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Finished Products of Varicella Vaccine Live
| Model No. : | 0.5ml/vial |
|---|
Product description
In a clinical trial involving 928 people of 13 years old and above immunized by the product, the total occurrence rate of systemic reactions was 28.76% which was mainly fever, please see table 3, and the total occurrence rate of local reactions was 8.24% which was mainly redness, swelling and pain, please see table 4.
Table 3 Systemic reactions in 13 years old and above
|
Dose |
Age/ years |
Group |
Cases (n) |
Mild (%) |
Moderate (%) |
Severe (%) |
Total (%) |
|
First dose |
13~16 |
The product |
299 |
69 (23.08) |
14 (4.68) |
0 (0.00) |
83 (27.76) |
|
Control |
149 |
53 (35.57) |
4 (2.68) |
0 (0.00) |
57 (38.26) |
||
|
17~50 |
The product |
320 |
49 (15.31) |
3 (0.94) |
1 (0.31) |
53 (16.56) |
|
|
Control |
160 |
21 (13.13) |
6 (3.75) |
0 (0.00) |
27 (16.88) |
||
|
Total |
The product |
619 |
118 (19.06) |
17 (2.75) |
1 (0.16) |
136 (21.97) |
|
|
Control |
309 |
74 (23.95) |
10 (3.24) |
0 (0.00) |
84 (27.18) |
||
|
Second dose |
13~16 |
The product |
293 |
41 (13.99) |
4 (1.37) |
1 (0.34) |
46 (15.70) |
|
Control |
146 |
19 (13.01) |
4 (2.74) |
0 (0.00) |
23 (15.75) |
||
|
17~50 |
The product |
307 |
21 (6.84) |
0 (0.00) |
0 (0.00) |
21 (6.84) |
|
|
Control |
154 |
15 (9.74) |
1 (0.65) |
1 (0.65) |
17 (11.04) |
||
|
Total |
The product |
600 |
62 (10.33) |
4 (0.67) |
1 (0.17) |
67 (11.17) |
|
|
Control |
300 |
34 (11.33) |
5 (1.67) |
1 (0.33) |
40 (13.33) |
||
|
Total |
13~50 |
The product |
619 |
155 (25.04) |
21 (3.39) |
2 (0.32) |
178 (28.76) |
|
Control |
309 |
88 (28.48) |
14 (4.53) |
1 (0.32) |
103 (33.33) |
Table 4 Local reactions in 13 years old and above
|
Dose |
Age/years |
Group |
Cases (n) |
Mild (%) |
Moderate (%) |
Severe (%) |
Total (%) |
|
First dose |
13~16 |
The product |
299 |
10 (3.34) |
5 (1.67) |
1 (0.33) |
16 (5.35) |
|
Control |
149 |
10 (6.71) |
4 (2.68) |
0 (0.00) |
14 (9.40) |
||
|
17~50 |
The product |
320 |
21 (6.56) |
8 (2.50) |
2 (0.63) |
31 (9.69) |
|
|
Control |
160 |
22 (13.75) |
11 (6.88) |
4 (2.50) |
37 (23.13) |
||
|
Total |
The product |
619 |
31 (5.01) |
13 (2.10) |
3 (0.48) |
47 (7.59) |
|
|
Control |
309 |
32 (10.36) |
15 (4.85) |
4 (1.29) |
51 (16.50) |
||
|
Second dose |
13~16 |
The product |
293 |
4 (1.37) |
1 (0.34) |
0 (0.00) |
5 (1.71) |
|
Control |
146 |
1 (0.68) |
0 (0.00) |
0 (0.00) |
1 (0.68) |
||
|
17~50 |
The product |
307 |
1 (0.33) |
1(0.33) |
0 (0.00) |
2 (0.65) |
|
|
Control |
154 |
1 (0.65) |
0 (0.00) |
0 (0.00) |
1 (0.65) |
||
|
Total |
The product |
600 |
5 (0.83) |
2 (0.33) |
0 (0.00) |
7 (1.17) |
|
|
Control |
300 |
2 (0.67) |
0 (0.00) |
0 (0.00) |
2 (0.67) |
||
|
Total |
13~50 |
The product |
619 |
35 (5.65) |
13 (2.10) |
3 (0.48) |
51 (8.24) |
|
Control |
309 |
32 (10.36) |
15 (4.85) |
4 (1.29) |
51 (16.50) |
There is no significant difference between vaccine group and control group in table 3 and 4.
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