Table 2.
Subjects with an rSBA vaccine response and rSBA GMTs before and 1 month after MenACWY-TT booster dose (booster ATP cohort for immunogenicity).
| Vaccine responsea (95% CIb) |
GMT (95% CIc) |
|||||
|---|---|---|---|---|---|---|
| n | 1 month after MenACWY-TT booster |
n | Before MenACWY-TT booster |
n | 1 month after MenACWY-TT booster |
|
| Serogroup A | ||||||
| MenACWY-TT (toddlers) | 62 | 90.3 (80.1, 96.4) | 62 | 28.9 (16.4, 51.0) | 62 | 5122.3 (3725.6, 7042.6) |
| MenC-CRM | 16 | 100.0 (79.4, 100.0) | 16 | 5.9 (3.1, 11.3) | 16 | 4871.0 (2465.1, 9624.9) |
| MenACWY-TT (children) | 73 | 87.7 (77.9, 94.2) | 73 | 96.3 (57.1, 162.5) | 74 | 4626.4 (3040.6, 7039.4) |
| MenACWY-PS | 17 | 94.1 (71.3, 99.9) | 17 | 8.0 (3.3, 19.3) | 17 | 6414.2 (3878.5, 10,607.8) |
| Serogroup C | ||||||
| MenACWY-TT (toddlers) | 62 | 82.3 (70.5, 90.8) | 62 | 128.0 (71.1, 230.6) | 62 | 7163.5 (5478.0, 9367.7) |
| MenC-CRM | 16 | 93.8 (69.8, 99.8) | 16 | 86.7 (29.0, 259.2) | 16 | 5792.6 (3630.6, 9242.2) |
| MenACWY-TT (children) | 74 | 75.7 (64.3, 84.9) | 74 | 181.0 (105.6, 310.3) | 74 | 4020.0 (3319.0, 4869.1) |
| MenACWY-PS | 17 | 94.1 (71.3, 99.9) | 17 | 96.2 (28.9, 320.2) | 17 | 15,101.0 (7099.3, 32,121.5) |
| Serogroup W | ||||||
| MenACWY-TT (toddlers) | 62 | 100.0 (94.2, 100.0) | 62 | 15.8 (9.1, 27.6) | 62 | 25,911.2 (19,119.7, 35,115.2) |
| MenC-CRM | 15 | 100.0 (78.2, 100.0) | 16 | 4.0 (NE, NE) | 15 | 17,970.4 (11,666.4, 27,680.7) |
| MenACWY-TT (children) | 74 | 100.0 (95.1, 100.0) | 74 | 206.4 (108.6, 392.1) | 74 | 27,944.4 (22,213.8, 35,153.3) |
| MenACWY-PS | 17 | 88.2 (63.6, 98.5) | 17 | 15.4 (4.2, 56.4) | 17 | 10,462.5 (3253.5, 33,645.5) |
| Serogroup Y | ||||||
| MenACWY-TT (toddlers) | 62 | 95.2 (86.5, 99.0) | 62 | 27.4 (14.7, 51.0) | 62 | 7660.5 (5262.9, 11,150.3) |
| MenC-CRM | 16 | 87.5 (61.7, 98.4) | 16 | 24.7 (6.0, 100.8) | 16 | 6316.9 (3223.8, 12,377.5) |
| MenACWY-TT (children) | 74 | 93.2 (84.9, 97.8) | 74 | 98.5 (54.3, 178.7) | 74 | 7529.7 (5827.5, 9729.2) |
| MenACWY-PS | 17 | 100.0 (80.5, 100.0) | 17 | 10.2 (3.5, 30.2) | 17 | 6959.2 (3636.7, 13,317.1) |
ATP = according-to-protocol; GMT = geometric mean titer; n = number of subjects with available results; NE = not estimable; rSBA = serum bactericidal antibody assays using rabbit complement.
aVaccine response was defined as an rSBA titer ≥1:32 in subjects who were seronegative (rSBA titer <1:8) before booster vaccination and as a ≥4-fold increase from pre-vaccination titers in subjects who were seropositive (rSBA titer ≥1:8) before vaccination.
bExact 2-sided CIs are based on the observed proportion of subjects using the Clopper and Pearson method.
cCIs are back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations or the mean of the ratio.