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Endpoint

Criteria to meet the primary objectives

Value (95% CI)

Criteria met?


Study in adults
   
AntiH1N1 GMTs

95% CI for ratio is within [0.5; 2] at Day 21

1.20 (0.96;1.49)

Yes

95% CI for ratio is within [0.5; 2] at Day 42

0.9 (0.76; 1.06)

Yes

Seroconversion rate

95% CI for the difference in within [10; +10] at Day 21

3.66 (0.82; 8.74)

Yes

Study in children

(each group)
  
CHMP

Seroconversion rate >40%

≥98.7% for each group

Yes

%(≥1:40) > 70%

≥98.3% for each group

Yes

Seroconversion factor >2.5

≥25.7 for each group

Yes

CBER

LL of the 95% CI on the seroconversion rate >40%

≥90.8 for each group

Yes

LL of the 95% CI on the % ≥1:40 is >70%

≥ 90.8 for each group

Yes

AntiH1N1 GMTs

95% CI for ratio (QPan0.9/DPan0.9) is within [0.5; 2] at Day 21

0.96 (0.73; 1.26)

Yes


95% CI 95 percent confidence interval, LL lower limit of the 95% CI, GMT geometric mean antibody titre. See Table 1 for details of treatment groups in each study.