Table 1.
Adjuvanted HAI-05 | Unadjuvanted HAI-05 | Placebo | |||
---|---|---|---|---|---|
15 µg | 45 µg | 90 µg | 90 µg | ||
n (%) | n (%) | n (%) | n (%) | n (%) | |
All subjects treated | 18 (100) | 20 (100) | 20 (100) | 20 (100) | 22 (100) |
Intent-to-treat population a | 18 (100) | 20 (100) | 20 (100) | 20 (100) | 22 (100) |
Per-protocol population b | 18 (100) | 20 (100) | 20 (100) | 20 (100) | 22 (100) |
Completed the study | 16 (88.9) | 20 (100) | 19 (95.0) | 20 (100) | 21 (95.5) |
Discontinued from the study c | 2 (11.1) | 0 | 1 (5.0) | 0 | 1 (4.5) |
a: The “Intent-to-treat” population included all subjects who received one dose of vaccine.
b: The “Per-protocol” population included all subjects who received two doses of vaccine and had a complete set of serum specimens for antibody determination.
c: Reason for discontinuation: lost to follow-up.