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Table 2 Incidence of solicited adverse events within 7 days after each vaccination (safety population)

From: Safety and immunogenicity of a freeze-dried, Vero cell culture-derived, inactivated Japanese encephalitis vaccine (KD-287, ENCEVAC®) versus a mouse brain-derived inactivated Japanese encephalitis vaccine in children: a phase III, multicenter, double-blinded, randomized trial

 

Severity

1 st dose, n*(%)

2 nd dose, n*(%)

3 rd dose, n*(%)

KD-287 (n = 102)

JEV-GCC (n = 102)

KD-287 (n = 102)

JEV-GCC (n = 100)

KD-287 (n = 100)

JEV-GCC (n = 96)

Erythema

Mild

9 (8.8)

18 (17.6)

7 (6.9)

14 (14.0)

7 (7.0)

14 (14.6)

Moderate

3 (2.9)

2 (2.0)

5 (4.9)

2 (2.0)

7 (7.0)

6 (6.3)

Severe

1 (1.0)

0 (0)

0 (0)

0 (0)

1 (1.0)

0 (0)

Pain

Mild

14 (13.7)

10 (9.8)

3 (2.9)

5 (5.0)

18 (18.0)

11 (11.5)

Moderate

2 (2.0)

2 (2.0)

2 (2.0)

1 (1.0)

2 (2.0)

3 (3.1)

Severe

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

1 (1.0)

Swelling

Mild

3 (2.9)

7 (6.9)

6 (5.9)

7 (7.0)

5 (5.0)

11 (11.5)

Moderate

2 (2.0)

1 (1.0)

2 (2.0)

1 (1.0)

1 (1.0)

2 (2.1)

Severe

1 (1.0)

0 (0)

0 (0)

0 (0)

1 (1.0)

0 (0)

Fever

Mild

19 (18.6)

10 (9.8)

13 (12.7)

12 (12.0)

13 (13.0)

14 (14.6)

Moderate

8 (7.8)

4 (3.9)

2 (2.0)

4 (4.0)

1 (1.0)

3 (3.1)

Severe

4 (3.9)

1 (1.0)

2 (2.0)

3 (3.0)

0 (0)

1 (1.0)

Crying

Mild

27 (26.5)

20 (19.6)

15 (14.7)

6 (6.0)

14 (14.0)

14 (14.6)

Moderate

5 (4.9)

4 (3.9)

3 (2.9)

6 (6.0)

2 (2.0)

3 (3.1)

Severe

2 (2.0)

0 (0)

0 (0)

1 (1.0)

0 (0)

1 (1.0)

Irritability

Mild

12 (11.8)

11 (10.8)

5 (4.9)

6 (6.0)

13 (13.0)

4 (4.2)

Moderate

1 (1.0)

4 (3.9)

2 (2.0)

5 (5.0)

0 (0)

6 (6.3)

Severe

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

Vomiting

Mild

8 (7.8)

11 (10.8)

4 (3.9)

3 (3.0)

1 (1.0)

4 (4.2)

Moderate

2 (2.0)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

Severe

1 (1.0)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

Diarrhea

Mild

17 (16.7)

11 (10.8)

3 (2.9)

5 (5.0)

3 (3.0)

4 (4.2)

Moderate

4 (3.9)

1 (1.0)

0 (0)

2 (2.0)

0 (0)

2 (2.1)

Severe

0 (0)

1 (1.0)

0 (0)

0 (0)

1 (1.0)

1 (1.0)

Decreased appetite

Mild

10 (9.8)

13 (12.7)

5 (4.9)

8 (8.0)

6 (6.0)

8 (8.3)

Moderate

2 (2.0)

0 (0)

0 (0)

1 (1.0)

1 (1.0)

0 (0)

Severe

2 (2.0)

0 (0)

1 (1.0)

0 (0)

0 (0)

1 (1.0)

Somnolence

Mild

9 (8.8)

12 (11.8)

8 (7.8)

7 (7.0)

14 (14.0)

17 (17.7)

Moderate

0 (0)

1 (1.0)

0 (0)

1 (1.0)

0 (0)

0 (0)

Severe

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

0 (0)

  1. *Number of subjects reporting the specific characteristic.