Table 3.
Summary of the secondary 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) | |||
|---|---|---|---|---|
| rSBA | n/M | % (95% CI) | M | % (95% CI) |
| MenACYW-TT | 213/213 | 100 (98.3, 100) | 213 | 2143 (1870, 2456) |
| MCV4-TT | 199/210 | 94.8 (90.8, 97.4) | 210 | 315 (252, 395) |
| Difference (97.5% CI) | 5.24 (1.83, 9.85) | Ratio (97.5% CI) | 6.80 (5.04, 9.18) | |
| Conclusion | Non-inferiority*: Yes | Non-inferiority†: Yes Superiority‡: Yes |
||
| hSBA | n/M | % (95% CI) | M | % (95% CI) |
| MenACYW-TT | 213/214 | 99.5 (97.4, 100) | 214 | 515 (450, 591) |
| MenC-TT | 215/216 | 99.5 (97.4, 100) | 216 | 227 (198, 260) |
| Difference (97.5% CI) | −.0 (−2.71, 2.67) | Ratio (97.5% CI) | 2.27 (1.82, 2.84) | |
| 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 of GMTs was >1.