Table 2 |
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|
Overall incidence of solicited or unsolicited symptoms and incidence of individual solicited symptoms (any intensity and grade 3) in the 7-day follow-up period after vaccination (Total cohort) |
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| Group |
RTS, S/AS02D (N = 100) |
RTS, S/AS02A (N = 100) |
|||
|
|
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| % |
95% CI |
% |
95% CI |
||
|
|
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| Any symptoms* |
64.0 |
(53.8;73.4) |
72.0 |
(62.1; 80.5) |
|
| Grade 3 |
10.0 |
(4.9 ; 17.6) |
13.0 |
(7.1; 21.2) |
|
|
|
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| General symptoms* |
43.0 |
(33.1; 53.3) |
42.0 |
(32.2; 52.3) |
|
| Grade 3 |
7.0 |
(2.9 ;13.9) |
8.0 |
(3.5; 15.2) |
|
|
|
|||||
| Local symptoms* |
39.0 |
(29.4;49.3) |
55.0 |
(44.7; 65.0) |
|
| Grade 3 |
3.0 |
(0.6; 8.5) |
5.0 |
(1.6; 11.3) |
|
|
|
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| Pain |
Any |
35.0 |
(25.7; 45.2) |
45.0 |
(35.0; 55.3) |
| Grade 3 |
2.0 |
(0.2; 7.0) |
1.0 |
(0.0; 5.4) |
|
|
|
|||||
| Swelling |
Any |
9.0 |
(4.2; 16.4) |
23.0 |
(15.2; 32.5) |
| Grade 3 |
1.0 |
(0.0; 5.4) |
4.0 |
(1.1; 9.9) |
|
|
|
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| Drowsiness |
Any |
12.0 |
(6.4; 20.0) |
8.0 |
(3.5; 15.2) |
| Grade 3 |
4.0 |
(1.1; 9.9) |
3.0 |
(0.6; 8.5) |
|
|
|
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| Fever |
Any |
2.0 |
(0.2; 7.0) |
1.0 |
(0.0; 5.4) |
| Grade 3 |
0.0 |
(0.0; 3.6) |
0.0 |
(0.0; 3.6) |
|
|
|
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| Irritability |
Any |
28.0 |
(19.5; 37.9) |
25.0 |
(16.9; 34.7) |
| Grade 3 |
11.0 |
(5.6; 18.8) |
10.0 |
(4.9; 17.6) |
|
|
|
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| Loss of Appetite |
Any |
6.0 |
(2.2; 12.6) |
3.0 |
(0.6; 8.5) |
| Grade 3 |
1.0 |
(0.0; 5.4) |
1.0 |
(0.0; 5.4) |
|
|
N = number of subjects having received at least one dose and included in the analysis of reactogenicity N (%) = number (percentage) of subjects presenting at least one type of symptom during the 7 day follow-up period after vaccination (day 0 to day 6) *Any/General/Local symptom = includes all/general/local solicited and unsolicited symptoms occurring during the 7-day post vaccination follow-up period | |||||
Macete et al. Trials 2007 8:11 doi:10.1186/1745-6215-8-11 |
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