Table 2 Summary of adverse events catching
From: A randomized phase 1/2a trial of ExPEC10V vaccine in adults with a history of UTI
Study vaccination group | ExPEC10V (%) | Placebo (%) |
|---|---|---|
N | 278 | 138 |
Solicited AEs | 179 (64.4) | 59 (42.8) |
Solicited AEs of grade 3 | 25 (9.0) | 2 (1.4) |
Solicited local AEs | 139 (50.0) | 22 (15.9) |
Pain/tenderness | 132 (47.5) | 20 (14.5) |
Erythema | 60 (21.6) | 1 (0.7) |
Swelling | 44 (15.8) | 2 (1.4) |
Solicited local AEs of grade 3 | 19 (6.8) | 1 (0.7) |
Solicited systemic AEs | 139 (50.0) | 53 (38.4) |
Fatigue | 98 (35.3) | 31 (22.5) |
Headache | 74 (26.6) | 34 (24.6) |
Myalgia | 84 (30.2) | 23 (16.7) |
Fever | 15 (5.4) | 3 (2.2) |
Nausea | 40 (14.4) | 8 (5.8) |
Solicited systemic AEs of grade 3 | 9 (3.2) | 1 (0.7) |
Solicited systemic AEs related to study vaccine | 118 (42.4) | 41 (29.7) |
Solicited systemic AEs of grade 3 related to study vaccine | 8 (2.9) | 1 (0.7) |
Any unsolicited AEsa | 79 (28.4) | 36 (26.1) |
Urinary tract infection | 7 (2.5) | 10 (7.2) |
COVID-19 | 3 (1.1) | 1 (0.7) |
Cystitis | 3 (1.1) | 1 (0.7) |
Myalgia | 7 (2.5) | 6 (4.3) |
Back pain | 3 (1.1) | 1 (0.7) |
Arthralgia | 3 (1.1) | 0 |
Fatigue | 5 (1.8) | 2 (1.4) |
Injection-site pruritis | 7 (2.5) | 0 |
Diarrhea | 3 (1.1) | 3 (2.2) |
Nausea | 4 (1.4) | 0 |
Headache | 5 (1.8) | 3 (2.2) |
Vertigo | 3 (1.1) | 1 (0.7) |
Oropharyngeal pain | 1 (0.4) | 2 (1.4) |
Any unsolicited AEs of grade 3 | 4 (1.4) | 0 |
Unsolicited AEs thought to be related to study vaccine | 30 (10.8) | 7 (5.1) |
SAEb | 9 (3.2) | 6 (4.3) |
SAEs thought to be related to study vaccine | 0 | 0 |
