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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
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