Table 1.
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 | TIV-TIVc | 23 | 20 | 0.20 | 1714 | <0.01 | 192 | <0.01 | 270 | 0.12 | |
PL-TIVd | 16 | 37 | 62 | 28 | 562 | ||||||
Proportion titer ≥40 | TIV-TIVc | 23 | 0.48 | 0.33 | 0.91 | 0.63 | 0.87 | 0.03 | 0.87 | 0.44 | |
PL-TIVd | 16 | 0.69 | 0.81 | 0.50 | 0.99 | ||||||
Proportion titer≥160 | TIV-TIVc | 23 | 0.09 | 0.66 | 0.91 | <0.01 | 0.74 | 0.01 | 0.83 | 0.64 | |
PL-TIVd | 16 | 0.19 | 0.44 | 0.25 | 0.93 | ||||||
Geometric mean ratio of post-dose to pre-dose |
TIV-TIVc | 23 | 85.7 | <0.01 | 1.4 | <0.01 | |||||
PL-TIVd | 16 | 1.7 | 19.9 | ||||||||
Proportion ratio ≥4 | TIV-TIVc | 23 | 0.83 | <0.01 | 0.17 | <0.01 | |||||
PL-TIVd | 16 | 0.19 | 0.69 | ||||||||
Proportion ratio ≥8 | TIV-TIVc | 23 | 0.83 | <0.01 | 0.09 | <0.01 | |||||
PL-TIVd | 16 | 0.12 | 0.62 | ||||||||
Seasonal A(H3N2)b | |||||||||||
Geometric mean titer | TIV-TIVc | 23 | 18 | 0.02 | 859 | 0.01 | 45 | 0.33 | 243 | <0.01 | |
PL-TIVd | 16 | 103 | 140 | 26 | 819 | ||||||
Proportion titer ≥40 | TIV-TIVc | 23 | 0.39 | 0.14 | 0.91 | 0.63 | 0.65 | 0.54 | 0.95 | 0.84 | |
PL-TIVd | 16 | 0.69 | 0.81 | 0.50 | 1.00 | ||||||
Proportion titer≥160 | TIV-TIVc | 23 | 0.22 | 0.48 | 0.87 | 0.06 | 0.30 | 0.65 | 0.86 | 0.35 | |
PL-TIVd | 16 | 0.38 | 0.56 | 0.19 | 1.00 | ||||||
Geometric mean ratio of post-dose to pre-dose |
TIV-TIVc | 23 | 47.0 | <0.01 | 5.4 | <0.01 | |||||
PL-TIVd | 16 | 1.4 | 31.6 | ||||||||
Proportion ratio ≥4 | TIV-TIVc | 23 | 0.91 | <0.01 | 0.65 | 0.09 | |||||
PL-TIVd | 16 | 0.12 | 0.94 | ||||||||
Proportion ratio ≥8 | TIV-TIVc | 23 | 0.78 | <0.01 | 0.34 | <0.01 | |||||
PL-TIVd | 16 | 0.06 | 0.88 | ||||||||
Seasonal Bb | |||||||||||
Geometric mean titer | TIV-TIVc | 23 | 292 | 0.04 | 1444 | <0.01 | 11 | 0.57 | 73 | 1.00 | |
PL-TIVd | 16 | 118 | 123 | 9 | 73 | ||||||
Proportion titer ≥40 | TIV-TIVc | 23 | 0.96 | 1.00 | 1.00 | 0.41 | 0.22 | 0.86 | 0.78 | 0.80 | |
PL-TIVd | 16 | 0.94 | 0.94 | 0.19 | 0.69 | ||||||
Proportion titer≥160 | TIV-TIVc | 23 | 0.74 | 0.23 | 0.96 | <0.01 | 0.04 | 0.85 | 0.49 | 0.88 | |
PL-TIVd | 16 | 0.50 | 0.50 | 0.00 | 0.56 | ||||||
Geometric mean ratio of post-dose to pre-dose |
TIV-TIVc | 23 | 4.9 | <0.01 | 6.5 | 0.76 | |||||
PL-TIVd | 16 | 1.0 | 8.0 | ||||||||
Proportion ratio ≥4 | TIV-TIVc | 23 | 0.61 | <0.01 | 0.65 | 0.83 | |||||
PL-TIVd | 16 | 0.00 | 0.56 | ||||||||
Proportion ratio ≥8 | TIV-TIVc | 23 | 0.35 | 0.01 | 0.60 | 1.00 | |||||
PL-TIVd | 16 | 0.00 | 0.56 | ||||||||
Pandemic A(H1N1)b | |||||||||||
Geometric mean titer | TIV-TIVc | 23 | 7 | 0.93 | 8 | 0.03 | 11 | 0.66 | 65 | 0.06 | |
PL-TIVd | 16 | 6 | 6 | 9 | 20 | ||||||
Proportion titer ≥40 | TIV-TIVc | 23 | 0.00 | 1.00 | 0.00 | 1.00 | 0.22 | 0.75 | 0.63 | 0.44 | |
PL-TIVd | 16 | 0.00 | 0.00 | 0.12 | 0.45 | ||||||
Proportion titer≥160 | TIV-TIVc | 23 | 0.00 | 1.00 | 0.00 | 1.00 | 0.09 | 0.88 | 0.58 | 0.11 | |
PL-TIVd | 16 | 0.00 | 0.00 | 0.12 | 0.26 | ||||||
Geometric mean ratio of post-dose to pre-dose |
TIV-TIVc | 23 | 1.3 | 0.06 | 6.1 | 0.09 | |||||
PL-TIVd | 16 | 1.0 | 2.3 | ||||||||
Proportion ratio ≥4 | TIV-TIVc | 23 | 0.04 | 1.00 | 0.55 | 0.31 | |||||
PL-TIVd | 16 | 0.00 | 0.32 | ||||||||
Proportion ratio ≥8 | TIV-TIVc | 23 | 0.00 | 1.00 | 0.46 | 0.63 | |||||
PL-TIVd | 16 | 0.00 | 0.32 |
P-values comparing between TIV-TIV and PL-TIV were obtained by the Chi-square test, Fisher’s Exact test, Wilcoxon-signed rank test or Wald test where appropriate.
Antibody titers measured by hemagglutination inhibition assays to A/Brisbane/59/2007 (H1N1), A/Brisbane/10/2007-like virus A/Uruguay/716/2009 (H3N2), B/Florida/4/2006, A/California/7/2009 (H1N1) viruses in year 1;A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2009 (H3N2), B/Brisbane/60/2008, A/California/7/2009 (H1N1) viruses in year 2 (see methods for details of strains used).
The TIV-TIV group consists of subjects who received TIV in 2008–2009 and 2009–10. 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 2009–10 TIV (year 2) included A/Brisbane/59/2007-like (H1N1), A/Brisbane/10/2007-like (H3N2) and B/Brisbane/60/2008 strains.
The PL-TIV group consists of subjects who received placebo in 2008–2009 and TIV in 2009–10.