Table 3. Comparison between groups in rSBA vaccine response rate one month after vaccination (ATP immunogenicity cohort).
| |
|
% Vaccine response |
Difference in vaccine response rate* |
||
|---|---|---|---|---|---|
| Serogroup | Group | N | n | % (95% CI) | % (95%CI) |
| A |
ACWY-TT |
743 |
595 |
80.1 (77.0; 82.9) |
10.24 (4.11; 16.78) |
| |
MenPS |
252 |
176 |
69.8 (63.8; 75.4) |
|
| C |
ACWY-TT |
849 |
777 |
91.5 (89.4; 93.3) |
-0.49 (-3.85; 3.57) |
| |
MenPS |
288 |
265 |
92.0 (88.3; 94.9) |
|
| W-135 |
ACWY-TT |
860 |
776 |
90.2 (88.1; 92.1) |
4.72 (0.49; 9.65) |
| |
MenPS |
283 |
242 |
85.5 (80.9; 89.4) |
|
| Y |
ACWY-TT |
862 |
750 |
87.0 (84.6; 89.2) |
8.19 (3.24; 13.69) |
| MenPS | 288 | 227 | 78.8 (73.6; 83.4) | ||
N, number of subjects with pre and post vaccination results; n/%, number/percentage of subjects with a vaccine response (defined as an rSBA titer ≥ 1:32 in subjects with pre-vaccination titer < 1:8, or a ≥ 4-fold increase in titer for subjects with pre-vaccination titer ≥ 1:8). 95% CI = 95% confidence interval. *ACWY-TT minus MenPS. Bold: the lower limit of the standardized asymptotic 95% CI is above the pre-specified non-inferiority limit of -10% for all four serogroups.