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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.