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Table 3 Safety and reactogenicity on Days 0–6 post-vaccination (TVC)

From: Immunogenicity and safety of quadrivalent versus trivalent inactivated influenza vaccine: a randomized, controlled trial in adults

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)

  1. 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).
  2. b Abbreviations: 95% CI = 95% confidence interval (lower limit–upper limit).
  3. c N = total number of participants with symptom sheets returned.
  4. d Grade 3 symptoms were defined as symptoms that prevented normal everyday activity.
  5. Table displays local and general symptoms reported as related to vaccination. All reported local symptoms were considered related to vaccination.