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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.