775
Views
1
CrossRef citations to date
0
Altmetric
Research Paper

Safety and immunogenicity of trivalent inactivated influenza vaccine in adults 60 years of age and older: a phase II, a randomized, comparative trial in Kazakhstan

ORCID Icon, , , , , , ORCID Icon, , & show all
Pages 1791-1797 | Received 07 Nov 2018, Accepted 12 Dec 2019, Published online: 12 Feb 2020

References

  • Morrison-Griffiths S, Gaulton L. Seasonal influenza immunization program outside general practice: an evaluation. Hum Vaccin Immunother. 2016;12(1):248–51. PMID:26566596. doi:10.1080/21645515.2015.1099770.
  • Swaan CM, van der Sande MA, Speelman P, Conyn-van Spaendonck MA, Straus SM, Coutinho RA. Adverse events following influenza vaccination: reaction to specific reports and the necessity of a central registration system. Ned Tijdschr Geneeskd. 2007; 29; 151(39):2166–69. PMID:17957995.
  • Jadhav S, Datla M, Kreeftenberg H, Hendriks J. The developing countries vaccine manufacturers’ network (DCVMN) is a critical constituency to ensure access to vaccines in developing countries. Vaccine. 2008;26:1611–15. doi:10.1016/j.vaccine.2008.01.034.
  • Hendriks J, Holleman M, de Boer O, de Jong P, Luytjes W. An international technology platform for influenza vaccines. Vaccine. 2011;29(1):A8–11. PMID:21684431. doi:10.1016/j.vaccine.2011.04.124.
  • Haugh M, Gresset-Bourgeois V, Macabeo B, Woods A, Samson SI. A trivalent, inactivated influenza vaccine (Vaxigrip®): summary of almost 50 years of experience and more than 1.8 billion doses distributed in over 120 countries. Expert Rev Vaccines. 2017;16(6):545–64. PMID:28460594. doi:10.1080/14760584.2017.1324302.
  • Sokolova TM, Shuvalov AN, Poloskov VV, Shapoval IM, Kostinov MP. Grippol, Vaxigrip and influvac vaccines – inductors of innate and adaptive immunity factor genes in human blood cells. Zh Mikrobiol Epidemiol Immunobiol. 2014;(5):37–43. PMID:25536769.
  • WHO. Global Influenza Surveillance Network. Manual for the laboratory diagnosis and virological surveillance of influenza. Drug Saf. 2015;38(11):1059–74. PMID:26446142. doi:10.1007/s40264-015-0350-4.
  • Petrovsky N. Comparative safety of vaccine adjuvants: a summary of current evidence and future needs. Drug Saf. 2015;38(11):1059–74. PMID:26446142. doi:10.1007/s40264-015-0350-4.
  • Scheifele DW, Ward BJ, Dionne M, Vanderkooi OG, Loeb M, Coleman BL, Li Y. PHAC/CIHR Influenza Research Network (PCIRN). Compatibility of ASO3-adjuvanted H1N1pdm09 and seasonal trivalent influenza vaccines in adults: results of a randomized, controlled trial. Vaccine. 2012; 6; 30(32):4728–32. PMID:22652402. doi:10.1016/j.vaccine.2012.05.029.
  • Levine M, Beattie BL, McLean DM, Corman D. Characterization of the immune response to trivalent influenza vaccine in elderly men. J Am Geriatr Soc. 1987;35:609–15. doi:10.1111/j.1532-5415.1987.tb04335.x.
  • Mamadaliyev SM, Sandybayev NT, Kydyrbayev ZK, Khairullin BM, Zaitsev VL, Mambetaliev M, Kassenov MM, Chervyakova OV, Ryskeldinova S, Volgin YN, et al. Development of production technology and pre-clinical testing of a pandemic influenza A⁄H1N1 vaccine. Influenza Other Respir Viruses. 2011;5(1):354–57.
  • Sansyzbay AR, Erofeeva MK, Khairullin BM, Sandybayev NT, Kydyrbayev ZK, Mamadaliyev SM, Kassenov MM, Sergeeva MV, Romanova JR, Krivitskaya VZ, et al. An inactivated, adjuvanted whole virion clade 2.2 H5N1 (A/chicken/astana/6/05) influenza vaccine is safe and immunogenic in a single dose in humans. Clin Vaccine Immunol. 2013;20:1314–19. PMID:23803900. doi:10.1128/CVI.00096-13.
  • Mamadaliyev SM, Sandybayev NT, Kydyrbayev ZK, Khairullin BM, Zaitsev VL, Mambetaliev M, Kassenov MM, Chervyakova OV, Ryskeldinova S, Volgin YN, et al. Basic results of development of a production technology and control of a pandemic influenza A/H5N1 vaccine. Influenza Other Respir Viruses. 2011;5(1):350–53.
  • Sarsenbayeva G, Volgin Y, Kassenov M, Issagulov T, Bogdanov N, Nurpeissova A, Sagymbay A, Abitay R, Stukova M, Khairullin B, et al. A novel preservative-free seasonal influenza vaccine safety and immune response studying in the frame of preclinical research. J Med Virol. 2017;9999:1–6. doi:10.1002/jmv.24771.
  • Sarsenbayeva G, Volgin Y, Kassenov M, Issagulov T, Bogdanov N, Sansyzbay A, Abitay R, Nurpeisova A, Sagymbay A, Koshemetov Z, et al. Safety and immunogenicity of the novel seasonal preservative- and adjuvant-free influenza vaccine: blind, randomized, and placebo-controlled trial. J Med Virol. 2017;1–9. doi:10.1002/jmv.24922.
  • Sarsenbayeva G, Volgin Y, Kassenov M, Issagulov T, Bogdanov N, Sansyzbay A, Stukova M, Buzitskaya Z, Кulmagambetov I, Davlyatshin T, et al. Immunogenicity and safety of a novel seasonal influenza preservative-free vaccine manufactured in Kazakhstan: results of a randomized, comparative, phase II clinical trial in adults. Hum Vaccin Immunother. 2018;14:609–14. doi:10.1080/21645515.2017.1387345.
  • Committee for Medicinal Products for Human Use. Note for guidance on harmonisation of requirements for influenza vaccines. 1997 [accessed 2017 May 9]. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003945.pdf.
  • Thompson WW, Shay DK, Weintraub E, Brammer L, Cox N, Anderson LJ, Fukuda K. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA. 2003;289:179–86. PMID: 12517228. doi:10.1001/jama.289.2.179.
  • McElhaney JE, Zhou X, Talbot HK, Soethout E, Bleackley RC, Granville DJ, Pawelec G. The unmet need in the elderly: how immunosenescence, CMV infection, co-morbidities and frailty are a challenge for the development of more effective influenza vaccines. Vaccine. 2012;30:2060–67. PMID: 22289511. doi:10.1016/j.vaccine.2012.01.015.
  • Sambhara S, McElhaney JE. Immunosenescence and influenza vaccine efficacy. In Vaccines for Pandemic Influenza, RW Compans and WA Orenstein (eds). Curr Top Microbiol Immunol. 2009;333:413–29. doi:10.1007/978-3-540-92165-3_20.
  • Targonski PV, Jacobson RM, Poland GA. Immunosenescence: role and measurement in influenza vaccine response among the elderly. Vaccine. 2007;25:3066–69. PMID: 17275144. doi:10.1016/j.vaccine.2007.01.025;.
  • Wood JM, Newman RW, Ploss K. The use of correlates of immunity in European Union licensing of influenza vaccines. Dev Biol (Basel). 2003;115:9–16. PMID: 15088770.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.