Table 2b. Serious adverse event summary.
Number and percent of participants who experienced serious adverse events (SAEs), overall, by arm and grade of event. All events were determined to be unrelated to study product.
| Event | Overall (N=38) | Placebo (N=10) | CH505TF/GLA-SE vaccine (N=28) | Days since last injection | ||
|---|---|---|---|---|---|---|
|
| ||||||
| N (%) | Grade 3 | Grade 4 | Grade 3 | Grade 4 | ||
|
| ||||||
| Blood and lymphatic system disorders | ||||||
| Lymphadenitis | 1 (2.6%) | 1 (10.0%) | · | · | · | 21 |
| Infections and infestations | ||||||
| Bronchiolitis | 1 (2.6%) | · | · | 1 (3.6%) | · | 50 |
| Fungal skin infection | 1 (2.6%) | 1 (10.0%) | · | · | · | 43 |
| Sepsis | 1 (2.6%) | · | · | 1 (3.6%) | · | 12 |
| Ophthalmia neonatorum | 1 (2.6%) | · | · | 1 (3.6%) | · | 2 |
| Pneumonia | 1 (2.6%) | 1 (10.0%) | · | · | · | 72 |
All serious events are not related.
N is the number of participants who experienced one or more SAEs within a specific body system. Percentages are the number of participants who experienced an event of a specific relationship divided by the number enrolled.
For participants reporting multiple events within a body system or for a MedDRA preferred term, the maximum severity is counted