Group 1 (N=132) Group 2 (N=130) Group 1 minus Group 2

Antibody

Timepoint

Endpoint

% or GMC or log10GMC (95% CI) or log10(SD) % or GMC or log10GMC (95% CI) or log10(SD) % (95% CI)
Primary objective:  

    Anti‑Hep B Post‑Dose 3 ³10 mIU/mL

99.2%

(95.9; 100.0)

100.0%

(97.2; 100.0)

-0.76

(-4.17; 2.18)

Secondary objectives:  

    Anti‑Hep B Post‑Dose 3 ³100 mIU/mL

93.9%

(88.4; 97.3)

99.2%

(95.8; 100.0)

NC

NC

    GMC (IU/mL)

986

(764; 1270)

1139

(961; 1350)

NC

NC

    Log10GMC

2.99

(0.641)

3.06

(0.424)

NC

NC

    Anti‑PRP Post‑Dose 3 ³0.15 µg /mL

100.0%

(97.2; 100.0)

99.2%

(95.8; 100.0)

NC

NC

    ³1 µg/mL

84.8%

(77.6; 90.5)

83.8%

(76.4; 89.7)

NC

NC

    GMC (µg/mL)

5.22

(4.04; 6.73)

3.93

(3.17; 4.89)

NC

NC

    Log10GMC

0.718

(0.642)

0.595

(0.543)

NC

NC

    Anti‑D Pre‑Dose 1 ³0.01 IU/mL

82.6%

(75.0; 88.6)

84.6%

(77.2; 90.3)

NC

NC

    ³0.1 IU/mL

66.7%

(57.9; 74.6)

70.0%

(61.3; 77.7)

NC

NC

    GMC (IU/mL)

0.183

(0.122; 0.277)

0.276

(0.178; 0.427)

NC

NC

    Log10GMC

-0.737

(1.04)

-0.560

(1.10)

NC

NC

  Post‑Dose 3 ³0.01 IU/mL

95.5%

(90.4; 98.3)

100.0%

(97.2; 100.0)

NC

NC

    ³0.1 IU/mL

58.3%

(49.4; 66.8)

65.4%

(56.5; 73.5)

NC

NC

    GMC (IU/mL)

0.156

(0.119; 0.204)

0.192

(0.154; 0.239)

NC

NC

    Log10GMC

-0.807

(0.680)

-0.717

(0.554)

NC

NC

Group 1=DTaP-IPV-Hep B-PRP-T at 2, 4, 6 months
Group 2=DTaP-IPV-Hep B//PRP-T at 2, 4, 6 months
Data are % participants (95% CI) or geometric mean concentration (GMC) (calculated according to the number of participants available for the endpoint); N=number of participants in the per protocol analysis set; NC=not calculated (as not primary objective)
Table 1: Summary of seroprotection rates and geometric mean concentrations (per protocol analysis set).