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Adacel

Clinical Pharmacology
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Clinical Pharmacology

Adacel

 
Tetanus Antitoxin (IU/mL)
Pre-Vaccination
1 Month Post-Vaccination
Age Group (years)
Vaccine
N

%≥ 0.10

(95% CI)

% ≥ 1.0

(95% CI)

% ≥ 0.10

(95% CI)

% ≥ 1.0

(95% CI)

% Booster*

(95% CI)
11 - 17
ADACEL
527

99.6

(98.6, 100.0)

44.6

(40.3, 49.0)

100.0†

(99.3, 100.0)

99.6†

(98.6, 100.0)

91.7

(89.0, 93.9)
Td
516

99.2

(98.0, 99.8)

43.8

(39.5, 48.2)

100

(99.3, 100.0)

99.4

(98.3, 99.9)

91.3

(88.5, 93.6)
18-64
ADACEL
742

97.3

(95.9, 98.3)

72.9

(69.6, 76.1)

100.0†

(99.5, 100.0)

97.8†

(96.5, 98.8)

63.1

(59.5, 66.6)
Td
509

95.9

(93.8, 97.4)

70.3

(66.2, 74.3)

99.8

(98.9, 100.0)

98.2

(96.7, 99.2)

66.8

(62.5, 70.9)

* Booster response is defined as: A four-fold rise in antibody concentration, if the pre-vaccination concentration was below the cut-off value, and a two-fold rise in antibody concentration if the pre-vaccination concentration was above the cut-off value. The cut-off value for tetanus was 2.7 IU/mL.

† Seroprotection rates at ≥0.10 IU/mL or booster response rates to ADACEL vaccine were non-inferior to Td vaccine (upper limit of the 95% CI on the difference for Td vaccine minus ADACEL vaccine <10%).

† Seroprotection rates at ≥1.0 IU/mL were not designed as a primary endpoint; however, ADACEL vaccine met non-inferiority criteria (upper limit of the 95% CI on the difference for Td vaccine minus ADACEL vaccine <10%) at this level.

Table 2: Diphtheria Antitoxin Levels and Booster Response Rates

Diphtheria Antitoxin (IU/mL)
Pre-Vaccination
1 Month Post-Vaccination
Age Group (years)
Vaccine
N

% ≥ 0.10

(95% CI)

% ≥ 1.0

(95% CI)

% ≥ 0.10

(95% CI)

% ≥ 1.0

(95% CI)

% Booster*

(95% CI)
11-17
ADACEL
527

72.5

(68.5, 76.3)

15.7

(12.7, 19.1)

99.8†

(98.9, 100.0)

98.7†

(97.3, 99.5)

95.1

(92.9, 96.8)
Td
516

70.7

(66.5, 74.6)

17.3

(14.1, 20.8)

99.8

(98.9, 100.0)

98.4

(97.0, 99.3)

95

(92.7, 96.7)
18-64
ADACEL
741

62.6

(59.0, 66.1)

14.3

(11.9, 17.0)

94.1†

(92.1, 95.7)

78.0†

(74.8, 80.9)

87.4

(84.8, 89.7)
Td
507

63.3

(59.0, 67.5)

16

(12.9, 19.5)

95.1

(92.8, 96.8)

79.9

(76.1, 83.3)

83.4

(79.9, 86.5)
* Booster response is defined as: A four-fold rise in antibody concentration, if the pre-vaccination concentration was below the cut-off value, and a two-fold rise in antibody concentration if the pre-vaccination concentration was above the cut-off value. The cut-off value for diphtheria was 2.56 IU/mL.
Brand Name: Adacel
Generic Name: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed
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