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Table 5 Incidence of solicited adverse reactions as defined by the EMA in the first three days after vaccination

From: Evaluation of non-inferiority of intradermal versus adjuvanted seasonal influenza vaccine using two serological techniques: a randomised comparative study

  Intradermal vaccine Adjuvanted vaccine
  (N = 398) (N = 397)
  n n
  (%; [95% CI]) (%; [95% CI])
≥ 1 adverse reaction 51 55
  (12.8 [9.7;16.5]) (13.9 [10.6;17.6])
Injection-site indurationa 0 0
  (0 [0.0;0.9]) (0 [0.0;0.9])
Injection-site ecchymosis 13 12
  (3.3 [1.8;5.5]) (3.0 [1.6;5.2])
Pyrexiab 6 12
  (1.5 [0.6;3.3]) (3.0 [1.6;5.2])
Malaise 19 20
  (4.8 [2.9;7.4]) (5.0 [3.1;7.7])
Shivering 24 23
  (6.0 [3.9;8.8]) (5.8 [3.7;8.6])
  1. a > 5 cm for > 3 consecutive days.
  2. b Rectal equivalent temperature > 38.0°C for ≥ 24 hours.