Table 3. Seroprotection/seropositivity rates and antibody GMCs before and one month post-booster (ATP cohort for immunogenicity).
| Antibody |
Group |
Pre-vaccination |
Post-vaccination |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| |
|
N |
SP/S+ |
GMC/GMT |
N |
SP/S+ |
GMC/GMT |
|||||
| % (95% CI) | Value (95% CI) | % (95% CI) | Value (95% CI) | |||||||||
| Diphtheria |
Form 1 |
78 |
88.5 (79.2; 94.6) |
0.301 (0.237; 0.382) |
78 |
100 (95.4; 100) |
6.519 (5.460; 7.783) |
|||||
| Form 1/2 |
78 |
88.5 (79.2; 94.6) |
0.331 (0.258; 0.424) |
78 |
100 (95.4; 100) |
7.687 (6.112; 9.669) |
||||||
| Form 1/3 |
78 |
88.5 (79.2; 94.6) |
0.330 (0.264; 0.412) |
78 |
100 (95.4; 100) |
8.659 (7.132; 10.514) |
||||||
| Control |
77 |
84.4 (74.4; 91.7) |
0.374 (0.276; 0.508) |
77 |
100 (95.3; 100) |
6.807 (5.231; 8.858) |
||||||
| Tetanus |
Form 1 |
78 |
100 (95.4; 100) |
0.776 (0.639; 0.942) |
78 |
100 (95.4; 100) |
26.120 (22.650; 30.121) |
|||||
| Form 1/2 |
78 |
98.7 (93.1; 100) |
0.766 (0.622; 0.944) |
78 |
100 (95.4; 100) |
31.047 (25.954; 37.139) |
||||||
| Form 1/3 |
78 |
98.7 (93.1; 100) |
0.833 (0.668; 1.038) |
78 |
100 (95.4; 100) |
31.054 (26.837; 35.934) |
||||||
| Control |
77 |
98.7 (93.0; 100) |
0.932 (0.756; 1.149) |
77 |
100 (95.3; 100) |
24.402 (21.042; 28.298) |
||||||
| HBs |
Form 1 |
78 |
82.1 (71.7; 89.8) |
59.9 (40.3; 89.1) |
78 |
98.7 (93.1; 100) |
2713.4 (1846.9; 3986.2) |
|||||
| Form 1/2 |
78 |
85.9 (76.2; 92.7) |
46.9 (32.8; 67.2) |
78 |
98.7 (93.1; 100) |
2395.1 (1630.0; 3519.4) |
||||||
| Form 1/3 |
78 |
79.5 (68.8; 87.8) |
61.9 (42.2; 91.0) |
78 |
100 (95.4; 100) |
3992.8 (2747.2; 5803.1)* |
||||||
| Control |
77 |
90.9 (82.2; 96.3) |
88.5 (60.7; 129.0) |
77 |
100 (95.3; 100) |
3484.3 (2452.2; 4950.8) |
||||||
| PRP |
Form 1 |
78 |
35.9 (25.3; 47.6) |
0.134 (0.109; 0.166) |
78 |
98.7 (93.1; 100) |
2.871 (1.797; 4.587) |
|||||
| Form 1/2 |
78 |
34.6 (24.2; 46.2) |
0.137 (0.110; 0.172) |
78 |
97.4 (91.0; 99.7) |
2.243 (1.520; 3.310) |
||||||
| Form 1/3 |
78 |
38.5 (27.7; 50.2) |
0.152 (0.118; 0.197) |
78 |
91.0 (82.4; 96.3) |
1.575 (1.065; 2.330)* |
||||||
| Control |
77 |
45.5 (34.1; 57.2) |
0.171 (0.130; 0.226) |
77 |
98.7 (93.0; 100) |
3.305 (2.373; 4.603) |
||||||
| BPT |
Form 1 |
76 |
65.8 (54.0; 76.3) |
19.6 (16.4; 23.6) |
76 |
100 (95.3; 100) |
161.8 (143.6; 182.3)* |
|||||
| Form 1/2 |
78 |
64.1 (52.4; 74.7) |
20.1 (16.5; 24.5) |
74 |
98.6 (92.7; 100) |
182.9 (158.0; 211.9) |
||||||
| Form 1/3 |
78 |
65.4 (53.8; 75.8) |
18.9 (15.9; 22.4) |
77 |
100 (95.3; 100) |
211.0 (190.1; 234.2) |
||||||
| Control |
77 |
63.6 (51.9; 74.3) |
19.5 (16.0; 23.9) |
75 |
100 (95.2; 100) |
194.7 (170.6; 222.4) |
||||||
| Polio |
Form 1 |
78 |
97.4 (91.0; 99.7) |
321.1 (231.2; 446.0) |
78 |
100 (95.4: 100) |
2218.4 (1786.3; 2755.1)* |
|||||
| type 1 |
Form 1/2 |
78 |
89.7 (80.8; 95.5) |
219.1 (144.0; 333.6) |
78 |
98.7 (93.1: 100) |
1486.7 (1065.9; 2073.5)* |
|||||
| |
Form 1/3 |
78 |
94.9 (87.4; 98.6) |
296.6 (205.1; 428.8) |
78 |
100 (95.4: 100) |
1245.1 (1007.2; 1539.2)* |
|||||
| |
Control |
77 |
97.4 (90.9; 99.7) |
296.9 (213.9; 412.1) |
77 |
100 (95.3: 100) |
3760.2 (2973.7; 4754.7) |
|||||
| Polio |
Form 1 |
78 |
98.7 (93.1; 100) |
186.8 (140.1; 249.2) |
77 |
100 (95.3: 100) |
1598.8 (1293.5; 1976.3)* |
|||||
| type 2 |
Form 1/2 |
78 |
96.2 (89.2; 99.2) |
152.2 (111.8; 207.3) |
78 |
100 (95.4: 100) |
1056.4 (841.5; 1326.1)* |
|||||
| |
Form 1/3 |
78 |
100 (95.4; 100) |
183.4 (146.4; 229.7) |
78 |
100 (95.4: 100) |
966.5 (779.5; 1198.3)* |
|||||
| |
Control |
77 |
96.1 (89.0; 99.2) |
148.0 (112.4; 194.9) |
77 |
100 (95.3: 100) |
2883.2 (2275.2; 3653.8) |
|||||
| Polio |
Form 1 |
78 |
94.9 (87.4; 98.6) |
74.5 (56.0; 99.0) |
78 |
98.7 (93.1: 100) |
2820.0 (2129.9; 3733.9) |
|||||
| type 3 |
Form 1/2 |
78 |
97.4 (91.0; 99.7) |
82.1 (62.1; 108.6) |
78 |
98.7 (93.1: 100) |
2217.7 (1654.0; 2973.4)* |
|||||
| |
Form 1/3 |
78 |
97.4 (91.0; 99.7) |
102.1 (77.6; 134.4) |
78 |
100 (95.4: 100) |
1915.8 (1498.1; 2449.8)* |
|||||
| Control | 77 | 90.9 (82.2; 96.3) | 79.1 (57.9; 108.1) | 77 | 100 (95.3: 100) | 3626.4 (2618.2; 5022.9) | ||||||
Form 1 received DTPw-HBV-IPV (full dose)/Hib vaccine; Form 1/2 received DTPw-HBV-IPV (1/2 dose)/Hib vaccine; Form 1/3 received DTPw-HBV-IPV (1/3 dose)/Hib vaccine; Controls received DTPw-HBV/Hib Kft and IPV vaccines concomitantly; SP/S+, seroprotection defined as concentration ≥ 0.1 IU/ml for diphtheria and tetanus, ≥ 10 mIU/ml for HBs, ≥ 0.15 μg/ml for PRP, ≥ 1:8 for poliovirus, seropositivity defined as ≥ 15 El.U/ml for BPT; GMC/GMT, geometric mean antibody concentration/titer, calculated for all subjects; N, number of subjects with available results; 95% CI, exact 95% confidence interval; *statistically significant difference post-vaccination between the indicated Form vs. the Control Form (the 95% CI on the adjusted GMC/GMT ratio excluded the value “1”).