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. 2016 Nov 4;11(11):e0165384. doi: 10.1371/journal.pone.0165384

Table 1. Solicited adverse events following booster vaccination or in case of clade 2 primary vaccination within 3 to 7-days after vaccination.

Age groups 18–60 years > 60 years 18–60 years
Primary vaccine dose 7.5 μg(n = 39) 30 μg + Adjuvant (n = 38) 30 μg +Adjuvant (n = 60) 7.5 μg(n = 36) 30 μg +Adjuvant(n = 41) 30 μg +Adjuvant(n = 58) No previous H5N1 vaccine(n = 50)
Booster dose 7.5 μg Booster group Clade 2 Booster Group 7.5 μg Booster group Clade 2 Booster Group Clade 2 Priming group
% 95% CI % 95% CI % 95% CI % 95% CI % 95% CI % 95% CI % 95% CI
Injection site reactions
Pain 20.5 9.3;36.5 28.9 15.4;45.9 61 47.4;73.5 8.3 1.8;22.5 7.3 1.5;19.9 28.1 17.0;41.5 44 30;58.7
Erythema 12.8 4.3;27.4 13.2 4.4;28.1 25.4 15.0;38.4 2.8 0.1;14.5 0.0 0.0;8.6 12.3 5.1;23.7 10 3.3;21.8
Swelling 0 0;9.0 2.6 0.1;13.8 15.3 7.2;27 5.6 0.7;18.7 0.0 0.0;8.6 8.8 2.9;10.3 8 2.2;19.2
Induration* 7.7 1.6;20.9 2.6 0.1;13.8 25.4 15;38.4 0.0 0.0;9.7 0.0 0.0;8.6 8.8 2.9;10.3 14 5.8;26.7
Ecchymosis* 0.0 0.0;9.0 0 0.0;9.3 5.1 1.1;14.1 0.0 0.0;9.7 2.4 0.1;9.7 5.2 1.9;10.9 2 1.3;16.5
Systemic Reactions
Fever* 0.0 0.1;12.9 2.6 01;13.8 3.4 0.4;11.7 2.8 0.1;14.5 2.4 0.1;12.9 5.3 1.1;14.6 4 0.5;13.7
Headache 17.9 7.5;33.5 18.4 7.7;34.3 30.5 19.2;43.9 13.9 4.7;29.5 9.8 2.7;23.1 19.3 10;31.9 26 14.6;40.3
Malaise* 5.1 0.6;17.3 7.9 1.7;21.4 16.9 8.4;29 2.8 0.1;14.5 2.4 0.1;12.9 10.5 4.0;21.5 16 2.2;19.2
Myalgia 5.1 0.6;17.3 7.9 1.7;21.4 18.6 9.7;30.9 5.6 0.7;18.7 4.9 0.6;16.5 10.5 4.0;21.5 10 1.3;21.8
Shivering* 0.0 0.0;9.0 5.3 0.6;17.7 6.8 1.9;16.5 0.0 0.0;9.7 0.0 0.0;8.6 5.3 1.1;14.6 6 0.0;7.1

n = number of participants’ data analysed, based on the number of subjects who received at least 1 dose of vaccine

*participants were asked to specifically record these adverse events for 3-days after vaccination