TABLE 1.
Adverse Event (AE) | CD4% Stratum at Screening |
Overall (n = 319) |
||
---|---|---|---|---|
<15% (n = 39) |
15%–24% (n = 127) |
≥25% (n = 153) |
||
Death or GBS | 0 | 0 | 0 | 0 |
Laboratory AEs, grade ≥3 | 2 (5.2%) | 0 | 0 | 2 (0.6%) |
Signs and symptoms AEs, grade ≥3 | 1 (2.6%) | 3 (2.4%) | 1 (0.7%) | 5 (1.6%) |
Any of above | 3 (7.9%) | 3 (2.4%) | 1 (0.7%) | 7 (2.2%) |
Any of above, possibly related to MCV4 vaccine | 0 | 0 | 0 | 0 |