Table 1.
Solicited adverse events post-vaccination (day 0–7) in the Phase 1 US study
| |
10 μg MSP142/AS01 (N = 6*) |
50 μg MSP142/AS01 (N = 20*) |
||||
|---|---|---|---|---|---|---|
| G1 | G2 | G3 | G1 | G2 | G3 | |
|
Pain | ||||||
| Immunization 1 |
3 |
2 |
0 |
10 |
6 |
2 |
| Immunization 2 |
1 |
2 |
1 |
7 |
9 |
1 |
| Immunization 3 |
3 |
1 |
0 |
10 |
2 |
3 |
|
Redness | ||||||
| Immunization 1 |
1 |
0 |
1 |
3 |
1 |
4 |
| Immunization 2 |
1 |
0 |
1 |
1 |
2 |
4 |
| Immunization 3 |
2 |
0 |
1 |
3 |
2 |
3 |
|
Swelling | ||||||
| Immunization 1 |
0 |
1 |
1 |
0 |
2 |
8 |
| Immunization 2 |
0 |
1 |
2 |
3 |
2 |
6 |
| Immunization 3 |
1 |
0 |
3 |
1 |
3 |
10 |
|
Fever | ||||||
| Immunization 1 |
2 |
0 |
0 |
1 |
1 |
1 |
| Immunization 2 |
1 |
2 |
0 |
4 |
4 |
2 |
| Immunization 3 |
2 |
0 |
0 |
3 |
5 |
0 |
|
Fatigue | ||||||
| Immunization 1 |
1 |
0 |
0 |
6 |
4 |
1 |
| Immunization 2 |
1 |
1 |
1 |
5 |
7 |
2 |
| Immunization 3 |
1 |
2 |
0 |
7 |
3 |
3 |
|
Nausea | ||||||
| Immunization 1 |
0 |
0 |
0 |
1 |
0 |
0 |
| Immunization 2 |
1 |
1 |
0 |
1 |
1 |
0 |
| Immunization 3 |
0 |
0 |
0 |
0 |
1 |
1 |
|
Headache | ||||||
| Immunization 1 |
2 |
1 |
0 |
3 |
3 |
1 |
| Immunization 2 |
3 |
0 |
0 |
3 |
6 |
2 |
| Immunization 3 |
1 |
2 |
0 |
2 |
6 |
2 |
|
Malaise | ||||||
| Immunization 1 |
1 |
0 |
0 |
4 |
1 |
2 |
| Immunization 2 |
0 |
1 |
2 |
3 |
6 |
4 |
| Immunization 3 |
0 |
2 |
0 |
4 |
5 |
3 |
|
Myalgia | ||||||
| Immunization 1 |
0 |
0 |
0 |
1 |
2 |
1 |
| Immunization 2 |
2 |
0 |
0 |
4 |
5 |
2 |
| Immunization 3 |
0 |
2 |
0 |
6 |
2 |
3 |
|
Joint Pain | ||||||
| Immunization 1 |
0 |
0 |
0 |
2 |
2 |
0 |
| Immunization 2 |
0 |
1 |
0 |
3 |
2 |
2 |
| Immunization 3 | 0 | 2 | 0 | 4 | 4 | 1 |