TABLE 3.
Timing | Phase II | Phase III | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
MA group | HA group | MB group | HB group | MA group | ||||||
GMT (Confidence interval) |
Rates of antibody rise of 4‐fold or higher (%) [Confidence interval (%)] |
GMT (Confidence interval) |
Rates of antibody rise of 4‐fold or higher (%) [Confidence interval (%)] |
GMT (Confidence interval) |
Rates of antibody rise of 4‐fold or higher (%) [Confidence interval (%)] |
GMT (Confidence interval) |
Rates of antibody rise of 4‐fold or higher (%) [Confidence interval (%)] |
GMT (Confidence interval) |
Rates of antibody rise of 4‐fold or higher (%) [Confidence interval (%)] |
|
Number of analyzed subjects | 62 | 61 | 63 | 60 | 364 | |||||
Before vaccination (Day 0) |
5.1 (4.9‐5.2) |
- |
5.1 (4.9‐5.2) |
- | 5.0 | - | 5.0 | - | 5.0 | - |
After the 1st vaccination (Day 21) |
9.8 (8.0‐12.0) |
27.4 (16.9‐40.2) |
13.1 (10.7‐16.2) |
39.3 (27.1‐52.7) |
8.7 (7.3‐10.3) |
20.6 (11.5‐32.7) |
9.5 (7.8‐11.7) |
21.7 (12.1‐34.2) |
10.2 (9.5‐11.1) |
27.5 (22.9‐32.4) |
After the 2nd vaccination (Day 42) |
234.3 (182.5‐300.7) |
100.0 (94.0‐100.0) |
265.2 (205.0‐343.0) |
98.3 (90.9‐100.0) |
171.3 (130.9‐224.1) |
100.0 (94.1‐100.0) |
211.1 (162.1‐274.9) |
98.3 (91.1‐100.0) |
301.1 (275.4‐329.2) |
99.7 (98.5‐100.0) |
Strain measured: A/Indonesia/05/2005(H5N1). Vaccine strain: A/Indonesia/05/2005(H5N1).Subjects analyzed: FAS.GMT: geometric mean antibody titer. Confidence interval: lower limit and upper limit of the 95% two‐sided confidence interval based on Student's t‐distribution. MA group; 3.75 μg HA + AS03. HA group; 7.5 μg HA + AS03. MB group; 3.75 μg HA + 1/2 AS03. HB group; 7.5 μg HA + 1/2 AS03.