| Dengue vaccine group Control group |
| Age cohort |
2–5 yrs |
6–11 yrs |
12–17 yrs |
18–45 yrs |
All |
2–5 yrs |
6–11 yrs |
12–17 yrs |
18–45 yrs |
All |
| N=40 |
N=40 |
N=20 |
N=20 |
N=120 |
N=20 |
N=20 |
N=10 |
N=10 |
N=60 |
| Subjects experiencing at least one / n, % |
| Injection site reactions |
| Pain |
Any |
5, 13% |
12, 30% |
10, 50% |
7, 35% |
34, 29% |
13, 65% |
19, 95% |
9, 90% |
7, 70% |
48, 80% |
|
Erythema |
Any |
1, 3% |
5, 13% |
2, 10% |
0 |
8, 7% |
3, 15% |
4, 20% |
3, 30% |
3, 30% |
13, 22% |
| |
Grade 3 |
|
|
|
|
|
|
1, 5% |
|
|
1, 2% |
|
Swelling |
Any |
0 |
2, 5% |
1, 5% |
2, 10% |
5, 4% |
4, 20% |
4, 20% |
0 |
1, 10% |
9, 15% |
| |
Grade 3 |
|
|
|
|
|
|
1, 5% |
|
|
1, 2% |
| Systemic reaction |
| Fever |
Any |
12, 30% |
10, 25% |
9, 45% |
2, 10% |
33, 28% |
6, 30% |
5, 25% |
2, 20% |
3, 30% |
16, 27% |
| |
Grade 3 |
1, 3% |
|
|
|
1, 1% |
2, 10% |
|
|
|
2, 3% |
|
Headache |
Any |
11, 28% |
12, 31%* |
10, 50% |
9, 45% |
42, 35% |
5, 25% |
7, 35% |
5, 50% |
1, 10% |
18, 30% |
| |
Grade 3 |
|
|
|
1, 5% |
1, 1% |
|
|
|
|
|
|
Malaise |
Any |
7, 18% |
9, 23%* |
11, 55% |
8, 40% |
35, 29% |
2, 10% |
4, 20% |
3, 30% |
5, 50% |
14, 23% |
|
Myalgia |
Any |
3, 8% |
8, 21%* |
8, 40% |
5, 25% |
24, 20% |
3, 15% |
3, 15% |
5, 50% |
3, 30% |
14, 23% |
|
Asthenia |
Any |
3, 8% |
6, 15%* |
5, 25% |
2, 10% |
16, 13% |
2, 10% |
0 |
0 |
1, 10% |
3, 5% |
| |
Grade 3 |
|
1, 3% |
|
1, 5% |
2, 2% |
|
|
|
|
|
*N=39 due to missing data for one participant. Grade 3 injection site pain: Incapacitating, unable to perform usual activities, Grade 3 erythema or swelling: adults/
adolescents: >10 cm; children: >5 cm, Grade 3 fever > 39.0°C, Grade 3: headache, malaise, myalgia, or asthenia: Daily activity prevented |
