| 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, % (95%CI) |
|
Solicited reaction |
17 |
25 |
17 |
15 |
74 |
16 |
19 |
9 |
8 |
52 |
| |
43% |
63% |
85% |
75% |
62% |
80% |
95% |
90% |
80% |
87% |
| |
(27.0;59.1) |
(45.8;77.3) |
(62.1;96.8) |
(50.9;91.3) |
(52.4;70.4) |
(56.3;94.3) |
(75.1;99.9) |
(55.5;99.7) |
(44.4;97.5) |
(75.4;94.1) |
|
Solicited injection |
6 |
14 |
10 |
9 |
39 |
13 |
19 |
9 |
7 |
48 |
|
site reaction |
15% |
35% |
50% |
45% |
33% |
65% |
95% |
90% |
70 |
80% |
| |
(5.7;29.8) |
(20.6;51.7) |
(27.2;72.8) |
(23.1;68.5) |
(24.2;41.7) |
(40.8;84.6) |
(75.1;99.9) |
(55.5;99.7) |
(34.8;93.3) |
(67.7;89.2) |
|
Solicited systemic |
16 |
19 |
16 |
12 |
63 |
10 |
10 |
6 |
7 |
33 |
|
reaction |
40% |
48% |
80% |
60% |
53% |
50% |
50% |
60% |
70% |
55% |
| |
(24.9;56.7) |
(31.5;63.9) |
(56.3;94.3) |
(36.1;80.9) |
(43.2;61.7) |
(27.2;72.8) |
(27.2;72.8) |
(26.2;87.8) |
(34.8;93.3) |
(41.6;67.9) |
| Unsolicited AE |
8 |
7 |
11 |
7 |
33 |
5 |
6 |
5 |
4 |
20 |
| |
20% |
18% |
55% |
35% |
28% |
25% |
30% |
50% |
40% |
33% |
| |
(9.1; 35.6) |
(7.3;32.8) |
(31.5;76.9) |
(15.4;59.2) |
(19.7;36.4) |
(8.7;49.1) |
(11.9;54.3) |
(18.7;81.3) |
(12.2;73.8) |
(21.7;46.7) |
|
Unsolicited AR |
0 |
1 |
2 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
| |
0% |
3% |
10% |
0% |
3% |
0% |
0% |
0% |
0% |
0% |
| |
(0;8.8) |
(0.1;13.2) |
(1.2; 31.7) |
(0;16.8) |
(0.5;7.1) |
(0;16.8) |
(0;16.8) |
(0;30.8) |
(0;30.8) |
(0;6.0) |
|
SAE |
1 |
0 |
1 |
1 |
3 |
0 |
1 |
1 |
1 |
3 |
| |
3% |
0% |
5% |
5% |
3% |
0% |
5% |
10% |
10% |
5% |
| |
(0.1;13.2) |
(0;8.8) |
(0.1;24.9) |
(0.1;24.9) |
(0.5;7.1) |
(0;16.8) |
(0.1;24.9) |
(0.3;44.5) |
(0.3;44.5) |
(1;13.9) |
• Solicited reaction: any adverse event (AE) pre-listed in the protocol that is automatically considered to be vaccine-related, and as such termed an
• ‘adverse reaction’ (AR)
• Solicited injection site reaction: any AR associated with the site of injection that is pre-listed in the protocol (pain, erythema, swelling)
• Solicited systemic reaction: any AR not associated with the site of injection that is pre-listed in the protocol (fever, headache, malaise, myalgia, asthenia)
• Unsolicited AE: any observed AE that is not a solicited injection site or solicited systemic reaction
• Unsolicited AR: any unsolicited AE that is considered to be vaccine-related
SAE: any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization,
results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event |
