Skip to main content
SpringerLink
Log in

Inactivated Quadrivalent Split-Virus Seasonal Influenza Vaccine (Fluarix® Quadrivalent): A Review of Its Use in the Prevention of Disease Caused by Influenza A and B

  • Adis Drug Evaluation
  • Published:
Drugs Aims and scope Submit manuscript

Abstract

The inactivated quadrivalent split-virus seasonal influenza vaccine [Fluarix® quadrivalent, manufactured in Dresden (D-QIV)] contains 15 μg haemagglutinin from each of the four influenza virus strains expected to circulate in the upcoming influenza season. Unlike seasonal trivalent influenza vaccines (TIVs), which have been used previously, quadrivalent influenza vaccines (QIVs) contain two influenza A subtype viruses and two B type viruses. As two different B viruses have co-circulated in recent years, incorporating both B lineages reduces the risk of the dominant B strain not being included in the vaccine. D-QIV is approved for active immunization of individuals aged ≥3 years to prevent disease caused by the influenza A subtype viruses and B type viruses contained in the vaccine. In large randomized, controlled trials, D-QIV was highly immunogenic in healthy adults (including individuals aged ≥65 years) and children, and exceeded the criteria for vaccine licensure. Immune responses for D-QIV, compared with those for TIVs, were non-inferior against influenza A strains and common B strains and superior against the additional B strain. D-QIV was generally well tolerated in all age groups studied and, overall, reactogenicity and tolerability were generally similar to observations with TIVs. Quadrivalent influenza vaccines are expected to offer substantial cost-effectiveness benefits in seasons where the B lineage selected for inclusion in TIVs does not match the dominant circulating strain. Thus, by incorporating both circulating influenza B lineages, vaccination with D-QIV is likely to reduce the risk of the dominant circulating B type virus not matching the strain selected for the vaccine and, therefore, more effectively protect target populations from influenza than TIVs.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

References

  1. US Centers for Disease Control and Prevention (CDC). Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2010 [published errata appear in MMWR Recomm Rep. 2010; 59(31):993 and 2010; 59(35):1147. MMWR Recomm Rep. 2010; 59(rr-8):1–62.

  2. Heikkinen T, Silvennoinen H, Peltola V, et al. Burden of influenza in children in the community. J Infect Dis. 2004;190(8):1369–73.

    Article  PubMed  Google Scholar 

  3. World Health Organization (WHO). WHO position paper: vaccines against influenza [online]. 2012. http://www.who.int/immunization/position_papers/PP_influenza_november2012_summary.pdf. Accessed 3 Jul 2013.

  4. Thompson WW, Shay DK, Weintraub E, et al. Influenza-associated hospitalizations in the United States. JAMA. 2004;292(11):1333–40.

    Article  PubMed  CAS  Google Scholar 

  5. US Centers for Disease Control and Prevention (CDC). Estimates of death associated with seasonal influenza: United States, 1976-2007. MMWR Morb Mortal Wkly Rep. 2010; 59(33):1057–62.

  6. Molinari NA, Ortega-Sanchez IR, Messonnier ML, et al. The annual impact of seasonal influenza in the US: measuring disease burden and costs. Vaccine. 2007;25(27):5086–96.

    Article  PubMed  Google Scholar 

  7. US Centers for Disease Control and Prevention (CDC). Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP): United States, 2012-13 influenza season. MMWR Morb Mortal Wkly Rep. 2012; 61(32):613–18.

  8. Ambrose CS, Levin MJ. The rationale for quadrivalent influenza vaccines. Hum Vaccin Immunother. 2012;8(1):81–8.

    Article  PubMed  Google Scholar 

  9. Belshe RB, Coelingh K, Ambrose CS, et al. Efficacy of live attenuated influenza vaccine in children against influenza B viruses by lineage and antigenic similarity. Vaccine. 2010;28(9):2149–56.

    Article  PubMed  CAS  Google Scholar 

  10. GlaxoSmithKline. Fluarix® Quadrivalent (influenza virus vaccine): full prescribing information. 2013. http://us.gsk.com/products/assets/us_fluarix_quadrivalent.pdf. Accessed 24 Jul 2013.

  11. Curran MP, Leroux-Roels I. Inactivated split-virion seasonal influenza vaccine (Fluarix®): a review of its use in the prevention of seasonal influenza in adults and the elderly. Drugs. 2010;70(12):1519–43.

    Article  PubMed  Google Scholar 

  12. Kieninger D, Lin W-Y, Yu CJ, et al. Immunogenicity and safety profile of a candidate inactivated quadrivalent influenza vaccine in adults and the elderly: a randomized controlled study [abstract]. In: 4th International Conference and Exhibition on Influenza Vaccines for the World; 9–12 Oct 2012; Valencia.

  13. Domachowske JB, Pankow-Culot H, Bautista M, et al. A randomized trial of candidate inactivated quadrivalent influenza vaccine versus trivalent influenza vaccines in children aged 3-17 years. J Infect Dis. 2013;207(12):1878–87.

    Article  PubMed  CAS  Google Scholar 

  14. Beran J, Peeters M, Dewe W, et al. Immunogenicity and safety of quadrivalent versus trivalent inactivated influenza vaccine: a randomized, controlled trial in adults. BMC Infect Dis. 2013;13:224.

    Article  PubMed  CAS  Google Scholar 

  15. U.S. Food and Drug Administration Department of Health and Human Services. Guidance for industry: clinical data needed to support the licensure of seasonal inactivated influenza vaccines. 2007. http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm091990.pdf. Accessed 16 Jul 2013.

  16. European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit. Committee for Proprietary Medicinal Products. Note for guidance on harmonization of requirements for influenza vaccines (CPMP/BWP/214/96) [online]. 1997. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003945.pdf. Accessed 23 Jun 2013.

  17. Beran J, Vesikari T, Wertzova V, et al. Efficacy of inactivated split-virus influenza vaccine against culture-confirmed influenza in healthy adults: a prospective, randomized, placebo-controlled trial. J Infect Dis. 2009;200(12):1861–9.

    Article  PubMed  CAS  Google Scholar 

  18. Hehme NW, Kunzel W, Petschke F, et al. Ten years of experience with the trivalent split-influenza vaccine, Fluarix™. Clin Drug Investig. 2002;22(11):751–69.

    Article  CAS  Google Scholar 

  19. Meier G, Van Bellinghen LA, Van Vlaenderen I. Potential benefits analysis of quadrivalent influenza vaccine (QIV) on influenza disease burden in the United Kingdom, year by year analysis (2000-2010) [abstract]. In: International Society for Pharmacoeconomics and Outcomes Research 18th Annual Meeting 18–22 May 2013; New Orleans, LA.

  20. Meier G, Clements KM, McGarry L, et al. Universal mass vaccination with quadrivalent influenza vaccine (QIV) in the United States [abstract]. In: International Society for Pharmacoeconomics and Outcomes Research 18th Annual Meeting 18–22 May 2013; New Orleans, LA.

  21. Tricco AC, Chit A, Soobiah C, et al. Comparing influenza vaccine efficacy against mismatched and matched strains: a systematic review and meta-analysis. BMC Med. 2013;11:153.

    Article  PubMed  Google Scholar 

  22. Barr IG, Jelley LL. The coming era of quadrivalent human influenza vaccines: who will benefit? Drugs. 2012;72(17):2177–85.

    Article  PubMed  Google Scholar 

  23. Belshe RB. The need for quadrivalent vaccine against seasonal influenza. Vaccine. 2010;28(Suppl 4):D45–53.

    Article  PubMed  Google Scholar 

  24. McElhaney JE. The unmet need in the elderly: designing new influenza vaccines for older adults. Vaccine. 2005;23(Suppl 1):S10–25.

    Article  PubMed  Google Scholar 

  25. Australian and New Zealand Society for Geriatric Medicine. Immunisation of older people: revision number 2. 2011. http://www.anzsgm.org/documents/PS7Immunisation300811_000.pdf. Accessed Jul 26 2013.

  26. Thompson WW, Shay DK, Weintraub E, et al. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA. 2003;289(2):179–86.

    Article  PubMed  Google Scholar 

  27. Hu JJ, Kao CL, Lee PI, et al. Clinical features of influenza A and B in children and association with myositis. J Microbiol Immunol Infect. 2004;37(2):95–8.

    PubMed  Google Scholar 

  28. Hite LK, Glezen WP, Demmler GJ, et al. Medically attended pediatric influenza during the resurgence of the Victoria lineage of influenza B virus. Int J Infect Dis. 2007;11(1):40–7.

    Article  PubMed  Google Scholar 

  29. Peltola V, Ziegler T, Ruuskanen O. Influenza A and B virus infections in children. Clin Infect Dis. 2003;36(3):299–305.

    Article  PubMed  Google Scholar 

  30. Reed C, Meltzer MI, Finelli L, et al. Public health impact of including two lineages of influenza B in a quadrivalent seasonal influenza vaccine. Vaccine. 2012;30(11):1993–8.

    Article  PubMed  Google Scholar 

Download references

Disclosure

The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from comments received were made by the author on the basis of scientific and editorial merit.

Author information

Authors and Affiliations

  1. Adis, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, North Shore, 0754, Auckland, New Zealand

    Kate McKeage

Authors
  1. Kate McKeage
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Kate McKeage.

Additional information

The manuscript was reviewed by: M.C. Woodward, Heidelberg Repatriation Hospital, Austin Health, Heidelberg, Australia. I.G. Barr, WHO Collaborating Centre for Influenza, Melbourne, Australia.

Rights and permissions

Reprints and permissions

About this article

Cite this article

McKeage, K. Inactivated Quadrivalent Split-Virus Seasonal Influenza Vaccine (Fluarix® Quadrivalent): A Review of Its Use in the Prevention of Disease Caused by Influenza A and B. Drugs 73, 1587–1594 (2013). https://doi.org/10.1007/s40265-013-0114-3

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40265-013-0114-3

Keywords

Search

Navigation