Table 4 Equivalence of geometric mean concentrations/titers (GMC/GMTs) between three lots of DTwP-HepB-IPV-Hib at 28 days post 3rd dose of primary vaccination series in infants aged 6–8 weeks - PP Population

From: A phase III randomized-controlled study of safety and immunogenicity of DTwP-HepB-IPV-Hib vaccine (HEXASIIL®) in infants

Antibody

Lot 1 (N = 270a)

Lot 2 (N = 264a)

Lot 3 (N = 270a)

GMC/T ratio (95% CI)b

GMC/T

(95% CI)

GMC/T

(95% CI)

GMC/T

(95% CI)

Lot 1/ Lot 2

Lot 1/Lot 3

Lot 2/Lot 3

Anti-D (IU/ml)

0.867

(0.770, 0.977)

1.023

(0.908, 1.153)

1.022

(0.909, 1.149)

0.847 (0.716, 1.002)

0.848 (0.718, 1.002)

1.001 (0.847, 1.183)

Anti-T (IU/ml)

3.997

(3.657, 4.369)

3.782

(3.478, 4.113)

3.929

(3.597, 4.291)

1.056 (0.935, 1.194)

1.017 (0.897, 1.152)

0.962 (0.852, 1.087)

Anti-wP (U/ml)

44.212

(39.306, 49.730)

45.480

(40.462, 51.120)

49.802

(44.829, 55.327)

0.972 (0.823, 1.147)

0.887 (0.758, 1.039)

0.913 (0.780, 1.068)

Anti-PT (IU/ml)

37.321

(32.736, 42.548)

39.785

(34.793, 45.493)

39.483

(34.697, 44.930)

0.938 (0.778, 1.131)

0.945 (0.786, 1.135)

1.007 (0.836, 1.213)

Anti-HBs (mIU/ml)

1703.715

(1394.042, 2082.180)

1938.477

(1525.147, 2463.823)

1721.089

(1411.152, 2099.099)

0.879 (0.643, 1.201)

0.990 (0.747, 1.312)

1.126 (0.826, 1.537)

Anti-PRP (µg/ml)

2.825

(2.363, 3.378)

2.801

(2.349, 3.340)

2.841

(2.392, 3.373)

1.008 (0.785, 1.295)

0.994 (0.776, 1.273)

0.985 (0.771, 1.260)

Anti-Polio 1 (1/dil)

3180.539

(2835.895, 3567.068)

3233.812

(2889.801, 3618.774)

3232.618

(2866.445, 3645.567)

0.983 (0.837, 1.154)

0.983 (0.833, 1.161)

1.000 (0.848, 1.179)

Anti-Polio 2 (1/dil)

121.728

(104.942, 141.199)

148.507

(128.207, 172.019)

101.066

(86.021, 118.744)

0.819 (0.665, 1.009)

1.204 (0.968, 1.498)

1.469 (1.181, 1.826)

Anti-Polio 3 (1/dil)

2056.808

(1836.936, 2302.997)

1933.902

(1711.787, 2184.837)

1879.468

(1653.096, 2136.838)

1.063 (0.901, 1.255)

1.094 (0.922, 1.297)

1.028 (0.862, 1.227)

  1. CI Confidence Interval, IU International Unit, PRP polyribosylribitol phosphate, PT Pertussis Toxin
  2. n Number of subjects contributing to the analysis, N per protocol population
  3. aFor Anti-Polio 1, 2 and 3, for Lot 1 N = 269; for Lot 2 N = 262; for Lot 3 N = 265
  4. bEquivalence concluded as the limits of 2-sided 95% CI of difference between lots are between the interval (0.5, 2.0).
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