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Table 3 Non-inferiority of QIV versus TIVs against shared strains according to HI-assay based GMT and SCR at Day 21 in the per-protocol immunogenicity sub-cohort

From: Immunogenicity, reactogenicity and safety of an inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine: a phase III, randomized trial in adults aged ≥18 years

Vaccine antigen Adjusted GMT Adjusted GMT ratio (95% CI)
  TIV-Vic + TIV-Yam, N = 1135 QIV, N = 1801 TIV-Vic + TIV-Yam/QIV
A/California/7/2009 (H1N1) 214.8 201.6 1.07 (0.96, 1.18)
A/Victoria/210/2009 (H3N2) 312.2 318.5 0.98 (0.90, 1.07)
B/Brisbane/60/2008 TIV-Vic, N = 605 QIV, N = 1801 TIV-Vic/QIV
(Victoria lineage) 395.3 404.2 0.98 (0.9, 1.07)
B/Brisbane/3/2007 TIV-Yam, N = 530 QIV, N = 1801 TIV-Yam/QIV
(Yamagata lineage) 584.7 600.8 0.97 (0.89, 1.07)
  Number seroconverted (SCR) SCR difference (95% CI)
  TIV-Vic + TIV-Yam, N = 1135 QIV, N = 1801 TIV-Vic + TIV-Yam minus QIV
A/California/7/2009 (H1N1) 892 (78.6%) 1396 (77.5%) 1.08 (−2.03, 4.11)
A/Victoria/210/2009 (H3N2) 769 (67.8%) 1287 (71.5%) −3.71 (−7.15, −0.30)
B/Brisbane/60/2008 TIV-Vic, N = 605 QIV, N = 1801 TIV-Vic minus QIV
(Victoria lineage) 335 (55.4%) 1046 (58.1%) −2.71 (−7.29, 1.83)
B/Brisbane/3/2007 TIV-Yam, N = 530 QIV, N = 1801 TIV-Yam minus QIV
(Yamagata lineage) 313 (59.1%) 1112 (61.7%) −2.69 (−7.47, 2.01)
  1. Non-inferiority was demonstrated if the lower limit of the 95% CI was ≤1.5; Non-inferiority was demonstrated if the lower limit of the 95% CI ≤10.0.
  2. CI confidence interval, GMT geometric mean titer, HI Hemagglutination inhibition, SCR seroconversion rate (proportion with pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer), TIV trivalent inactivated influenza vaccine, Vic Victoria lineage B strain, Yam Yamagata lineage B strain, QIV quadrivalent inactivated influenza vaccine.
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