Table 2.
Group | n | Pre-dose 1 | p-valuea | Post-dose 1 | p-valuea | Pre-dose 2 | p-valuea | Post-dose 2 | p-valuea | ||
---|---|---|---|---|---|---|---|---|---|---|---|
Seasonal A(H1N1)b | |||||||||||
Geometric mean titer | PL-TIVc | 16 | 19 | 0.32 | 789 | <0.01 | 77 | 0.79 | 174 | 0.17 | |
PL-PLd | 9 | 37 | 47 | 63 | 69 | ||||||
Proportion titer ≥40 | PL-TIVc | 16 | 0.31 | 0.44 | 0.94 | 0.12 | 0.67 | 1.00 | 0.88 | 0.95 | |
PL-PLd | 9 | 0.56 | 0.67 | 0.78 | 0.78 | ||||||
Proportion titer≥160 | PL-TIVc | 16 | 0.25 | 0.74 | 0.81 | 0.01 | 0.46 | 0.87 | 0.75 | 0.58 | |
PL-PLd | 9 | 0.22 | 0.22 | 0.33 | 0.56 | ||||||
Geometric mean ratio of post-dose to pre-dose |
PL-TIVc | 16 | 41.2 | <0.01 | 2.3 | 0.35 | |||||
PL-PLd | 9 | 1.3 | 1.1 | ||||||||
Proportion ratio ≥4 | PL-TIVc | 16 | 0.81 | <0.01 | 0.24 | 0.80 | |||||
PL-PLd | 9 | 0.11 | 0.11 | ||||||||
Proportion ratio ≥8 | PL-TIVc | 16 | 0.81 | <0.01 | 0.22 | 0.85 | |||||
PL-PLd | 9 | 0.11 | 0.11 | ||||||||
Seasonal A(H3N2)b | |||||||||||
Geometric mean titer | PL-TIVc | 16 | 32 | 0.20 | 902 | <0.01 | 177 | <0.01 | 281 | <0.01 | |
PL-PLd | 9 | 14 | 15 | 15 | 16 | ||||||
Proportion titer ≥40 | PL-TIVc | 16 | 0.56 | 0.49 | 1.00 | <0.01 | 0.86 | 0.03 | 0.94 | 0.01 | |
PL-PLd | 9 | 0.33 | 0.33 | 0.33 | 0.33 | ||||||
Proportion titer≥160 | PL-TIVc | 16 | 0.25 | 0.75 | 0.94 | <0.01 | 0.57 | 0.02 | 0.69 | 0.02 | |
PL-PLd | 9 | 0.11 | 0.22 | 0.00 | 0.11 | ||||||
Geometric mean ratio of post-dose to pre-dose |
PL-TIVc | 16 | 28.0 | <0.01 | 1.6 | 0.21 | |||||
PL-PLd | 9 | 1.1 | 1.1 | ||||||||
Proportion ratio ≥4 | PL-TIVc | 16 | 0.88 | <0.01 | 0.20 | 0.43 | |||||
PL-PLd | 9 | 0.00 | 0.00 | ||||||||
Proportion ratio ≥8 | PL-TIVc | 16 | 0.88 | <0.01 | 0.14 | 0.69 | |||||
PL-PLd | 9 | 0.00 | 0.00 | ||||||||
Seasonal Bb | |||||||||||
Geometric mean titer | PL-TIVc | 16 | 153 | 0.98 | 1660 | 0.03 | 9 | 0.51 | 8 | 0.62 | |
PL-PLd | 9 | 148 | 235 | 7 | 7 | ||||||
Proportion titer ≥40 | PL-TIVc | 16 | 0.88 | 1.00 | 0.94 | 1.00 | 0.19 | 0.95 | 0.19 | 0.95 | |
PL-PLd | 9 | 0.89 | 1.00 | 0.11 | 0.11 | ||||||
Proportion titer≥160 | PL-TIVc | 16 | 0.56 | 0.69 | 0.81 | 1.00 | 0.00 | 1.00 | 0.06 | 0.77 | |
PL-PLd | 9 | 0.44 | 0.78 | 0.00 | 0.00 | ||||||
Geometric mean ratio of post-dose to pre-dose |
PL-TIVc | 16 | 10.8 | 0.00 | 1.0 | 0.89 | |||||
PL-PLd | 9 | 1.6 | 1.0 | ||||||||
Proportion ratio ≥4 | PL-TIVc | 16 | 0.69 | 0.01 | 0.06 | 0.77 | |||||
PL-PLd | 9 | 0.11 | 0.00 | ||||||||
Proportion ratio ≥8 | PL-TIVc | 16 | 0.69 | 0.01 | 0.06 | 0.77 | |||||
PL-PLd | 9 | 0.11 | 0.00 | ||||||||
Pandemic A(H1N1)b | |||||||||||
Geometric mean titer | PL-TIVc | 16 | 7 | 0.31 | 10 | 0.02 | 9 | 0.21 | 15 | 0.42 | |
PL-PLd | 9 | 6 | 7 | 20 | 27 | ||||||
Proportion titer ≥40 | PL-TIVc | 16 | 0.00 | 1.00 | 0.00 | 1.00 | 0.14 | 0.25 | 0.38 | 0.65 | |
PL-PLd | 9 | 0.00 | 0.00 | 0.44 | 0.56 | ||||||
Proportion titer≥160 | PL-TIVc | 16 | 0.00 | 1.00 | 0.00 | 1.00 | 0.01 | 0.27 | 0.12 | 0.47 | |
PL-PLd | 9 | 0.00 | 0.00 | 0.22 | 0.33 | ||||||
Geometric mean ratio of post-dose to pre-dose |
PL-TIVc | 16 | 1.4 | 0.26 | 1.7 | 0.64 | |||||
PL-PLd | 9 | 1.2 | 1.4 | ||||||||
Proportion ratio ≥4 | PL-TIVc | 16 | 0.06 | 1.00 | 0.25 | 0.74 | |||||
PL-PLd | 9 | 0.00 | 0.22 | ||||||||
Proportion ratio ≥8 | PL-TIVc | 16 | 0.00 | 1.00 | 0.12 | 0.95 | |||||
PL-PLd | 9 | 0.00 | 0.22 |
P-values comparing between PL-TIV and PL-PL were obtained by the Chi-square test, Fisher’s Exact test, Wilcoxon-signed rank test or Wald test where appropriate.
See methods and legend of Table 1 for details of viruses antigens used for hemagglutination inhibition assays.
The PL-TIV group consists of subjects who received placebo in 2009–2010 and TIV in 2008–2009. The 2008–09 TIV (year 1) included A/Brisbane/59/2007-like (H1N1), A/Brisbane/10/2007-like (H3N2) and B/Florida/4/2006-like strains.
The PL-PL group consists of subjects who received placebo in 2009–2010 and 2008–2009.