Table 1.
Seroprotection/seropositivity rates and GMCs one month after booster vaccination (ATP cohort for immunogenicity)
dTpa-new | dTpa-previous | ||||||||
---|---|---|---|---|---|---|---|---|---|
Antibody | Timing | N | n | Seroprotection* (95% CI) | GMC(95% CI) | N | n | Seroprotection* (95% CI) | GMC(95% CI) |
anti-diphtheria | Pre | 321 | 284 | 88.5 (84.5–91.8) | 0.472 (0.403–0.553) | 319 | 286 | 89.7 (85.8–92.8) | 0.456 (0.392–0.530) |
Post | 321 | 320 | 99.7 (98.3–100) | 6.784 (6.178–7.450) | 319 | 319 | 100 (98.9–100) | 6.493 (5.915–7.128) | |
anti-tetanus | Pre | 321 | 311 | 96.9 (94.3–98.5) | 0.956 (0.835–1.095) | 319 | 314 | 98.4 (96.4–99.5) | 0.899 (0.789–1.026) |
Post | 321 | 321 | 100 (98.9–100) | 18.937 (17.313–20.713) | 319 | 319 | 100 (98.9–100) | 18.515 (16.851–20.342) | |
dTpa-new | dTpa-previous | ||||||||
Antibody | Timing | N | n | Seropositivity** (95% CI) | GMC(95% CI) | N | n | Seropositivity** (95% CI) | GMC (95% CI) |
anti-PT | Pre | 320 | 175 | 54.7 (49.1–60.2) | 7.5 (6.6–8.7) | 319 | 175 | 54.9 (49.2–60.4) | 7.2 (6.3–8.2) |
Post | 318 | 316 | 99.4 (97.7–99.9) | 140.2 (126.0–156.1) | 318 | 315 | 99.1 (97.3–99.8) | 125.9 (112.7–140.7) | |
anti-FHA | Pre | 316 | 310 | 98.1 (95.9–99.3) | 48.9 (43.3–55.2) | 315 | 310 | 98.4 (96.3–99.5) | 49.4 (43.6–56.0) |
Post | 319 | 319 | 100 (98.9–100) | 1080.2 (995.2–1172.5) | 319 | 319 | 100 (98.9–100) | 1013.7 (940.0–1093.2) | |
anti-PRN | Pre | 321 | 269 | 83.8 (79.3–87.7) | 14.0 (12.3–15.9) | 319 | 272 | 85.3 (80.9–89.0) | 13.4 (11.9–15.0) |
Post | 321 | 321 | 100 (98.9–100) | 652.4 (572.1–743.9) | 318 | 318 | 100 (98.8–100) | 619.2 (546.0–702.2) |
dTpa-new = Subjects who received Boostrix™ in new syringe presentation; dTpa-previous = Subjects who received Boostrix™ in previous syringe presentation.
N = Number of subjects with both pre- and post-vaccination results available; 95% CI = 95% confidence interval; D, diphtheria; T, tetanus; PT, pertussis toxin; FHA, filamentous hemagglutinin; PRN, pertactin IU, international unit; El.U, ELISA unit; GMC, geometric mean concentration calculated on all subjects.
Seroprotection=anti-diphtheria and anti-tetanus antibody concentration ≥0.1 IU/mL.
Seropositive=Anti-PT, Anti-FHA and Anti-PRN antibodies ≥5 EU/mL.