TABLE 3.

SBA-MenC, PSC, and PRP antibody persistence (prebooster) and immune response 1 month after polysaccharide challenge and DTPa-HBV-IPV/Hib booster doses (postbooster)

GroupaTime pointbResultc for:
SBA-MenCdPSCPRP
% of subjects with a titer of ≥1:8 (95% CI*)eGMT (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)Preboost88.6 (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)
Postboost100.0 (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-MenC10Preboost83.3 (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)Postboost98.7 (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-MenC5Preboost87.1 (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)Postboost100.0 (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)Preboost80.2 (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)
Postboost96.5 (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)Preboost3.3 (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)
Postboost17.6 (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.