Table 2.
Multi-dose Vial (Thimerosal Containing) | |||||||
---|---|---|---|---|---|---|---|
Influenza Strain | Immunogenicity evaluation | Lot 1 N=270n (%) | Lot 2 N=275 n (%) | Lot 3 N=269 n (%) | Prefilled Syringe (Thimerosal-free) N= 263 n (%) | All active vaccines N=1077 n (%) | Placebo N=264 n (%) |
H1N1: A/Caledonia/20/99 | Seroconversion or Significant Increase in Titer | 131 (48.5%) |
133 (48.4%) |
132 (49.1%) |
128 (48.7%) |
524 (48.7%) |
6 (2.3%) |
Seroprotection | 261 (96.7%) |
270 (98.2%) |
262 (97.4%) |
260 (98.9%) |
1053 (97.8%) |
197 (74.6%) |
|
H3N2:A/New York/55/2004 | Seroconversion or Significant Increase in Titer | 187 (69.3%) |
196 (71.3%) |
203 (75.5%) |
184 (70%) |
770 (71.5%) |
0 (0%) |
Seroprotection | 270 (100.0%) |
274 (99.6%) |
269 (100.0%) |
263 (100.0%) |
1076 (99.9%) |
190 (72.0) |
|
B Strain: B/Malaysia/2506/2004 | Seroconversion or Significant Increase in Titer | 194 (71.9%) |
187 (68.0%) |
186 (69.1%) |
184 (70.0%) |
751 (69.7%) |
1 (0.4%) |
Seroprotection | 258 (95.6%) |
258 (93.8%) |
250 (92.9%) |
249 (94.7%) |
1015 (94.2%) |
124 (47.0%) |
Seroconversion or Significant Increase in titer is defined as pre-vaccination HI < 10 increased to HI ≥ 40 postvaccination or fourfold rise in prevaccination titer. Seroprotection is defined as HI ≥ 40.