TABLE 2.
Noninferiority of the Proportion of Participants (%) Who Had Achieved hSBA Vaccine Seroresponsea at Day 30 Between Vaccine Groups (Per Protocol Analysis Set)
| MenACYW-TT | MenACWY-CRM | MenACYW-TT–MenACWY-CRM | |||
|---|---|---|---|---|---|
| (n = 458) | (n = 460) | ||||
| Serogroup | n/M | % (95% CI) | n/M | % (95% CI) | Difference, % (95% CI) |
| A | 252/455 | 55.4 (50.7-60.0) | 219/458 | 47.8 (43.2-52.5) | 7.6 (1.1-14.0) |
| C | 436/458 | 95.2 (92.8-97.0) | 219/458 | 47.8 (43.2-52.5) | 47.4 (42.2-52.2) |
| W | 361/458 | 78.8 (74.8-82.5) | 294/459 | 64.1 (59.5-68.4) | 14.8 (8.9-20.5) |
| Y | 419/458 | 91.5 (88.5-93.9) | 364/459 | 79.3 (75.3-82.9) | 12.2 (7.7-16.7) |
hSBA vaccine seroresponse was demonstrated if a participant had prevaccination titers <1:8, then the postvaccination titer had to be ≥1:16, or for a participant with a prevaccination titer ≥1:8, the postvaccination titer had to be at least 4-fold greater than the prevaccination titer; 95% CIs of the single proportion was calculated from the exact binomial method.
CI, confidence interval; PPAS, Per Protocol Analysis Set; n, number of participants who achieved an hSBA vaccine seroresponse; M, number of participants with available data for the endpoint; N, number of participants in the PPAS.
The overall noninferiority would be demonstrated if the lower limit of the 2-sided 95% CI is > –10% for all 4 serogroups.