|
Solicited symptom
|
% of subjects (95% CI) reporting symptoms, Day 0–6a
|
|---|
| |
All grades
|
Grade 1
|
Grade 2
|
Grade 3
|
|---|
| |
TIV/AS03(≥65) (N = 69)
|
|
Injection site
|
|
Ecchymosisb
|
2.9 (0.4–10)
|
2.9 (0.4–10)
|
0.0 (0.0–5.2)
|
0.0 (0.0–5.2)
|
|
Painc
|
62 (50–74)
|
52 (40–64)
|
10 (4.2–20)
|
0.0 (0.0–5.2)
|
|
Rednessb
|
7.2 (2.4–16)
|
5.8 (1.6–14)
|
1.4 (0.0–7.8)
|
0.0 (0.0–5.2)
|
|
Swellingb
|
12 (5.1–22)
|
8.7 (3.3–18)
|
2.9 (0.4–10)
|
0.0 (0.0–5.2)
|
|
Systemic
|
|
Arthralgiacd
|
20 (12–32)
|
15 (7.2–25)
|
5.8 (1.6–14)
|
0.0 (0.0–5.2)
|
|
Fatiguecd
|
32 (21–44)
|
17 (9.3–28)
|
15 (7.2–25)
|
0.0 (0.0–5.2)
|
|
Gastrointestinalc
|
8.7 (3.3–18)
|
5.8 (1.6–14)
|
2.9 (0.4–10)
|
0.0 (0.0–5.2)
|
|
Headachec
|
32 (21–44)
|
23 (14–35)
|
8.7 (3.3–18)
|
0.0 (0.0–5.2)
|
|
Myalgiacd
|
25 (15–37)
|
17 (9.3–28)
|
7.2 (2.4–16)
|
0.0 (0.0–5.2)
|
|
Shiveringcd
|
16 (8.2–27)
|
12 (5.1–22)
|
4.3 (0.9–12)
|
0.0 (0.0–5.2)
|
|
Temperaturee
|
2.9 (0.4–10)
|
1.4 (0.0–7.8)
|
0.0 (0.0–5.2)
|
1.4 (0.0–7.8)
|
| |
TIV(≥65) (N = 73)
|
|
Injection site
|
|
Ecchymosisb
|
1.4 (0.0–7.4)
|
1.4 (0.0–7.4)
|
0.0 (0.0–4.9)
|
0.0 (0.0–4.9)
|
|
Painc
|
21 (12–32)
|
18 (9.8–29)
|
2.7 (0.3–9.5)
|
0.0 (0.0–4.9)
|
|
Rednessb
|
0.0 (0.0–4.9)
|
0.0 (0.0–4.9)
|
0.0 (0.0–4.9)
|
0.0 (0.0–4.9)
|
|
Swellingb
|
1.4 (0.0–7.4)
|
1.4 (0.0–7.4)
|
0.0 (0.0–4.9)
|
0.0 (0.0–4.9)
|
|
Systemic
|
|
Arthralgiacd
|
4.1 (0.9–12)
|
1.4 (0.0–7.4)
|
2.7 (0.3–9.5)
|
0.0 (0.0–4.9)
|
|
Fatiguecd
|
16 (8.8–27)
|
12 (5.8–22)
|
4.1 (0.9–12)
|
0.0 (0.0–4.9)
|
|
Gastrointestinalc
|
5.5 (1.5–13)
|
2.7 (0.3–9.5)
|
2.7 (0.3–9.5)
|
0.0 (0.0–4.9)
|
|
Headachec
|
9.6 (3.9–19)
|
8.2 (3.1–17)
|
1.4 (0.0–7.4)
|
0.0 (0.0–4.9)
|
|
Myalgiacd
|
11 (4.9–21)
|
9.6 (3.9–19)
|
1.4 (0.0–7.4)
|
0.0 (0.0–4.9)
|
|
Shiveringcd
|
0.0 (0.0–4.9)
|
0.0 (0.0–4.9)
|
0.0 (0.0–4.9)
|
0.0 (0.0–4.9)
|
|
Temperaturee
|
0.0 (0.0–4.9)
|
0.0 (0.0–4.9)
|
0.0 (0.0–4.9)
|
0.0 (0.0–4.9)
|
| |
TIV(18-40) (N = 50)
|
|
Injection site
|
|
Ecchymosisb
|
0.0 (0.0–7.1)
|
0.0 (0.0–7.1)
|
0.0 (0.0–7.1)
|
0.0 (0.0–7.1)
|
|
Painc
|
70 (55–82)
|
46 (32–61)
|
24 (13–38)
|
0.0 (0.0–7.1)
|
|
Rednessb
|
0.0 (0.0–7.1)
|
0.0 (0.0–7.1)
|
0.0 (0.0–7.1)
|
0.0 (0.0–7.1)
|
|
Swellingb
|
0.0 (0.0–7.1)
|
0.0 (0.0–7.1)
|
0.0 (0.0–7.1)
|
0.0 (0.0–7.1)
|
|
Systemic
|
|
Arthralgiacd
|
8.0 (2.2–19)
|
6.0 (1.3–17)
|
2.0 (0.1–11)
|
0.0 (0.0–7.1)
|
|
Fatiguecd
|
42 (28–57)
|
36 (23–51)
|
6.0 (1.3–17)
|
0.0 (0.0–7.1)
|
|
Gastrointestinalc
|
12 (4.5–24)
|
12 (4.5–24)
|
0.0 (0.0–7.1)
|
0.0 (0.0–7.1)
|
|
Headachec
|
28 (16–43)
|
22 (11–36)
|
6.0 (1.3–17)
|
0.0 (0.0–7.1)
|
|
Myalgiacd
|
22 (11–36)
|
18 (8.6–31)
|
4.0 (0.5–14)
|
0.0 (0.0–7.1)
|
|
Shiveringcd
|
4.0 (0.5–14)
|
2.0 (0.1–11)
|
0.0 (0.0–7.1)
|
2.0 (0.1–11)
|
|
Temperaturee
|
0.0 (0.0–7.1)
|
0.0 (0.0–7.1)
|
0.0 (0.0–7.1)
|
0.0 (0.0–7.1)
|
-
aValues reported at two significant figures.
-
bGrade 1, >20– ≤ 50 mm; Grade 2, >50– ≤ 100 mm; and Grade 3, >100 mm.
-
cGrade 1, “easily tolerated” (“painful on touch” for injection site pain); Grade 2, “interferes with normal activity” (or “painful when limb is moved” for injection site pain); and Grade 3, “prevents normal activity” (or “considerable pain at rest” for injection site pain).
-
dSymptom was generalised/widespread.
-
eGrade 1, 38.0– < 38.5°C; Grade 2, 38.5– < 39.0°C; and Grade 3, 39.0– ≤ 40.0°C. No subjects reported temperature above 40°C.
- CI, confidence interval; TIV, trivalent influenza vaccine; TIV/AS03, AS03-adjuvanted trivalent influenza vaccine.
