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Table 6 Solicited injection site and general adverse events during the 4-day post-vaccination periods in the total vaccinated cohorts

From: A historically-controlled Phase III study in adults to characterize the acceptability of a process change for manufacturing inactivated quadrivalent influenza vaccine

  TIV QIV
% (95% CI) % (95% CI)
  18–60 years >60 years 18–60 years >60 years
N = 50 N = 69 N = 56 N = 56
Injection site events     
Pain 82.0 (68.6–91.4) 26.1 (16.3–38.1) 73.2 (59.7–84.2) 33.9 (21.8–47.8)
Redness 0.0 (0.0–7.1) 0.0 (0.0–5.2) 1.8 (0.0–9.6) 0.0 (0.0–6.4)
Swelling 4.0 (0.5–13.7) 1.4 (0.0–7.8) 1.8 (0.0–9.6) 3.6 (0.4–12.3)
General events     
Chest tightness 0.0 (0.0–7.1) 4.3 (0.9–12.2) 0.0 (0.0–6.4) 3.6 (0.4–12.3)
Chills 4.0 (0.5–13.7) 0.0 (0.0–5.2) 1.8 (0.0–9.6) 8.9 (3.0–19.6)
Cough 4.0 (0.5–13.7) 0.0 (0.0–5.2) 5.4 (1.1–14.9) 7.1 (2.0–17.3)
Fatigue 30.0 (17.9–44.6) 10.1 (4.2–19.8) 17.9 (8.9–30.4) 8.9 (3.0–19.6)
Headache 26.0 (14.6–40.3) 8.7 (3.3–18.0) 19.6 (10.2–32.4) 8.9 (3.0–19.6)
Joint pain at other location 12.0 (4.5–24.3) 4.3 (0.9–12.2) 12.5 (5.2–24.1) 5.4 (1.1–14.9)
Muscle pain 34.0 (21.2–48.8) 8.7 (3.3–18.0) 37.5 (24.9–51.5) 10.7 (4.0–21.9)
Red eyes 8.0 (2.2–19.2) 1.4 (0.0–7.8) 5.4 (1.1–14.9) 0.0 (0.0–6.4)
Sore throat 16.0 (7.2–29.1) 2.9 (0.4–10.1) 12.5 (5.2–24.1) 8.9 (3.0–19.6)
Swelling of the face 2.0 (0.1–10.6) 0.0 (0.0–5.2) 0.0 (0.0–6.4) 0.0 (0.0–6.4)
Increased temperature 2.0 (0.1–10.6) 1.4 (0.0–7.8) 0.0 (0.0–6.4) 0.0 (0.0–6.4)
  1. TIV, inactivated trivalent influenza vaccine; QIV, inactivated quadrivalent influenza vaccine.