|
|
|
Group 1 (N=132) |
Group 2 (N=130) |
Group 1 minus Group 2 |
Antibody |
Timepoint |
Endpoint |
% or GMC or log10GMC |
(95% CI) or log10(SD) |
% or GMC or log10GMC |
(95% CI) or log10(SD) |
% |
(95% CI) |
| Primary objective: |
|
|
|
|
|
|
|
| Anti‑Hep B |
Post‑Dose 3 |
³10 mIU/mL |
99.2% |
(95.9; 100.0) |
100.0% |
(97.2; 100.0) |
-0.76 |
(-4.17; 2.18) |
| Secondary objectives: |
|
|
|
|
|
|
|
| Anti‑Hep B |
Post‑Dose 3 |
³100 mIU/mL |
93.9% |
(88.4; 97.3) |
99.2% |
(95.8; 100.0) |
NC |
NC |
| |
|
GMC (IU/mL) |
986 |
(764; 1270) |
1139 |
(961; 1350) |
NC |
NC |
| |
|
Log10GMC |
2.99 |
(0.641) |
3.06 |
(0.424) |
NC |
NC |
| Anti‑PRP |
Post‑Dose 3 |
³0.15 µg /mL |
100.0% |
(97.2; 100.0) |
99.2% |
(95.8; 100.0) |
NC |
NC |
| |
|
³1 µg/mL |
84.8% |
(77.6; 90.5) |
83.8% |
(76.4; 89.7) |
NC |
NC |
| |
|
GMC (µg/mL) |
5.22 |
(4.04; 6.73) |
3.93 |
(3.17; 4.89) |
NC |
NC |
| |
|
Log10GMC |
0.718 |
(0.642) |
0.595 |
(0.543) |
NC |
NC |
| Anti‑D |
Pre‑Dose 1 |
³0.01 IU/mL |
82.6% |
(75.0; 88.6) |
84.6% |
(77.2; 90.3) |
NC |
NC |
| |
|
³0.1 IU/mL |
66.7% |
(57.9; 74.6) |
70.0% |
(61.3; 77.7) |
NC |
NC |
| |
|
GMC (IU/mL) |
0.183 |
(0.122; 0.277) |
0.276 |
(0.178; 0.427) |
NC |
NC |
| |
|
Log10GMC |
-0.737 |
(1.04) |
-0.560 |
(1.10) |
NC |
NC |
| |
Post‑Dose 3 |
³0.01 IU/mL |
95.5% |
(90.4; 98.3) |
100.0% |
(97.2; 100.0) |
NC |
NC |
| |
|
³0.1 IU/mL |
58.3% |
(49.4; 66.8) |
65.4% |
(56.5; 73.5) |
NC |
NC |
| |
|
GMC (IU/mL) |
0.156 |
(0.119; 0.204) |
0.192 |
(0.154; 0.239) |
NC |
NC |
| |
|
Log10GMC |
-0.807 |
(0.680) |
-0.717 |
(0.554) |
NC |
NC |
Group 1=DTaP-IPV-Hep B-PRP-T at 2, 4, 6 months
Group 2=DTaP-IPV-Hep B//PRP-T at 2, 4, 6 months
Data are % participants (95% CI) or geometric mean concentration (GMC) (calculated according to the number of participants available for the endpoint); N=number of participants in the per protocol analysis set; NC=not calculated (as not primary objective) |
