Group 1 | Group 2 | Group 3 | Group 4 | |
---|---|---|---|---|
TST/QFT at inclusion | Neg/Neg | Neg/Neg | Pos/Neg | Pos/Pos |
Vaccination | H1 only | H1/IC31® | H1/IC31® | H1/IC31® |
Number of participants | 12 | 12 | 3 | 12 |
na (%) total AEs | n (%) total AEs | n (%) total AEs | n (%) total AEs | |
Local AEs | ||||
Any local AE | 5 (42) 9 | 3 (25) 9 | 1 (33) 4 | 9 (75) 20 |
Injection site pain | 0 (0) 0 | 3 (25) 6 | 1 (33) 1 | 4 (33) 5 |
Injection site swelling | 1 (8) 1 | 2 (17) 2 | 1 (33) 1 | 1 (8) 1 |
Injection site erythema | 2 (17) 2 | 0 (0) 0 | 1 (33) 1 | 2 (17) 2 |
Injection site Itching | 3 (25) 3 | 0 (0) 0 | 1 (33) 1 | 0 (0) 0 |
Injection site numbness | 0 (0) 0 | 0 (0) 0 | 0 (0) 0 | 2 (17) 2 |
Injection site stiffness | 0 (0) 0 | 0 (0) 0 | 0 (0) 0 | 2 (17) 2 |
Injection site rash | 0 (0) 0 | 1 (8) 1 | 0 (0) 0 | 0 (0) 0 |
Erythema at TST site | 2 (17) 2 | 0 (0) 0 | 0 (0) 0 | 3 (25) 4 |
Itching at TST site | 1 (8) 1 | 0 (0) 0 | 0 (0) 0 | 3 (25) 4 |
Systemic AEs | ||||
Any systemic AE | 11 (92) 86 | 9 (75) 72 | 2 (67) 7 | 12 (100) 45 |
Headache | 3 (25) 5 | 7 (58) 15 | 1 (33) 1 | 7 (58) 9 |
Sediment in urineb | 5 (42) 5 | 3 (25) 5 | 1 (33) 2 | 5 (42) 6 |
Fever | 2 (17) 2 | 3 (25) 4 | 1 (33) 1 | 3 (25) 3 |
Sweating | 3 (25) 4 | 1 (8) 1 | 0 (0) 0 | 2 (17) 2 |
Anorexia | 2 (17) 2 | 1 (8) 1 | 1 (33) 1 | 1 (8) 2 |
Weakness | 1 (8) 1 | 2 (17) 2 | 0 (0) 0 | 2 (17) 2 |
Other (96 different categories) | 10 (83) 67 | 9 (75) 44 | 1 (33) 2 | 7 (58) 21 |