Event | Wenzel 2013 [27] | Wenzel 2016 [15] | Castro 2018 [26] | Rabe 2018 [25] | Weinstein 2018 [24] |
---|---|---|---|---|---|
Any adverse event | 42(80.8) | 483(79.1) | 1023(81.0) | 64 (62.1) | 195 (78.3) |
Serious adverse event | 1 (2.0) | 45 (7.4) | 104 (8.2) | 9 (8.7) | 15 (6.0) |
Any adverse event leading to death | NM | 2(<0.1) | 5 (0.4) | 0 | 0 |
Study discontinuation owing to treatment-emergent adverse event | 3 (5.8) | 27 (4.4) | 63 (5.0) | 1 (1.0) | 8 (3.0) |
Most common adverse events | |||||
Injection-site reactions | 15 (28.8) | 79 (12.9) | 212 (16.8) | 9 (8.7) | 60 (24.1) |
Upper respiratory tract infection | 7 (13.5) | 216 (35.4) | 146 (11.6) | NM | NM |
Viral upper respiratory tract infection | 3 (5.8) | 83 (13.6) | 230 (18.2) | 9 (8.7) | NM |
Headache | 6 (11.5) | 62 (10.1) | 86 (6.8) | NM | NM |
Nasopharyngitis | 7 (13.5) | 59 (9.7) | NM | NM | NM |
Bronchitis | NM | 51 (8.3) | 144 (11.4) | 7 (6.8) | NM |
Sinusitis | 1 (2.0) | 36 (5.9) | 62 (4.9) | 7 (6.8) | NM |