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Human Vaccines & Immunotherapeutics Volume 14, 2018 - Issue 3: Special Issue on Influenza Vaccines, commemorating the 100th anniversary of Pandemic Flu
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Research Paper

Safety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a phase I randomized clinical trial in healthy Serbian adults

Goran StevanovicClinic for Infectious and Tropical Diseases, Clinical Centre of Serbia, Faculty of Medicine University of Belgrade, Belgrade, SerbiaCorrespondence[email protected]
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,
Lidija LavadinovicClinic for Infectious and Tropical Diseases, Clinical Centre of Serbia, Faculty of Medicine University of Belgrade, Belgrade, SerbiaView further author information
,
Svetlana Filipovic VignjevicDiagnostics and Research and Development, Institute of Virology, Vaccines and Sera “Torlak”, Belgrade, SerbiaView further author information
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Renée HoltCenter for Vaccine Innovation and Access, PATH, Seattle, WA, USAView further author information
,
Katarina IlicDiagnostics and Research and Development, Institute of Virology, Vaccines and Sera “Torlak”, Belgrade, SerbiaView further author information
,
Francesco Berlanda ScorzaCenter for Vaccine Innovation and Access, PATH, Seattle, WA, USAView further author information
,
Erin SparrowUniversal Health Coverage and Health Systems, The World Health Organization, Geneva, SwitzerlandView further author information
,
Vera StoiljkovicManaging Director of the Institute of Virology, Vaccines and Sera “Torlak”, Belgrade, SerbiaView further author information
,
Guido TorelliUniversal Health Coverage and Health Systems, The World Health Organization, Geneva, SwitzerlandView further author information
,
Tamra MadenwaldCenter for Vaccine Innovation and Access, PATH, Seattle, WA, USAView further author information
,
Muriel SocquetCenter for Vaccine Innovation and Access, PATH, Geneva, SwitzerlandView further author information
,
Aleksandra BaracClinic for Infectious and Tropical Diseases, Clinical Centre of Serbia, Faculty of Medicine University of Belgrade, Belgrade, SerbiaView further author information
,
Yordanka Ilieva-BorisovaComac Medical, Sofia, BulgariaView further author information
,
Mijomir PelemisClinic for Infectious and Tropical Diseases, Clinical Centre of Serbia, Faculty of Medicine University of Belgrade, Belgrade, SerbiaView further author information
&
Jorge FloresCenter for Vaccine Innovation and Access, PATH, Seattle, WA, USAView further author information
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Pages 579-586 | Received 26 Sep 2017, Accepted 03 Dec 2017, Published online: 23 Feb 2018

References

  • Lafond KE, Nair H, Rasooly MH, Valente F, Booy R, Rahman M, Kitsutani P, Yu H, Guzman G, Coulibaly D, et al. Global Role and Burden of Influenza in Pediatric Respiratory Hospitalizations, 1982–2012: A Systematic Analysis. PLoS Med. 2016;13(3):e1001977. https://doi.org/10.1371/journal.pmed.1001977. PMID:27011229.
  • Zhou H, Thompson WW, Viboud CG, Ringholz CM, Cheng PY, Steiner C, Abedi GR, Anderson LJ, Brammer L, Shay DK. Hospitalizations associated with influenza and respiratory syncytial virus in the United States, 1993–2008. Clin Infect Dis. 2012;54(10):1427-36. https://doi.org/10.1093/cid/cis211. PMID:22495079.
  • Dawood FS, Fiore A, Kamimoto L, Nowell M, Reingold A, Gershman K, Meek J, Hadler J, Arnold KE, Ryan P, et al. Influenza-associated pneumonia in children hospitalized with laboratory-confirmed influenza, 2003–2008. Pediatr Infect Dis J. 2010;29(7):585-90. https://doi.org/10.1097/INF.0b013e3181d411c5. PMID:20589966.
  • Nair H, Brooks WA, Katz M, Roca A, Berkley JA, Madhi SA, Simmerman JM, Gordon A, Sato M, Howie S, et al. Global burden of respiratory infections due to seasonal influenza in young children: a systematic review and meta-analysis. Lancet. 2011;378(9807):1917-30. https://doi.org/10.1016/S0140-6736(11)61051-9. PMID:22078723.
  • Factsheet about seasonal influenza, European Centre for Disease Prevention and Control. https://ecdc.europa.eu/en/seasonal-influenza/facts/factsheet (accessed 4 February 2018).
  • Paules C, Subbarao K. Influenza. Lancet. 2017;390(10095):697-708. https://doi.org/10.1016/S0140-6736(17)30129-0. PMID:28302313.
  • Vaccines against influenza WHO position paper – November 2012. Weekly Epidemiological Record. World Health Organization. 2013;87(47):461-76. http://www.who.int/wer/2012/wer8747.pdf. PMID:23210147.
  • Fineberg HV. Pandemic preparedness and response–lessons from the H1N1 influenza of 2009. N Engl J Med. 2014;370(14):1335-42. https://doi.org/10.1056/NEJMra1208802.
  • Friede M, Palkonyay L, Alfonso C, Pervikov Y, Torelli G, Wood D, Kieny MP. WHO initiative to increase global and equitable access to influenza vaccine in the event of a pandemic: supporting developing country production capacity through technology transfer. Vaccine. 2011;29(Suppl 1):A2-7. https://doi.org/10.1016/j.vaccine.2011.02.079. PMID:21684422.
  • Grohmann G, Francis DP, Sokhey J, Robertson J. Challenges and successes for the grantees and the Technical Advisory Group of WHO's influenza vaccine technology transfer initiative. Vaccine. 2016;34(45):5420-4. https://doi.org/10.1016/j.vaccine.2016.07.047. PMID:27506497.
  • Wahid R, Holt R, Hjorth R, Berlanda Scorza F. Chemistry, manufacturing and control (CMC) and clinical trial technical support for influenza vaccine manufacturers. Vaccine. 2016;34(45):5430-5. https://doi.org/10.1016/j.vaccine.2016.07.046. PMID:27484011.
  • WHO vaccine-preventable diseases: Monitoring system. 2017 global summary, selected for: Immunization schedule for 3 vaccines (Influenza, Influenza_Adult, Influenza_Pediatric). http://apps.who.int/immunization_monitoring/globalsummary/schedules (accessed 11 September 2017).
  • Unpublished studies. Immunogenicity (mice); Toxicity: single dose, repeated dose (rats); Local Tolerance (rabbits), 2014–2015, Institute of Virology, Vaccines and Sera “Torlak”, Belgrade, Serbia (data on file).
  • WHO influenza vaccines. http://www.who.int/influenza/vaccines/about/en/ (accessed 11 September 2017).
  • WHO FluNet. Influenza Laboratory Surveillance Information by the Global Influenza Surveillance and Response System (GISRS) http://gamapserver.who.int/gareports/Default.aspx?ReportNo=1 (accessed 15 May 2017).
  • Lee GM, Greene SK, Weintraub ES, Baggs J, Kulldorff M, Fireman BH, Baxter R, Jacobsen SJ, Irving S, Daley MF, et al. H1N1 and seasonal influenza vaccine safety in the vaccine safety datalink project. Am J Prev Med. 2011;41(2):121-8. https://doi.org/10.1016/j.amepre.2011.04.004. PMID:21767718.
  • Delore V, Salamand C, Marsh G, Arnoux S, Pepin S, Saliou P. Long-term clinical trial safety experience with the inactivated split influenza vaccine, Vaxigrip. Vaccine. 2006;24(10):1586-92. https://doi.org/10.1016/j.vaccine.2005.10.008. PMID:16271424.
  • European Medicines Agency: 21 July 2016 EMA/CHMP/VWP/457259/2014 Committee for Medicinal Products for Human Use. Guideline on Influenza Vaccines Non-clinical and Clinical Module. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2016/07/WC500211324.pdf (accessed 11 September 2017).
  • Anh DD, Thiem VD, Anh NTH, Huong VM, Nga NT, Thang TC, Thai DH, Chien VC, Holt R, Wahid R, et al. Randomized safety and immunogenicity trial of a seasonal trivalent inactivated split virion influenza vaccine (IVACFLU-S) in healthy young Vietnamese adults. Vaccine. 2016;34(45):5457-62. https://doi.org/10.1016/j.vaccine.2016.08.052. PMID:27567493.

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