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Vaccine. 2014 Mar 14;32(13):1480-7. doi: 10.1016/j.vaccine.2014.01.022. Epub 2014 Jan 28.

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

Author information

  • 1Hospital General de Durango, Durango, Mexico. Electronic address:
  • 2Universidad Nacional Autonoma de Mexico, Mexico City, Mexico.
  • 3National Institute of Public Health, Cuernavaca, Morelos, Mexico.
  • 4Secretaria de Salud del Estado de Mexico, Zumpango, Mexico.
  • 5GlaxoSmithKline Vaccines, King of Prussia, PA, USA.
  • 6GlaxoSmithKline Vaccines, Rixensart, Belgium.



Two influenza B lineages have been co-circulating since the 1980s, and because inactivated trivalent influenza vaccine (TIV) contains only one B strain, it provides little/no protection against the alternate B-lineage. We assessed a candidate inactivated quadrivalent influenza vaccine (QIV) containing both B lineages versus TIV in healthy adults.


Subjects received one dose of QIV (lot 1, 2, or 3) or one of two TIVs (B strain from Victoria or Yamagata lineage); randomization was 2:2:2:1:1. Hemagglutination-inhibition assays were performed 21-days post-vaccination; superiority of QIV versus TIV for the alternate B-lineage was demonstrated if the 95% confidence interval (CI) lower limit for the GMT ratio was ≥1.5, and non-inferiority against the shared strains was demonstrated if the 95% CI upper limit for the GMT ratio was ≤1.5. Reactogenicity and safety were assessed during the post-vaccination period. NCT01196975.


Immunogenicity of QIV lots was consistent, QIV was superior to TIV for the alternate B-lineage strain, and QIV was non-inferior versus TIVs for shared strains (A/H1N1, A/H3N2, B-strain). Reactogenicity and safety profile of the QIV was consistent with seasonal influenza vaccines.


QIV provided superior immunogenicity for the added B strain without affecting the antibody response to the TIV strains, and without compromising safety.

Copyright © 2014. Published by Elsevier Ltd.


Inactivated quadrivalent influenza vaccine; Seasonal influenza; Victoria lineage; Yamagata lineage

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