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TABLE 2

Postvaccination Immunogenicity and Analysis of Noninferiority of QIVc Relative to US-Licensed QIV for GMT Ratio and SCR Difference in Subjects 6 Through 47 Months Using Cell-Derived Target Virus (Per Protocol Set)

US-licensed QIVaQIVcQIV Versus QIVc (95% CI)Noninferiority Criteria Met
 Day 29 or 57 GMTb (95% CI) GMT ratioc  
A/H1N1 57.3 (50.76 to 64.63) 78.0 (70.75 to 86.03) 0.73 (0.645 to 0.836) Yes 
A/H3N2 23.9 (21.57 to 26.57) 23.1 (21.21 to 25.12) 1.04 (0.927 to 1.160) Yes 
B/Yamagata 26.0 (23.54 to 28.63) 35.6 (32.93 to 38.58) 0.73 (0.656 to 0.809) Yes 
B/Victoria 19.6 (17.81 to 21.58) 22.4 (20.70 to 24.19) 0.88 (0.791 to 0.972) Yes 
 SCR SCR differenced  
A/H1N1 46.78 (42.64 to 50.96) 58.24 (55.25 to 61.19) −11.46 (−16.447 to −6.423) Yes 
A/H3N2 30.77 (27.01 to 34.73) 27.64 (24.99 to 30.42) 3.13 (−1.443 to 7.812) Yes 
B/Yamagata 31.65 (27.87 to 35.63) 46.52 (43.53 to 49.53) −14.87 (−19.610 to −9.983) Yes 
B/Victoria 24.35 (20.89 to 28.07) 30.31 (27.60 to 33.13) −5.96 (−10.327 to −1.440) Yes 
US-licensed QIVaQIVcQIV Versus QIVc (95% CI)Noninferiority Criteria Met
 Day 29 or 57 GMTb (95% CI) GMT ratioc  
A/H1N1 57.3 (50.76 to 64.63) 78.0 (70.75 to 86.03) 0.73 (0.645 to 0.836) Yes 
A/H3N2 23.9 (21.57 to 26.57) 23.1 (21.21 to 25.12) 1.04 (0.927 to 1.160) Yes 
B/Yamagata 26.0 (23.54 to 28.63) 35.6 (32.93 to 38.58) 0.73 (0.656 to 0.809) Yes 
B/Victoria 19.6 (17.81 to 21.58) 22.4 (20.70 to 24.19) 0.88 (0.791 to 0.972) Yes 
 SCR SCR differenced  
A/H1N1 46.78 (42.64 to 50.96) 58.24 (55.25 to 61.19) −11.46 (−16.447 to −6.423) Yes 
A/H3N2 30.77 (27.01 to 34.73) 27.64 (24.99 to 30.42) 3.13 (−1.443 to 7.812) Yes 
B/Yamagata 31.65 (27.87 to 35.63) 46.52 (43.53 to 49.53) −14.87 (−19.610 to −9.983) Yes 
B/Victoria 24.35 (20.89 to 28.07) 30.31 (27.60 to 33.13) −5.96 (−10.327 to −1.440) Yes 

CI, confidence interval; GMT, geometric mean titer; HI, hemagglutination inhibition; MN, microneutralization; QIV, US-licensed quadrivalent inactivated influenza vaccine; QIVc, cell-derived quadrivalent inactivated influenza vaccine; SCR, seroconversion rate.

a

A/Idaho/07/2018 (A/H1N1), A/Indiana/08/2018 (A/H3N2), B/Singapore/INFTT-16-0610/2016 (B/Yamagata), and B/Iowa/06/2017 (B/Victoria).

b

Measured by HI assay for A/H1N1, B/Yamagata, and B/Victoria strains (QIVc, n = 1092; QIV, n = 575) and by MN assay for the A/H3N2 strain (QIVc, n = 1078; QIV, 572). The generalized linear model specification was an adjusted analysis GMT model: log-transformed postvaccination HI (or MN) titer = vaccine + age strata + gender + vaccination history [y/n] + log-transformed prevaccination HI (or MN) titer + site + age strata x vaccine.

c

GMT ratio: Day 29 or 57 GMT QIV divided by Day 29 or 57 GMT QIVc.

d

SCR difference: QIV SCR minus QIVc SCR.

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