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Table 3 Seroprotection rates and GMCs for diphtheria, tetanus, HBV and pertussis before dose 1 (pre) and one month post-dose 3 (post; ATP cohort for immunogenicity)

From: The immunogenicity and safety of a reduced PRP-content DTPw-HBV/Hib vaccine when administered according to the accelerated EPI schedule

  

Seroprotection rates/Vaccine response rates

GMC

  

DTPw-HBV/Hib 2.5 [Kft]

DTPw-HBV/Hib

DTPw -HBV/Hib2.5

DTPw-HBV/Hib 2.5 [Kft]

DTPw-HBV/Hib

DTPw -HBV/Hib2.5

 

Time point

N

%

95% CI

N

%

95% CI

N

%

95% CI

Value

95% CI

Value

95% CI

Value

95% CI

Diphtheria ≥0.1 IU/ml (or ≥0.016 IU/ml by neutralization assay)

Pre

93

31.2

22.0-41.6

89

34.8

25.0-45.7

85

24.7

16.0-35.3

0.086

0.070-0.105

0.082

0.069-0.097

0.076

0.063-0.093

 

Post

93

100

96.1-100

89

98.9

95.9-100

85

100

95.8-100

2.89

2.30-3.64

1.76

1.41-2.19

1.65

1.36-2.02

Tetanus ≥0.1 IU/ml

Pre

93

100

96.1-100

89

100

95.9-100

85

100

95.8-100

1.950

1.561-2.437

2.416

1.991-2.932

2.112

1.751-2.548

 

Post

93

100

96.1-100

89

100

95.9-100

85

100

95.8-100

4.74

3.78-5.95

2.82

2.32-3.45

2.77

2.24-3.44

HBV ≥10 mIU/ml

Pre

85

25.9

17.0-36.5

85

24.7

16.0-35.3

84

21.4

13.2-31.7

8.3

6.7-10.3

8.0

6.5-9.8

6.6

5.8-7.5

 

Post

92

100

96.1-100

89

100

95.9-100

85

100

95.8-100

781.1

629.7-968.8

598.2

477.7-749.1

695.3

542.1-891.7

Anti-BPT antibodies ≥15 El.U/ml

Pre

93

16.1

9.3-25.2

89

19.1

11.5-28.8

85

22.4

14.0-32.7

9.1

8.2-10.1

9.1

8.3-10.0

9.8

8.7-11.0

 

Post

93

98.9

94.2-100

89

98.9

93.9-100

85

100

95.8-100

63.4

55.4-72.7

83.7

73.6-95.2

100.3

88.4-113.7

VR for anti-BPT antibody

Post

93

97.8

92.4-99.7

89

98.9

93.9-100

85

98.8

93.6-100

      
  1. BPT = Bordetella pertussis; CI = confidence interval; GMC = geometric mean concentration; HBV = hepatitis B vaccine; IU = international unit; N = number of subjects with available results; VR = vaccine response.