Table 3.
Influenza strain antibody response for microneutralization (vaccine immunogenicity analysis set)
| Antibody response measure | Benralizumab 30 mg Q4W (N=50) | Placebo (N=49) |
|---|---|---|
| GMT Week 8, GM (GSD; CV%) | ||
| Influenza A, H1N1 | 735.2 (4.2; 263.0) | 898.7 (3.4; 188.9) |
| Influenza A, H3N2 | 1,353.0 (2.5; 114.7) | 1,218.2 (2.7; 132.2) |
| Influenza B, Yamagata lineage | 123.0 (2.7; 129.8) | 106.2 (2.7; 129.4) |
| Influenza B, Victoria lineage | 43.7 (2.8; 138.4) | 67.0 (3.5; 196.8) |
| GMT Week 12, GM (GSD; CV%) | ||
| Influenza A, H1N1 | 3,774.1 (3.4; 181.7) | 3,969.1 (3.0; 154.0) |
| Influenza A, H3N2 | 4,307.5 (3.2; 169.0) | 4,351.3 (3.2; 171.0) |
| Influenza B, Yamagata lineage | 350.2 (2.4; 103.6) | 336.2 (2.5; 114.3) |
| Influenza B, Victoria lineage | 164.5 (3.3; 178.5) | 234.4 (2.8; 135.0) |
| GMFR Week 8 to Week 12, GM (GSD; CV%) | ||
| Influenza A, H1N1 | 5.1 (6.2; 521.4) | 4.4 (4.8; 329.4) |
| Influenza A, H3N2 | 3.2 (3.0; 149.8) | 3.6 (3.7; 210.0) |
| Influenza B, Yamagata lineage | 2.8 (3.0; 148.9) | 3.2 (2.9; 141.3) |
| Influenza B, Victoria lineage | 3.8 (3.8; 224.1) | 3.5 (3.5; 195.3) |
| Antibody titer ≥4-fold rise from Week 8 to Week 12, n (90% CIa) [%] | ||
| Influenza A, H1N1 | 21 (0.30–0.55) [42.0] | 20 (0.29–0.54) [40.8] |
| Influenza A, H3N2 | 22 (0.32–0.57) [44.0] | 21 (0.31–0.56) [42.9] |
| Influenza B, Yamagata lineage | 14 (0.18–0.40) [28.0] | 19 (0.27–0.52) [38.8] |
| Influenza B, Victoria lineage | 20 (0.28–0.53) [40.0] | 19 (0.27–0.52) [38.8] |
Note:
a
Results using the Clopper–Pearson method.
Abbreviations: CV%, geometric coefficient of variation; GM, geometric mean; GMFR, geometric mean fold rise; GMT, geometric mean titer; GSD, geometric standard deviation; N, number of patients within each treatment group; n, number of patients in analysis; Q4W, every 4 weeks.