Table 3.
Safety and reactogenicity on Days 0–6 post-vaccination (TVC)
| Treatment groupa | ||||
|---|---|---|---|---|
|
Symptom % (95% CI)b |
QIV |
LD QIV-AS |
LD TIV-AS |
TIV |
| Nc |
105 |
104 |
105 |
105 |
| Any symptom |
79.0 (70.0–86.4) |
86.5 (78.4–92.4) |
77.1 (67.9–84.8) |
67.6 (57.8–76.4) |
| Grade 3d |
3.8 (1.0–9.5) |
4.8 (1.6–10.9) |
9.5 (4.7–16.8) |
1.9 (0.2–6.7) |
| Local Symptoms |
72.4 (62.8–80.7) |
76.9 (67.6–84.6) |
70.5 (60.8–79.0) |
49.5 (39.6–59.5) |
| Grade 3 |
0 (0–3.5) |
1.9 (0.2–6.8) |
2.9 (0.6–8.1) |
0 (0–3.5) |
| Pain |
72.4 (62.8–80.7) |
76.0 (66.6–83.8) |
70.5 (60.8–79.0) |
49.5 (39.6–59.5) |
| Grade 3 |
0 (0–3.5) |
1.9 (0.2–6.8) |
2.9 (0.6–8.1) |
0 (0–3.5) |
| Redness |
2.9 (0.6–8.1) |
5.8 (2.1–12.1) |
4.8 (1.6–10.8) |
1.0 (0–5.2) |
| >100 mm |
0 (0–3.5) |
0 (0–3.5) |
0 (0–3.5) |
0 (0–3.5) |
| Swelling |
2.9 (0.6–8.1) |
3.8 (1.1–9.6) |
6.7 (2.7–13.3) |
1.9 (0.2–6.7) |
| >100 mm |
0 (0–3.5) |
0 (0–3.5) |
0 (0–3.5) |
0 (0–3.5) |
| General Symptoms |
44.8 (35.0–54.8) |
57.7 (47.6–67.3) |
53.3 (43.3–63.1) |
43.8 (34.1–53.8) |
| Grade 3 |
3.8 (1.0–9.5) |
4.8 (1.6–10.9) |
7.6 (3.3–14.5) |
1.9 (0.2–6.7) |
| Arthalgia |
5.7 (2.1–12.0) |
24.0 (16.2–33.4) |
12.4 (6.8–20.2) |
10.5 (5.3–18.0) |
| Grade 3 |
1.0 (0–5.2) |
2.9 (0.6–8.2) |
1.9 (0.2–6.7) |
0 (0–3.5) |
| Fatigue |
30.5 (21.9–40.2) |
45.2 (35.4–55.3) |
34.3 (25.3–44.2) |
31.4 (22.7–41.2) |
| Grade 3 |
1.9 (0.2–6.7) |
3.8 (1.1–9.6) |
2.9 (0.6–8.1) |
1.0 (0–5.2) |
| Headache |
22.9 (15.2–32.1) |
31.7 (22.9–41.6) |
24.8 (16.9–34.1) |
21.9 (14.4–31.0) |
| Grade 3 |
2.9 (0.6–8.1) |
1.9 (0.2–6.8) |
1.0 (0–5.2) |
0 (0–3.5) |
| Myalgia |
16.2 (9.7–24.7) |
38.5 (29.1–48.5) |
31.4 (22.7–41.2) |
14.3 (8.2–22.5) |
| Grade 3 |
1.0 (0–5.2) |
2.9 (0.6–8.2) |
2.9 (0.6–8.1) |
1.0 (0–5.2) |
| Nausea |
7.6 (3.3–14.5) |
9.6 (4.7–17.0) |
7.6 (3.3–14.5) |
7.6 (3.3–14.5) |
| Grade 3 |
1.9 (0.2–6.7) |
1.9 (0.2–6.8) |
1.9 (0.2–6.7) |
1.0 (0–5.2) |
| Shivering |
3.8 (1.0–9.5) |
9.6 (4.7–17.0) |
8.6 (4.0–15.6) |
3.8 (1.0–9.5) |
| Grade 3 |
1.0 (0–5.2) |
1.9 (0.2–6.8) |
1.0 (0–5.2) |
0 (0–3.5) |
| Fever (°C) |
1.0 (0–5.2) |
2.9 (0.6–8.2) |
1.9 (0.2–6.7) |
1.0 (0–5.2) |
| >39°C | 0 (0–3.5) | 0 (0–3.5) | 0 (0–3.5) | 0 (0–3.5) |
a Groups were administered the quadrivalent influenza vaccine (QIV), the low-dose adjuvanted quadrivalent influenza vaccine (LD QIV-AS), the low-dose adjuvanted trivalent influenza vaccine (LD TIV-AS) or the trivalent influenza vaccine (TIV).
b Abbreviations: 95% CI = 95% confidence interval (lower limit–upper limit).
c N = total number of participants with symptom sheets returned.
d Grade 3 symptoms were defined as symptoms that prevented normal everyday activity.
Table displays local and general symptoms reported as related to vaccination. All reported local symptoms were considered related to vaccination.