Number of volunteers Vaccine 3.75µg HA Vaccine 7.5µg HA Vaccine 15µg HA Placebo Total
Absolute number % Absolute number % Absolute number % Absolute number % Absolute number %
Number of volunteers 12 22.2
(13.2-34.9)
12 22.2
(13.2-34.9)
12 22.2
(13.2-34.9)
18 33.3
(22.2-46.6)
54 100.0
(93.4-100)
Number with at least 1 AE 1 8.3
(1.5-35.4)
3 25.0
(8.9-53.2)
1 8.3
(1.5-35.4)
0 0 5 9.26
(4-19.9)
Number with at least one vaccination-related AE 0 0 3* 25.0
(8.9-53.2)
1** 8.3
(1.5-35.4)
0 0 4 7.4
(2.9-17.6)
Number with no AE 11 91.6
(64.6-98.5)
9 75.0
(46.8-91.1)
11 91.6
(64.6-98.5)
18 100.0
(82.4-100)
49 90.7
(80.1-96)
Number with at least one serious adverse drug reaction 0 0 0 0 0 0 0 0 0 0
*Local reactions of mild intensity occurring within 6 hours of vaccination; **Systemic reactions of moderate intensity occurring within 6 hours of vaccination.
Table 3: Adverse events to Refluvac® vaccine observed during the study.