Table 4.
Percentages of subjects with rSBA titers of ≥1:8 and ≥1:128, GMTs (prior to and 1 month after vaccination), and vaccine responses, with the GlaxoSmithKline rSBA assay (ATP cohort for immunogenicity)
| Antibody and groupa | Time point | No. of subjects with available results | % (95% CI) of subjects with rSBA titers of: |
GMT (95% CI)b | No. (% with VR [95% CI]) of subjects with pre- and postvaccination results availablec | |
|---|---|---|---|---|---|---|
| ≥1:8 | ≥1:128 | |||||
| MenA | ||||||
| ACWY-A | Prevaccination | 320 | 92.5 (89.0–95.1) | 85.0 (80.6–88.7) | 348.4 (293.0–414.2) | |
| Postvaccination | 359 | 100 (99.0–100) | 100 (99.0–100) | 4,846.0 (4,459.8–5,265.7)d | 302 (79.1 [74.1–83.6]) | |
| ACWY-B | Prevaccination | 328 | 95.7 (92.9–97.6) | 89.0 (85.1–92.2) | 401.4 (347.2–464.1) | |
| Postvaccination | 343 | 100 (98.9–100) | 100 (98.9–100) | 5,064.6 (4,657.5–5,507.2)d | 298 (79.9 [74.9–84.3]) | |
| Men-PS | Prevaccination | 310 | 95.2 (92.1–97.3) | 88.7 (84.6–92.0) | 424.4 (362.9–496.5) | |
| Postvaccination | 356 | 100 (99.0–100) | 100 (99.0–100) | 3,421.0 (3,134.7–3,733.4) | 293 (73.7 [68.3–78.7]) | |
| MenC | ||||||
| ACWY-A | Prevaccination | 351 | 60.1 (54.8–65.3) | 37.9 (32.8–43.2) | 36.3 (29.3–45.0) | |
| Postvaccination | 374 | 100 (99.0–100) | 100 (99.0–100) | 6,025.4 (5,269.0–6,890.2) | 346 (93.6 [90.5–96.0]) | |
| ACWY-B | Prevaccination | 350 | 60.9 (55.5–66.0) | 42.9 (37.6–48.2) | 44.7 (35.6–56.2) | |
| Postvaccination | 370 | 100 (99.0–100) | 100 (99.0–100) | 7,070.7 (6,225.3–8,030.9) | 342 (95.6 [92.9–97.5]) | |
| Men-PS | Prevaccination | 361 | 62.0 (56.8–67.1) | 44.0 (38.9–49.3) | 46.9 (37.2–59.0) | |
| Postvaccination | 372 | 100 (99.0–100) | 99.5 (98.1–99.9) | 5,953.1 (5,188.2–6,830.7) | 353 (94.1 [91.0–96.3]) | |
| MenW-135 | ||||||
| ACWY-A | Prevaccination | 343 | 86.3 (82.2–89.8) | 71.1 (66.0–75.9) | 185.9 (153.1–225.6) | |
| Postvaccination | 375 | 100 (99.0–100) | 100 (99.0–100) | 9,836.7 (8,939.2–10,824.3)d | 338 (97.0 [94.6–98.6])d | |
| ACWY-B | Prevaccination | 333 | 85.9 (81.7–89.4) | 72.1 (66.9–76.8) | 191.2 (155.9–234.4) | |
| Postvaccination | 370 | 100 (99.0–100) | 100 (99.0–100) | 8,855.5 (8,021.8–9,775.9)d | 327 (95.4 [92.5–97.4])d | |
| Men-PS | Prevaccination | 345 | 86.4 (82.3–89.8) | 70.7 (65.6–75.5) | 205.5 (167.6–252.0) | |
| Postvaccination | 372 | 100 (99.0–100) | 99.7 (98.5–100) | 4,675.1 (4,145.9–5,272.0) | 337 (90.2 [86.5–93.2]) | |
| MenY | ||||||
| ACWY-A | Prevaccination | 363 | 92.3 (89.0–94.8) | 84.6 (80.4–88.1) | 387.5 (324.9–462.2) | |
| Postvaccination | 375 | 100 (99.0–100) | 100 (99.0–100) | 11,632.5 (10,675.1–12,675.8)d | 358 (93.3 [90.2–95.7])d | |
| ACWY-B | Prevaccination | 359 | 94.2 (91.2–96.3) | 85.8 (81.7–89.2) | 426.8 (362.2–502.8) | |
| Postvaccination | 371 | 100 (99.0–100) | 100 (99.0–100) | 10,386.7 (9,557.5–11,287.9)d | 353 (91.8 [88.4–94.4])d | |
| Men-PS | Prevaccination | 364 | 92.3 (89.1–94.8) | 86.0 (82.0–89.4) | 412.6 (346.8–490.8) | |
| Postvaccination | 373 | 100 (99.0–100) | 100 (99.0–100) | 6,315.9 (5,787.9–6,892.1) | 357 (86.3 [82.3–89.7]) | |
ACWY-A, subjects vaccinated with MenACWY-TT lot A; ACWY-B, subjects vaccinated with MenACWY-TT lot B; Men-PS, subjects vaccinated with Men-PS; CI, confidence interval; prevaccination, month 0; postvaccination, month 1.
The geometric mean antibody titers have not been adjusted for baseline titers or country.
Vaccine responses were defined as follows: for initially seronegative subjects (rSBA titer of <1:8), postvaccination titer of ≥1:32; for initially seropositive subjects (rSBA titer of ≥1:8), postvaccination titer ≥4 times the prevaccination antibody titer.
Statistically significantly higher value in the ACWY-A or ACWY-B group than in the Men-PS group (exploratory analysis).