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Table 2 Lot-to-lot consistency of QIV lots based on HI-assay based GMTs 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

  Min Max Adjusted GMT ratio
  n Adjusted GMT n Adjusted GMT Min/Max¶§(95% CI)
A/California/7/2009 (H1N1) 600 196.5 599 209.0 0.94 (0.80–1.10)
A/Victoria/210/2009 (H3N2) 600 306.8 599 330.6 0.93 (0.81–1.06)
B/Brisbane/60/2008 (Victoria lineage) 600 410.7 599 396.7 1.04 (0.93–1.15)
B/Brisbane/3/2007 (Yamagata lineage) 600 605.0 599 599.0 1.01 (0.90–1.13)
  1. Lot with lowest GMT; Lot with highest GMT; Pair with the largest GMT ratio for each strain from pairwise comparisons was assessed and consistency was demonstrated if the 2-sided 95% CI limit was between 0.67 and 1.5 for all four strains; §for each strain, lot 1/lot 2.
  2. CI confidence interval, GMT geometric mean titer, HI hemagglutination inhibition, QIV quadrivalent inactivated influenza vaccine.
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