Immunogenic Noninferiority Comparison of QIV to TIV-Yam and TIV-Vic in Children 3–17 Years of Age: ATP Immunogenicity Cohort
| . | TIV-Vic + TIV-Yam N (adjusted GMT) . | QIV N (adjusted GMT) . | GMT ratio GMT ratio (95% CI)a . |
|---|---|---|---|
| A/California/7/2009 (H1N1) | 1747 (421.4) | 876 (366.3) | 1.15 (1.06, 1.25)b |
| A/Victoria/210/2009 (H3N3) | 1746 (144.3) | 876 (145.8) | 0.99 (.92, 1.07)b |
| B/Brisbane/60/2008 (Victoria) | 870 (243.4) | 876 (252.5) | 0.96 (.87, 1.07)c |
| B/Florida/4/2006 (Yamagata) | 877 (564.6) | 876 (525.2) | 1.08 (.99, 1.16)d |
| . | TIV-Vic + TIV-Yam n/N seroconverted (SCR)e . | QIV n/N seroconverted (SCR)e . | SCR difference % difference (95% CI)a . |
| A/California/7/2009 (H1N1) | 1505/1747 (86.1%) | 739/876 (84.4%) | 1.79% (−1.04, 4.77)f |
| A/Victoria/210/2009 (H3N3) | 1200/1746 (68.7%) | 614/876 (70.1%) | −1.36% (−5.05, 2.41)f |
| B/Brisbane/60/2008 (Victoria) | 622/870 (71.5%) | 653/876 (74.5%) | −3.05% (−7.21, 1.12)g |
| B/Florida/4/2006 (Yamagata) | 644/877 (73.4%) | 659/876 (75.2%) | −1.80% (−5.89, 2.30)h |
| . | TIV-Vic + TIV-Yam N (adjusted GMT) . | QIV N (adjusted GMT) . | GMT ratio GMT ratio (95% CI)a . |
|---|---|---|---|
| A/California/7/2009 (H1N1) | 1747 (421.4) | 876 (366.3) | 1.15 (1.06, 1.25)b |
| A/Victoria/210/2009 (H3N3) | 1746 (144.3) | 876 (145.8) | 0.99 (.92, 1.07)b |
| B/Brisbane/60/2008 (Victoria) | 870 (243.4) | 876 (252.5) | 0.96 (.87, 1.07)c |
| B/Florida/4/2006 (Yamagata) | 877 (564.6) | 876 (525.2) | 1.08 (.99, 1.16)d |
| . | TIV-Vic + TIV-Yam n/N seroconverted (SCR)e . | QIV n/N seroconverted (SCR)e . | SCR difference % difference (95% CI)a . |
| A/California/7/2009 (H1N1) | 1505/1747 (86.1%) | 739/876 (84.4%) | 1.79% (−1.04, 4.77)f |
| A/Victoria/210/2009 (H3N3) | 1200/1746 (68.7%) | 614/876 (70.1%) | −1.36% (−5.05, 2.41)f |
| B/Brisbane/60/2008 (Victoria) | 622/870 (71.5%) | 653/876 (74.5%) | −3.05% (−7.21, 1.12)g |
| B/Florida/4/2006 (Yamagata) | 644/877 (73.4%) | 659/876 (75.2%) | −1.80% (−5.89, 2.30)h |
Abbreviations: ATP, according to protocol; CI, confidence interval; GMT, geometric mean titer; N, number; QIV, quadrivalent influenza vaccine; SCR, seroconversion rate; TIV-Vic, trivalent influenza vaccine Victoria lineage B strain; TIV-Yam, trivalent influenza vaccine Yamagata lineage B strain .
a Immunogenic noninferiority demonstrated if the upper limit of the 2-sided 95% CI of the adjusted GMT was ≤1.5 and the upper limit of the 2-sided 95% CI of the difference between SCR was ≤10% for all vaccine strains.
b (TIV-Vic + TIV-Yam) divided by QIV.
c TIV-Vic divided by QIV.
d TIV-Yam divided by QIV.
e SCR was defined as the proportion of vaccinees with either a prevaccination titer <1:10 and a postvaccination titer ≥1:40, or a prevaccination titer ≥1:10 and at least a 4-fold increase in postvaccination titer.
f (TIV-Vic + TIV-Yam) minus QIV.
g TIV-Vic minus QIV.
h TIV-Yam minus QIV.
Immunogenic Noninferiority Comparison of QIV to TIV-Yam and TIV-Vic in Children 3–17 Years of Age: ATP Immunogenicity Cohort
| . | TIV-Vic + TIV-Yam N (adjusted GMT) . | QIV N (adjusted GMT) . | GMT ratio GMT ratio (95% CI)a . |
|---|---|---|---|
| A/California/7/2009 (H1N1) | 1747 (421.4) | 876 (366.3) | 1.15 (1.06, 1.25)b |
| A/Victoria/210/2009 (H3N3) | 1746 (144.3) | 876 (145.8) | 0.99 (.92, 1.07)b |
| B/Brisbane/60/2008 (Victoria) | 870 (243.4) | 876 (252.5) | 0.96 (.87, 1.07)c |
| B/Florida/4/2006 (Yamagata) | 877 (564.6) | 876 (525.2) | 1.08 (.99, 1.16)d |
| . | TIV-Vic + TIV-Yam n/N seroconverted (SCR)e . | QIV n/N seroconverted (SCR)e . | SCR difference % difference (95% CI)a . |
| A/California/7/2009 (H1N1) | 1505/1747 (86.1%) | 739/876 (84.4%) | 1.79% (−1.04, 4.77)f |
| A/Victoria/210/2009 (H3N3) | 1200/1746 (68.7%) | 614/876 (70.1%) | −1.36% (−5.05, 2.41)f |
| B/Brisbane/60/2008 (Victoria) | 622/870 (71.5%) | 653/876 (74.5%) | −3.05% (−7.21, 1.12)g |
| B/Florida/4/2006 (Yamagata) | 644/877 (73.4%) | 659/876 (75.2%) | −1.80% (−5.89, 2.30)h |
| . | TIV-Vic + TIV-Yam N (adjusted GMT) . | QIV N (adjusted GMT) . | GMT ratio GMT ratio (95% CI)a . |
|---|---|---|---|
| A/California/7/2009 (H1N1) | 1747 (421.4) | 876 (366.3) | 1.15 (1.06, 1.25)b |
| A/Victoria/210/2009 (H3N3) | 1746 (144.3) | 876 (145.8) | 0.99 (.92, 1.07)b |
| B/Brisbane/60/2008 (Victoria) | 870 (243.4) | 876 (252.5) | 0.96 (.87, 1.07)c |
| B/Florida/4/2006 (Yamagata) | 877 (564.6) | 876 (525.2) | 1.08 (.99, 1.16)d |
| . | TIV-Vic + TIV-Yam n/N seroconverted (SCR)e . | QIV n/N seroconverted (SCR)e . | SCR difference % difference (95% CI)a . |
| A/California/7/2009 (H1N1) | 1505/1747 (86.1%) | 739/876 (84.4%) | 1.79% (−1.04, 4.77)f |
| A/Victoria/210/2009 (H3N3) | 1200/1746 (68.7%) | 614/876 (70.1%) | −1.36% (−5.05, 2.41)f |
| B/Brisbane/60/2008 (Victoria) | 622/870 (71.5%) | 653/876 (74.5%) | −3.05% (−7.21, 1.12)g |
| B/Florida/4/2006 (Yamagata) | 644/877 (73.4%) | 659/876 (75.2%) | −1.80% (−5.89, 2.30)h |
Abbreviations: ATP, according to protocol; CI, confidence interval; GMT, geometric mean titer; N, number; QIV, quadrivalent influenza vaccine; SCR, seroconversion rate; TIV-Vic, trivalent influenza vaccine Victoria lineage B strain; TIV-Yam, trivalent influenza vaccine Yamagata lineage B strain .
a Immunogenic noninferiority demonstrated if the upper limit of the 2-sided 95% CI of the adjusted GMT was ≤1.5 and the upper limit of the 2-sided 95% CI of the difference between SCR was ≤10% for all vaccine strains.
b (TIV-Vic + TIV-Yam) divided by QIV.
c TIV-Vic divided by QIV.
d TIV-Yam divided by QIV.
e SCR was defined as the proportion of vaccinees with either a prevaccination titer <1:10 and a postvaccination titer ≥1:40, or a prevaccination titer ≥1:10 and at least a 4-fold increase in postvaccination titer.
f (TIV-Vic + TIV-Yam) minus QIV.
g TIV-Vic minus QIV.
h TIV-Yam minus QIV.
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