Table 2.
Summary of the primary objective results: serogroup C seroprotection rates (≥1:8) and GMTs following a single dose of MenACYW-TT, MCV4-TT or MenC-TT (PPAS)
| Seroprotection rates (95% CI) | GMTs (95% CI) | |||
|---|---|---|---|---|
| hSBA | n/M | % (95% CI) | M | % (95% CI) |
| MenACYW-TT | 213/214 | 99.5 (97.4, 100) | 214 | 515 (450, 591) |
| MCV4-TT | 188/211 | 89.1 (84.1, 93.0) | 211 | 31.6 (26.5, 37.6) |
| Difference (97.5% CI) | 10.43 (5.68, 16.20) | Ratio (97.5% CI) | 16.3 (12.7, 21.0) | |
| Conclusion | Non-inferiority*: Yes Superiority†: Yes |
Non-inferiority‡: Yes Superiority§: Yes |
||
| rSBA | n/M | % (95% CI) | M | % (95% CI) |
| MenACYW-TT | 213/213 | 100 (98.3, 100) | 213 | 2143 (1870, 2456) |
| MenC-TT | 215/215 | 100 (98.3, 100) | 215 | 1624 (1425, 1850) |
| Difference (97.5% CI) | 0.0 (−2.30, 2.28) | Ratio (97.5% CI) | 1.32 (1.06, 1.64) | |
| Conclusion | Non-inferiority*: Yes | Non-inferiority‡: Yes Superiority§: Yes |
||
GMT, geometric mean titer; M, number of participants with available data; n, number of participants meeting the endpoint; PPAS, hSBA and rSBA per protocol analysis sets.
*Non-inferiority was demonstrated if the lower-limit of the 97.5% CI of the difference was >–10%.
†Superiority was demonstrated if the lower-limit of the 97.5% CI of the difference was >0%.
‡Non-inferiority was demonstrated if the lower-limit of the 97.5% CI of the ratio of GMTs was >1/1.5.
§Superiority was demonstrated if the lower-limit of the 97.5% CI of the ratio between GMTs was >1.