Reaction Severity

Group 1 (N=132)

Group 2 (N=131)

Injection Site Reactions:  

    Pain Any

77.3 (69.2;84.1)

77.1 (68.9;84.0)

  Grade 3

7.6 (3.7;13.5)

4.6 (1.7;9.7)

    Erythema Any

59.1 (50.2;67.6)

50.4 (41.5;59.2)

  Grade 3

2.3 (0.5;6.5)

3.8 (1.3;8.7)

    Swelling Any

40.9 (32.4;49.8)

39.7 (31.3;48.6)

  Grade 3

2.3 (0.5;6.5)

1.5 (0.2;5.4)

Systemic Reactions:  

    Pyrexia Any

28.0 (20.6;36.5)

27.5 (20.0;36.0)

  Grade 3

0.0 (0.0;2.8)

2.3 (0.5;6.5)

    Vomiting Any

22.0 (15.2;30.0)

24.4 (17.3;32.7)

  Grade 3

0.0 (0.0;2.8)

0.0 (0.0;2.8)

    Crying Any

75.8 (67.5;82.8)

71.0 (62.4;78.6)

  Grade 3

0.8 (0.0;4.1)

0.8 (0.0;4.2)

    Somnolence Any

55.3 (46.4;64.0)

62.6 (53.7;70.9)

  Grade 3

1.5 (0.2;5.4)

1.5 (0.2;5.4)

    Anorexia Any

40.9 (32.4;49.8)

44.3 (35.6;53.2)

  Grade 3

0.0 (0.0;2.8)

0.8 (0.0;4.2)

    Irritability Any

75.8 (67.5;82.8)

74.8 (66.5;82.0)

  Grade 3

1.5 (0.2;5.4)

0.8 (0.0;4.2)

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) (calculated according to the number of participants available for the endpoint) N=number of participants in the safety analysis set
Table 2: Summary of solicited injection site and systemic adverse reactions occurring within 7 days after any dose of vaccine (safety analysis set).