Table 1.
Dose | Baseline |
28 days after injection |
90 days after injection |
180 days after injection |
360 days after injection |
||||
---|---|---|---|---|---|---|---|---|---|
SP rate |
SC rate |
SP rate |
SC rate |
SP rate |
SC rate |
SP rate |
SC rate |
SP rate |
|
Number of participants (Percentage, 95% CI) | |||||||||
Placebo (n=81) | 4 (4.9, 1.4–12.2) | 4 (4.9, 1.4–12.2) | 6 (7.4, 2.8–15.4) | 2 (2.5, 0.3–8.6) | 4 (4.9, 1.4–12.2) | 17 (21.0, 12.7–31.5) | 19 (23.5, 14.8–34.2) | – | – |
15 μg (n=84) | 4 (4.8, 1.3–11.8) | 81 (96.4, 89.9–99.3)a | 80 (95.2, 88.3–98.7)a | 75 (89.3, 80.6–95.0)a | 72 (85.7, 76.4–92.4)a | 77 (91.7, 83.6–96.6)a | 75 (89.3, 80.6–95.0)a | 59 (70.2, 59.3–79.7) | 39 (46.4, 35.5–57.7) |
30 μg (n=87) | 3 (3.4, 0.7–9.8) | 86 (98.9, 93.8–100.0)a | 85 (97.7, 92.0–99.7)a | 80 (92.0, 84.1–96.7)a | 79 (90.8, 82.7–96.0)a | 83 (95.4, 88.6–98.7)a | 76 (87.4, 78.5–93.5)a | 65 (74.7, 64.3–83.4) | 43 (49.4, 38.5–60.4) |
45 μg (n=88) | 2 (2.3, 0.3–8.0) | 88 (100.0, 95.9–100.0)a | 86 (97.7, 92.0–99.7)a | 83 (94.3, 87.2–98.1)a | 82 (93.2, 85.8–97.5)a | 84 (95.5, 88.8–98.8)a | 80 (90.9, 82.9–96.0)a | 72 (95.5, 88.8–98.8) | 49 (55.7, 44.7–66.3) |
Seroprotection (SP) was defined as an HI titer of no less than 1:40; seroconversion (SC) was defined as an increase in the HI titer by a factor of four or more.
P<0.05 compared with the placebo.