Table 2 Non-inferiority outcomes of Haemagglutination Inhibition (HI) antibody geometric mean titres (GMT) ratio (ATP cohort for immunogenicity)
Ratio order | Strain | Adjusted GMTa ratio | Non-inferiority criteria |
|---|---|---|---|
TIV b co-administration | Value [97.5% CI c ] | ||
Group D Day 42/Group F Day 42 | A/California/7/2009 | 0.62 [0.48-0.81] | If the lower bound of 95% CI for GMT ratio between Group D Day 42; Group F Day 42 was >0.5 |
Group C Day 42/Group E Day 42 | A/California/7/2009 | 0.66 [0.51-0.85] | If the lower bound of 95% CI for GMT ratio between Group C Day 42; Group E Day 42 was >0.5 |
Sequential administration | Value [95% CI] | ||
Group B Day 63/Group F Day 42 | A/California/7/2009 | 0.68 [0.54-0.86] | If the lower bound of 95% CI for GMT ratio between Group B Day 63; Group F Day 42 was >0.5 |
(TIV prior to adjuvanted H1N1 vaccine) | |||
Group A Day 63/Group E Day 42 | A/California/7/2009 | 0.60 [0.48-0.76] | If the lower bound of 95% CI for GMT ratio between Group A Day 63; Group E Day 42 was >0.5 |
(TIV prior to unadjuvanted H1N1 vaccine) | |||
Group B Day 63/Group A Day 63 | A/California/7/2009 | 2.69 [2.14-3.39] | If the lower bound of 95% CI for GMT ratio between Group B Day 63; Group A Day 63 was >0.5; Superiority criteria: Lower bound >1.0 |
(adjuvanted H1N1/unadjuvanted H1N1) | |||
Immune response to seasonal influenza strains | Value [95% CI] | ||
Group D Day 21/Group A+B Day 21 | A/Brisbane/59/2007 | 0.91 [0.70-1.17] | If the lower bound of 95% CI for GMT ratio between Group D Day 21; Group A+B Day 21 was >0.5 |
(co-administration, adjuvanted) | A/Uruguay/716/2007 | 1.15 [0.81-1.63] | |
B/Brisbane/60/2008 | 0.92 [0.74-1.15] | ||
Group C Day 21/Group A+B Day 21 | A/Brisbane/59/2007 | 1.23 [0.96-1.58] | If the lower bound of 95% CI for GMT ratio between Group C Day 21; Group A+B Day 21 was >0.5 |
(co-administration, unadjuvanted) | A/Uruguay/716/2007 | 1.15 [0.81-1.63] | |
B/Brisbane/60/2008 | 0.74 [0.60-0.92] | ||
Group F Day 63/Group A+B Day 21 | A/Brisbane/59/2007 | 0.96 [0.75-1.24] | If the lower bound of 95% CI for GMT ratio between Group F Day 63; Group A+B Day 21 was >0.5 |
(Sequential adjuvanted) | A/Uruguay/716/2007 | 1.20 [0.85-1.69] | |
B/Brisbane/60/2008 | 1.00 [0.81-1.24] | ||
Group E Day 63/Group A+B Day 21 | A/Brisbane/59/2007 | 0.84 [0.65-1.08] | If the lower bound of 95% CI for GMT ratio between Group E Day 63; Group A+B Day 21 was >0.5 |
(Sequential unadjuvanted) | |||
A/Uruguay/716/2007 | 1.24 [0.88-1.76] | ||
B/Brisbane/60/2008 | 0.94 [0.76-1.17] | ||