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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.