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Table 3 Results of the inferential analysis comparing groups in the study in adults and in children (ATP immunogenicity cohorts)

From: Extended antigen sparing potential of AS03-adjuvanted pandemic H1N1 vaccines in children, and immunological equivalence of two formulations of AS03-adjuvanted H1N1 vaccines: results from two randomised trials

Endpoint Criteria to meet the primary objectives Value (95% CI) Criteria met?
Study in adults    
Anti-H1N1 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
Anti-H1N1 GMTs 95% CI for ratio (Q-Pan0.9/D-Pan0.9) is within [0.5; 2] at Day 21 0.96 (0.73; 1.26) Yes
  1. 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.