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Table 2 Non-inferiority outcomes of Haemagglutination Inhibition (HI) antibody geometric mean titres (GMT) ratio (ATP cohort for immunogenicity)

From: A randomized, controlled non-inferiority trial comparing A(H1N1)pmd09 vaccine antigen, with and without AS03 adjuvant system, co-administered or sequentially administered with an inactivated trivalent seasonal influenza vaccine

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]  
  1. a GMT: Geometric Mean Titre.
  2. b TIV: Trivalent inactivated influenza vaccine.
  3. c CI: Confidence Interval.
  4. BOLD : values of adjusted GMT ratio that did not met the pre-specified criteria.
  5. Group definitions:
  6. Group A: TIV+Placebo (Day 0); 15 μg (Day 21); 15 μg (Day 42).
  7. Group B: TIV+Placebo (Day 0); 3.75 μg/AS03 (Day 21); 3.75 μg/AS03 (Day 42).
  8. Group C: 15 μg+TIV (Day 0); 15 μg (Day 21); Placebo (Day 42).
  9. Group D: 3.75 μg/AS03+TIV (Day 0); 3.75 μg/AS03 (Day 21); Placebo (Day 42).
  10. Group E: 15 μg+Placebo (Day 0); 15 μg (Day 21); TIV (Day 42).
  11. Group F: 3.75 μg/AS03+Placebo (Day 0); 3.75 μg/AS03 (Day 21); TIV (Day 42).
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BMC Infectious Diseases

ISSN: 1471-2334

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