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Table 1 Seroprotection (SP), vaccine response (VR) rates and GMCs one month post-primary and pre- and one month post-booster vaccination (ATP immunogenicity cohort)

From: Primary and booster vaccination in Latin American children with a DTPw-HBV/Hib combination: a randomized controlled trial

  Post-Primary Pre-Booster Post-Booster
Group N %SP/VR
(95% CI)
GMC
(95% CI)
N %SP
(95% CI)
GMC
(95% CI)
N %SP/BR
(95% CI)
GMC
(95% CI)
Anti-diphtheria (≥0.1 IU/mL)          
DTPw-HBV/Hib 398 97.7 (95.8, 99.0) 2.093§ (1.851, 2.366) 109 81.7 (73.1, 88.4) 0.263 (0.218, 0.316) 110 100 (96.7, 100) 6.755 (5.726, 7.970)
Tritanrix™-HBV/Hib 132 93.9 (88.4, 97.3) 1.350§ (1.077, 1.691) 33 75.8 (57.7, 88.9) 0.214 (0.153, 0.300) 34 100 (89.7, 100) 4.974 (3.197, 7.738)
Anti-tetanus (≥0.1 IU/mL)          
DTPw-HBV/Hib 399 99.7 (98.6, 100) 6.679 (6.084, 7.333) 110 98.2 (93.6, 99.8) 0.652 (0.555, 0.767) 110 100 (96.7, 100) 18.555 (16.406, 20.984)
Tritanrix™-HBV/Hib 131 100 (97.2, 100) 5.884 (4.964, 6.974) 34 100 (89.7, 100) 0.748 (0.564, 0.991) 34 100 (89.7, 100) 15.430 (12.205, 19.507)
Anti-HBs (≥10 mIU/mL)          
DTPw-HBV/Hib 400 99.8 (98.6, 100) 2417.5§ (2127.3, 2747.3) 110 94.5 (88.5, 98.0) 126.9 (98.1, 164.2) 110 99.1 (95.0, 100) 19247.5 (14422.5, 25686.6)
Tritanrix™-HBV/Hib 132 97.7 (93.5, 99.5) 1319.3§ (1035.8, 1680.3) 34 94.1 (80.3, 99.3) 97.3 (65.5, 144.3) 34 97.1 (84.7, 99.9) 14366.8 (7612.5, 27114.2)
Anti-PRP (≥0.15 μg/mL)          
DTPw-HBV/Hib 400 99.0 (97.5, 99.7) 12.530§ (11.180, 14.043) 110 95.5 (89.7, 98.5) 1.006§ (0.768, 1.319) 110 100 (96.7, 100) 34.364§ (27.563, 42.843)
Tritanrix™-HBV/Hib 132 100 (97.2, 100) 21.393§ (17.971, 25.467) 34 100 (89.7, 100) 2.059§ (1.357, 3.123) 34 100 (89.7, 100) 66.616§ (43.734, 101.468)
Anti-PRP (≥1.0 μg/mL)          
DTPw-HBV/Hib 400 97.3 (95.1, 98.6) - 110 46.4 (36.8, 56.1) - 110 99.1 (95.0, 100) -
Tritanrix™-HBV/Hib 132 100 (97.2, 100) - 34 79.4 (62.1, 91.3) - 34 100 (89.7, 100) -
Anti-BPT (VR or BR)          
DTPw-HBV/Hib 394* 97.9 (96.0, 99.1) 82.6 (76.7, 89.1) 110   10.9 (9.8, 12.1) 109 99.1 (95.0, 100) 105.1 (93.6, 118.0)
Tritanrix™-HBV/Hib 131 95.4 (90.3, 98.3) 90.5 (77.7, 105.5) 33   11.1 (9.1, 13.7) 34# 100 (89.5, 100) 128.4 (99.2, 166.3)
  1. N = number of subjects with available results; *390 subjects for vaccine response; #33 subjects for booster response
  2. Vaccine (VR) response to the pertussis component defined as the appearance of antibody concentration ≥15 EL.U/mL in subjects seronegative at pre-vaccination or maintenance of pre-vaccination antibody concentrations one month after the third dose in initially seropositive subjects prior to primary vaccination.
  3. Booster (BR) response to the pertussis component defined as the appearance of antibody concentration ≥15 EL.U/mL in subjects seronegative at pre-booster or post-booster antibody concentration two-fold higher than pre-booster antibody concentrations in initially seropositive subjects prior to the booster vaccination.
  4. %SP = percentage of subjects who achieve seropositivity as is described for each antigen; GMC = geometric mean antibody concentration; 95%CI = 95% confidence interval; § non-overlapping CI