Table 1.
Criteria for the Evaluation of Primary and Secondary End Points
| Lower limit of CI,a % |
CHMP, point estimates |
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| End points | CBER (SCR) | Protocol defined (SPR) | SCR, % | SPR, % | GMFR |
| Coprimary end points | |||||
| 14 days after last dose for A/Indonesia/5/2005 | >40 | >50 | — | — | — |
| Secondary end points | |||||
| 21 days after last dose for A/Indonesia/5/2005 | >40 | >50 | >40 | >70 | >2.5 |
| 14 and 21 days after last dose for A/Vietnam/1194/2004 and A/turkey/Turkey/1/2005 | >40 | >50 | >40 | >70 | >2.5 |
NOTE. The seroconversion rate (SCR) was defined as the percentage of participants with either a prevaccination titer <1:10 and a postvaccination titer ≥1:40 or a prevaccination titer ≥1:10 and a minimum 4-fold increase in postvaccination titer. The seroprotection rate (SPR) was defined as the percentage of participants who attained reciprocal hemagglutination inhibition (HI) titers of ≥40. The geometric mean fold rise (GMFR) was defined as the geometric mean of the within-subject ratio of postvaccination/prevaccination reciprocal HI titers. CBER, Center for Biologics Evaluation and Research; CHMP: European Committee for Human Medicinal Products.
For coprimary end points, 98.75% confidence intervals (CIs) were used; for secondary end points, 95% CIs were used.