| 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 |
