Table 3.
Evaluation based on the criteria of the EMA guidelines: (a) percentage of subjects with HAI titers of ≥1:40; (b) percentage of subjects with HAI titers of <1:10 before vaccination and ≥1:40 after vaccination, or with HAI titers of ≥1:10 before vaccination and an increase of at least 4-fold after vaccination; (c) GMT ratios between post-vaccination GMTs and pre-vaccination GMTs.
| (a) | ||||||||
| Percentage of Subjects with HAI ≥ 1:40 | ||||||||
| n = 32 | Pre-Vaccine | 2 wks | 5 mos | |||||
| H1N1 | 15.6% (5/32) | 56.3% (18/32) | 43.8% (14/32) | |||||
| H3N2 | 68.8% (22/32) | 90.6% (29/32) | 68.8% (22/32) | |||||
| Yamagata lineage | 31.3% (10/32) | 53.1% (17/32) | 40.6% (13/32) | |||||
| Victoria lineage | 18.8% (6/32) | 34.4% (11/32) | 31.3% (10/32) | |||||
| (b) | ||||||||
| HAI | ||||||||
| n = 32 | 2 wks | 5 mos | ||||||
| H1N1 | 37.5% (12/32) | 21.9% (7/32) | ||||||
| H3N2 | 28.1% (9/32) | 12.5% (4/32) | ||||||
| Yamagata lineage | 15.6% (5/32) | 9.4% (3/32) | ||||||
| Victoria lineage | 15.6% (5/32) | 12.5% (4/32) | ||||||
| (c) | ||||||||
| n = 32 | GMT (GMT Ratio) | |||||||
| Pre-Vaccine | 2 wks Post-Vaccine | 5 mos Post-Vaccine | ||||||
| H1N1 | 10.9 | 28.9 (2.7) | 27.1 (2.5) | |||||
| H3N2 | 30.2 | 54.2 (1.8) | 43.6 (1.4) | |||||
| Yamagata lineage | 17.9 | 24.8 (1.4) | 22.8 (1.3) | |||||
| Victoria lineage | 12.2 | 17.2 (1.4) | 17.9 (1.5) | |||||
2 wks—two weeks post-vaccination; 5 mos—five months post-vaccination. 2 wks—two weeks post-vaccination; 5 mos—five months post-vaccination. Notes: GMT ratio requirements ≥ 2.5.