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