Table 1.
Adverse Effects after Vaccination with Inactivated Influenza Virus Vaccine With or Without QS21 Adjuvant
| No. Subjects with Indicated Severity (0-3) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Aqueous Vaccine | QS21 Vaccine | ||||||||
| Evaluation Time | Adverse Effect | 0 | 1 | 2 | 3 | 0 | 1 | 2 | 3 |
| Day 0 (Observed) | Local Pain:1 | ||||||||
| Immediate | 14 | 1 | 0 | 0 | 13 | 2 | 0 | 0 | |
| At 30 min | 13 | 2 | 0 | 0 | 5 | 9 | 1 | 0 | |
| Day 1 (Observed) | Local: | ||||||||
| Pain1 | 7 | 8 | 0 | 0 | 2 | 9 | 4 | 0 | |
| Redness2 | 15 | 0 | 0 | 0 | 14 | 1 | 0 | 0 | |
| Swelling/induration2 | 15 | 0 | 0 | 0 | 14 | 1 | 0 | 0 | |
| Systemic:3 | |||||||||
| Fever | 15 | 0 | 0 | 0 | 14 | 15 | 0 | 0 | |
| Feverish | 15 | 0 | 0 | 0 | 13 | 2 | 0 | 0 | |
| Headache | 14 | 1 | 0 | 0 | 12 | 3 | 0 | 0 | |
| Fatigue | 14 | 1 | 0 | 0 | 10 | 5 | 0 | 0 | |
| Myalgias | 15 | 0 | 0 | 0 | 10 | 5 | 0 | 0 | |
| Days 1-74 (Diary) | Local: | ||||||||
| Pain1 | 7 | 4 | 4 | 0 | 1 | 3 | 11 | 0 | |
| Redness2 | 15 | 0 | 0 | 0 | 13 | 2 | 0 | 0 | |
| Swelling2 | 15 | 0 | 0 | 0 | 13 | 2 | 0 | 0 | |
| Systemic:3 | |||||||||
| Fever | 15 | 0 | 0 | 0 | 14 | 1 | 0 | 0 | |
| Headache | 10 | 4 | 1 | 0 | 9 | 5 | 1 | 0 | |
| Fatigue | 11 | 4 | 0 | 0 | 8 | 6 | 1 | 0 | |
| Myalgias | 15 | 0 | 0 | 0 | 6 | 6 | 3 | 0 | |
| Nausea/vomiting | 12 | 2 | 1 | 0 | 13 | 2 | 0 | 0 | |
1
0 = none, 1 = tender to touch, 2 = hurts to move, 3 = unable to move
2
0 = none, 1 = 0.5 – 5 cm, 2 = 5 – 10 cm, 3 = >10 cm
3
0 = none, 1 = slight/mild, 2 = interferes with activity, 3 = incapacitating
4
Highest severity for day 1-7 interval
5
Temp = 100.6°F