Table 2a. Most frequent adverse event summary.
Adverse events occurring in 20% or more participants are shown. Number and percent of infants who experienced each adverse event, overall, by arm and grade of event.
| Placebo (N=10) | CH505TF/GLA-SE vaccine (N=28) | ||||||
|---|---|---|---|---|---|---|---|
|
| |||||||
| Event N (%) | Overall (N=38) | Grade 1 | Grade 2 | Grade 3 | Grade 1 | Grade 2 | Grade 3 |
|
| |||||||
| Lower respiratory tract infection | 4 (10.5%) | · | · | 1 (10.0%) | · | 2 (7.1%) | 1 (3.6%) |
| Upper respiratory tract infection | 10 (26.3%) | 1 (10.0%) | 1 (10.0%) | · | 3 (10.7%) | 5 (17.9%) | · |
| Gastrointestinal tract | 18 (47.4%) | 6 (60.0%) | 1 (10.0%) | 7 (25.0%) | 4 (14.3%) | · | |
| Skin infections | 6 (15.8%) | 1 (10.0%) | · | 1 (10.0%) | 3 (10.7%) | 1 (3.6%) | · |
| Conjunctivitis | 3 (7.9%) | 1 (10.0%) | 1 (10.0%) | · | 1 (3.6%) | · | · |
| Underweight | 9 (23.7%) | 4 (40.0%) | · | · | 5 (17.9%) | · | · |
| Presumed allergic | 1 (2.6%) | · | · | 1 (3.6%) | · | · | |
| Haematological abnormalities | 30 (78.9%) | 4 (40.0%) | 5 (50.0%) | · | 17 (60.7%) | 4 (14.3%) | · |
| CMV Hepatitis | 1 (2.6%) | 1 (10.0%) | · | · | · | · | · |
| Sepsis | 1 (2.6%) | · | · | · | · | 1 (3.6%) | |
LRTI: includes bronchiolitis, bronchitis, pneumonia; URTI: includes pharyngitis, nasopharyngitis, tonsilitis, otitis; Gastrointestinal: includes gastroenteritis, diarrhoea, vomiting; Skin infections: tinea corporis, impetigo, fungal infection