Table 5

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

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])


a > 5 cm for > 3 consecutive days.

b Rectal equivalent temperature > 38.0°C for ≥ 24 hours.

Van Damme et al. BMC Infectious Diseases 2010 10:134   doi:10.1186/1471-2334-10-134

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