Table 2. Serum HI antibody responses after two doses of the nasal A/Victoria vaccine.
| EMA criteria | FDA criteria | Week | Serum a | |
|---|---|---|---|---|
| GMT (Mean geometric increase) | >2.5 | No standard | 0 | 16.2 (1.00) |
| 6 | 68.8 (4.25b) | |||
| Conversion rate or Significant increase in titer [n/N (%, 95% CI)] | >40% | LL of 95%CI > 40% | 6 | 20/46 (43.5, 28.5–58.4) |
| Protection rate [n/N (%, 95% CI)] |
>70% | LL of 95%CI > 70% | 0 | 13/46 (28.3, 14.7–41.8) |
| 6 | 35/46 (76.1, 63.2–88.9) |
a Serum HI titers of <1:10 were considered negative and were arbitrarily assigned a titer of 1:5. b In bold values that exceed EMA criteria as defined for HI titers.