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Table 5 Summary of solicited injection site and systemic reactions within 7 days of intradermal or intramuscular influenza vaccination

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

  Year 2 Year 3
  9 μgID
(N= 544)
15 μg IM
(N= 547)
9 μg ID
(N= 418)
15 μg IM (N= 410)
Solicited injection site reactions, n (%) 420 (77.2) 253 (46.3) 317 (75.8) 186 (45.5)
   Erythema     
>0.5 cm 378 (69.5) 53 (9.7) 274 (65.6) 50 (12.2)
>5 cm 29 (5.4) 3 (0.6) 25 (6.0) 2 (0.5)
   Induration     
>0.5 cm 212 (39.0) 47 (8.6) 166 (39.7) 49 (12.0)
>5 cm 7 (1.3) 2 (0.4) 2 (0.5) 2 (0.5)
   Oedema     
>0.5 cm 233 (42.8) 28 (5.1) 150 (35.9) 33 (8.0)
>5 cm 9 (1.7) 2 (0.4) 7 (1.7) 2 (0.5)
   Bruising     
>0.5 cm 10 (1.8) 10 (1.8) 14 (3.3) 13 (3.2)
>5 cm 0 1 (0.2) 1 (0.2) 2 (0.5)
   Pain     
any grade 204 (37.5) 214 (39.1) 180 (43.1) 152 (37.1)
grade 3 3 (0.6) 2 (0.4) 5 (1.2) 4 (1.0)
   Pruritus     
any grade 172 (31.6) 39 (7.1) 121 (28.9) 31 (7.6)
grade 3 3 (0.6) 1 (0.2) 6 (1.4) 1 (0.2)
Solicited systemic reactions, n (%) 155 (28.5) 181 (33.1) 123 (29.4) 101 (24.6)
   Pyrexia     
>37.5°C 8 (1.5) 5 (0.9) 10 (2.4) 2 (0.5)
>38.5°C 0 0 2 (0.5) 1 (0.2)
   Asthenia     
any grade 97 (17.8) 108 (19.7) 75 (17.9) 52 (12.7)
grade 3 11 (2.0) 6 (1.1) 8 (1.9) 6 (1.5)
   Headache     
any grade 88 (16.2) 82 (15.0) 69 (16.5) 57 (13.9)
grade 3 7 (1.3) 4 (0.7) 3 (0.7) 3 (0.7)
   Arthralgia     
any grade 31 (5.7) 33 (6.0) 26 (6.2) 8 (2.0)
grade 3 1 (0.2) 2 (0.4) 2 (0.5) 0
   Myalgia     
any grade 40 (7.4) 84 (15.4) 47 (11.2) 41 (10.0)
grade 3 1 (0.2) 4 (0.7) 2 (0.5) 2 (0.5)
   Rigors     
any grade 41 (7.5) 44 (8.0) 35 (8.4) 31 (7.6)
grade 3 1 (0.2) 3 (0.6) 3 (0.7) 1 (0.2)
   Increased sweating     
any grade 35 (6.4) 39 (7.1) 28 (6.7) 25 (6.1)
grade 3 2 (0.4) 2 (0.4) 0 2 (0.5)
   Malaise     
any grade 31 (5.7) 37 (6.8) 18 (4.3) 22 (5.4)
grade 3 3 (0.6) 4 (0.7) 2 (0.5) 1 (0.2)
  1. Data are from the safety population. ID, intradermal; IM, intramuscular; n, number of subjects reporting the event; N, number of subjects in the subgroup; %, n/(N minus the number of subjects with missing data for the given variable).
  2. Pain: Grade 1: mild/well tolerated, Grade 2: moderate/hindering movement, Grade 3 pain: preventing normal daily activity. Pruritus: Grade 1: mild/occasional, Grade 2: moderate/frequent, Grade 3 severe/continuous. Asthenia, headache, arthralgia, myalgia, rigors, increased sweating, malaise: Grade 1: symptom present but well tolerated, Grade 2: symptom interfered with normal daily activities, Grade 3 symptom prevented normal daily activities.