Table 3.
Percentages of subjects experiencing mild to moderate (and severe) solicited systemic adverse events within 14 days of vaccination (safety analysis set)
| Percentages of subjects in each group with solicited systemic adverse events (severe in parentheses) |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Group A Shantha Liquid 1 Dose (n = 197) |
Group B Shantha Liquid 2 Doses (n = 97) |
Group A + B Shantha Liquid 1 or 2 Doses (n = 294) |
Group C IDT Liquid 2 Doses (n = 100) |
Group D IDT Lyophilized 2 Doses (n = 602) |
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| Dose 1 | Placebo | Dose 1 | Dose 2 | Dose 1 | Dose 2 | Dose 1 | Dose 2 | Dose 1 | Dose 2 | |
| Headache | 31.4 (3.1) |
16.8 (3.2) |
30.5 (5.3) |
21.7 (2.4) |
31.1 (3.8) |
18.5 (2.9) |
29.6 (1.0) |
18.0 (3.4) |
32.8 (1.9) |
20.0 (2.9) |
| Asthenia | 20.4 (2.1) |
9.7 (1.3) |
20.0 (0) |
10.8 (1.2) |
20.3. (1.4) |
10.1 (1.3) |
18.4 (1.0) |
13.5 (1.1) |
19.6 (2.1) |
10.8 (0.6) |
| Malaise | 21.5 (3.7) |
12.9 (1.3) |
7.4 (0) |
10.8 (1.2) |
21.3 (2.8) |
12.2 (1.3) |
16.3 (1.0) |
13.5 (2.2) |
19.1 (1.7) |
11.8 (1.0) |
| Myalgia | 23.0 (1.0) |
14.2 (1.3) |
31.6 (2.1) |
18.1 (2.4) |
25.9 (1.4) |
15.5 (1.7) |
22.4 (2.0) |
18.0 (0) |
25.8 (1.0) |
15.7 (0.4) |
| Fever | 1.6 (0) |
0 (0) |
1.1 (0) |
2.4 (0) |
1.4 (0) |
0.8 (0) |
1.0 (0) |
0 (0) |
1.4 (0) |
0.4 (0) |
Severe fever described as body temperature >39.0ºC. Severe headache, asthenia, malaise, and myalgia all described as that preventing normal activity.