100 (98.3;100) | |
| ≥1.0 IU/mL | 66.4 (59.7;72.6) | 96.3 (92.9;98.4) | 63.0 (56.2;69.4) | 97.3 (94.1;99.0) | |
| GMC | 1.36 (1.19;1.56) | 4.51 (4.09;4.97) | 1.20 (1.03;1.40) | 4.42 (4.02;4.86) | |
| GMCR | NA | 3.30 (2.79;3.91) | NA | 3.69 (3.07;4.43) | |
| Anti-HBs | ≥10 mIU/mL | 26.4 (20.6;32.8) | 98.6 (96.0;99.7) | 25.3 (19.7;31.7) | 98.6 (96.0;99.7) |
| ≥100 mIU/mL | 9.7 (6.1;14.5) | 93.5 (89.4;96.4) | 6.5 (3.6;10.6) | 96.8 (93.5;98.7) | |
| GMC | 6.35 (5.18;7.79) | 1694 (1349;2128) | 5.99 (4.97;7.21) | 2058 (1672;2532) | |
| GMCR | NA | 271 (205;358) | NA | 342 (266;440) | |
| Anti-polio 1 | ≥8 (1/dil) | 42.4 (35.7;49.3) | 100 (98.3; 100) | 49.3 (42.5;56.1) | 100 (98.3; 100) |
| GMT | 6.47 (5.51;7.60) | 2272 (1992;2592) | 6.70 (5.85;7.66) | 1516 (1320;1742) | |
| GMTR | NA | 351 (279;442) | NA | 226 (189;271) | |
| Anti-polio 2 | ≥8 (1/dil) | 57.5 (50.6;64.2) | 100 (98.3; 100) | 55.1 (48.2;61.8) | 98.2 (95.4;99.5) |
| GMT | 9.10 (7.83;10.60) | 2355 (2085;2660) | 8.11 (6.99;9.41) | 53.2 (47.3;59.8) | |
| GMTR | NA | 256 (209;312) | NA | 6.52 (5.34;7.96) | |
| Anti-polio 3 | ≥8 (1/dil) | 28.6 (22.7;35.1) | 100 (98.3; 100) | 33.9 (27.7;40.6) | 100 (98.3; 100) |
| GMT | 5.30 (4.74;5.93) | 3040 (2649;3488) | 5.97 (5.35;6.67) | 1407 (1242;1595) | |
| GMTR | NA | 579 (484;692) | NA | 236 (200;278) | |
| Anti-PRP | ≥0.15 µg/mL | 30.1 (24.1;36.7) | 100 (98.3; 100) | 26.7 (21.0;33.1) | 99.5 (97.5;100) |
| ≥1 µg/mL | 3.7 (1.6;7.2) | 96.3 (92.9;98.4) | 1.8 (0.5;4.7) | 94.5 (90.6;97.1) | |
| GMC | 0.078 (0.064;0.094) | 15.2 (13.0;17.8) | 0.071 (0.060;0.083) | 11.2 (9.50;13.1) | |
| GMCR | NA | 196 (152;253) | NA | 157 (125;197) | |
| Anti-PT | ≥2 EU/mL | 66.8 (60.1;73.0) | 96.8 (93.5;98.7) | 69.9 (63.3;75.9) | 97.3 (94.1;99.0) |
| VR* | NA | 63.6 (56.8;70.0) | NA | 69.4 (62.8;75.4) | |
| ≥4-fold rise | NA | 54.8 (48.0;61.6) | NA | 60.3 (53.5;66.8) | |
| GMC (EU/mL) | 6.55 (5.22;8.21) | 44.2 (34.8;56.1) | 6.38 (5.12;7.94) | 65.3 (51.6;82.6) | |
| GMCR | NA | 6.75 (4.41;10.3) | NA | 10.2 (6.79;15.4) | |
| Anti-FIM | ≥2 EU/mL | 88.0 (82.9;92.0) | 100 (98.3;100) | 87.2 (82.1;91.3) | 99.1 (96.7;99.9) |
| VR* | NA | 94.9 (91.1;97.4) | NA | 95.4 (91.8;97.8) | |
| ≥4-fold rise | NA | 89.4 (84.5;93.2) | NA | 93.2 (89.0;96.1) | |
| GMC (EU/mL) | 11.4 (9.31;14.0) | 928 (798;1080) | 10.7 (8.77;13.0) | 1161 (985;1369) | |
| GMCR | NA | 81.2 (60.3;109) | NA | 109 (81.4;146) | |
| Anti-PRN | ≥2 EU/mL | 48.8 (42.0;55.7) | 94.0 (90.0;96.8) | 50.7 (43.9;57.5) | 98.6 (96.0;99.7) |
| VR* | NA | 72.4 (65.9;78.2) | NA | 81.3 (75.5;86.2) | |
| ≥4-fold rise | NA | 64.5 (57.8;70.9) | NA | 72.6 (66.2;78.4) | |
| GMC (EU/mL) | 3.38 (2.72;4.19) | 21.1 (17.9;24.9) | 3.88 (3.07; 4.89) | 39.3 (34.1;45.2) | |
| GMCR | NA | 6.26 (4.88;8.02) | NA | 10.1 (7.82;13.1) | |
| Anti-FHA | ≥2 EU/mL | 90.3 (85.6;93.9) | 100 (98.3;100) | 91.3 (86.8;94.7) | 100 (98.3;100) |
| VR* | NA | 57.1 (50.3;63.8) | NA | 66.7 (60.0;72.9) | |
| ≥4-fold rise | NA | 37.3 (30.9;44.1) | NA | 48.9 (42.1;55.7) | |
| GMC (EU/mL) | 20.5 (16.1;26.0) | 42.9 (38.4;48.0) | 24.8 (19.4;31.7) | 93.2 (83.4;104) | |
| GMCR | NA | 2.10 (1.56;2.82) | NA | 3.75 (2.73;5.16) | |
VR rate defined for anti-PT, anti-FIM, anti-PRN, and anti-FHA as: if pre-first vaccination concentration is <4 × lower limit of quantification (LLOQ) then post-third vaccination concentration ≥4 × LLOQ; if pre-first vaccination concentration ≥4 × LLOQ then post-third vaccination concentration ≥prevaccination concentration.
GMC indicates geometric mean concentration;GMCR, geometric mean concentration ratio; GMT, geometric mean titer; GMTR, geometric mean titer ratio; NA, not applicable; VR, vaccine response rate.
Data are % (95% CI) participants with titer or concentration above threshold, VR, 4-fold rise from pre-first vaccination, GMT, or GMC.