SBA-MenC, PSC, and PRP antibody persistence (prebooster) and immune response 1 month after polysaccharide challenge and DTPa-HBV-IPV/Hib booster doses (postbooster)
| Groupa | Time pointb | Resultc for: | |||||
|---|---|---|---|---|---|---|---|
| SBA-MenCd | PSC | PRP | |||||
| % of subjects with a titer of ≥1:8 (95% CI*)e | GMT (95% CI) | % of subjects with a concn of ≥0.30 μg/ml (95% CI*) | GMC (μg/ml) (95% CI) | % of subjects with a concn of ≥0.15 μg/ml (95% CI*) | GMC (μg/ml) (95% CI) | ||
| MenC (n = 82/75) | Preboost | 88.6 (79.5, 94.7) | 189.1* (124.5, 287.3) | 100.0 (95.4, 100.0) | 3.85 (3.20, 4.64) | 88.9 (80.0, 94.8) | 0.68 (0.50, 0.94) |
| Postboost | 100.0 (94.9, 100.0) | 3,508.9# (2,580.1, 4,772.2) | 100.0 (94.9, 100.0) | 28.10# (22.59, 34.95) | 100.0 (95.2, 100.0) | 34.77 (26.19, 46.15) | |
| Hib10-MenC10 | Preboost | 83.3 (73.6, 90.6) | 108.9 (71.5, 165.9) | 100.0 (95.7, 100.0) | 2.84* (2.37, 3.41) | 96.5* (90.1, 99.3) | 1.15* (0.90, 1.49) |
| (n = 88/80) | Postboost | 98.7 (93.1, 100.0) | 2,530.1# (1,831.7, 8,494.7) | 100.0 (94.9, 100.0) | 30.01# (24.09, 37.38) | 100.0 (95.5, 100.0) | 37.99 (29.39, 49.11) |
| Hib5-MenC5 | Preboost | 87.1 (78.0, 93.4) | 159.3 (107.9, 235.3) | 98.9 (93.8, 100.0) | 3.22* (2.59, 4.01) | 98.9* (94.0, 100.0) | 2.07* (1.57, 2.71) |
| (n = 90/83) | Postboost | 100.0 (95.5, 100.0) | 5,385.4# (4,425.0, 5,554.2) | 100.0 (95.3, 100.0) | 34.58# (29.10, 41.09) | 100.0 (95.7, 100.0) | 73.24# (57.78, 92.83) |
| Control (n = 93/86) | Preboost | 80.2 (70.6, 87.8) | 104.0 (68.4, 158.3) | 100.0 (96.0, 100.0) | 4.53 (3.71, 5.52) | 85.7 (76.8, 92.2) | 0.55 (0.40, 0.74) |
| Postboost | 96.5 (90.0, 99.3) | 1,552.6# (1,044.4, 2,307.9) | 98.7 (93.1, 100.0) | 16.59# (12.98, 21.12) | 98.8 (93.7, 100.0) | 34.34 (24.87, 47.4) | |
| Group O (n = 95/94) | Preboost | 3.3 (0.7, 9.4) | 4.6 (3.9, 5.5) | 3.2 (0.7, 9.0) | 0.16 (0.15, 0.18) | 92.6 (85.3, 97.0) | 1.87 (1.31, 2.68) |
| Postboost | 17.6 (10.4, 27.0) | 9.3 (6.3, 13.6) | 95.7 (89.5, 98.8) | 3.05 (2.36, 3.93) | 100.0 (96.2, 100.0) | 51.35 (36.96, 71.35) | |
↵ a n, number of subjects in the according-to-protocol cohort for persistence/immunogenicity post-booster vaccination; group O, MenC vaccine-naïve age-matched controls.
↵ b Preboost, prior to booster vaccination; postboost, after booster vaccination.
↵ c *, statistically significant difference compared to the control group; #, statistically significant difference compared to group O. The 95% CIs for the group differences in seroprotection/seropositivity rates do not include a value equivalent to 0, and the 95% CIs for the GMC or GMT ratio do not include a value equivalent to 1.
↵ d Direct comparison with results from the primary phase cannot be made due to the use of different assays in each phase.
↵ e 95% CI*, exact 95% CI.