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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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BMC Infectious Diseases

ISSN: 1471-2334

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