Table 6.
Study PSC03 |
Sanofi PI high dose* |
|||
---|---|---|---|---|
Adults age ⩾ 65 years |
Adults age ⩾ 65 years |
|||
Flublok | Fluzone | Fluzone | Fluzone HD | |
Number of subjects | 436 | 433 | 1248–1249 | 2529–2531 |
A (H1N1) | ||||
GMT | 177 | 148 | 67 | 116 |
GMT ratio | 1.2 | 1.7 | ||
Seroconversion | 43 | 33 | 23 | 49 |
Difference in seroconversion | 10 | 25 | ||
A (H3 N2) | ||||
GMT | 339 | 199 | 333 | 609 |
GMT ratio | 1.7 | 1.8 | ||
Seroconversion | 78 | 58 | 51 | 69 |
Difference in seroconversion | 20 | 18 | ||
B (Note: different antigen in Flublok versus Fluzone) | ||||
GMT | 150 | 195 | 52 | 69 |
GMT ratio | 0.8 | 1.3 | ||
Seroconversion | 29 | 39 | 30 | 42 |
Difference in seroconversion | −10 | 12 |
Data derived from clinical study PSC03 [Keitel et al. 2010] and Fluzone high-dose package insert [Sanofi-Pasteur, 2014].
The Geometric Mean Titer (GMT) ratio presented in bold shows comparable immunogenicity between Flublok and Fluzone HD.