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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.