Table 3 GMC/GMT, GMFR at baseline and 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

 

DTwP-HepB-IPV-Hib (N = 804a)

DTwP-HepB-Hib + IPV (N = 406a)

 

Baseline

Post 3rd dose#

Baseline

Post 3rd dose#

GMFR p value$

Anti-D (IU/ml)

GMC

0.144 (0.131, 0.157)

0.968 (0.904, 1.036)

0.168 (0.148, 0.190)

0.969 (0.883, 1.063)

NA

GMFR

NA

6.72 (6.088, 7.421)

NA

5.77 (5.038, 6.605)

0.6195

Anti-T (IU/ml)

GMC

1.018 (0.958, 1.083)

3.903 (3.712, 4.103)

1.192 (1.102, 1.289)

3.877 (3.622, 4.149)

NA

GMFR

NA

3.83 (3.604, 4.072)

NA

3.25 (3.022, 3.499)

0.1008

Anti-wP (U/ml)

GMC

8.485 (7.923, 9.088)

46.445 (43.511, 49.576)

10.145 (9.176, 11.217)

49.839 (45.651, 54.413)

NA

GMFR

NA

5.47 (5.044, 5.940)

NA

4.91 (4.386, 5.502)

0.6208

Anti-PT (IU/ml)

GMC

3.500 (3.350, 3.656)

38.840 (36.013, 41.890)

3.2697 (3.089, 3.460)

35.843 (31.774, 40.434)

NA

GMFR

NA

11.10 (10.168, 12.111)

NA

10.96 (9.589, 12.533)

0.2441

Anti-HBs (mIU/ml)

GMC

2.087 (1.892, 2.302)

1783.552 (1577.500, 2016.518)

2.094 (1.837, 2.388)

1721.769 (1430.532, 2072.298)

NA

GMFR

NA

854.61 (735.484, 993.041)

NA

822.07 (655.646, 1030.750)

0.7476

Anti-PRP (µg/ml)

GMC

0.310 (0.286, 0.336)

2.822 (2.551, 3.122)

0.371 (0.331, 0.417)

4.818 (4.216, 5.506)

NA

GMFR

NA

9.09 (8.182, 10.103)

NA

12.96 (11.108, 15.123)

<0.0001

Anti-Polio 1 (1/dil)

GMT

210.055 (182.346, 241.975)

3215.314 (3008.131, 3436.768)

189.217 (155.240, 230.631)

2360.426 (2100.827, 2652.102)

NA

GMFR

NA

15.08 (13.045, 17.438)

NA

12.31 (9.984, 15.188)

<0.0001

Anti-Polio 2 (1/dil)

GMT

14.074 (13.052, 15.177)

122.157 (111.840, 133.427)

13.430 (12.117, 14.884)

152.352 (136.314, 170.277)

NA

GMFR

NA

8.68 (7.615, 9.899)

NA

11.45 (9.648, 13.589)

0.0023

Anti-Polio 3 (1/dil)

GMT

38.511 (33.270–44.577)

1955.913 (1824.171, 2097.168)

28.455 (23.391, 34.614)

1361.409 (1221.327, 1517.557)

NA

GMFR

NA

50.79 (43.494, 59.299)

NA

48.23 (39.143, 59.435)

<0.0001

  1. CI Confidence Interval, dil dilution, N per protocol population, n Number of subjects contributing to the analysis
  2. $p values were calculated using Mix Model. #Pre and post 3rd dose GMT/GMC comparison for all antigens using paired t test has p < 0.0001. p < 0.05 was considered significant
  3. aFor Anti-Polio 1, 2 and 3 N = 796 each for DTwP-HepB-IPV-Hib group and N = 402 each for DTwP-HepB-Hib + IPV group.
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