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Table 4 Safety summary: number of subjects with European Medicines Evaluation Agency -specified reactions after each intradermal and intramuscular vaccination according to vaccine history during the study

From: Intradermal influenza vaccination of healthy adults using a new microinjection system: a 3-year randomised controlled safety and immunogenicity trial

  Year 1
  3 μg ID (N= 384) 6 μg ID (N= 383) 15 μg IM (N= 382)
≥ 1 EMEA reaction, n (%) 38 (9.9) 39 (10.2) 50 (13.1)
Injection site induration* 0 0 1 (0.3)
Injection site ecchymosis (bruising) 2 (0.5) 1 (0.3) 7 (1.8)
Fever 4 (1.0) 5 (1.3) 6 (1.6)
Malaise 12 (3.1) 17 (4.4) 19 (5.0)
Shivering (rigors) 26 (6.8) 26 (6.8) 21 (5.5)
  Year 2 (vaccine history and group)
  ID/ID (N = 363) IM/ID (N = 181) ID total ( N = 544) ID/IM (N = 363) IM/IM (N = 184) IM total ( N = 547)
≥ 1 EMEA reaction, n (%) 41 (11.3) 20 (11.0) 61 (11.2) 39 (10.7) 28 (15.2) 67 (12.2)
Injection site induration* 0 0 0 0 0 0
Injection site ecchymosis (bruising) 5 (1.4) 2 (1.1) 7 (1.3) 7 (1.9) 3 (1.6) 10 (1.8)
Fever 3 (0.8) 2 (1.1) 5 (0.9) 3 (0.8) 0 3 (0.5)
Malaise 19 (5.2) 8 (4.4) 27 (5.0) 17 (4.7) 15 (8.2) 32 (5.9)
Shivering (rigors) 27 (7.4) 9 (5.0) 36 (6.6) 23 (6.3) 18 (9.8) 41 (7.5)
  Year 3 (vaccine history and group)
  ID/ID/ID (N = 137) IM/ID/ID (N = 71) ID/IM/ID (N = 138) IM/IM/ID(N = 72) ID total ( N = 418) ID/ID/IM (N = 132) IM/ID/IM (N = 72) ID/IM/IM (N = 134) IM/IM/IM (N = 72) IM total ( N = 410)
≥ 1 EMEA reaction, n (%) 13 (9.5) 11 (15.5) 19 (13.8) 11 (15.3) 54 (12.9) 18 (13.6) 6 (8.3) 13 (9.7) 10 (13.9) 47 (11.5)
Injection site induration* 0 0 0 0 0 0 0 0 0 0
Injection site ecchymosis (bruising) 4 (2.9) 3 (4.2) 2 (1.4) 4 (5.6) 13 (3.1) 3 (2.3) 1 (1.4) 3 (2.2) 4 (5.6) 11 (2.7)
Fever 3 (2.2) 1 (1.4) 3 (2.2) 0 7 (1.7) 1 (0.8) 0 0 1 (1.4) 2 (0.5)
Malaise 3 (2.2) 5 (7.0) 6 (4.3) 2 (2.8) 16 (3.8) 9 (6.8) 1 (1.4) 6 (4.5) 4 (5.6) 20 (4.9)
Shivering (rigors) 8 (5.8) 4 (5.6) 12 (8.7) 7 (9.7) 31 (7.4) 11 (8.3) 4 (5.6) 6 (4.5) 5 (6.9) 26 (6.3)
  1. Data are from the safety population. EMEA, European Medicines Evaluation Agency; ID, intradermal; IM, intramuscular; n, number of subjects reporting the event; N, number of subjects in the subgroup.
  2. *>5 cm for more than 3 days; axillary temperature >37.5°C for ≥ 24 hours.